Below are the list of deferred or rejected applications.
| S/N | Product name | Active ingredient(s) | Product class | Applicant name & address | Manufacturer name & address | Reason for Rejection/ Deferment |
|---|---|---|---|---|---|---|
| 1 | Clopidogrel 75mg | Clopidogrel | Anti-Platelets | Golden Gazelle Nigeria Ltd., Nzimako Clifford Chukwuma Nzimako | Mascot Health Series Pvt. Ltd. Plot No. 79,80, Sec-6A, IIE, Sidcul, Haridwar-249403, Uttarakhand, INDIA. | Incompletete CTD Dossier Submission |
| 2 | Azithromycin 500mg | Azithromycin | Antibiotics | Golden Gazelle Nigeria Ltd., Nzimako Clifford Chukwuma Nzimako | MASCOT HEALTH SERIES PRIVATE LIMITED HARIDWAR, UTTARAKHAND, INDIA | Incompletete CTD Dossier Submission |
| 3 | AMIKACINE INJECTION 500MG/2ML | Amikacine | Antibiotics | LADFIELD GLOBAL RESOURCES LTD, Pharm. Oyelade Rasheed OKWUDILI EZEIKPE | Anhui Chengshi Pharmaceutical Co., Ltd, No. 5068 Huaishang Road, Bengbu, Anhui P. R. China | Incompletete CTD Dossier Submission |
| 4 | Carvedilol 6.25mg | Carvedilol | Antihypertensives (Beta-blockers) | GOLDMOORE INTERNATIONAL LIMITED, Chuks Enoma Emmanuel Enoma | Ciron Drugs & Pharmaceuticals Pvt., PLOT No 30to37,43 to 45,CFC-B,Dewan UDYOG NAGAR,ALIYAL PLAGHAR DISTRICT THANE 401404 | Incompletete CTD Dossier Submission |
| 5 | Dorzolamide Hcl | Dorzolamide Hcl | Carbonic Anhydrase Inhibitor(Opthalmic) | AL-TINEZ PHARMACEUTICALS LTD , comfort Comfort Abba | Sion Healthcare, N0 19 Somnath Industrial Park,Kerala GIDC,Bavla, Ahmedabad – 382220,Gujarat- India | Incompletete CTD Dossier Submission |
| 6 | KETOTIFEN 0.025% | Ketotifen Fumarate | Antihistamine | FIDSON HEALTHCARE PLC, Nmaka I. TIJANI | KM 38, LAGOS-ABEOKUTA EXPRESSWAY, OTA, OGUN STATE. | Incompletete CTD Dossier Submission |
| 7 | KETOCONAZOLE 200MG | Ketoconazole | Antifungal | GIMBA PHARMACY LIMITED, ogechi LUCY HARRISONEZEBUO | Astamed Healthcare (I) Pvt. Ltd. PLOT B-2 & 3, PHASE 11, GENESIS IND. COMPLEX, KOLGAONA, PALGHAR, THANE,MAHARASHTRA STATE, INDIA. | Incompletete CTD Dossier Submission |
| 8 | Ceftriaxone for Injection | Ceftriaxone | Antibiotics | XCEL PHARMACEUTICAL LTD., Esther Odeyemi Esther Odeyemi | Swiss Pharma Pvt Ltd, 3709 phase – IV, VATVA G.I.D.C. KERALA (BAVLA), DIST. AHMEDABAD, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 9 | CLOMIPHENE CITRATE | CLOMIPHENE CITRATE | Selective Estrogen Receptor Modulator (SERM) | EUROMED LIMITED, Euromed Limited EBERE OTUDOH | Special Product’s Line S.p.A S.P.A, VIA FRATTA ROTONDA VADO LARGO, 1-03012 ANAGNI (FR), ITALY | Incompletete CTD Dossier Submission |
| 10 | Haematinic Syrup of Iron, Folic Acid, Vitamin B12 & Zinc Sulfate) | Haematinic Syrup of Iron, Folic Acid, Vitamin B12 & Zinc Sulfate) | Haematinic/Nutritonal supplement | DANMALIKI PHARMACEUTICAL COMPANY & GEN. ENT. LTD, NNAMDI EZEUKWU EZEUKWU EZEUKWU | Gopaldas Visram & Co. Ltd Plot No. A590/591, T.T.C. Ind. Area, M.I.D.C. Mahape, Navi Mumbai â 400710, INDIA | Incompletete CTD Dossier Submission |
| 11 | Artemether 20 & Lumentrantrine 120 Tablet | Artemether and Lumenfantrine | Antimalaria | Zat Pharmaceutical Product Ltd, Zat Pharmaceutical Ltd Ajokpaoghene Onaidhe | RKD Pharmaceutical LLP 414, Marathon Max, Mulund (West) Mumbai-80, India | Incompletete CTD Dossier Submission |
| 12 | Ketoconazole | Ketoconazole | Antifungal | LIFE VEST GLOBAL PHARMACY LIMITED, Gaminiwei Moses Bourdillon Moses Bourdillon | Wintech Pharmaceuticals Ltd Office No. 2 & 3, 3rd floor, Broadway Shopping Centre, Dr. Ambedkar Road, Dadar T.T. Mumbai- 400014, India. Tel: (+ 9122) 42123456 (100 lines). | Incompletete CTD Dossier Submission |
| 13 | Paracetamol | Paracetamol | Analgesic | Juhel Nigeria Limited, Samson Ezema Chukwuka Ezema | DO PHARMA SA , AVETA. BP: 10039 Lome-TOGO | Incompletete CTD Dossier Submission |
| 14 | Salbutamol Sulfate + Bromhexine Hydrochloride + Guaifenesin + Menthol Syrup | Salbutamol Sulfate | Beta-2 adrnegic agonist bronchodilator | Tripple Ace Pharmaceuticals Limited , Pharmacist Olusola Akande Tosin Lawal | Bhagwanpur, Roorkee, Distt. Haridwar, Uttarakhand, . | Incompletete CTD Dossier Submission |
| 15 | Ketamine injection | Ketamine Hydrochloride | Anesthethic | Ryla PHARMACY COMPANY LIMITED, Ryla Pharmacy Company Ltd ADEREMI ADELEKE | Farbe Firma Pvt. Ltd plot no 1508,gidc,city. ANKLESHWAR-393002 | Incompletete CTD Dossier Submission |
| 16 | Artemether 80 & Lumentrantrine 480 Tablet | Artemether and Lumenfantrine | Antimalaria | Zat Pharmaceutical Product Ltd, Zat Pharmaceutical Ltd Ajokpaoghene Onaidhe | R K D Pharmaceutical LLP 414, Marathon Max, Mulund (West) Mumbai-80, India | Incompletete CTD Dossier Submission |
| 17 | Tramadol Capsules BP 100 mg | Tramadol | Opiod-Analgesic | AFRICURE PHARMACEUTICALS LIMITED, Jaiprakash S. Pande KELECHI CHUKWU | Osaka Pharmaceuticals Pvt. Ltd Old National Highway. No. 8, Sankarda 391350 (Dist Vadodara) Gujarat, India | Incompletete CTD Dossier Submission |
| 18 | Amoxycillin & clavulanate poatssium 228MG/5ML | Amoxycillin & clavulanate poatssium | Antibiotics | GLOBEZZA INTERNATIONAL LIMITED, Globezza Intl Limited ADEREMI ADELEKE | GLOBEZZA BIOTECH, NO 4 & 6, OYINLOLA OLAJIDE STREET, BY PAB BUS STOP, COUNCIL IKOTUN ROASD, LAGOS .NIGERIA | Incompletete CTD Dossier Submission |
| 19 | AZITHROMYCIN TABLETS USP 500MG | Azithromycin | Antibiotics | GLOBEZZA INTERNATIONAL LIMITED, Globezza Intl Limited ADEREMI ADELEKE | GLOBEZZA BIOTECH, NO 4 & 6, OYINLOLA OLAJIDE STREET, BY PAB BUS STOP, COUNCIL IKOTUN ROASD, LAGOS .NIGERIA | Incompletete CTD Dossier Submission |
| 20 | Abiraterone Acetate USP | Abiraterone Acetate | Androgen Biosynthesis inhibitor | GLENMARK PHARMACEUTICALS NIGERIA LIMITED, Bourdillon Gaminiwei Moses Moses Bourdillon | Glenmark Pharmaceuticals Limited B/2, Mahalaxmi Chambers 22, Bhulabhai Desai Road Mumbai- 400 026, India | Incompletete CTD Dossier Submission |
| 21 | ARTESUNATE FOR INJECTION 120 MG | Artesunate | Antibiotics | ROVI PHARMACEUTICALS LTD, GODSWILL UGBOAJA C.G. CHUKWUMA UGBOAJA | Survey no. 416, At. Indrad, Ta. Kadi, Dist. Mehsana-382715, Gujarat (INDIA) | Incompletete CTD Dossier Submission |
| 22 | AZITHROMYCIN TABLETS USP 250MG | Azithromycin | Antibiotics | Asterra Pharmaceuticals Limited, Eucharia Nkechi Ejeh Nkechi Ejeh | Uniza Lifecare Private Limited, Sr. No. 919/7 (Old Survey no. 404), Kadi-Detroj Road, Balasar, Tal- Kadi, Dist- Mehsana- 382715, Gujrat, India. | Incompletete CTD Dossier Submission |
| 23 | DUTASTERIDE 0.5MG | Dutasteride | Benign Prostastic Hyperplasia(BPH) Agent | FAMATEX PHARMACEUTICALS LTD, RACHEL ADEWUNMI BELLO | Cyndea Pharma S.L., POLIGONO INDUSTRIAL EMILIANO REVILLA SANZ, AVENIDA DE AGREDA 31, OLVEGA 42110 SORIA, SPAIN. | Incompletete CTD Dossier Submission |
| 24 | ARTESUNATE FOR INJECTION 60 MG | Artesunate | Antibiotics | ROVI PHARMACEUTICALS LTD, GODSWILL UGBOAJA C.G. CHUKWUMA UGBOAJA | Ratnatris Pharmaceuticals Private Limited, Survey no. 416, At. Indrad, Ta. Kadi, Dist. Mehsana-382715, Gujarat, India | Incompletete CTD Dossier Submission |
| 25 | PREPENEM INJECTION | Meropenem | Antibiotics | Savante Healthcare Limited, Michael Eniola Ayenero | JW Pharmaceutical Corporation, 56 HANJIN I-GIL, SONGAK-EUP, DANGJIN-SI, CHUNGCHEONGNAM-DO, REPUBLIC OF SOUTH KOREA | Incompletete CTD Dossier Submission |
| 26 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP 1000/625MG | Amoxixillin and Clavulanate Potassium | Antibiotics | Fadob Pharmaceutical Nigeria Limited, Fadob Pharmaceuticals Janefrances Ikwuegbuenyi | Sparsh Bio-Tech Private Limited, Plot No. 1, Survey No. 242/243/244, Lakhabavad, Jamnagar – 361 006, India | Incompletete CTD Dossier Submission |
| 27 | AMLODIPINE | AMLODIPINE | Antihypertensives | NEMEL PHARMACEUTICALS LIMITED , NEMEL PHARMACEUTICALS LIMITED CHIOMA NWODO | Nemel Pharmaceutical Limited, PLOT 35 EMENE INDUSTRIAL LAYOUT | Incompletete CTD Dossier Submission |
| 28 | CEFTRIAXONE FOR INJECTION 1GM | Ceftriaxone | Antibiotics | GOLDEN HEALTHCARE LIMITED , Golden Healthcare limited BAMISAYE AKANDE | FINEBIOTICS PHARMA LIMITED. A-1401,MONDEAL HEIGHTS,NR WIDE ANGLE S.G. HIGHWAY,AHMEDABAD GUJARAT, INDIA. | Incompletete CTD Dossier Submission |
| 29 | Carvedilol 6.25mg | Carvedilol | Antihypertensive | GOLDMOORE INTERNATIONAL LIMITED, Chuks Enoma Emmanuel Enoma | Ciron Drugs & Pharmaceuticals Pvt. Ltd. Plot no 35 to 37,43 to 45,CFC B,Dew Udyog,Nagar Aliyali Plaghar Dist. Thane 401404,INDIA | Incompletete CTD Dossier Submission |
| 30 | Labetalol Injection | Labetalol Hydrochloride | Antihypertensive | Tripple Ace Pharmaceuticals Limited , Pharmacist Olusola Akande Tosin Lawal | Bhagwanpur, Roorkee, Uttarakhand, Haridwar India. | Incompletete CTD Dossier Submission |
| 31 | METHOCARBAMOL 400 MG AND PARACETAMOL 500 MG TABLETS | Methorcarbamol and | Muscle Relaxant/Analgesic Combination | ACCRETE PHARMACY LIMITED, OMORENUWA SOPHIA OAMEN SOPHIA OAMEN | Stallion Laboratories Pvt. Ltd, C-1B 305/2, 3, 4 & 5, G.I.D.C, Kerala (Bavla), Dist. Ahmedabad, Gujarat, India. | Incompletete CTD Dossier Submission |
| 32 | Artemether80mg & Lumefantrine | Artemether and Lumenfantrine | Antimalaria | PETSOW LABORATORIES LIMITED, CHINYERE ONYEABOR C ONYEABOR | Petsow Laboratories Limited, PLOT 8-10, EZIAMA INDUSTRIAL ESTATE, EZIAMA ABA, ABIA STATE, NIGERIA | Incompletete CTD Dossier Submission |
| 33 | LEVOFLOXACIN | LEVOFLOXACIN | Antibiotics | EMZOR PHARMACEUTICAL INDUSTRIES LIMITED, Chinelo Umeh Sylvia Umeh | Emzor Pharmaceutical Industries Ltd, Flowergate Mixed Development Scheme. Km 1 Sagamu/Benin Expressway,Sagamu.Ogun State. | Incompletete CTD Dossier Submission |
| 34 | Tramadol Capsules BP 100 mg | Tramadol Hydrochloride | Opiod-Analgesic | ALL BIO HEALTH CARE NIGERIA LTD, Mr.Lawal Mansur Mansur Mansur | Osaka Pharmaceuticals Pvt Ltd, Old National Highway. No. 8, Sankarda 391350 (Dist Vadodara) Gujarat, India | Incompletete CTD Dossier Submission |
| 35 | Cefuroxime Axetil | Cefuroxime | Antibiotics | Fadob Pharmaceutical Nigeria Limited, Fadob Pharmaceuticals Janefrances Ikwuegbuenyi | 2nd Floor, B/3, Safal Profitaire, Corporate Road, Prahlad Nagar, Ahmedabad-380 015, India. | Incompletete CTD Dossier Submission |
| 36 | Chlorpheniramine Maleate and Phenylephrine Hydrochloride Capsules | Chlorpheniramine Maleate and Phenylephrine Hydrochloride | Antihistamine | DOR GLORY PHARMACEUTICALS NIGERIA LIMITED, Mr Ilomuanya M EMMANUEL CHIJIOKE | Pell Tech Healthcare Pvt. Ltd, 202, Sonmur Apartment, Near Marve Road, S.V. Road, Malad (W), Mumbai â 400 064, INDIA. | Incompletete CTD Dossier Submission |
| 37 | Metformin BP 1000 mg | Metformin | Antidiabetic | NAFRO PHARMA NIGERIA LIMITED, Kayode GBENGA ONI | Lucent Biotech Ltd, Factory.; 165/3, Nalhera, Anantpur Puhana, Roorkee Dist: Haridwar -247667, Uttarakhand, India. | Incompletete CTD Dossier Submission |
| 38 | Pentazocine Injection BP 30 mg/ml | Pentazocine | Opiod-Analgesic | T.O.C. PHARMACEUTICALS NIGERIA LIMITED, Osita Nwajide Nwajide Nwajide | Old National Highway. No. 8, Sankarda 391350 (Dist Vadodara) Gujarat, India | Incompletete CTD Dossier Submission |
| 39 | ARTESUNATE | Artesunate | Antimalaria | UC-REBOK INVESTMENT LIMITED, Taiwo Preye Edotimi | Pharmax India Private Limited, 9,KURLA INDUSTRIAL ESTATE, NETAJI PALKAR ROAD, GHATKOPAR (WEST) MAHARASHTRA, MUMBAI-400086 | Incompletete CTD Dossier Submission |
| 40 | CIPROFLOXACIN USP 500 MG | Ciprofloxacin | Antibiotics | ACCRETE PHARMACY LIMITED, OMORENUWA SOPHIA OAMEN SOPHIA OAMEN | Sunrise Remedies Private Limited, 2244,AT & POST:- SANTEJ, TAL.- KALOL, DIST.: GANDHINAGAR. | Incompletete CTD Dossier Submission |
| 41 | Artemether & Lumefantrine | Artemether and Lumenfantrine | Antimalaria | PAMODI PHARMACEUTICAL LIMITED, Blessing Grace G GRACE | Astamed Healthcare (I) Pvt. Ltd, PLOT NO. 2 & 3, PHASE-II, GENESIS INDUSTRIAL COMPLEX, KOLGAON, PALGHAR, INDIA | Incompletete CTD Dossier Submission |
| 42 | Gastro-resistant Omeprazole Capsules BP 20mg | Omeprazole | Proton Pump Inhibitors (PPIs) | EMINENT DRUGS AND PHARMACEUTICAL LIMITED , Chike O. Oranebo | J-201, J-202/1, MIDC Tarapur, Boisar, Dist-Palghar 401 506, Maharashtra State, India | Incompletete CTD Dossier Submission |
| 43 | DESLORATADINE | Loratidine | Antihistamine | KENSINGTON INTERNATIONAL MARKETING COMPANY (NIGERIA) LTD., VICTORIA IMOUDU CHINELO IMOUDU | Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16 3450-232 Mortágua, PORTUGAL | Incompletete CTD Dossier Submission |
| 44 | Diazepam Injection BP | Diazepam | Benzodiazepines | DOR GLORY PHARMACEUTICALS NIGERIA LIMITED, Mr Ilomuanya M EMMANUEL CHIJIOKE | Address: Vllage-Rampur Jattan, Trilokpur Road Kala Amb Sirmour ( H.P ), 173030 | Incompletete CTD Dossier Submission |
| 45 | AMLODIPINE 10MG | Amlodipine | Antihypertensives | EMIE PHARMACEUTICALS (UK) LTD, Mehtab Hussain – Wanogho | Don Valley Pharmaceuticals, 31-Km, Main Ferozepur Road, Lahore, 54400, Pakistan | Incompletete CTD Dossier Submission |
| 46 | Tramadol Capsules Bp 100 mg | Tramadol | Opiod-Analgesic | T.O.C. PHARMACEUTICALS NIGERIA LIMITED, Osita Nwajide Nwajide Nwajide | Old National Highway. No. 8, Sankarda 391350 (Dist Vadodara) Gujarat, India | Incompletete CTD Dossier Submission |
| 47 | Benzhexol Tablets BP 5 mg | Trihexyphenidyl hydrochloride | Anticholinergics | PATBLESS PHARMACEUTICAL LTD, PATRICK ANYARAH ANYARAH | AR Lifesciences, 819/B Rakanpur Indl . area, Tal . Kalol , Dist . Gandhinagar , Gujarat, India | Incompletete CTD Dossier Submission |
| 48 | PENTAZOCINE INJECTION BP 30MG/ML | Pentazocine | Opiod-Analgesic | HONIX HEALTHCARE LIMITED, HONIX CHIJIOKE CHIJIOKE | NATIONAL HIGHWAY NO.8,, AT. & POST. SAKARDA,, TA. & DIST. VADODARA, INDIA | Incompletete CTD Dossier Submission |
| 49 | PENTAZOCINE INJECTION BP 30MG/ML | Pentazocine | Opiod-Analgesic | OLITHFEM PHARM LTD, OLITH OLIVER OLIVER | NATIONAL HIGHWAY NO.8,, AT. & POST. SAKARDA,, TA. & DIST. VADODARA, INDIA | Incompletete CTD Dossier Submission |
| 50 | Artemether & Lumefantrine | Artemether and Lumenfantrine | Antimalaria | AZMU PHARMACEUTICAL S LIMITED | Astamed Healthcare (India) Pvt. Ltd, PLOT NO. 2 & 3, PHASE-II, GENESIS INDUSTRIAL COMPLEX, KOLGAON, PALGHAR, INDIA | Incompletete CTD Dossier Submission |
| 51 | Vacomycin Hydrochloride | Vacomycin Hydrochloride | Antibiotics | PRECIOUS TRUST LIMITED, Marcelina Ngozi Victor Ngozi Victor | Bhagwanpur, Roorkee, Distt. Haridwar, Uttarakhand India. | Incompletete CTD Dossier Submission |
| 52 | IMATINIB CAPSULES 100 MG | Imatinib Mesilate | Antineoplastic | PHARMACY PLUS LTD, CHUKWUEMEKA OBI SHADRACK OBI | Admac Lifesciences Plot No. 107A & 107B,EPIP, Phase-1, Jharmajri, Baddi, Distt. Solan – 174103 (HP) | Incompletete CTD Dossier Submission |
| 53 | CEFUROXIME SODIUM FOR INJECTION USP 750MG | Cefuroxime | Antibiotics | GRIDPULSE PHARMACEUTICALS LTD, GRIDPULSE PHARMACEUTICAL LTD MUSA ALIYU | Kilitch Drugs (India) Limited, PLOT NO. C-301/2, M.I.D.C., T.T.C., INDUSTRIAL AREA, PEWANE, NAVI MUMBAI-400705, MAHARASHTRA , INDIA | Incompletete CTD Dossier Submission |
| 54 | LOPERAMIDE CAPSULE BP 2MG | Loperamide Hydrochloride | Antidiarrheal | ARMAN PHARMACEUTICAL CO., LTD, IFY Mercy Ohazulike | Ebco Private Limited, Plot No. 2 & 3. Phase II, Genesis Ind. Complex, Kolgaon. Dist. Thane, Tal. Palghar, 401404 Maharashtra State, hidia | Incompletete CTD Dossier Submission |
| 55 | Artemether and Lumefantrine | Artemether and Lumefantrine | Antimalaria | GEN-MED PHARMACEUTICAL LTD., Ogochukwu Mainasara Ogochukwu Mainasara | Amico Formulations LLP, L.S. No. 111/1, Near Samalaya Railway Station, Village-Vadadala, Taluka-Savli, Vadodara, Gujarat-391 520, India | Incompletete CTD Dossier Submission |
| 56 | RISPERIDONE | RISPERIDONE | Antipsychotics | PRECIOUS TRUST LIMITED, Marcelina Ngozi Victor Ngozi Victor | Swiss Pharma Pvt. Ltd, Plot No. – 3709, GIDC, Phase-IV, Vatva, Dist-Ahmedabad-382 445, Gujarat, Country: India. | Incompletete CTD Dossier Submission |
| 57 | DAPOXETINE 30MG | Dapoxetin Hydrochloride | Selective Serotonin Reuptake Inhibitors (SSRIs) | Steavic Pharmaceuticals Ltd, Chukwuka Agbenro Joseph Agbenro | Egniol Services Private Limited, 109-122, 1ST FLOOR,I SQUARE CORPORATE PARK, NEAR HIR PARTY PLOT, NEAR CIMS HOSPITAL, SCIENCE CITY, MAIN ROAD, SOLA, AHMEDABAD-380059, GUJARAT-INDIA. | Incompletete CTD Dossier Submission |
| 58 | BENZHEXOL HYDROCHLORIDE | Trihexyphenidyl hydrochloride | Anticholinergics | UC-REBOK INVESTMENT LIMITED, Taiwo Preye Edotimi | S-12, MIDC, TARAPUR BOISAR,DIST-PALGHAR, PIN-401506 INDIA. | Incompletete CTD Dossier Submission |
| 59 | Ciprofloxacin Tablets BP 500 mg | Ciprofloxacin | Antibiotics | LIFEVEST GLOBAL PHARMACEUTICAL LTD , Violet Onoba Kaine Onoba Kaine | Wintech Pharmaceuticals Ltd, Plot No. 45-46, STICE, Musalgaon, Sinnar, 422112 (Dist.-Nashik), Maharashtra, India | Incompletete CTD Dossier Submission |
| 60 | TRAMADOL BP 100MG | Tramadol Hydrochloride | Opiod-Analgesic | OLITHFEM PHARM LTD, OLITH OLIVER OLIVER | Osaka Pharmaceuticals Pvt. Ltd, Old National Highway. No. 8, Sankarda 391350 (Dist Vadodara) Gujarat, India | Incompletete CTD Dossier Submission |
| 61 | ARTEMETHER, LUMEFANTRINE | Artemether and Lumefantrine | Antimalaria | CHRIS MARK PHARMACEUTICAL LIMITED , CHRISMARK PHARMACEUTICAL LIMITED Suresh Mahajan | Halewood Laboratories Pvt. Ltd, Plot No. 319, Phase â II, G.I.D.C., Vatva, Ahmedabad â 382445, India | Incompletete CTD Dossier Submission |
| 62 | Artemether and Lumefantrine Tablets | Artemether and Lumefantrine | Antimalaria | UCHE ST Company Nig. Ltd, Ifeyinwa Mercy Ohazulike | Merits Organics LIMITED, Plot No 2104/2/A, G.I.D.C , Sarigam , Bhilad, Dist- Valsad-396155, Gujarat , INDIA | Incompletete CTD Dossier Submission |
| 63 | Artemether 80 mg and Lumefantrine 480 mg Tablets | Artemether and Lumefantrine | Antimalaria | PARTONE PHARMACEUTICALS LIMITED, PARTONE PHARMACEUTICAL LIMITED IFEANYI E | Lesanto Laboratories, Plot No. 9, 10, 11 & 20, Survey No. 53,Manor Road, Near Railway Bridge, Palghar (E), Thane-401404, Maharashtra, India | Incompletete CTD Dossier Submission |
| 64 | Ampicillin Sodium for Injection (1000mg & 500mg) | Ampicillin | Antibiotics | PEMASON PHARMACEUTICALS LTD, Pemason Pharmaceuticals Ltd – OGBANSIEGBE | Reyoung Pharmaceutical Co., Ltd, No.1, Ruiyang Road, Yiyuan County, Shandong Province, P.R. China | Incompletete CTD Dossier Submission |
| 65 | Rivaroxaban | Rivaroxaban | Anticoagulant | Swiss Pharma Nigeria Ltd, Emmanuel O Ogana | Pharlab Indústria Farmacêutica S.A, Rua OlÃmpio Rezende de Oliveira, 28-B Américo Silva, Lagoa da Prata – Minas Gerais, Brazil | Incompletete CTD Dossier Submission |
| 66 | Tramadol Hydrohloride BP 100mg | Tramadol Hydrochloride | Opiod-Analgesic | HONIX HEALTHCARE LIMITED, HONIX CHIJIOKE CHIJIOKE | Osaka Pharmaceuticals Pvt Ltd, Old National Highway. No. 8, Sankarda 391350 (Dist Vadodara) Gujarat, India | Incompletete CTD Dossier Submission |
| 67 | NEPAFENAC | Nepafenac | Non-Steroidal Anti-Inflammatory drugs (NSAIDs) | FANYVAL VISION LIMITED, Marcelina Ngozi Victor Ngozi Victor | Zee Laboratories Ltd, Behind 47, Indiatrial Area, Paonta Sahib – 173025 (India) | Incompletete CTD Dossier Submission |
| 68 | ACECLOFENAC AND PARACETAMOL TABLET | Aceclofenac and Paracetamol | Non-Steroidal Anti-Inflammatory drugs (NSAIDs) | JUCEE BIOCHEMICAL LIMITED, Efidi Bumiegha RUTH EFIDI | Flourish Pharma, FAC 24 E, GOA-IDC, Daman Ind. Estate, Sommnath, Dabhel, Daman. | Incompletete CTD Dossier Submission |
| 69 | METRONIDAZOLE | Metronidazole | Antibiotic/Antimicrobial | SOMSONIKE INTEGRATED COMPANY LTD., JUDE OKOYE AZUBUIKE OKOYE | Guizhou Tiandi Pharmaceutical Co., Ltd., NO. BAOKANG ROAD, HONG XING PHARMACEUTICAL INDUSTRIAL PARK, DINGXAIO TOWN , XINGYI CITY OIANXINAN BOUYEI AND MIAO AUTONOMOUS PREFECTURE, GUIZHOU PROVINCE, CHINA. | Incompletete CTD Dossier Submission |
| 70 | AMOXICILLIN TRIHYDRATE 500MG | Amoxicillin Trihydrate | Antibiotics | A.NWAEZE PHARM. CO., LTD, Oge LUCY HARRISONEZEBUO | Reyoung Pharmaceutical Co., Ltd, NO 1, YUIYANG ROAD, YIYUAN COUNTY, SHANDONG PROVINCE, P.R. CHINA. | Incompletete CTD Dossier Submission |
| 71 | Artemether and Lumefantrine | Artemether and Lumefantrine | Antimalaria | JAMIN INTERNATIONAL COMPANY LIMITED, BENJAMIN I ENEBELI | Maxheal Laboratories Pvt. Ltd, PLOT NO. – 2-7/80-85, SURSEZ, G.I.D.C SACHIN, SURAT GUJARAT- 394230. INDIA | Incompletete CTD Dossier Submission |
| 72 | Artemether80mg & Lumefantrine | Artemether and Lumefantrine | Antimalaria | PETSOW LABORATORIES LIMITED, CHINYERE ONYEABOR C ONYEABOR | Petsow Laboratories Limited, PLOT 8-10, EZIAMA INDUSTRIAL ESTATE, EZIAMA ABA, ABIA STATE, NIGERIA | Incompletete CTD Dossier Submission |
| 73 | ARTEMETHER 80MG AND LUMEFANTRINE 480MG | Artemether and Lumefantrine | Antimalaria | LYN-EDGE PHARMACEUTICALS LTD, Blessing Oge MOMAH | Fredun Pharmaceuticals Limited, PLOT NO. 14, 15, 16, ZORABIAN INDUSTRIAL, COMPLEX, VILLAGE VEVOOR, TAL, PALGHAR, PALGHAR 401404 MAHARASHTRA STATE, INDIA | Incompletete CTD Dossier Submission |
| 74 | Artemether & Lumefantrine | Artemether and Lumefantrine | Antimalaria | XCEL PHARMACEUTICAL LTD., Esther Odeyemi Esther Odeyemi | Stallion Laboratories Pvt., C-1B, 305/2, 3, 4& 5, G.I.D.C. Kerala (Bavla), Dist.: Ahmedabad, Gujarat, India. | Incompletete CTD Dossier Submission |
| 75 | Otilonium Bromide | Otilonium Bromide | Anticholinergic | PHILLIPS PHARMACEUTICALS (NIGERIA) LIMITED, SAMSON OMATTAH AMAECHI OMATTAH | A. Menarini Manufacturing Logistics and Services S.r.L. (AMMLS) Via Campo di Pile,67100 L’Aquila (AQ), Italy | Incompletete CTD Dossier Submission |
| 76 | Artemether Injection 80 mg/ml | Artemether | Antimalaria | REAVEMS GLOBAL NIGERIA LIMITED, REAVEMSGLOBAL IFEANYI I | Jawahar Nagar, Rohta Road, Meerut, UP, India | Incompletete CTD Dossier Submission |
| 77 | CIPROFL;OXACIN HYDROCHLORIDE USP 0.3w/v | Ciprofloxacin | Antibiotics | FIRST J POCCO PHARMACY LIMITED, Jude Okwudili Okoro | Scott-Edil Pharmacia Ltd, 56, EPIP JHARMAJRI, BADDI DIST SOLAN,HP INDIA | Incompletete CTD Dossier Submission |
| 78 | ARTESUNATE | Artesunate | Antimalaria | NAZA PHARMACY NIG. LTD, EGBETADE SUNDAY STEPHEN EGBETADE | PLOT NO. 73-77, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN 396210 | Incompletete CTD Dossier Submission |
| 79 | MECLIZINE HYDROCHLORIDE USP 25MG PYRIDXINE HYDROCHLORIDE BP 50MG | Meclizine Hydrochloride and Pyridixine Hydrochloride | Antiemetic and Vitamin B6 supplement | SHUGA GLOBAL INVESTMENT LIMITED , EBELE CALLYSTUS EBELE NWAFOR | Towa Pharma Private Limited, SURVEY NO.17 JALIYANAMATH VILLAGE DEHGAM RAKHIYAL ROAD, TA DEHGAM DIST GANDHINAGAR INDIA SURVEY NO.17 JALIYANAMATH VILLAGE DEHGAM RAKHIYAL ROAD, TA DEHGAM DIST GANDHINAGAR INDIA | Incompletete CTD Dossier Submission |
| 80 | CHLORAMPHENICOL | Chloramphenicol | Antibiotics | BAZREAL GLOBAL LIMITED, EGBETADE SUNDAY STEPHEN EGBETADE | Jiangxi Xierkangtai Pharmaceutical Co., Ltd, NORTH ZONE, HIGH NEW TECHNOLOGY INDUSTRIAL ZONE, PINGXIANG JIANGXI, CHINA | Incompletete CTD Dossier Submission |
| 81 | AMPICILLIN TRIHYDRATE 250MG, CLOXACILLIN SODIUM 250MG | Ampicillin and Cloxacillin Sodium | Antibiotics | KADARK PHARMACEUTICALS LIMITED, KADARK AKINTUNDE AKINOLA | Miraflash Nigeria Limited, 2-8 SUCCESS ESTATE ,OFF BRENTFIELD AVENUE OKE AFA OMOTEDO, MAGBORO, OGUN STATE | Incompletete CTD Dossier Submission |
| 82 | ARTEMETHER AND LUMEFANTRINE | Artemether and Lumefantrine | Antimalaria | Life Camp Pharmacy Ltd., Onah Linus Chinwero Linus Chinwero | Swiss Pharma Pvt. Ltd, Plot No. – 3709, GIDC, Phase-IV, Vatva, Dist-Ahmedabad-382 445, Gujarat, Country: India. | Incompletete CTD Dossier Submission |
| 83 | BENZHEZOL HYDROCHLORIDE 5MG | Trihexyphenidyl hydrochloride | Anticholinergics | CHRISNELB PHARMACEUTICAL NIG. LTD., Chris LUCY HARRISONEZEBUO | PLOT S-12, M.I.D.C. TARAPUR, BOISAR, DIST- THANE 401-506, MAHARASHTRA, INDIA. | Incompletete CTD Dossier Submission |
| 84 | LISINOPRIL 10MG TABLETS | Lisinopril | Antihypertensive | CHI PHARMACEUTICALS LTD, Juliet JULIET NWAFOR | Medopharm Remedies & Pharmaceuticals, 34-B, Industrial area, Malur â 563 160. Karnataka, India. | Incompletete CTD Dossier Submission |
| 85 | Tramadol Hcl 100mg | Tramadol Hydrochloride | Opiod-Analgesic | OSM pharmatical company ltd, O S M PHARMATICAL COMPANY LTD Ihezuo Ihezuo | Pharma Lord (Pvt.) Ltd, Ltd 12-km Lahore road, Layyah, Pakistan | Incompletete CTD Dossier Submission |
| 86 | Pregabalin Capsules | Pregabalin | Anticonvulsant | Dezubik Pharmacy Ltd, Chukwu-Ebuka Amadi O. Amadi Okocha | Globela Pharma Pvt. Ltd, 357-358, G. I. D. C., SACHIN, SURAT â 394 230, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 87 | CIPROFLOXACIN LACTATE | Ciprofloxacin | Antibiotic | SOMSONIKE INTEGRATED COMPANY LTD., JUDE OKOYE AZUBUIKE OKOYE | Guizhou Tiandi Pharmaceutical Co., Ltd, NO. BAOKANG ROAD, HONG XING PHARMACEUTICAL INDUSTRIAL PARK, DINGXAIO TOWN , XINGYI CITY OIANXINAN BOUYEI AND MIAO AUTONOMOUS PREFECTURE, GUIZHOU PROVINCE, CHINA. | Incompletete CTD Dossier Submission |
| 88 | TRAMADOL HYDROCHLORIDE BP | Tramadol Hydrochloride | Opiod-Analgesic | ANLEOSON PHARMACEUTICAL LTD, JUDE OKOYE AZUBUIKE OKOYE | Merit Organics Ltd, 2104/2/A, G.I.D.C ,SARIGAM BHILAD – 396 155, GUJARAT | Incompletete CTD Dossier Submission |
| 89 | Lansoprazole, Clarithromycin and Tinidazole | Lansoprazole, Clarithromycin and Tinidazole | Proton Pump Inhibitor, Macrolide Antibiotic and Antimicrobial | BOCHEPHARM NIGERIA LIMITED, BOCHE PHARM NIG. LTD C EZENWE | Coral Laboratories Ltd, PLOT NO 57/1 (16) BHENSLORE, DUNETHA, NANI DAMAN 396 210, INDIA | Incompletete CTD Dossier Submission |
| 90 | Dorzolamide Hydrochloride + Timolol Maleate | Dorzolamide Hydrochloride + Timolol Maleate | Carbonic Anhydrase Inhibitor and Beta-Blocker | HESSPHARM LIMITED, Violet Onoba Kaine onoba Kaine | Hetero Drugs Limited, Nos. 213, 214 and 255, Bonthapally Village, Jinnaram Mandal, Medak District, Andhra Pradesh. | Incompletete CTD Dossier Submission |
| 91 | Citric Acid Monohydrate | Citric Acid Monohydrate | Organic acid | CEEMIKE PHARMACEUTICAL CO. LTD., Sunday Eloke Ebinum Eloke Ebinum | Bell, Sons & Co. (Druggists) Ltd, Gifford House, Slaidburn Crescent, Southport, Merseyside PR9 9AL, U.K. | Incompletete CTD Dossier Submission |
| 92 | Amoxycillin & clavulanate poatssium tablet USP | Amoxycillin & clavulanate poatssium | Antibiotics | GLOBEZZA INTERNATIONAL LIMITED, Globezza Intl Limited ADEREMI ADELEKE | Globezza Biotech, NO 4 & 6, OYINLOLA OLAJIDE STREET, BY PAB BUS STOP, COUNCIL IKOTUN ROASD, LAGOS .NIGERIA | Incompletete CTD Dossier Submission |
| 93 | Omeprazole | Omeprazole | Proton Pump Inhibitors(PPIs) | CUBAT PHARMACEUTICALS LIMITED , Ubatu Chinwe Catherine Catherine Ubatu | Youcare Pharmaceutical Group, No. 6 Hongda Middle Road, Beijing, Economic & Technological | Incompletete CTD Dossier Submission |
| 94 | Artemether 80 mg & Lumefantrine 480 mgTablets | Artemether and Lumefantrine | Antimalaria | Evaron Pharmaceuticals Limited, Evaron Obianuju Nwosu | Asoj Soft Caps Pvt. Ltd, Asoj, Baroda â Halol Highway, Dist. Baroda â 391 510. Gujarat. | Incompletete CTD Dossier Submission |
| 95 | Artemether & Lumefantrine | Artemether & Lumefantrine | Antimalaria | OSM pharmatical company ltd, O S M PHARMATICAL COMPANY LTD Ihezuo Ihezuo | Pharma Lord (Pvt.) Ltd, 12km, Lahore Road, Layyah. Punjab-Pakistan. | Incompletete CTD Dossier Submission |
| 96 | CIPROFLOXACIN HCL 500mg Tablets | Ciprofloxacin | Antibiotics | MUPIX PHARMACEUTICALS LIMITED , Ihionu Michael Uchechukwu Ihionu | Globela Pharma Pvt. Ltd, PLOT NO 357 & 358,Road NO 3 Sachin GIDC,Surat-394230 Gujarat India | Incompletete CTD Dossier Submission |
| 97 | LOPERAMIDE HYDROCHLORIDE 2MG | Loperamide Hydrochloride | Antidiarrheal | CHRISNELB PHARMACEUTICAL NIG. LTD., Chris LUCY HARRISONEZEBUO | McCoy Pharma Pvt. Ltd, PLOT S-12, M.I.D.C. TARAPUR, BOISAR, DIST- THANE 401-506, MAHARASHTRA, INDIA. | Incompletete CTD Dossier Submission |
| 98 | LIPOSOMAL AMPHOTERICIN B INJECTION LYOPHILIZED 50mg | Amphotericin B | Antifungal | CHANRAI HEALTH CARE LTD, Ejiro Augustina Ogunleye | Bharat Serums and Vaccines Limited (BSV), PLOT NO. 27, ADDITIONAL M.I.D.C AMBERNATH (E) -421501 India | Incompletete CTD Dossier Submission |
| 99 | Benzylpenicillin sodium for Injection 1mega | Benzylpenicillin Sodium | Antibiotics | PEMASON PHARMACEUTICALS LTD, Pemason Pharmaceuticals Ltd – OGBANSIEGBE | Reyoung Pharmaceutical Co., Ltd, No.1, Ruiyang Road, Yiyuan County, Shandong Province, P.R. China | Incompletete CTD Dossier Submission |
| 100 | Cabazitaxel Injection 60mg/1.5 ml (40 mg/ml) and Diluent for Cabazitaxel Injection. | Cabazitaxel | Antineoplastics | ANTHILL INVESTMENT LIMITED, LEKAN ASA OLUWASEGUN JEMISEYE | MSN Laboratories Private Limited, âMSN Houseâ, Plot No.: C-24, Industrial Estate, Sanathnagar, Hyderabad-500 018, India. Phone: + 91- 40 – 30438600 / 615. | Incompletete CTD Dossier Submission |
| 101 | α-β ARTEETHER | α-β Arteether | Antimalaria | Medicrown Nigeria Limited pharmaceuticals, Emeka Ikeogu C Ikeogu | Kamla Lifesciences Limited, G- 84/1, Tarapur, M.I.D.C., Boisar, District- Palghar- 401506 | Incompletete CTD Dossier Submission |
| 102 | Terbinafine Hydrochloride BP eq. to Terbinafine 250 mg | Terbinafine Hydrochloride | Antifungal | ANYITEX PHARMACEUTICAL LIMITED, IFEANYI AGHA OKUNLOLA OKUNLOLA | Atoz Pharmaceuticals Private Limited, 702, Mauryansh Elanza, Nr. Shyamal Cross Road, Satellite, Ahmedabad-380 051, Gujarat, India. | Incompletete CTD Dossier Submission |
| 103 | Empagliflozin | Empagliflozin | Antidiabetic | Provamati Healthcare Company Limited , Jide Adebisi – OLUGBENGA | Don Valley Pharmaceuticals (Pvt) Limited, 31-Km, Main Ferozepur Road, Lahore, Pakistan. | Incompletete CTD Dossier Submission |
| 104 | ESOMEPRAZOLE AND DOMPERIDONE | Esomeprazole and Domperidone | Proton Pump Inhibitor(PPIs) and Prokinetic | RESTORE HEALTHCARE LIMITED, REGINALD IKECHUKWU IKECHUKWU OGUAMANAM | Stallion Laboratories Pvt. Ltd, C-1B, 305/2, 3, 4&5, G.I.D.C. KERALA (BAVLA), DIST.: AHMEDABAD, GUJARAT, INDIA. | Incompletete CTD Dossier Submission |
| 105 | AMOXICILLIN AND CLAVULANATE | Amoxicillin and Clavulanic Potassium | Antibiotics | VETHY PHARMACEUTICAL AND ALLIED VENTURES LTD, Violet Onoba Kaine onoba Kaine | Swiss Pharma Pvt. Ltd, 3709, G.I.D.C. Phase IV, Vatva, Ahmedabad â382445, India | Incompletete CTD Dossier Submission |
| 106 | OMEPRAZOLE 20MG | Omeprazole | Proton Pump Inhibitors(PPIs) | MASRICH PHARMACEUTICAL AND ALLIED VENTURES LTD, Violet Onoba Kaine Onoba Kaine | Swiss Pharma Pvt. Ltd, 3709, G.I.D.C. Phase IV, Vatva, Ahmedabad â382445, India | Incompletete CTD Dossier Submission |
| 107 | EPHEDRINE SULFATE INJECTION USP 50 mg/ml | Ephedrine Sulfate | Alpha- and Beta-Adrenergic Agonist | PRAIPEC PHARMACEUTICAL LIMITED, Violet Onoba Kaine Onoba Kaine | Merit Organics Ltd Plot No 2104/2/A , G.I.D>C , Sarigam , Bhilad, Dist Valsad-396155 Gujarat INDIA | Incompletete CTD Dossier Submission |
| 108 | ARTESUNATE AMODIAQUINE BILAYER TABLETS 25 mg/67.5 mg, 50 mg/ 135 mg & 100 mg/270 mg | Artesunate and Amodiaquine | Antimalaria | MICRONOVA PHARM IND LTD , Pharm. Solomon Ogbuefi EBELE OGBUEFI | Micro Labs Limited, Plot No. S-155 to S-159 & N1, Phase â III & Phase IV, Verna Industrial Estate, Verna, Goa â 403722, India. | Incompletete CTD Dossier Submission |
| 109 | CEFTRIAXONE AND SULTACTAM FOR INJECTION 1.5GM | Ceftriaxone Sodium and Sulbactam Sodium | Antibiotics | Malven medics international company limited , malven medics international company limited BAMISAYE AKANDE | SWISS PARENTERAL LIMITED ( UNIT-11), PLOT NO. 402,412-414 KERALA INDUSTRIAL ESTATE, GIDC, NEAR BAULA DIST.AHMEDABAD- 382220 GUJARAT STATE, INDIA | Incompletete CTD Dossier Submission |
| 110 | Paracetamol and Diclofenac Tablet | Paracetamol and Diclofenac | Non-Steroidal Anti-Inflammatory drugs (NSAIDs) | CHRIS MARK PHARMACEUTICAL LIMITED , CHRISMARK PHARMACEUTICAL LIMITED Suresh Mahajan | Halewood Laboratories Pvt. Ltd, sPlot No. 319, Phase â II, G.I.D.C., Vatva, Ahmedabad â 382445, India | Incompletete CTD Dossier Submission |
| 111 | CO-AMOXICLAV 625MG | Amoxicillin and Clavulanic Potassium | Antibiotics | VITAFORTIS HEALTHCARE LIMITED, Mr Osinowo Adefemi Adebisi ADEFEMI ADEBISI | Aaltop Healthcare Pvt. Ltd, 402, B-WING, M. K. PLAZA, NEAR HYPERCITY MALL GHODBUNDER ROAD, THANE (WEST)-400607, MAHARASHTRA, INDIA | Incompletete CTD Dossier Submission |
| 112 | PIROXICAM 20MG | Piroxicam | Analgesic | VELLOUSLIFE PHARMACEUTICAL LIMITED, OGECHUKWU LUCY OHAZULIKE LUCY HARRISONEZEBUO | Liaoning Huarui Union Pharmaceutical Co., Ltd, YUANQU ROAD NO 1, TONGYUANPU ECONOMIC DEVELOPMENT ZONE DANDONG CITY, LIAONING PROVINCE, CHINA. | Incompletete CTD Dossier Submission |
| 113 | Rosuvastatin 20mg Tablet | Rosuvastatin | HMG-CoA reductase inhibitor | LADFIELD GLOBAL RESOURCES LTD, Pharm. Oyelade Rasheed OKWUDILI EZEIKPE | Globela Pharma Pvt. Ltd, 357-358, G.I.D.C, Sachin, Surat-394 Gujarat, India | Incompletete CTD Dossier Submission |
| 114 | TRAMADOL HYDROCHLORIDE 100MG | Tramadol Hydrochloride | Opiod-Analgesic | FIRST J POCCO PHARMACY LIMITED, Jude Okwudili Okoro | Alembic Pharmaceuticals Limited, PLOT NO 21-22 E.P.I.P. PHASE 1, JHARMAJRI, BADDI, DIST SOLAN 173 205, (H.P) INDIA | Incompletete CTD Dossier Submission |
| 115 | Clarithromycin Tablets BP 500 mg | Clarithromycin | Antibiotics | LIFEVEST GLOBAL PHARMACEUTICAL LTD , Violet Onoba Kaine Onoba Kaine | Wintech Pharmaceuticals Ltd, Plot No. 45-46, STICE, Musalgaon, Sinnar, 422112 (Dist.-Nashik), Maharashtra, India | Incompletete CTD Dossier Submission |
| 116 | Pyrimethamine+Sulphadoxine | Pyrimethamine+Sulphadoxine | Antimalaria | NEW HEALTHWAY COMPANY LIMITED, ASOGWA UCHE MARK ASOGWA | ew Healthway Company Limited, Km 22 Lagos â Badagry Exp. Way Ajangbadi Lagos | Incompletete CTD Dossier Submission |
| 117 | AMOXILLIN 500MG AND POTASSIUM CLAVULANATE TABLETS 500MG | Amoxixillin and Clavulanate Potassium | Antibiotics | Greenfield Pharmaceutical Limited, Temitope Maydon Wulemot Omosekeji | Maxheal Pharmaceuticals (India) Ltd, 95/6, MIDC, SATPUR, NASHIK-422 007, MAHARASHTRA, INDIA | Incompletete CTD Dossier Submission |
| 118 | Rosuvastatin (as rosuvastatin calcium) + Ezetimibe | Rosuvastatin and Ezetimibe | HMG-CoA Reductase Inhibitor | SANOFI AVENTIS NIGERIA LIMITED, Zainab Adelabu Anuoluwapo Adelabu | Sanofi Ä°laç Sanayi ve Ticaret A.Å, Sanofi Ilac Sanayi ve Ticaret Anonim Sirketi KüçükkarıÅtıran, Mahallesi Merkez Sok. No: 223/A 39780 BüyükkarıÅtıran Lüleburgaz Kırklareli Turkey | Incompletete CTD Dossier Submission |
| 119 | METRONIDAZOLE INJECTION | Metronidazole | Antibiotics | COSSYVET PHARMACEUTICALS LIMITED, Nkechi V EHIGIATOR | Hebei Tiancheng Pharmaceutical Co., Ltd, NO. 18 JINGUANG STREET, ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, CANGZHOU HEIBEI CHINA | Incompletete CTD Dossier Submission |
| 120 | HYPROMELLOSE | Hydroxypropyl Methylcellulose | Hydrophilic Polymer | AL-TINEZ PHARMACEUTICALS LTD , comfort Comfort Abba | Sion Healthcare (SHL) Limited, N0 19 Somnath Industrial Park,Kerala GIDC,Bavla, Ahmedabad – 382220,Gujarat- India | Incompletete CTD Dossier Submission |
| 121 | BENDROFLUMETHIAZIDE B.P 2.5mg | Bendrofluazide | Antihypertensive | SHUGA GLOBAL INVESTMENT LIMITED , EBELE CALLYSTUS EBELE NWAFOR | Towa Pharma Private Limited, SURVEY NO 17, JALIYANAMATH VILLAGE DEGGAM RAKHIYAL ROAD, TA DEHGAM DIST GANDHINAGAR INDIA | Incompletete CTD Dossier Submission |
| 122 | TRAMADOL HYDROCHLORIDE INJECTION 100MG/2ML | Tramadol Hydrochloride | Opiod-Analgesic | GLOBAL HEALTHCARE LIMITED, kazeem omololu GBADE OMOLOLU | Bharat Parenterals Limited, VILLAGE; HARIPURA, TA. SAVLI, DIST., VADODARA-391520 GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 123 | Ceftriaxone Sodium | Ceftriaxone | Antibiotics | NAXOS HEALTHCARE LTD, Adesanya Oluwaseun Oriyomi Adesanya | Venus Remedies Limited, Hill Top Industrial Estate, Jharmajri, EPIP Phase-I (Extn), Bhatoli Kalan, Baddi, Distt, Solan, Himachal Pradesh,173205,lndia | Incompletete CTD Dossier Submission |
| 124 | CIPROFLOXACIN HYDROCHLORIDE | Ciprofloxacin | Antibiotics | COSSYVET PHARMACEUTICALS LIMITED, Nkechi V EHIGIATOR | Hebei Tiancheng Pharmaceutical Co., Ltd, 18 JINGUANG STREET ECONOMIC AND TECHNOLOGICAL ZONE CANGZHOU HEIBEI CHINA | Incompletete CTD Dossier Submission |
| 125 | Sitagliptin 100and Metformin 1000 Hydrochloride Tablets | Sitagliptin and Metformin Hydrochloride | Antidiabetic | Global oneword healthcare limited , Global Oneword Healthcare Ltd O Okafor | Signature Phytochemical Industries, Plot No. 112 MI, Selaqui Industrial Estate, Selaqui, Dehradun, Uttarakhand-248 197. | Incompletete CTD Dossier Submission |
| 126 | DICLOFENAC SODIUM BP | Diclofenac Sodium | Analgesic | Phillmichael & Ashertoria pharmaceutical limited , Phill Michael O Okafor | HAB Pharmaceuticals & Research Ltd, 10, Pharmacity, Selaqui, Dehradun, Uttarakhand – 248011, India | Incompletete CTD Dossier Submission |
| 127 | ENOXAPARIN SODIUM 60MG/0.6ML | Enoxaparin Sodium | Anticoagulant | TRIDEM PHARMA NIG LTD, AKINYELE SAMUEL AKINYELE | Gland Pharma Limited, No; 143 to 148, 150 &151, NEAR GANDI MAISAMMA X ROAD, D.P PALLY, DUNDIGAL POST, DUNDIGAL GANDIMAISAMMA MANDAL, MELCHAL-MALKAJGIRI DISTRICT, HYDERABAD, 500 043, TELANGANA, INDIA. | Incompletete CTD Dossier Submission |
| 128 | Telmisartan 80mg/Hydrochlorothiazide 12.5mg Caplet | Telmisartan and Hydrochlorothiazide | Antihypertensive | Phamatex Industries Limited, Innocent Nduka Ifeanyichukwu Nduka | Phamatex Industries Limited, Marble House, No. 1, Crystal Glass Close, Amuwo-Odofin Industrial Estate, Lagos, Nigeria | Incompletete CTD Dossier Submission |
| 129 | ROSUVASTATIN 20mg | Rosuvastatin | HMG-CoA reductase inhibitor | CLARION MEDICALS LIMITED, CHINENYE IGWEGBE A. IGWEGBE | The Madras Pharmaceuticals , NO 137-B OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI -600 096, TAMILNADU, INDIA | Incompletete CTD Dossier Submission |
| 130 | α-β Arteether | α-β Arteether | Antimalaria | MEDICART PHARMACEUTICALS LIMITED, OJEJE AMIN ONIMISI AMIN OJEJE | Swiss Parenterals Limited, PLOT NO.: 402, 412-414, KERALA INDUSTRIAL ESTATE, G.I.D.C., Nr BAVLA, DIST.: AHMEDABAD-382 220, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 131 | DICLOFENAC POTASSIUM 50MG | Diclofenac Potassium | Analgesic | CUREALL IMPEX NIGERIA LIMITED, nafropharma@gmail.com GBENGA ONI | AR Lifesciences, 819/b, Rakanpur Indl. Area, Tal. Kalol, Dist. Gandhinagar, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 132 | Prochlorperazine Maleate | Prochlorperazine Maleate | Antiemetic/Antipsychotics | MAZHAR BROTHERS NIGERIA LIMITED, QC Manager Zeeshan Qamar | Rock Pharmaceutical Laboratories (Pvt) Ltd, 134-B, 135-B, Nowshera Industrial Estate, Risalpur, KPK, Pakistan | Incompletete CTD Dossier Submission |
| 133 | DICLOFENAC SODIUM BP 75MG AND MISOPROSTOL 200MCG | Diclofenac Sodium and Misoprostol | Non-Steroidal Anti-Inflammatory drugs (NSAIDs) and Prostaglandin Analogue | RESTORE HEALTHCARE LIMITED, REGINALD IKECHUKWU IKECHUKWU OGUAMANAM | C/8 SADAR ESTATE AJWA ROAD, VADODARA , 390019 HUJARAT INDIA | Incompletete CTD Dossier Submission |
| 134 | PREGABALIN BP 75MG | Pregabalin | Anticonvulsant | DIGITALL HEALTHCARE LIMITED, MR.STEPHEN U EKWEALOR STEPHEN EKWEALOR | Lark Laboratories (India) Ltd, SP-1192 E, RIICO INDUSTRIAL AREA, PHASE IV, BHIWADI 301019 DIST ALWAR INDIA, SP-1192 E, RIICO INDUSTRIAL AREA, PHASE IV, BHIWADI 301019 DIST ALWAR INDIA | Incompletete CTD Dossier Submission |
| 135 | METFORMIN TABLETS BP 500MG | Metformin | Antidiabetic | SOCIETY FOR FAMILY HEALTH, Olabisi Abimbola Oyindamola Olabisi | Centurion Laboratories Pvt. Ltd, Plot No. G/5 & G/6 B.I.D.C. Gorwa, Dist. Vadodara-390016, Gujarat, India | Incompletete CTD Dossier Submission |
| 136 | TADALAFIL USP | Tadalafil | Phosphodiesterase type 5 (PDE5) inhibitors | Richygold International Limited, Amobi Ijeoma l Vivian Amobi | Richygold International Limited, 103C AMUWO ODOFIN INDUSTRIAL SCHEME OFF OSHODI APAPA EXPRESS WAY SANYA LAGOS | Incompletete CTD Dossier Submission |
| 137 | DICLOFENAC POTASSIUM TABLET 50MG | Diclofenac Potassium | Analgesic | A.A DAN MALAM PHARMACEUTICAL NIG. LTD, DANMALAM ADEWALE TEMITOPE | Amoli Organics Pvt. Ltd, 407, DALAMAL HOUSE, JAMNALAL BAJAJ ROAD, NARIMAN POINT, MUMBAI -400 021, INDIA | Incompletete CTD Dossier Submission |
| 138 | LOPERAMIDE HYDROCHLORIDE TABLETS USP 2 mg | Loperamide Hydrochloride | Antidiarrheal | PATBLESS PHARMACEUTICAL LTD, PATRICK ANYARAH ANYARAH | AR Lifesciences, 819/B Rakanpur Indl . area, Tal . Kalol , Dist . Gandhinagar , Gujarat, India | Incompletete CTD Dossier Submission |
| 139 | GABAPENTIN CAPSULES USP | Gabapentin | Anticonvulsant | Global oneword healthcare limited , Global Oneword Healthcare Ltd O Okafor | HAB Pharmaceuticals & Research Ltd, 10, Pharmacity, Selaqui, Dehradun, Uttarakhand – 248011, India | Incompletete CTD Dossier Submission |
| 140 | Meropenem | Meropenem Trihydrate | Antibiotics | Excel charis pharmaceutical chemical ltd, EXCEL CHARIS O Okafor | Swiss Parenterals Ltd, 62, 6th Floor, Titanium, Corporate Road, Prahladnagar, Ahmedabad â 380 015 Gujarat, (INDIA) | Incompletete CTD Dossier Submission |
| 141 | GLYCERIN 0.75G | Glycerol | Laxative | CEEMIKE PHARMACEUTICAL CO. LTD., Sunday Eloke Ebinum Eloke Ebinum | Bell, Sons & Co. (Druggists) Ltd, Gifford House, Slaidburn Crescent, Southport, Merseyside PR9 9AL, U.K. | Incompletete CTD Dossier Submission |
| 142 | BENZHEXOL HYDROCHLORIDE BP 5MG | Benzhexol Hydrochloride | Anticholinergic | YELLOW PHARMACEUTICALS COMPANY LIMITED, ESTHER OLUBUNMI KOLAWOLE | Eurolife Healthcare Pvt. Ltd, KHASRA NO.242, BHAGWANPUR, ROORKEE, DISRR.HARIDWAR, UTTARAKHAND, INDIA. | Incompletete CTD Dossier Submission |
| 143 | CIPROFLOXACIN 500MG | Ciprofloxacin | Antibiotics | MASRICH PHARMACEUTICAL AND ALLIED VENTURES LTD, Violet Onoba Kaine Onoba Kaine | Swiss Pharma Pvt. Ltd, 3709, G.I.D.C. Phase IV, Vatva, Ahmedabad â382445, India | Incompletete CTD Dossier Submission |
| 144 | LEVOFLOXACIN USP 500MG | Levofloxacin | Antibiotics | VETHY PHARMACEUTICAL AND ALLIED VENTURES LTD, Violet Onoba Kaine onoba Kaine | Swiss Pharma Pvt. Ltd, s3709, G.I.D.C. Phase IV, Vatva, Ahmedabad â382445, India | Incompletete CTD Dossier Submission |
| 145 | Azithromycin Tablets USP 500mg | Azithromycin | Antibiotics | JMD Pharmalinks Ltd, Flora Godsdelight Onwuka | Encore Healthcare Private Limited, D-5, MIDC Industrial Area, Paithan – 431148, Dist. Aurangabad, India. | Incompletete CTD Dossier Submission |
| 146 | Alendronic acid 70mg; Cholecalciferol 5600IU tablets | Alendronic acid and Cholecalciferol | Bisphosphonate and Vitamin D analog | MEGA LIFESCIENCES NIG. LTD TITILAYO OGIERIAKHI | Pharmathen International S.A, Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece | Incompletete CTD Dossier Submission |
| 147 | LISINOPRIL TABLETS 10 MG | Lisinopril | Antihypertensives | Phillmichael & Ashertoria pharmaceutical limited , Phill Michael O Okafor | HAB Pharmaceuticals & Research Ltd, 10, Pharmacity, Selaqui, Dehradun, Uttarakhand – 248011, India | Incompletete CTD Dossier Submission |
| 148 | Empagliflozin and Metformin Hydrochloride | Empagliflozin and Metformin Hydrochloride | Antidiabetic | Worldwide Commercial Ventures Ltd (WWCVL), Worldwide Commercial Ventures Limited Uzu Ubokor | Cipla Ltd, Unit III Plot No. L-139 to L-146 Verna Industrial Estate, Verna, Salcette, Goa â 403 722. India. | Incompletete CTD Dossier Submission |
| 149 | ARTEMETHER AND LUMEFANTRINE | Artemether and Lumefantrine | Antimalaria | VELLOUSLIFE PHARMACEUTICAL LIMITED, OGECHUKWU LUCY OHAZULIKE LUCY HARRISONEZEBUO | YUANQU ROAD NO 1, TONGYUANPU ECONOMIC DEVELOPMENT ZONE DANDONG CITY, LIAONING PROVINCE, CHINA. | Incompletete CTD Dossier Submission |
| 159 | Thiamine Hydrochloride BP 10mg; Riboflavin Sod. Phosphate Eq. To Riboflavin 0.5 mg; Pyridoxine Hydrochloride BP 1mg; Nicotinamide BP 10mg | Thiamine Hydrochloride, Riboflavin Sodium Phosphate, Pyridoxine Hydrochloride, Nicotinamide | Water-soluble vitamins / Nutrients | MARK PHARMACEUTICAL LTD, MARK PHARMACEUTICALS LTD. NKECHI CHIME | Nichepharm Lifesciences Private Limited, KHASRA NO1/1/4/1, MAUZA CENTRAL HOPE TOWN, PARGANA, PACHCHWADOON TEHSIL VIKAS NAGAR, DEHRADUN, UTTARAKHAND, 248197 INDIA | Incompletete CTD Dossier Submission |
| 151 | Atracurium Besylate Injection USP 50mg/5mL | Atracurium Besylate | Non-Depolarizing Neuromuscular Blocking Agents | L’PACEMAKER PHARMACEUTICALS LIMITED, LPACEMAKER PHARM GBOLAHAN YUSUF | Celon Laboratories Pvt. Ltd, Plot No.3, ALEAP Industrial Estate, Gajularamaram (V), Quthbullapur (M), Medchal â Malkajgiri (dist.), Telangana, India | Incompletete CTD Dossier Submission |
| 152 | Diclofenac Potassium BP | Diclofenac Potassium | Analgesic | ROEYZN PHARMACEUTICAL LIMITED , Roeyzn pharmaceutical K ANSARI | Kesar Pharma Limited, Plot Survey No.50-P/2, At Village, Bileshwarpura, Po Chhatral-382729. Tal.Kalol, Dist. Gandhinagar | Incompletete CTD Dossier Submission |
| 153 | ARTEMETHER AND LUMEFANTRINE | Artemether and Lumefantrine | Antimalaria | Chuvet Pharmaceutical and Allied Ventures LTD, Violet Kaine Onoba Onoba Kaine | Swiss Pharma Pvt. Ltd, 3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382445, Dist.: Ahmedabad. Gujarat State, India | Incompletete CTD Dossier Submission |
| 154 | ARTEMETHER INJECTION 80MG/ML | Artemether | Antimalaria | SPAN PHARM NIGERIA LTD, MICHAEL NNAKA NWACHUKWU NWACHUKWU | Shanxi Zhongbao Shuguang Pharmaceutical Co., Ltd, No 1. Kangle Street, Qi County, Shanxi, China | Incompletete CTD Dossier Submission |
| 155 | ENOXAPARIN SODIUM | Enoxaparin Sodium | Anticoagulant | NAXOS HEALTHCARE LTD, Adesanya Oluwaseun Oriyomi Adesanya | Venus Remedies Limited, HILL TOP INDUSTRIAL ESTATE, JHARMAJRI, EPIP PHASE-1 (Extn), BHATOLI KALAN, BADDI DISTT, SOLAN, HIMACHAL PRADESH, 173205, INDIA | Incompletete CTD Dossier Submission |
| 156 | Levofloxacin ( as hemihydrate) | Levofloxacin Hemihydrate | Antibiotics | Zangon Kabo Pharmaceutical Company limited , Zangon Kabo Pharmaceutical O Okafor | Venus Pharma, 23-Km, Multan Road, Lahore â PAKISTAN | Incompletete CTD Dossier Submission |
| 157 | Artesunate | Artesunate | Antimalaria | ESMERO PHARMACEUTICAL LIMITED, Ekpenyong Mike MIKE UDO | Montage Laboratories Pvt. Ltd, Dhandha Idar Road, Himmatnagar-383001, Gujarat, India | Incompletete CTD Dossier Submission |
| 158 | AMLODIPINE / CHLORTHALIDONE | Amlodipine/Chlorthalidone | Antihypertensive Combination | NEMEL PHARMACEUTICALS LIMITED , NEMEL PHARMACEUTICALS LIMITED CHIOMA NWODO | Nemel Pharmaceutical Limited, PLOT 35 EMENE INDUSTRIAL LAYOUT | Incompletete CTD Dossier Submission |
| 159 | Emtricitabine and Tenofovir Alafenamide 200 mg / 25 mg Tablets | Emtricitabine and Tenofovir Alafenamide | Antiviral Combination | OXUS PHARMA LTD, Oxus Pharma Limited OKECHUKWU ABEL | MACLEODS PHARMACEUTICALS LTD.,Village Theda, P.O. Lodhimajra, Tehsil baddi Dist: Solan, Himachal Pradesh, India 174101 | Incompletete CTD Dossier Submission |
| 169 | CARVEDILOL 3.125MG | Carvedilol | Antihypertensive | FIDSON HEALTHCARE PLC, Nmaka I. TIJANI | Golden Cross Pharma Pvt. Ltd, PLOT NO.: 17&18 GOLDEN INDUSTRIAL ESTATE SOMNATH ROAD, DABHEL, DAMAN -396215, INDIA | Incompletete CTD Dossier Submission |
| 170 | CEFUROXIME SODIUM USP 750MG | Cefuroxime Sodium | Antibiotics | SYNERMED NIGERIA LTD, Ijeoma Ijeoma Onwumerobi | VILL SAINI MAJRA, TEHSIL NALAGARH DISTT SOLAN, INDIA | Incompletete CTD Dossier Submission |
| 171 | TADALAFIL TABLETS USP 20MG | Tadalafil | Phosphodiesterase type 5 (PDE5) inhibitors | SICONE NIGERIA LTD, GBADEGESIN OLANRELE FALEYE | Globela Pharma Pvt. Ltd, 357-358, G.I.D.C. SACHIN, SURAT – 394 230, GUJARAT, INDIA. | Incompletete CTD Dossier Submission |
| 172 | Brimonidine Tartrate Ophthalmic Solution | Brimonidine Tartrate | Antiglaucoma Agent | MEDIHEIRS NIGERIA LTD, Osaretin Asowata Asenoguan Asowata | Divine Laboratories Pvt. Ltd, BLOCK NO.471, DABHASA, Padra Jambusar Road Padra 391440 Gujarat India | Incompletete CTD Dossier Submission |
| 173 | Isoflurane for Inhalation 250ml | Isoflurane | Inhalation Anaesthetics | ALPHA PHARMACY & STORES LIMITED, OLUSOLA ADENIOLA ADENIKE ADENIOLA | Lunan Better Pharmaceutical Co., Ltd, No 243, Yinqueshan Road, Linyi City, Shandong Province, People’s Republic of China | Incompletete CTD Dossier Submission |
| 174 | BISOPROLOL FUMARATE AND PERINDOPRIL ARGININE | Bisoprolol Fumarate and Perindopril Arginine | Antihypertensives | SERVIER PHARMACEUTICALS DEVELOPMENT, kelechi GOODLUCK EBIRIM | Les Laboratoires Servier Industrie, 905, ROUTE DE SARAN 45520 GIDY FRANCE | Incompletete CTD Dossier Submission |
| 175 | Piperacillin Sodium and Tazobactam Sodium | Piperacillin Sodium and Tazobactam Sodium | Combination Antibiotic | Pharmastation Limited, Amara Chikwendu Chetenne Chikwendu | Reyoung Pharmaceutical Co., Ltd, No. 1 Ruiyang Road, Yiyuan county, shandong province, China. | Incompletete CTD Dossier Submission |
| 176 | CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3% W/V | Ciprofloxacin | Antibiotic | HIGH CLOUT PHARMA LIMITED , HIGH CLOUT OLANRELE FALEYE | Kamla Lifesciences Limited, PLOT NO. G-84/1, TARAPUR, M.I.D.C, BOISAR, TAL. & DIST. PALGHAR , 401 506 MAHARASHTRA. INDIA | Incompletete CTD Dossier Submission |
| 177 | Abemaciclib 150mg,100mg,150mg,200mg | Abemaciclib | CDK4/6 inhibitors (Cyclin-dependent kinase 4 and 6 inhibitors) | CHI PHARMACEUTICALS LTD, Juliet JULIET NWAFOR | Eli Lilly and Company, LILLY, S.A. Avda de la Industria, 30, Alcobendas, 28108 Madrid | Incompletete CTD Dossier Submission |
| 178 | Dapagliflozin | Dapagliflozin | Antidiabetic | Codix Pharma Limited, Codix Pharma Limited Bolatito Ogunnowo | West-Coast Pharmaceutical Works Ltd, F.P. No. 17 & 16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad â 382481. Gujarat State (INDIA) | Incompletete CTD Dossier Submission |
| 179 | IBUPROFEN SUSPENSION 100 MG/5ML | Ibuprofen | Analgesic | CHEMIRON CARE LTD, Chemiron Care Ltd Sashikant Singh | Chemiron Care Limited and Drury Industries Limited, Plot C21/3, Anioma Street, Agbara industrial Estate, Ogun State, Nigeria. | Incompletete CTD Dossier Submission |
| 180 | Loratadine | Loratadine | Antihistamine | ALL TIMES GENERICS LTD, Obinna Daniels Peter Daniels | Endurance Healthcare PVT Ltd, 8th Floor, Devpath, B/H Lal Bungalow, Off. C.G. Road, Ahmedabad-380006 (Gujarat) India | Incompletete CTD Dossier Submission |
| 181 | Loratadine | Loratadine | Antihistamine | ALL TIMES GENERICS LTD, Obinna Daniels Peter Daniels | Endurance Healthcare PVT Ltd, 8th Floor, Devpath, B/H Lal Bungalow, Off. C.G. Road, Ahmedabad-380006 (Gujarat) India | Incompletete CTD Dossier Submission |
| 182 | LEVONORGESTREL AND ETHINYLESTRADIOL | LEVONORGESTREL AND ETHINYLESTRADIOL | Combined Oral Contraceptives | MSI Nigeria Reproductive Choices Ltd/Gte, Joseph Adukwu Ngbede Adukwu | Renata PLC, RAJENDRAPUR POTENT PRODUCT FACILITY, NOYAPARA, BHAWAL MIRZAPUR, RAJENDRAPUR, GAZIPUR, BANGLADESH | Incompletete CTD Dossier Submission |
| 183 | Moxifloxacin Ophthalmic Solution USP | Moxifloxacin | Antibiotics | I Globe Pharma Ltd, I globe Pharma EVANS NDUBUISI | FDC Limited, B-8, MIDC Industrial Area, Waluj, Aurangabad- 431136, MAHARASHTRA -INDIA | Incompletete CTD Dossier Submission |
| 184 | Estradiol Valerate 2mg | Estradiol Valerate | Estrogen Receptor Agonist | Bayer Nigeria Ltd, Bayer Healthcare Osaretin Jaiyeola | BAYER WEIMAR GMBH UND CO. KG. DOBEREINERSTRASSE 20, 99427 WEIMAR, GERMANY | Incompletete CTD Dossier Submission |
| 185 | ARTHEMETER 80MG / LUMEFANTRINE 480MG | Artemether and Lumefantrine | Antimalaria | Zangon Kabo Pharmaceutical Company limited , Zangon Kabo Pharmaceutical O Okafor | Star Laboratories (Pvt) Ltd, 23-Km, Multan Road, Near Chung, 53800 Lahore. PAKISTAN | Incompletete CTD Dossier Submission |
| 186 | AMOXICILLIN CAPSULES 500MG | Amoxicillin Sodium | Antibiotics | PINNACLE HEALTH PHARMACEUTICAL & STORES LIMITED, Amaka Ubajekwe CLEMENTINA UBAJEKWE | Reyoung Pharmaceutical Co., Ltd, NO. 1 RUIYANG ROAD, YIYUAN COUNTRY, SHANDONG PROVINCE, PR CHINA | Incompletete CTD Dossier Submission |
| 187 | Sildenafil 100 mg and Dapoxetine 60 mg | Sildenafil and Dapoxetin | Sexual dysfunction agents | SJS LIFE SCIENCES LTD, ABOLARINDE RECHEAL OBADIAH RECHEAL OBADIAH | McW Healthcare Pvt. Ltd, 286, 287A, 287B, SECTOR E, INDUSTRIAL AREA, SANWER ROAD, INDORE (M.P.) INDIA | Incompletete CTD Dossier Submission |
| 188 | Oxytocin | Oxytocin | Uterotonics | Worldwide Commercial Ventures Ltd (WWCVL), Worldwide Commercial Ventures Limited Uzu Ubokor | Survey No. 46/1-4, Kadaiya Village, Daman-396 210, India | Incompletete CTD Dossier Submission |
| 189 | ESTRADIOL | Estradiol | Estrogen Receptor Agonist | ASSENE-LABOREX LIMITED, ASSENE-LABOREX LIMITED CHINYEREM AMUZIE | Laboratoires Besins International, 13, RUE PERIER,92120 MONTROUGE, FRANCE | Incompletete CTD Dossier Submission |
| 190 | ARTESUNATE 60MG | Artesunate | Antimalaria | TRIDEM PHARMA NIG LTD, AKINYELE SAMUEL AKINYELE | Guilin Pharmaceutical Co., Ltd, No. 43 QILIDIAN ROAD, GUILIN 541004, GUANGXI, CHINA | Incompletete CTD Dossier Submission |
| 191 | BISOPROLOL FUMARATE AND PERINDOPRIL ARGININE | Bisoprolol Fumarate and Perindopril Arginine | Antihypertensives | SERVIER PHARMACEUTICALS DEVELOPMENT, kelechi GOODLUCK EBIRIM | Les Laboratoires Servier Industrie, 905, ROUTE DE SARAN 45520 GIDY FRANCE | Incompletete CTD Dossier Submission |
| 192 | Telmisartan & Amlodipine Besylate tablet | Telmisartan & Amlodipine Besylate | Antihypertensives | GENERIX GLOBAL INVESTMENT LTD, Ikhafa Steve Iruedo Steve Iruedo | Scott-Edil Pharmacia Ltd, 56 EPIP, Phase-I Jharmajri, Baddi, Distt. Solan (HP) INDIA | Incompletete CTD Dossier Submission |
| 193 | CEFIXIME TRIHYDRATE 400MG | Cefixime Trihydrate | Antibiotics | KADARK PHARMACEUTICALS LIMITED, KADARK AKINTUNDE AKINOLA | Miraflash Nigeria Limited, 2-8 SUCCESS ESTATE ,OFF BRENTFIELD AVENUE OKE AFA OMOTEDO, MAGBORO, OGUN STATE. | Incompletete CTD Dossier Submission |
| 194 | Docetaxel Injection USP | Docetaxel Anhydrous | Antineoplastic Agents | Superior Pharmaceuticals Ltd, Shogbola Ruth Okiemute Shogbola | Beta Drugs Limited, Kharuni-Lodhimajra Road , Vill. Nandpur Baddi, Dist Solan, Himanchal Pradesh -173205 | Incompletete CTD Dossier Submission |
| 195 | Sodium Cromoglicate Eye Drops BP 2%w/v | Sodium Cromoglicate | Mast Cell Stabilizers | I Globe Pharma Ltd, I globe Pharma EVANS NDUBUISI | FDC Limited, B-8, MIDC Industrial Area, Waluj, Aurangabad- 431136, MAHARASHTRA -INDIA | Incompletete CTD Dossier Submission |
| 196 | Flucytosine Tablets 500mg | Flucytosine | Antifungal | OXUS PHARMA LTD, Oxus Pharma Limited OKECHUKWU ABEL | Oxalis Lab Limited,Village Theda, P.O. Lodhimajra, Tehsil baddi Dist: Solan, Himachal Pradesh, India 174101 | Incompletete CTD Dossier Submission |
| 197 | Rosuvastatin (as rosuvastatin calcium) + Ezetimibe | Rosuvastatin and Ezetimibe | Statin and Cholesterol Absorption Inhibitor | SANOFI AVENTIS NIGERIA LIMITED, Zainab Adelabu Anuoluwapo Adelabu | Sanofi Winthrop Industrie, TOURS 30-36, avenue Gustave Eiffel 37000 TOURS FRANCE | Incompletete CTD Dossier Submission |
| 198 | Gabapentine 300mg+Methycobalamine 0.5mg | Gabapentin and Methylcobolamine | Anticonvulsant and Vitamin B12 Analogue | ALL TIMES GENERICS LTD, Obinna Daniels Peter Daniels | Stallion Laboratories Private Limited, 8th Floor, Devpath, B/H Lal Bungalow, Off. C.G. Road, Ahmedabad-380006 (Gujarat) India, | Incompletete CTD Dossier Submission |
| 199 | ARTEMETHER AND LUMEFANTRINE TABLETS 80MG+480MG | Artemether and Lumefantrine | Antimalaria | PHARMEXCO PHARMACEUTICAL LIMITED, PAUL IBEGBULEM OGUIKE IBEGBULEM | Ciron Drugs & Pharmaceuticals Pvt. Ltd, C-1101/1102, Lotus Corporate Park, Graham Firth Steel Compound, Jay Coach Junction, Western Express Highway, Goregaon (East), Mumbai â 400 063. | Incompletete CTD Dossier Submission |
| 200 | Omeprazole BP 20MG | Omeprazole | Proton Pump Inhibitors (PPIs) | CUREALL IMPEX NIGERIA LIMITED, nafropharma@gmail.com GBENGA ONI | AR Lifesciences, 819/b, Rakanpur Indl. Area, Tal. Kalol, Dist. Gandhinagar, Gujarat, INDIA, | Incompletete CTD Dossier Submission |
| 201 | Atazanavir sulfate and Ritonavir | Atazanavir sulfate and Ritonavir | Antiviral Combination | JYNA PHARMA LIMITED, jyna pharma Nneamaka Chukwuemeka | Laurus Labs Limited, Plot No:19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam-District-531011, Andhra Pradesh, India. | Incompletete CTD Dossier Submission |
| 202 | CEFTRIAXONE SODIUM 1G | Ceftriaxone Sodium | Antibiotics | Pharmastation Limited, Amara Chikwendu Chetenne Chikwendu | Reyoung Pharmaceutical Co., Ltd, No. 1 Ruiyang Road, Yiyuan county, shandong province, China. | Incompletete CTD Dossier Submission |
| 203 | Dolutegravir(sodium)/Lamivudine/Tenofovir disoproxil fumarate | Dolutegravir(sodium)/Lamivudine/Tenofovir disoproxil fumarate | Antiviral Combination | Pharmasymbiosis Ltd., Matilda Onawole Abimbola Onawole | Celltrion Pharm, Inc, 82,2-Sandan-ro,Ochang-eup,Cheongju-si,Chungbuk,28117 | Incompletete CTD Dossier Submission |
| 204 | Artemether 80 mg & Lumefantrine 480 mg Tablets | Artemether and Lumefantrine | Antimalaria | JAMIN INTERNATIONAL COMPANY LIMITED, BENJAMIN I ENEBELI | Impulse Pharma Pvt. Ltd, J-202/1 , MIDC Tarapur, Boisar, Dist. Palghar – 401506, Maharashtra State, India. | Incompletete CTD Dossier Submission |
| 205 | ARTEMETHER INJECTION | Artemether | Antimalaria | APHANTEE PHARM NIGERIA LTD, CHUKWUDI I ENEBELI | Guizhou Tiandi Pharmaceutical Co., Ltd, No.6 Baokang Road, Hongxing Pharmaceutical Indutrial Park, Dingxiao Town, Xingyi City Qianxiânan Bouyei and Miao Autonomous Prefecture, Guizhou Province, China | Incompletete CTD Dossier Submission |
| 206 | ROSUVASTATIN | Rosuvastatin | HMG-CoA reductase inhibitor | CLARION MEDICALS LIMITED, CHINENYE IGWEGBE A. IGWEGBE | The Madras Pharmaceuticals, NO 137-B OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI -600 096, TAMILNADU, INDIA | Incompletete CTD Dossier Submission |
| 207 | AMOXICILLIN CAPSULES 250MG | Amoxicillin Sodium | Antibiotics | PINNACLE HEALTH PHARMACEUTICAL & STORES LIMITED, Amaka Ubajekwe CLEMENTINA UBAJEKWE | Reyoung Pharmaceutical Co., Ltd, NO. 1 RUIYANG ROAD, YIYUAN COUNTRY, SHANDONG PROVINCE, PR CHINA | Incompletete CTD Dossier Submission |
| 208 | BRINZOLAMIDE USP 1.0%W/V & BRIMONIDINE TARTRATE BP 0.2%W/V | Brinzolamide and Brimonidine Tartrate | Ocular Hypertensives | KORLYNS PHARMACEUTICALS LTD, KORLYNS PHARMACEUTICALS LTD ELIZABETH OZIEGBE | Indiana Ophthalmics LLP, PLOT 135-137 WADHWAN SURENDRANAGAR 363 035 GUJARAT INDIA | Incompletete CTD Dossier Submission |
| 209 | ADMAL | Arteether | Antimalaria | Advantage Pharmaceuticals Limited | Ciron Drugs & Pharmaceuticals Pvt. Ltd, PLOT NO. 35 TO 37, 43 TO 45, CFC-B, DEWAN UDYOG NAGAR, ALIYALI, PLAGHAR DIST. THANE-401 404, INDIA | Incompletete CTD Dossier Submission |
| 210 | MEROPENEM FOR INJECTION USP 1 GM | Meropenem Trihydrate | Antibiotics | GOLDEN HEALTHCARE LIMITED , Golden Healthcare limited BAMISAYE AKANDE | SWISS PARENTERALS LIMITED (UNIT -II) PLOT NO 402,412-414 KERALA INDUSTRIAL ESTATE GIDC NEAR BAULA DIST . AHMEDABED -382220 GUJARAT STATE, INDIA | Incompletete CTD Dossier Submission |
| 211 | Clopidogrel Bisulphate tablet, 75mg | Clopidogrel Bisulphate | Antiplatelets | Phamatex Industries Limited, Innocent Nduka Ifeanyichukwu Nduka | Phamatex Nigeria Limited, Marble House, No. 1, Crystal Glass Close, Amuwo-Odofin Industrial Estate, Lagos, Nigeria | Incompletete CTD Dossier Submission |
| 212 | Pregabalin USP 75 mg | Pregabalin | Anticonvulsants | NAFRO PHARMA NIGERIA LIMITED, Kayode GBENGA ONI | Lucent Biotech Limited, Factory; 165/3, Nalhera, Anantpur Puhana, Roorkee Dist: Haridwar -247667, Uttarakhand, India. | Incompletete CTD Dossier Submission |
| 213 | Levofloxacin | Levofloxacin Hemihydrate | Antibiotics | Teta Pharmaceuticals Nig Ltd, Teta Pharmaceuticals Nig Ltd Adewale Sanni | Lesanto Laboratories, Plot No: 9,10,11 & 20, Survey no : 53, Manor road,Near Railway Bridge, Palghar (E), Thane – 401404, Maharsahtra, India | Incompletete CTD Dossier Submission |
| 214 | Artemether 80 Mg & Lumefantrine 480 mg | Artemether and Lumefantrine | Antimalaria | ETHICAL MARKETING AND SERVICES LTD, Bukola GBENGA ONI | Briyosis Soft Caps Private Limited, Jarod – Rasulabad Road, Jarod, Vadodara, Gujarat 391510, India | Incompletete CTD Dossier Submission |
| 215 | Sildenafil | Sildenafil | Phosphodiesterase type 5 (PDE5) inhibitors | EMIE PHARMACEUTICALS (UK) LTD, Mehtab Hussain – Wanogho | Biodeal Pharmaceuticals Pvt Ltd, Nalagarh – Ropar Road, Village – Sainimajra, Nalagarh, District Solan (HP), 174101, India | Incompletete CTD Dossier Submission |
| 216 | Paracetamol | Acetaminophen | Analgesic | Newwaves Ecosystem Limited, Samuel Adekunle Odejinmi | Niyi Raheem Nig. LTD, 12, Isolo Street, Akilo | Incompletete CTD Dossier Submission |
| 217 | Latanoprost Eye Drops | Latanoprost | Antiglaucoma Agent | Val Valentino Pharmaceutical Company Limited, valentine ofojebe Chike Ofojebe | Ciron Drugs & Pharmaceuticals Pvt. Ltd, C- 1101/1102, Lotus Corporate Park, Graham Firth Steel Compound, Jay Coach Junction, Western Express Highway, Goregaon (East) Mumbai, Maharashtra, India â 400063 | Incompletete CTD Dossier Submission |
| 218 | Cefixime | Cefixime Trihydrate | Antibiotics | ZOLON HEALTHCARE LIMITED, Colette UGOCHI OKWUCHI | Flowergate Mixed Development Scheme. Km 1 Sagamu/Benin Expressway,Sagamu.Ogun State. | Incompletete CTD Dossier Submission |
| 219 | SULFADOXINE 500MG + PYRIMETHAMINE 25MG | Sulfadoxine and Pyrimethamine | Antimalaria | EMZOR PHARMACEUTICAL INDUSTRIES LIMITED, Chinelo Umeh Sylvia Umeh | FLOWERGATE MIXED DEVELPMENT SCHEME, KM1, SAGAMU-BENIN EXPRESSWAY, MAKUN SAGAMU, OGUN STATE | Incompletete CTD Dossier Submission |
| 220 | Empagliflozin/Metformin Hydrochloride | Empagliflozin/Metformin Hydrochloride | Antidiabetic | Fensyl MHP Consulting Limited, Rita Etim Wisdom Etim | Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173 55216 Ingelheim am Rhein Germany Boehringer Ingelheim Ellas A.E. 5th km Paiania â Markopoulo Koropi Attiki, 19400 Greece | Incompletete CTD Dossier Submission |
| 2024/2025 | ||||||
| 221 | TENSIVINFORTE | AMLODIPINE; TELMISARTAN; CHLORTHALIDONE | Antihypertensive | NEMEL PHARMACEUTICALS IND. LIMITED, NEMEL PHARMACEUTICALS IND. LIMITED CHIOMA NWODO | NEMEL PHARMACEUTICALS LIMITED PLOT 35 EMENE INDUSTRIAL LAYOUT | Incompletete CTD Dossier Submission |
| 222 | ZILAX | CLOPIDOGREL | Antiplatelets | NEMEL PHARMACEUTICALS IND. LIMITED, NEMEL PHARMACEUTICALS IND. LIMITED CHIOMA NWODO | NEMEL PHARMACEUTICALS LIMITED PLOT 35 EMENE INDUSTRIAL LAYOUT | Incompletete CTD Dossier Submission |
| 223 | DOXITAN-40; DOXITAN-80 | TELMISARTAN | Antihypertensive | NEMEL PHARMACEUTICALS IND. LIMITED, NEMEL PHARMACEUTICALS IND. LIMITED CHIOMA NWODO | NEMEL PHARMACEUTICALS LIMITED PLOT 35 EMENE INDUSTRIAL LAYOUT | Incompletete CTD Dossier Submission |
| 224 | ARCHY ORS POWDER PLUS ZINC TABLET 20mg | lucose, Sodium CL, Sodiun Citrate, Potassium CL)ZINC TABLET 20mg | Oral Rehydration Therapy and Mineral Supplement | ARCHY PHARMACEUTICALS LIMITED., ARCHY PHARM EZENWA NDUBUEZE | ARCHY PHARMACEUTICALS NIG LTD Plot 30, Win Funke Street, Off Access bank junction Ahmadiyya, Lagos Abeokuta Expressway, Ojokoro Lagos | Incompletete CTD Dossier Submission |
| 225 | Nalis Levonorgestrel Tablets | Levonorgestrel 0.75 mg Tablets | Progestogen | Nalis Pharmaceuticals Limited, Nalis Pharma Uche Onwumah | ARCHY PHARMACEUTICALS NIG LTD Plot 30, Win Funke Street, Off Access bank junction Ahmadiyya, Lagos Abeokuta Expressway, Ojokoro Lagos | Incompletete CTD Dossier Submission |
| 226 | ARCHILLIN COUGH SYRUP FOR CHILDREN | Diphenyhdramine Hydrochloride B.P 7mg + Ammoniun Chloride B.P 50mg + Sodium Citrate B.P 28.5mg /5ml | Antihistamine | ARCHY PHARMACEUTICALS LIMITED., ARCHY PHARM EZENWA NDUBUEZE | ARCHY PHARMACEUTICALS NIG LTD Plot 30, Win Funke Street, Off Access bank junction Ahmadiyya, Lagos Abeokuta Expressway, Ojokoro Lagos | Incompletete CTD Dossier Submission |
| 227 | ARCHICHLOR TABLET | CHLORPHENIRAMINE MALEATE BP 4MG | Antihistamine | ARCHY PHARMACEUTICALS LIMITED., ARCHY PHARM EZENWA NDUBUEZE | ARCHY PHARMACEUTICALS NIG LTD Plot 30, Win Funke Street, Off Access bank junction Ahmadiyya, Lagos Abeokuta Expressway, Ojokoro Lagos | Incompletete CTD Dossier Submission |
| 228 | Amlodipine Tablets | Amlodipine Besylate | Antihypertensive | Nalis Pharmaceuticals Limited, Nalis Pharma Uche Onwumah | Nalis Pharmaceuticals Ltd, R67/68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State, Nigeria | Incompletete CTD Dossier Submission |
| 229 | ARCHICHLOR SYRUP 2MG/5ML | CHLORPHENIRAMINE MALEATE 2MG/5ML | Antihistamine | ARCHY PHARMACEUTICALS LIMITED., ARCHY PHARM EZENWA NDUBUEZE | ARCHY PHARMACEUTICALS NIG LTD Plot 30, Win Funke Street, Off Access bank junction Ahmadiyya, Lagos Abeokuta Expressway, Ojokoro Lagos | Incompletete CTD Dossier Submission |
| 230 | CHLORTAMOL SYRUP | PARACETAMOL+CHLORPHENIRAMINE MALEATE | Analgesic/Antihistamine | ARCHY PHARMACEUTICALS LIMITED., ARCHY PHARM EZENWA NDUBUEZE | ARCHY PHARMACEUTICALS NIG LTD Plot 30, Win Funke Street, Off Access bank junction Ahmadiyya, Lagos Abeokuta Expressway, Ojokoro Lagos | Incompletete CTD Dossier Submission |
| 231 | VILPHAC 200MG TABLETS | OFLOXACIN | Antibiotic | UNICURE PHARMACEUTICAL LIMITED, Su Weiyang Ukamaka Charles | UNICURE PHARMACEUTICAL LIMITED, IKOFA VILLAGE, LAGOS BENIN EXPRESSWAY, IJEBU ODE, OGUN STATE, NIGERIA | Incompletete CTD Dossier Submission |
| 232 | LUMITIDE 40MG TABLET | FUROSEMIDE | Loop Diuretic (Antihypertensives) | UNICURE PHARMACEUTICAL LIMITED, Su Weiyang Ukamaka Charles | UNICURE PHARMACEUTICAL LIMITED, IKOFA VILLAGE, LAGOS BENIN EXPRESSWAY, IJEBU ODE, OGUN STATE, NIGERIA | Incompletete CTD Dossier Submission |
| 233 | ENZALUTAMIDE CAPSULES | ENZALUTAMIDE CAPSULES 40 MG | Antineoplastic | EMBASSY PHARMACEUTICAL AND CHEM.LTD, EMBASSY PHARMACEUTICAL AND CHEM.LTD. Augustine Ola | ADMAC LIFESCIENCES, Plot No. 107A & B, EPIP Phase-I, Jharmajri, Baddi, Distt. Solan (H.P) â 174 103 INDIA | Incompletete CTD Dossier Submission |
| 234 | DOCETAXEL INJECTION | DOCETAXEL INJECTION USP 20mg/0.5mL | Antineoplastic | EMBASSY PHARMACEUTICAL AND CHEM.LTD, EMBASSY PHARMACEUTICAL AND CHEM.LTD. Augustine Ola | ADMAC LIFESCIENCES, Plot No. 107A & B, EPIP Phase-I, Jharmajri, Baddi, Distt. Solan (H.P) â 174 103 INDIA | Incompletete CTD Dossier Submission |
| 235 | LEVOGOL 750 TABLETS | LEVOFLOXACIN | Antibiotic | GLOBAL ORGANICS LIMITED, Gabriel Akwaja Oludinanwa Akwaja | GLOBAL ORGANICS LIMITED, Plot No. 868, Km. 34, Lagos – Abeokuta Exxpressway, Ajegunle, Lagos | Incompletete CTD Dossier Submission |
| 236 | IBUPKRIS-400 CAPLETS | IBUPROFEN BP | Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | KRISHAT PHARMA INDUSTRIES LIMITED, KRISHAT PHARMA IND LTD BHARAT SHAH | KRISHAT PHARMA INDUSTRIES LIMITED, KM 15, LAGOS-IBADAN EXPRESSWAY, IBADAN, OYO STATE, NIGERIA | Incompletete CTD Dossier Submission |
| 237 | LISIKRIS TABLETS 5MG | LISINOPRIL DIHYDRATE BP | Antihypertensive | KRISHAT PHARMA INDUSTRIES LIMITED, KRISHAT PHARMA IND LTD BHARAT SHAH | KRISHAT PHARMA INDUSTRIES LIMITED, KM 15, LAGOS-IBADAN EXPRESSWAY, IBADAN, OYO STATE, NIGERIA | Incompletete CTD Dossier Submission |
| 238 | Fluconazole 200 mg Tablet | Fluconazole | Antibiotic | ARTEMIS LABORATORIES LIMITED, Bourdillon Gaminiwei Moses Moses Bourdillon | Artemis Laboratories Limited, Plot 4, Block 4, Ogun State Housing Corporation & Industrial Estate, Ota, Ogun State, Nigeria. | Incompletete CTD Dossier Submission |
| 239 | Methyldopa 250mg Tablets | Methyldopa | Antihypertensive | ARTEMIS LABORATORIES LIMITED, Bourdillon Gaminiwei Moses Moses Bourdillon | Artemis Laboratories Limited, Plot 4, Block 4, Ogun State Housing Corporation & Industrial Estate, Ota, Ogun State, Nigeria. | Incompletete CTD Dossier Submission |
| 240 | KRISVEGA TABLETS | SILDENAFIL CITRATE | Phosphodiesterase type 5 (PDE5) inhibitors | KRISHAT PHARMA INDUSTRIES LIMITED, KRISHAT PHARMA IND LTD BHARAT SHAH | KRISHAT PHARMA INDUSTRIES LIMITED, KM 15, LAGOS-IBADAN EXPRESSWAY, IBADAN, OYO STATE, NIGERIA | Incompletete CTD Dossier Submission |
| 241 | ELECTROKICK PLUS | 0RS REHYDRATION SALT 20.5G + ZINC SULPHATE TABLETS 20MG | Oral Rehydration Therapy/Mineral Supplement | HALEWOOD LABORATORIES PVT LTD, Halewood Laboratories Pvt Ltd Suresh Mahajan | Halewood Laboratories Pvt. Ltd.Plot No. 319, Phase II, GIDC, Vatva, Ahmedabad-382445. India | Incompletete CTD Dossier Submission |
| 242 | DICLOFENAC SODIUM 50mg TABLET | DICLOFENAC SODIUM 50mg TABLET | Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | Funag (NIG.) Ltd, Abisola Omotosho Adenike Omotosho | FUNAG PHARMACEUTICAL LIMITED, 15, Funag Road, Iboko Village. Ishasi â Akute, Ogun State | Incompletete CTD Dossier Submission |
| 243 | Paracetamol, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Tablets | Paracetamol 500mg, Phenylephrine Hydrochloride 5mg & Chlorpheniramine Maleate 2mg Tablets | Analgesic/Nasal Decongestant/Antihistamine | Funag (NIG.) Ltd, Abisola Omotosho Adenike Omotosho | FUNAG PHARMACEUTICAL LIMITED, 15, Funag Road, Iboko Village. Ishasi â Akute, Ogun State | Incompletete CTD Dossier Submission |
| 244 | PRIYA APETAMAX TABLET | CYPROHEPTADINE HYDROCHLORIDE 4mg TABLET | Antihistamine | Funag (NIG.) Ltd, Abisola Omotosho Adenike Omotosho | FUNAG PHARMACEUTICAL LIMITED, 15, Funag Road, Iboko Village. Ishasi â Akute, Ogun State | Incompletete CTD Dossier Submission |
| 245 | ARTEMETHRIN 20/120 DISPERSIBLE TABLET | ARTEMETHER 20mg + LUMENFANTRINE 120mg DISPERSIBLE TABLET | Antimalaria | A. C. Drugs LTD, Somto Harris Anietom | AC DRUGS LIMITED , NO C5/C6 OLD AIRPORT ROAD EMENE, ENUGU, ENUGU | Incompletete CTD Dossier Submission |
| 246 | BW-Levofloxacin | Levofloxacin Hemihydrate | Antibiotic | Blueworld Pharmaceutical Food & Chemical Limited, Kelechi Nworie Martins Nworie | Blueworld Pharmaceutical Food & Chemical Limited, KM 3 Deeper Life Uzoiyi Road Near NIPP Power Plant, Off Aba-PH Expressway, Umugo ugwunagbor L.G.A Aba Abia State | Incompletete CTD Dossier Submission |
| 247 | BW-Omeprazole | Omeprazole | Proton Pump Inhibitors (PPIs) | Blueworld Pharmaceutical Food & Chemical Limited, Kelechi Nworie Martins Nworie | Blueworld Pharmaceutical Food & Chemical Limited, KM 3 Deeper Life Uzoiyi Road Near NIPP Power Plant, Off Aba-PH Expressway, Umugo ugwunagbor L.G.A Aba Abia State | Incompletete CTD Dossier Submission |
| 248 | BW-Zithrox | Azithromycin dihydrate | Antibiotic | Blueworld Pharmaceutical Food & Chemical Limited, Kelechi Nworie Martins Nworie | Blueworld Pharmaceutical Food & Chemical Limited, KM 3 Deeper Life Uzoiyi Road Near NIPP Power Plant, Off Aba-PH Expressway, Umugo ugwunagbor L.G.A Aba Abia State | Incompletete CTD Dossier Submission |
| 249 | FIDSON PARACETAMOL SYRUP | Paracetamol 125MG/5ML BP SYRUP | Analgesic | FIDSON HEALTHCARE LTD, Nmaka I. TIJANI | FIDSON HEALTHCARE PLC , 17-21 FIDSON AVENUE SANGO OTA OGUN STATE | Incompletete CTD Dossier Submission |
| 250 | MYOPRESS 10 TABLET | AMLODIPINE BESYLATE BP 10MG | Antihypertensive | FIDSON HEALTHCARE LTD, Nmaka I. TIJANI | FIDSON HEALTHCARE PLC , 17-21 FIDSON AVENUE SANGO OTA OGUN STATE | Incompletete CTD Dossier Submission |
| 251 | Sagar Prednisolone Tablets | Prednisolone Tablet BP 5mg | Corticosteroids | SAGAR VITACEUTICALS NIG LTD , Folusho Ajenifuja AJENIFUJA SUNDAY | SAGAR VITACEUTICALS NIGERIA LIMITED,Commercial District B block Plot 6, New Makun City, Along Lagos-Ibadan Expressway, K/m 53/55 Sagamu , Ogun State. NIGERIA. | Incompletete CTD Dossier Submission |
| 252 | CLOVAXAN TABLETS | Amoxicillin Dispersible Tablets 250 mg | Antibiotic | Anchorage Pharmaceutical Industries Limited, Angel Abdul Rauf | ANCHORAGE PHARMACEUTICAL INDUSTRIES LIMITED, 1 Anchorage Road, Off Enugu-Onitsha Expressway, Enugu, Nigeria. | Incompletete CTD Dossier Submission |
| 253 | Moxie Cough Syrup | Ammonium Chloride & Sodium Citrate | Expectorant/Mucolytic | PHARMALLIANCE CONSULTING LIMITED, Bourdillon Gaminiwei Moses Moses Bourdillon | Oak-Faith Pharmaceutical Resources Limited, Off Km 44, Lagos-Ibadan Expressway, Mowe, Ogun State | Incompletete CTD Dossier Submission |
| 254 | CLOVAXAN (Amoxicillin Dispersible Tablets 250 mg) | Amoxicillin Dispersible Tablets 250 mg | Antibiotic | Anchorage Pharmaceutical Industries Limited, Angel Abdul Rauf | ANCHORAGE PHARMACEUTICAL INDUSTRIES LIMITED, 1 Anchorage Road, Off Enugu-Onitsha Expressway, Enugu, Nigeria. | Incompletete CTD Dossier Submission |
| 255 | TROZ 400 TABLETS | METRONIDAZOLE 400MG | Antibiotic | GLOBAL ORGANICS LIMITED, Gabriel Akwaja Oludinanwa Akwaja | GLOBAL ORGANICS LIMITED, Plot No. 868, Km. 34, Lagos – Abeokuta Exxpressway, Ajegunle, Lagos | Incompletete CTD Dossier Submission |
| 256 | TROZ 200 TABLETS | METRONIDAZOLE 200MG | Antibiotic | GLOBAL ORGANICS LIMITED, Gabriel Akwaja Oludinanwa Akwaja | GLOBAL ORGANICS LIMITED, Plot No. 868, Km. 34, Lagos – Abeokuta Exxpressway, Ajegunle, Lagos | Incompletete CTD Dossier Submission |
| 257 | ELTRAD 25 TABLETS | ELTROMBOPAG TABLETS 25MG | Thrombopoietin receptor agonist | HETERO LABS NIG LTD, ANGELA AROH ANGELA AROH | HETERO LABS LIMITED, UNIT V, TSIIC FORMULATION SEZ, SY. NO. 439, 440. 441, 458, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR DISTRICT, TELANGANA STATE, INDIA | Incompletete CTD Dossier Submission |
| 258 | REALS CEFIXIME CAPSULES | CEFIXIME | Antibiotic | REALS SPECIALTIES LIMITED, REALS SPECIALTIES LIMITED AGNES IKE | MIRAFLASH NIGERIA LIMITED, 2-8, SUCCESS ESTATE, OFF BRENTFIELD, MAGBORO, OGUN STATE | Incompletete CTD Dossier Submission |
| 259 | CLOVAXAN DISPERSIBLE TABLETS | Amoxicillin Dispersible Tablets 125 mg | Antibiotic | Anchorage Pharmaceutical Industries Limited, Angel Abdul Rauf | ANCHORAGE PHARMACEUTICAL INDUSTRIES LIMITED, 1 Anchorage Road, Off Enugu-Onitsha Expressway, Enugu, Nigeria. | Incompletete CTD Dossier Submission |
| 260 | Clovaxan Tablets | Amoxicillin 500 mg Tablets | Antibiotic | Anchorage Pharmaceutical Industries Limited, Angel Abdul Rauf | ANCHORAGE PHARMACEUTICAL INDUSTRIES LIMITED, 1 Anchorage Road, Off Enugu-Onitsha Expressway, Enugu, Nigeria. | Incompletete CTD Dossier Submission |
| 261 | CIPROLEX TABLET | Ciprofloxacin 500mg Tablet | Antibiotic | Life Vision Pharmacy Limited, MuhammasSani Bashir Aliyu Aliyu Bashir | ECOMED PHARMA LTD, Plot 32, Lynson Chemical Avenue, Km.38, Lagos Abeokuta Expressway, Sango Ota, Ogun State, Nigeria. | Incompletete CTD Dossier Submission |
| 262 | CATAGOL 50 TABLETS | DICLOFENAC POTASSIUM | Analgesic | GLOBAL ORGANICS LIMITED, Gabriel Akwaja Oludinanwa Akwaja | GLOBAL ORGANICS LIMITED, Plot No. 868, Km. 34, Lagos – Abeokuta Exxpressway, Ajegunle, Lagos | Incompletete CTD Dossier Submission |
| 263 | ACEFEN TABLETS | ACECLOFENAC | Analgesic | GLOBAL ORGANICS LIMITED, Gabriel Akwaja Oludinanwa Akwaja | GLOBAL ORGANICS LIMITED, Plot No. 868, Km. 34, Lagos – Abeokuta Exxpressway, Ajegunle, Lagos | Incompletete CTD Dossier Submission |
| 264 | LEVOGOL 750 TABLETS | LEVOFLOXACIN 750MG | Antibiotic | GLOBAL ORGANICS LIMITED, Gabriel Akwaja Oludinanwa Akwaja | GLOBAL ORGANICS LIMITED, Plot No. 868, Km. 34, Lagos – Abeokuta Exxpressway, Ajegunle, Lagos | Incompletete CTD Dossier Submission |
| 265 | CEFUROXIME SUSPENSION | CEFUROXIME AXETIL | Antibiotic | XENTIAL PHARMACEUTICALS NIGERIA LIMITED, Ihuoma Chigorom Nwozuzu | MIRAFLASH NIGERIA LIMITED, 2-8, SUCCESS ESTATE, OFF BRENTFIELD, MAGBORO, OGUN STATE | Incompletete CTD Dossier Submission |
| 266 | LEVOGOL 500 TABLETS | LEVOFLOXACIN 500MG | Antibiotic | GLOBAL ORGANICS LIMITED, Gabriel Akwaja Oludinanwa Akwaja | GLOBAL ORGANICS LIMITED, Plot No. 868, Km. 34, Lagos – Abeokuta Exxpressway, Ajegunle, Lagos | Incompletete CTD Dossier Submission |
| 267 | Amlodipine Besylate | Amlodipine Besylate 5mg | Antihypertensive | Swiss Pharma Nigeria Ltd, Rosemary O Ogana | Swiss Pharma Nigeria Limited, No. 5 Dopemu Road, Agege, Lagos. Nigeria | Incompletete CTD Dossier Submission |
| 268 | Nalis Levonorgestrel Tablets | Levonorgestrel Tablets | Thrombopoietin receptor agonist | Nalis Pharmaceuticals Limited, Nalis Pharma Uche Onwumah | Nalis Pharmaceuticals Ltd, R67/68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State, Nigeria | Incompletete CTD Dossier Submission |
| 269 | Nalis Loratadine 10 mg Tablets | Loratadine 10 mg Tablets | Antihypertensive | Nalis Pharmaceuticals Limited, Nalis Pharma Uche Onwumah | Nalis Pharmaceuticals Ltd, R67/68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State, Nigeria | Incompletete CTD Dossier Submission |
| 270 | ASTEPRO | THEOPHYLLINE/SALBUTAMOL/CHLORPHENIRAMINE MALEATE | Bronchodilator/Antihistamine | EVERGREEN MORNING STAR PHARCEUTICAL IND. LTD., Declan chikaodi unogu chikaodi unogu | EVERGREEN MORNING STAR PHARMACEUTICAL INDUSTRY LIMITED, EVERGREEN INDUSTRIAL COMPLEX NDIOWERRE ORLU, ORLU LGA, IMO STATE. | Incompletete CTD Dossier Submission |
| 271 | EGMP Folic acid 1mg | FOLIC ACID | Multivitamin | EVERGREEN MORNING STAR PHARCEUTICAL IND. LTD., Declan chikaodi unogu chikaodi unogu | EVERGREEN MORNING STAR PHARMACEUTICAL INDUSTRY LIMITED, EVERGREEN INDUSTRIAL COMPLEX NDIOWERRE ORLU, ORLU LGA, IMO STATE. | Incompletete CTD Dossier Submission |
| 272 | Dr. Botsford Ciprofloxacin 250 mg Caplets | CIPROFLOXACIN | Antibiotic | EVERGREEN MORNING STAR PHARCEUTICAL IND. LTD., Declan chikaodi unogu chikaodi unogu | EVERGREEN MORNING STAR PHARMACEUTICAL INDUSTRY LIMITED, EVERGREEN INDUSTRIAL COMPLEX NDIOWERRE ORLU, ORLU LGA, IMO STATE. | Incompletete CTD Dossier Submission |
| 273 | Swipha-Metformin SR 1000mg Tablet | Metformin Hydrochloride | Antidiabetic | Swiss Pharma Nigeria Ltd, Rosemary O Ogana | Swiss Pharma Nigeria Limited, No. 5 Dopemu Road, Agege, Lagos. Nigeria | Incompletete CTD Dossier Submission |
| 274 | Cerazette 75 mcg film-coated tablets. | Desogestrel 75mcg | Progestogen | Pharmasymbiosis Ltd., Matilda Onawole Abimbola Onawole | N. V. Organon, Kloosterstraat 6 5349 AB Oss Netherlands | Incompletete CTD Dossier Submission |
| 275 | ASTEPRO | THEOPHYLLINE/SALBUTAMOL/CHLORPHENIRAMINE MALEATE | Bronchodilator/Antihistamine | EVERGREEN MORNING STAR PHARCEUTICAL IND. LTD., Declan chikaodi unogu chikaodi unogu | EVERGREEN MORNING STAR PHARMACEUTICAL INDUSTRY LIMITED, EVERGREEN INDUSTRIAL COMPLEX NDIOWERRE ORLU, ORLU LGA, IMO STATE. | Incompletete CTD Dossier Submission |
| 276 | SWIPHA AZITHROMYCIN | AZITHROMYCIN DIHYDRATE | Antibiotic | Swiss Pharma Nigeria Ltd, Rosemary O Ogana | Swiss Pharma Nigeria Limited, No. 5 Dopemu Road, Agege, Lagos. Nigeria | Incompletete CTD Dossier Submission |
| 277 | Remnergic tablets | Theophylline BP 60mg + Salbutamol BP 2mg + Chlorphenamine BP 2mg | Bronchodilator/Antihistamine | REMG PHARMACEUTICALS LIMITED, Remg pharmaceuticals Limited CHINONSO SUNDAY | REMG PHARMACEUTICALS LIMITED, 2, FOGO CLOSE, OFF OLAMBE ROAD, AKUTE, IFO L.G.A. OGUN STATE | Incompletete CTD Dossier Submission |
| 278 | REMCIPRO | Ciprofloxacin Hydrochloride Tablets | Antibiotic | REMG PHARMACEUTICALS LIMITED, Remg pharmaceuticals Limited CHINONSO SUNDAY | REMG PHARMACEUTICALS LIMITED, 2, FOGO CLOSE, OFF OLAMBE ROAD, AKUTE, IFO L.G.A. OGUN STATE | Incompletete CTD Dossier Submission |
| 279 | REMVIGRA 100MG | SILDENAFIL CITRATE | Phosphodiesterase type 5 (PDE5) inhibitors | REMG PHARMACEUTICALS LIMITED, Remg pharmaceuticals Limited CHINONSO SUNDAY | REMG PHARMACEUTICALS LIMITED, 2, FOGO CLOSE, OFF OLAMBE ROAD, AKUTE, IFO L.G.A. OGUN STATE | Incompletete CTD Dossier Submission |
| 280 | UGOFRANIL | Clomipramine Hydrochloride Tablet 25mg | Antidepressant | UGOLAB PRODUCTIONS LTD., OGBUJI UGONNA EUGENE EUGENE OGBUJI | OSAKA PHARMACEUTICALS PVT. LTD, OLD N.H. NO. 8, AT & POST-SANKARDA-391350. DIST VADODARA GUJARAT INDIA | Incompletete CTD Dossier Submission |
| 281 | Alprazolam Tablet 0.5m | Alprazolam Tablets USP 0.5mg | Benzodiazepines | UGOLAB PRODUCTIONS LTD., OGBUJI UGONNA EUGENE EUGENE OGBUJI | ASTAMED HEALTHCARE (i) PVT.LTD, PLOT NO. 2 & 3 PHASE II, GENESIS INDUSTRIAL COMPLEX, KOLGAON, PALGHAR-401404 MAHARASHTRA STATE INDIA | Incompletete CTD Dossier Submission |
| 282 | FLUCONAZOLE CAPSULES | FLUCONAZOLE 150MG | Antibiotics | FIGAB GOLDENFINGER PHARMACEUTICALS LTD, UZOR MARK EZEH | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 283 | Hemant | Tranexamic acid Injection BP 100mg/ml | Antifibrinolytic | Hemant Surgical and Medical limited , Ilyaseen Ishaq Omeiza Siyaka | Hunan Dongting Pharmaceutical Co., Ltd., Address: No.16 Dongyan Road, Deshan, Changde, PC415001, Hunan Province, China. | Incompletete CTD Dossier Submission |
| 284 | CEFUROXIME AXETIL TABLETS BP 500 MG | CEFUROXIME AXETIL TABLETS BP 500 MG | Antibiotics | ELIMADAV DRUGS LIMITED, Edith NGOZI OZOR | M/s. AEVIAS HEALTHCARE, Survey No. 313/P2, Nedra- Chandravati Road, At. – Nedra, Ta. – Sidhpur, Dist. Patan-384151, Gujarat State, India | Incompletete CTD Dossier Submission |
| 285 | MECLIZINE HYDROCHLORIDE AND PYRIDOXINE HYDROCHLORIDE TABLETS | MECLIZINE HYDROCHLORIDE 25MG AND PYRIDOXINE HYDROCHLORIDE 50MG | Antihistamine/Vitamin | JOPAR BROTHERS PHARMACEUTICAL LTD, JOANACHIM IFEANYI IBEH | JIANGXI XIER KANGTAI PHARMACEUTICAL CO. LTD ADDRESS: NORTH ZONE, HIGH-NEW TECHNOLOGY INDUSTRIAL ZONE, PINGXIANG, JIANGXI, CHINA | Incompletete CTD Dossier Submission |
| 286 | Artemether Injection 80mg/1m | Artemether Injection 80mg/1m | Antimalaria | CLIFF PHARMACY LIMITED, CHINONSO NZENWA C NWACHUKWU | Anhui Chengshi Phamaceutical Co. Limited, No. 5068 Huaishang road,Bengbu,Anhui province, China | Incompletete CTD Dossier Submission |
| 287 | JEKTHROTEC TABLET | DICLOFENAC SODIUM AND MISOPROSTOL TABLET | Analgesic | ONYIJEK PHARMACEUTICAL COMPANY LIMITED, CHARITY AMAKA CHARITY EGOLE | Curis Lifesciences. Ltd, PF-23, Sanaand GIDC II, Sanand, Ahmedabad – 392110, Gujarat, India | Incompletete CTD Dossier Submission |
| 288 | RABETALOL-200 | LABETALOL HYDROCHLORIDE TABLETS USP 200MG | Antihypertensive | Goz Green Pharmaceutical, Onashokun Najeem Olawale Onashokun | CURIS LIFESCIENCES LTD, PF-23 SANAND GIDIC-11, SANAND AHMEDABAD-382110, GUJARAT | Incompletete CTD Dossier Submission |
| 289 | ARTEMETHER + LUMEFANTRINE 80/480 mg TABLETS | ARTEMETHER 80MG+ LUMEFANTRINE 480MG | Antimalaria | SURELIFE PHARMA IND LTD, CHIEF SIR UJAGBA CHIRF UJAGBA | SURELIFE PHARMACEUTICAL IND LTD. NO.1 S.I. ONYIA CLOSE BY FACTORYROAD OKWE, ASABA, DELTA STATE, NIGERIA. | Incompletete CTD Dossier Submission |
| 290 | Methylprednisolone Sodium Succinate for Injection USP 1000mg | Methylprednisolone Sodium Succinate for Injection USP 1000mg | Corticosteroids | CHIDRIX HEALTHCARE , CHIDI UGO EMEN | PROTECH BIOSYSTEMS PVT. LTD, BHAGWANPUR, ROORKEE, DISTT. HARIDWAR, UTTARAKHAND, INDIA. | Incompletete CTD Dossier Submission |
| 291 | Artesunate 60mg injectipon | ARTESUNATE 60MG INJECTION B.P 60MG | Antimalaria | Ryla PHARMACY COMPANY LIMITED, Ryla Pharmacy Company Ltd ADEREMI ADELEKE | HFA FORMULATION PVT LIMITED, 179/181 idimu- ikotun road,alake bus stop, samkoll garden,.ikotun,.lagos | Incompletete CTD Dossier Submission |
| 292 | LIPOTRIM | EZETIMIBE + ROSUVASTATIN | Antihyperlipidemic Combination | AMANA PEJI NIG. LTD., Mr. Eugene C. Duru C. Duru | Consern Pharma. Ltd, Focal Point, V.P.O, Tibba, Ludhiana, Punjab,India-141120 | Incompletete CTD Dossier Submission |
| 293 | MEDHEALTH 80/480 | ARTEMETHER & LUMEFANTRINE TABLETS 80MG/480MG | Antimalaria | metrak pharmacy and industries ltd, Metrak Charity c agudindu | McCoy Pharma Pvt. Ltd, S-12/13, M.I.D.C., Tarapur, Boisar, Palghar-401506, Maharashtra, India. | Incompletete CTD Dossier Submission |
| 294 | OMACEF | ARTEMETHER LUMEPHANTRINE | Antimalaria | GREAT OMACO PHARMACY LIMITED, EMMANUEL OZOEMENA EMMANUEL OZOEMENA | MERCURY HEALTHCARE PVT LTD, 12-B, Girichhaya, Loyalka Estate, Chowpatty Band Stand, Mumbai â 400 006, INDIA | Incompletete CTD Dossier Submission |
| 295 | CEFTRIAXONE FOR INJECTION USP 1 GM | CEFTRIAXONE FOR INJECTION USP 1 GM | Antibiotics | KITE LIFESCIENCES LTD, IFY IFY OHA | ALLIAANCE BIOTECH, VILL. KATHA, BADDI, DISTT. SOLAN (H.P.) INDIA | Incompletete CTD Dossier Submission |
| 296 | Pregabalin | Pregabalin | Anticonvulsant | lifemednigeria@gmail.com, lifemed ASSA GABRIEL | NUCLEUS FORMULATION PVT. LTD. PLOT No. 3484/3485, Phase IV, GIDC Chhatral 382729 , Tal. Kalol, Dist. Gandhinagar, Gujarat, INDIA. | Incompletete CTD Dossier Submission |
| 297 | CEFTRIAXONE FOR INJECTION USP 1 GM | CEFTRIAXONE FOR INJECTION USP 1 GM | Antibiotics | VALUELIFE PHARMACEUTICAL LIMITED, ALEX VINCENT CHIBUEZE ALEX | M/s. SWISS PHARMA PVT. LTD.Plot No- 3709,Phase-IV, G.I.D.C., Vatva, ahmedabad, INDIA | Incompletete CTD Dossier Submission |
| 298 | Softgels Artemether and Lumefantrine | Artemether and Lumefantrine | Antimalaria | CARDINALBELLS PHARMACEUTICALS LTD, Mr Jude DURU OKAFOR | ASOJ SOFT CAPS PVT. LTD.Asoj, Baroda â Halol Highway, Dist. Baroda â 391 510. Gujarat | Incompletete CTD Dossier Submission |
| 299 | Artemether + Lumefentrine Tablet 80 /480 mg | Artemether80mg & Lumefantrine480 | Antimalaria | CVUNS INTERNATIONAL LIMITED, UMESH ASSUDANI C ASSUDANI | STIVAPH HEALTHCARE PVT. LTD, PlotNo. âPF-01, Ground Floor, Sanand, GIDC -II, Village â BOL, Tal – Sanand, Dist.Ahmedabad â 382170 | Incompletete CTD Dossier Submission |
| 300 | PACCIN | OFLOXACIN AND TINIDAZOLE | Antibiotics | PACMAI INTERNATIONAL LTD., Benjamin Chukwudile Nnaemeka Chukwudile | CORONA REMEDIES LIMITED, C-MONDEAL BUSINESS PARK,NEAR GURUWARA,S.G. HIGHWAY, THALTEJ ,AHMEDABAD 380 059. GUJARAT, INDIA. | Incompletete CTD Dossier Submission |
| 301 | JESSY PENTAZOCIN INJECTION | PENTAZOCIN INJECTION | Opiod Analgesic | JESSY PHARMACEUTICALS NIG. LIMITED, john CHIADIZU JOHN | SHUKRA PHARMACEUTICALS LIMITED, PLOT NO 795, RAKANPUR, SOLA- SANTEJ ROAD, TA. KALOL, DIST. GANDHINAGER (GUJARAT), INDIA | Incompletete CTD Dossier Submission |
| 302 | ESOMEPRAZOLE SODIUM FOR INJECTION 40 MG | ESOMEPRAZOLE SODIUM FOR INJECTION 40 MG | Proton Pump Inhibitors (PPIs) | DONY-TRIUMPH AND COMPANY NIGERIA LIMITED, DONATUS NWACHUKWU chief NWACHUKWU | MAKCUR LABORATORIES LIMITED, 46/4-7, NARODA-DEHGAM HIGHWAY, DEHGAM, GANDHINAGAR, GUJARAT 382330 INDIA | Incompletete CTD Dossier Submission |
| 303 | Artemether injection 80mg/1ml | Artemether injection 80mg/1ml | Antimalaria | SPAN PHARM NIGERIA LTD, MICHAEL NNAKA NWACHUKWU NWACHUKWU | Jiangsu Swellxin Bio-Pharm. Pty. Ltd.Building D. No 7. Guang Dong Road, Free Trade Zone, Zhang Jia Gang-215634, Jiang Su, China | Incompletete CTD Dossier Submission |
| 304 | PENTAZOCINE INJECTI-ON | PENTAZOCINE INJECTION 30MG/ML | Opiod Analgesic | PATRICKLINGO PHARMACEUTICALS LIMITED, PATRICK ONWUELINGO T | M/s. FANTA-SY DRUGS PRIVATE LIMITED, Plot No. C-66 to 69, D-33 to 36 Industrial Area Hajipur, Vaishali, Bihar- 84-4101, INDIA — | Incompletete CTD Dossier Submission |
| 305 | 8 DAYS SILDENAFIL | SILDENAFIL 100MG | Phosphodiesterase type 5 (PDE5) inhibitors | 8 DAYS MULTI TRADE LTD, 8 DAYS MULTI TRADE MUKHTAR BELLO | SANGHARSH LIFECARE PVT,KHATA NO 693, SURVEY NO 192, VILLAGE GANESHPURA, DHANALI ROAD, AHMEDABAD MENSANA HIGHWAY, TAL. KADI, DIST -MEHSANA- 382 705, GUJRAT | Incompletete CTD Dossier Submission |
| 306 | ARTESUNATE INJECTION 120MG | ARTESUNATE 120MG | Antimalaria | GLASGATE PHARMACY LTD, DANIEL NGBEDE ENENCHE | ALLIAANCE BIOTECH ADDRESS: 440/3, VILL. KATHA, BADDI, DISTT. SOLAN (H.P), INDIA | Incompletete CTD Dossier Submission |
| 307 | Nouvasant pentazocine injection | Pentazocine Injection BP 30 mg/ml | Opiod Analgesic | NOUVASANT PHARMHEALTH LIMITED, nouvasant GODFREY CHIBUIKE | Merit Organics Ltd, Plot No 2104/2/A, G.I.D.C , Sarigam , Bhilad, Dist- Valsad-396155, Gujarat , INDIA. | Incompletete CTD Dossier Submission |
| 308 | ARTEMETHER 80 MG AND LUMEFANTRINE 480 MG TABLETS | ARTEMETHER 80 MG AND LUMEFANTRINE 480 MG | Antimalaria | FECCOX PHARMACY AND GENERAL ENTERPRISES LTD, CHIEF MBA WILLIAMS M CHIEF | M/s. IMPULSE PHARMA PVT. LTD, J-201, J-202/1, MIDC Tarapur, Boisar Dist. Palghar – 401506. India.. | Incompletete CTD Dossier Submission |
| 309 | MEDAXOL INFUSION | Metronidazole 5 mg/ml | Antibiotics | VIXA PHARMACEUTICALS CO. LTD, VIXA PHARMACEUTICALS CO. LTD UZOAMAKA ONONYE | Shijiazhuang No.4 Pharmaceutical Co., Ltd. No.288 Zhujiang Road, High-tech Industrial Development Zone, Shijiazhuang Yangzi Road, Economic & Technological Development Zone, Shijiazhuang | Incompletete CTD Dossier Submission |
| 310 | OSIPREGA 75 | Pregabalin | Anticonvulsant | DE-ZUBIK PHAMACEUTICAL LTD, Amadi Okocha J Amadi | Globela Pharma Pvt. Ltd . 357-358, Road No.-3, Sachin G.I.D.C, Surat, Gujarat, India. | Incompletete CTD Dossier Submission |
| 311 | ROTAMED 20/120 | Artemether 20MG & Lumefantrine120MG | Antimalaria | ROTABOL HEALTHCARE LTD, ROTIMI AFOLAOGUN A AFOLAOGUN | OM BIOMEDIC PVT. LTD. 1203, 12th Floor, Sri Krishna Bldg, New Link Road, Opp Laxmi Inds Estate, Nr. Fun Republic Mall, Andheri (West), Mumbai – 400053, Maharashtra, India. | Incompletete CTD Dossier Submission |
| 312 | PENTAMAX INJECTION | Pentazocine BP 30mg/ml | Opiod Analgesic | ENVOLVE PHARMACEUTICAL LIMITED, JUNAID OLAYINKA OLADAPO C NWACHUKWU | BHARAT PARENTERALS LTD SURVEY NO. 144 â A, JAROD SAMLAYA RAOD, VILLAGE: HARIPURA, TAL. SAVLI, DIST. â VADODARA â 391 520, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 313 | Lazecort | Hydrocortisone Sodium Succinate for Injection USP 100 mg | Corticosteroids | Lazek Pharmacy Ltd , Okafor Linus Chinyereze Okafor | Protech Biosystem Pvt Ltd, Bhagwanpur, Roorkee, Dist.- Haridwar, Uttarakhand, India | Incompletete CTD Dossier Submission |
| 314 | Basic joe para | paracetamol injection | Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | BASIC JOE GLOBAL VENTURES & PHARMACEUTICALS LIMITED, Cyriacus Ike Emehelu | HEBEI JIHENG (GROUP) PHARMACEUTICAL LTD. NO 1, WeiWu Street, Hengshui Idustrial Park, Hebei Province, China | Incompletete CTD Dossier Submission |
| 315 | LOPERAMIDE HYDROCHLORIDE TABLETS USP 2MG | LOPERAMIODE HYDROCHLORIDE TABLETS USP 2MG | Antidiarrhea | KUBA’S PHARM MED LTD, kuba E.C CYRIACUS | AR LIFESCIENCES, 819/B, Industrial Area, Rakanpur, Santej, Ta. Kalol, Dist-Gandhinagar, Gujarat-382721, INDIA. | Incompletete CTD Dossier Submission |
| 316 | Cartesunate Injection | Artesunate for injection | Antimalaria | GBGL PHARMA LIMITED, Dorothy Ngozi Ughenu Ngozi Ughenu | MAKCUR LABORATORIES LIMITED, 46/4-7, NARODA-DEHGAM HIGHWAY, DEHGAM, GANDHINAGAR, GUJARAT 382330 INDIA | Incompletete CTD Dossier Submission |
| 317 | Ceftriaxone 1000MG and Sulbactam 500MG | Ceftriaxone 1000MG and Sulbactam 500MG | Antibiotics | MAKKI PHARMACEUTICALS LTD, IFEANYI ARINZE CHIEF IFEANYI | Shandong Xier Kangtai Pharmaceutical Co., Ltd.Private Economy Garden, Xinyan Town, Yanzhou, Jining, Shandong, China | Incompletete CTD Dossier Submission |
| 318 | CELECOXIB 200MG | CELECOXIB 200MG | Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | KARIFIELD PHARMACEUTICAL LIMITED, KARIFIELD PHARMACEUTICAL LIMITED ABIGAIL EFE | RATNAMANI PHARMACEUTICAL LIMITED, 1004-1006 10th floor North Tower Bopal Ambli road Ahmedabad 380054 GUJARAT INDIA | Incompletete CTD Dossier Submission |
| 319 | GABADINO TABLETS | Pregabalin + Nortryptyline + Methylcobalamine | Anticonvulsant/Antidepressant | MEDIGATE PHARMACEUTICAL COMPANY LIMITED, Chima C. OGBU | CONSERN PHARMA LIMITED, Focal Point, Village & Post Office: Tibba, District: Ludhiana, Punjab, India | Incompletete CTD Dossier Submission |
| 320 | MARCLLERG | Antazoline Hydrochloride 0.05% w/v and Tetryzoline Hydrochloride 0.04% w/v Eye drops) | Antihistamine/Decongestant | Marcson Healthcare Ltd, Olufemi Atolagbe Simeon Chinwuba | CORAL LABORATORIES LTD.5, 6 Khokhani Industrial Complex No.2, Sativali, Vasai (E), Thane – 401 208. INDIA | Incompletete CTD Dossier Submission |
| 321 | Opizole | Omeprazole | Proton Pump Inhibitors (PPIs) | PIVOT PHARMACY LTD, Mr Henry .I.Nwankwo I Nwankwo | AâRAF (PVT Ltd), 23-Km, Raiwind Road Lahore â Pakistan | Incompletete CTD Dossier Submission |
| 322 | PENTAZOCINE INJECTION BP 30MG/ML | PENTAZOCINE BP 30MG/ML | Opiod Analgesic | ACTAVIS LIFE-CARE LIMITED, REGINALD IKECHUKWU MR REGINALD | FARBE FIRMA PVT.LTD.Plot no: 1508, G.I.D.C., Ankleswar Gujarat- 393 002, India | Incompletete CTD Dossier Submission |
| 323 | NCPC | PENICILLIN – V | Antibiotics | CHRIS NELB PHARMACEUTICAL NIG. LTD., Chris LUCY HARRISONEZEBUO | NORTH CHINA PHARMACEUTICAL CO., LTD.NO 388, HEPING EAST ROAD, SHIJIAZHUANG, CHINA. | Incompletete CTD Dossier Submission |
| 324 | Losartan Potassium Tablets BP 100 mg | Losartan | Antihypertensive | HEALCROSS PHARMACEUTICALS LTD, OKEREKE JUDE OKEREKE | Alpa Laboratories LTD, 33/2, A.B road, Pigdamber â 453 446 Indore(M.P.) – India. | Incompletete CTD Dossier Submission |
| 325 | Benzhexol Tablet | Benzhexol Tablet | Anticholinergic | Nalis Pharmaceuticals Limited, Nalis Pharma Uche Onwumah | Nalis Pharmaceuticals Ltd, R67/68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State, Nigeria | Incompletete CTD Dossier Submission |
| 326 | KATOLANE | Pyronaridine Tetraphosphate 180mg and Artesunate 60mg Tablet | Antimalaria | GREGDEN PHARMACY AND SUPERMARKET, Ogbuji Dennis Somto SOMTO OGBUJI | FLOURISH PHARMA, 24 E, GOA IDC, DAMANIND ESTATE, SOMNATH ROAD, DABHEL, DAMAN-396215 | Incompletete CTD Dossier Submission |
| 327 | CLOPIDOGREL TABLETS | CLOPIDOGREL TABLETS USP 75 MG | Antiplatelets | CHANNEL PHARMACEUTICALS LIMITED, Channel Pharmaceutical Ltd Augustine Ola | Stallion laboratories Pvt. Ltd, C-1B, 305/2,3,4 & 5, GIDC, Kerala (Bavla) Dist: Ahmedabad-382220, Gujarat, India | Incompletete CTD Dossier Submission |
| 328 | PREGABALIN CAPSULES BP 75MG | PREGABALIN BP 75MG | Anticonvulsant | Grandhigh General Services Ltd, Shehu Ahmed Shehu | ENDURANCE HEALTHCARE PVT LTD, C-1B 305/2,3,4 & 5 G.I.D.C KERALA (BAVLA) DIST, AHMEDDABAD, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 329 | MALLUART 560 | Artemether 80mg + Lumefantrine 480mg Capsules | Antimalaria | ROXIN PHARMACEUTICALS CO. NIG, James Ochiogu Chinonso Ochiogu | M/S. BRIYOSIS SOFT CAPS PVT. LTD, Address; Sr. no. 176/1/1, OPP.L.K. India, Jarod- Rasulabad Road, At & Post-Jarod, Tal- Waghodia, Dist.- Vadodara, Gujarat-391510, India | Incompletete CTD Dossier Submission |
| 330 | DEKSEL NANO SHOTS 60000IU | VITAMIN D3 | Vitamin D analogue | PULSE PHARMACEUTICALS NIGERIA PVT LTD, RANJU S NAIR | Pulse Pharmaceuticals Pvt Litd, No 400, 407, 409 Karondi, Roorkee, Uttarakhand-247667, INDIA | Incompletete CTD Dossier Submission |
| 331 | PENTAZOCINE INJECTION 30mg/ml,1ml | PENTAZOCINE INJECTION BP 30mg/ml | Opiod Analgesic | NCI PHARM CHEM IND LTD, NCI PHARM CHEM IND LTD NNENNA ONOVO | NANDANI MEDICAL LAB. PVT.LTD. 221/5 Bicholi Hapsi Kanadia Road Indore. (M.P.) | Incompletete CTD Dossier Submission |
| 332 | Ceflag S 1.5g inj | Ceftriaxone Sulbactam 1.5g injection | Antibiotics | LAGAS PHARMACEUTICAL LIMITED, Pharm. Ikwebe Ori Helen Ori Ikwebe | OM BIOMEDIC PVT LTD, Plot No. 68, 69, 82 & 83, Sector-6A, IIE, Sidcul Distt. Haridwar, Uttarakhand, India | Incompletete CTD Dossier Submission |
| 333 | Ketamine Injection BP 50mg/ml | Ketamine Injection BP 50mg/ml | Anaesthetics | MIGHTY FAVOUR PHARMACEUTICAL LTD,, OGUGUA NNAMDI OGUGUA N | M/s. Farbe Firma, Plot number 1508, GIDC Estate, Ankleshwar , Ankleshwar- 393002 | Incompletete CTD Dossier Submission |
| 334 | SOPHIZOLE CAPSULES | FLUCONAZOLE 200MG USP | Antifungal | SOPHIAWILLIAMS PHARMACY LIMITED, Smatt Aguba k Aguba | BENTOS PHARMACEUTICAL PRODUCTS LTD, KM 8 OLD LAGOS ROAD, IBADAN NIGERIA | Incompletete CTD Dossier Submission |
| 335 | Pentazocine Injection BP 30mg/ml | Pentazocine Injection BP 30mg/ml | Opiod Analgesic | NICKGRACE DRUG PHARMACY AND STORES LTD, NICKGRACE KAOSI OGBUOKIRI | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 336 | RRYZOL | BENZHEXOL | Anticholinergic | MAY GLOW PHARM LIMITED, PATRIC NDUBUISI ALAEKWE | BAADER SCHULZ LABRATORIES,PLOT NO. J/6 OIDC M.G UDYOG NAGAR DABHEL DAMAN396210 | Incompletete CTD Dossier Submission |
| 337 | CEFUROXIME AXETIL TABLETS USP 250MG & 500MG | CEFUROXIME AXETIL TABLETS USP 250MG & 500MG | Antibiotics | CRISTABEN PHARMA NIG LTD., Christiana Ofodu n/a Ofodu | ENDURANCE HEALTHCARE PVT.LTD, 3709, G.I.D.C., PHASE IV, VATVA City: AHMEDABAD 382 445, Gujarat State, India | Incompletete CTD Dossier Submission |
| 338 | DRICAR | TRYPSIN/CHYMOTRYPSIN TABLETS | Proteolytic Enzymes | MEGA VIEW RESOURCES & INDUSTRIES LIMITED, MEGA VIEW RESOURCES & INDUSTRIES LIMITED MICHAEL IHIONU | AR LIFESCIENCES, 819/B, Industrial Area, Rakanpur, Santej, Ta. Kalol, Dist-Gandhinagar, Gujarat-382721, INDIA. | Incompletete CTD Dossier Submission |
| 339 | ARTINAT INJECTION | Combipack Artesunate Injection 120 mg, Sodium Bicarbonate Injection BP 5.0 % w/v and Sodium Chloride Injection BP 0.9 % w/v | Antimalarial/Alkalinizing Agent/Electrolyte | Generics and Specialities Limited, Cyril Odidika Nkem Odidika | Lincoln Pharmaceuticals LtdTrimul Estate, AT and Post Khatraj, Tal Kalol, Dist. Gandhinagar, Gujarat, India | Incompletete CTD Dossier Submission |
| 340 | Cefuroxime Injection 0.75g | Cefuroxime 0.75g | Antibiotics | MULTIHCHRIS PHARMACEUTICAL AND CHEMICAL CO. LTD., Ifeanyi Nwafor Chris Nwafor | Hunan Kelun Pharmaceutical Co., Ltd.Kangwang Industrial Park, Yueyang Economic And Technological Development Zone, Hunan Province, P. R. China | Incompletete CTD Dossier Submission |
| 341 | Pentazocine Injection BP 30 mg/ ml | Pentazocine Injection BP 30 mg/ ml | Opiod Analgesic | IBU PHARM NIG. LTD, Mercy I Mattew | M/s. Farbe Firma, Plot number 1508, GIDC Estate, Ankleshwar , Ankleshwar- 393002 | Incompletete CTD Dossier Submission |
| 342 | TOBRAMYCIN EYE OINTMENT | TOBRAMYCIN USP 0.3% W/W | Antibiotics | FIDSON HEALTHCARE LTD, Nmaka I. TIJANI | CURIS LIFE SCIENCE PVT LTD,PF-23 Sanand, GIDC II, Sanand, Ahmedabad-363020, GUJARAT (INDIA) | Incompletete CTD Dossier Submission |
| 343 | OSYGABALIN | PREGABALIN CAPSULE BP 300ML | Anticonvulsant | OSSY ADAMU PHARMACEUTICAL COMPANY LIMITED | MAZHEAL LABORATORIES PVT. LTD,PLOT NO 2-7/80-85, SUAREZ ,SACHIN,DIST. SURAT(GUJARAT) 394 230 | Incompletete CTD Dossier Submission |
| 344 | LORENC | DICLOFENAC SUPPOSITORY | Analgesic | SEVEREIN PHARAMACEUTICAL COMPANYY LTD | GLEN HARMACEUTICALS LTD | Incompletete CTD Dossier Submission |
| 345 | PREGABALIN CAPSULES 300 MG | PREGABALIN CAPSULES 300 MG | Anticonvulsant | PILLAR PHARMACEUTICALS NIGERIA LIMITED | SWISS PHARMA PVT.LTDPLOT 3709 PHASE- IV G.I.D.C. VATVA AHMEDABAD GUJARAT 382445 INDIA. | Incompletete CTD Dossier Submission |
| 346 | Cyporin Ophthalmic Emulsion | Cyclosporine USP 0.05%w/v | Immunosuppressants | VITACARE PHARMACY LIMITED, DIKE FRANCIS EMEKA PAUL MOSES | Aristopharma Ltd. Plot # 14-22, Road # 11-12, Shampur-Kadamtali I/A, Dhaka-1204, Bangladesh | Incompletete CTD Dossier Submission |
| 347 | CHLOROQUINE INJECTION | CHLOROQUINE PHOSPHATE BP EQVT. TO CHLOROQUINE BASE 40 MG | Antimalaria | UPWARD FIELD NIGERIA LIMITED, FRANCIS EZERIBE Oluwafunke Ononiwu | VITAL HEALTHCARE PVT. LTD. PLOT NO. H/10, H10/1, M.I.D.C., SATPUR, NASHIK – 422007 MAHARASHTRA STATE, INDIA | Incompletete CTD Dossier Submission |
| 348 | SACUBITRIL VALSARTAN TABLETS 50mg, 100mg & 200mg | SACUBITRIL VALSARTAN TABLETS 50mg, 100mg & 200mg | Antihypertensive | PEAKPHARM NIGERIA LIMITED, PAUL IBEANUKA OGOCHUKWU IBEANUKA | C1B-305,2, 3, 4 & 5, G.I.D.C. Kerala (Bavla) Dist: Ahmedabad, Gujarat, | Incompletete CTD Dossier Submission |
| 349 | MICROMOX D | MOXIFLOXACIN HYDROCHLORIDE 0.5% & DEXAMETHASONE PHOSPHATE 0.1 % OPHTHALMIC SOLUTION | Antibiotic/Corticosteriods | MICRONOVA PHARM IND LTD , Pharm. Solomon Ogbuefi EBELE OGBUEFI | MICRO LABS LIMITED Plot No. 113-116, Phase IV, KIADB Industrial Area, Bommasandra, Bengaluru-560099, INDIA. | Incompletete CTD Dossier Submission |
| 350 | CEFTRIAXONE SODIUM AND SULBACTAM SODIUM FOR INJECTION | CEFTRIAXONE SODIUM AND SULBACTAM SODIUM | Antibiotics | ZADIP HEALTHCARE LTD, KC OWOH OWO CHIEF | PRIVATE ECONOMY GARDEN, XINYAN TOWN, YANZHOU, JINING CITY, SHANDONG CHINA | Incompletete CTD Dossier Submission |
| 351 | Benisun Artesunate Injection | Artesunate Injection | Antimalaria | BENZYK PHARMACEUTICAL LTD, Onyeka Confidence CONFIDENCE ONYEKA | SYNCOM FORMULATIONS INDIA LIMITED,256-257, Sector-1, Pithampur, Dist.-Dhar, (M.P) 454775 India | Incompletete CTD Dossier Submission |
| 352 | FLUCONAZOLE TABLETS USP 200 MG | FLUCONAZOLE TABLETS USP 200 MG | Antifungal | P K N PHARMACEUTICAL LIMITED, Tony OBINNA CHUKWUKA | SURMOUNT LABORATORIES PVT.LTD.A-2/4003, GIDC Ind. Estate, Ankleshwar-393002, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 353 | Chaibb Levofloxacin | Levofloxacin | Antibiotics | Chaibb Pharmaceuticals Ltd, Chaiib pharmaltd Chidinso Ndubuaku | Trioplus Pharmaceutical Pvt Ltd, Unit no 106, samruddhi commercial complex, chincholi bunder Road, mindspace, malad West, Mumbai 400064 | Incompletete CTD Dossier Submission |
| 354 | PENTAZOCINE INJECTION BP | Pentazocine Lactate BP equivalent to Pentazocine 30 mg | Opiod Analgesic | DOPAMATE NIGERIA LIMITED, ARUKWE EDOZIE MONDAY EDOZIE MONDAY | VITAL HEALTHCARE PVT. LTD. PLOT NO. H/10, H10/1, M.I.D.C., SATPUR, NASHIK-422007 REGD. OFFICE: 5/6, SHREYAS, 2ND HASNABAD LANE, SANTACRUZ (W), MUMBAI â 400 054. | Incompletete CTD Dossier Submission |
| 355 | CEFUROXIME AXETIL TABLETS USP 250MG & 500MG | CEFUROXIME AXETIL TABLETS USP 250MG & 500MG | Antibiotics | ELLASINIKS CHANNELS LTD, Pamela O. OBIEFUNA | ENDURANCE HEALTHCARE PVT.LTD, 3709, G.I.D.C., PHASE IV, VATVA City: AHMEDABAD 382 445, Gujarat State, India | Incompletete CTD Dossier Submission |
| 356 | NWAEZE | Artemeter/Lumefantrine | Antimalaria | Freedom Nwaeze Enterprises, Eze John Okonkwo John Okonkwo | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 357 | CAMOSUNATE | Amodiaquine + Artesunate | Antimalaria | GENEITH PHARMACEUTICALS LIMITED, Emmanuel Umenwa UZOAMAKA ONWUKA | FRONT Pharmaceutical PLC,Economic and Technical Development zone, Xuancheng, Anhui, China | Incompletete CTD Dossier Submission |
| 358 | RONYMAL TABLETS | ARTEMETHER 20MG & LUMEFANTRINE 120MG DISPERSIBLE TABLET | Antimalaria | RONYBO NIG. LTD, RONYBO NIG. LTD CLEMENTINA UBAJEKWE | TRIDENT LIFELINE LIMITED, Plot No. 4232, Road no. 42, Sachin, Surat-394230, India | Incompletete CTD Dossier Submission |
| 359 | Artemether and Lumefantrine 80 / 480 Tablets | Artemether and Lumefantrine 80 / 480 | Antimalaria | BARNAETO PHARMACY LTD. , OBINNA IGWEBUIKE O. | IMPUSLE PHARMA PVT LTD,PLOT NO 202, 202/1, MIDC TARAPUR BOISAR, TAL & DIST PALGHAR-401506, INDIA | Incompletete CTD Dossier Submission |
| 360 | CLARTEM DISPERSIBLE TABLETS | Artemether 20 mg and Lumefantrine 120 mg | Antimalaria | CLARION MEDICALS LIMITED, CHINENYE IGWEGBE A. IGWEGBE | Jiangsu Ruinian Qianjin Pharmaceutical Co., Ltd. | Incompletete CTD Dossier Submission |
| 361 | SUPAMIDE | Apixaban | Direct Oral Anticoagulants (DOACs) | Superior Pharmaceuticals Ltd, Shogbola Ruth Okiemute Shogbola | SWISS PHARMA PVT.LTD. 3709 G.I.D.C., Phase-IV, Vatva, Ahmedabad, Ahmedabad 382 445, Indi | Incompletete CTD Dossier Submission |
| 362 | CEFUROXIME AXETIL TABLETS USP 500 MG | CEFUROXIME AXETIL TABLETS USP 500 MG | Antibiotics | CENTCHARLY PHARMA LTD, VISHAL SHAH MR U | SWISS PHARMA PVT.LTD. 3709 G.I.D.C., Phase-IV, Vatva, Ahmedabad, Ahmedabad 382 445, Indi | Incompletete CTD Dossier Submission |
| 363 | ENTIFIRM 0.5 | ENTECAVIR TABLETS USP O.5 MG | Antiviral | GRACEPLUS HEALTHCARE LTD | KUREASIA PHARMA PRIVATE LIMITED, Industrial Area, Plot Number-1 Khasra No. 882, 883k, 883kh, Salempur, Mehdood-II Haridwar-249402, Uttarakhand, INDIA | Incompletete CTD Dossier Submission |
| 364 | GABAPREF | Pregabalin Capsules 75 mg | Anticonvulsant | PREFERRED DRUGS NIGERIA LIMITED., PREFERRED DRUGS NIGERIA LIMITED | Fredun Pharmaceuticals Limited, Plot No.14,15,16, Zorabian Industrial Complex, Vevoor, Palghar (E), Dist: Palghar -401 404 Maharashtra State | Incompletete CTD Dossier Submission |
| 365 | DYDROGESTERONE TABLETS B.P 10MG | DYDROGESTERONE TABLETS B.P 10MG | Progestogens | MARK PHARMACEUTICAL LTD, MARK PHARMACEUTICALS LTD. | WEST COAST PHARMACEUTICAL WORKS LTD, AHMEDABAD,F. P NO 17/16 5, MELDI BUSSTOP MATA TEMPLE, NEAR GOTA RAILWAY CROSSING | Incompletete CTD Dossier Submission |
| 366 | Haloperidol Injection BP 5mg/ml | Haloperidol BP | Antipsychotics | SYNMEDIC SPECIALTY LIMITED | PHARMAX INDIA PVT. LTD.9 KURLA INDUSTRIAL ESTATE, NETAJI PALKAR ROAD, NARAYAN NAGAR, GHATKOPAR WEST, MUMBAI-400086, INDIA | Incompletete CTD Dossier Submission |
| 367 | Ricnos Artemeth | Artemether 80mg + Lumefantrine 480mg | Antimalaria | RICNOS PHARMACEUTICAL NIGERIA LIMITED | Shukra Pharmaceutical Limited, Site 795, Rakanpur, Sola-Santej Road, Opp. Nilkanth Hotel Ta. Kalol, Dist Gandhinagar – 382721, Gujarat, India. | Incompletete CTD Dossier Submission |
| 368 | Pregabalin capsule 300mg | Pregabalin capsule 300mg | Anticonvulsant | KFC PHARMACEUTICAL NIGERIA LIMITED , Onyebuchi maduka Celestine maduka | KOPRAN RESEARCH LABORATORIES LIMITED K4/4, Additional MIDC, At & Post Birwadi Taluka Mahad, District Raigad 402302 Maharashtra, INDIA | Incompletete CTD Dossier Submission |
| 369 | Sildenafil Citrate & Dapoxetine Hydrochloride Tablets (50/30mg) & (100/60mg) | Sildenafil Citrate & Dapoxetine Hydrochloride Tablets (50/30mg) & (100/60mg) | PDE5 inhibitor (Phosphodiesterase type 5 inhibitor)/Selective Serotonin Reuptake Inhibitor (SSRI) | RIGHT ALLIANCE LIMITED, Folasade — Nleweoha | ENDURANCE HEALTHCARE PVT LTD, C-1B 305/2,3,4 & 5 G.I.D.C KERALA (BAVLA) DIST, AHMEDDABAD, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 370 | PENTAZOCINE INJECTION BP 30MG/ML | PENTAZOCINE INJECTION BP 30MG/ML | Opiod Analgesic | LYNORA PHARMACEUTICAL AND CHEMICAL LTD, NGOZI EVELYN EZUMBA EVELYN EZUMBA | M/s FARBE FIRMA Pvt Ltd.PLOT NO: 1508, NEAR ATIQUE BAKERY, GIDC ESTATE, ANKLESHWAR – 393002, GUJARAT, INDIA. | Incompletete CTD Dossier Submission |
| 371 | PETONCEF Cefuroxime axetil Tablets USP 250 mg | Cefuroxime axetil Tablets | Antibiotics | Peton Pharmaceutical Nig. Ltd, Nworie peter Ozioma Nworie | WISS PHARMA PVT. LTD. 3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382445, Dist.: Ahmedabad.Gujarat State, India | Incompletete CTD Dossier Submission |
| 372 | CEFUROXIME AXETIL TABLETS USP 500MG | CEFUROXIME AXETIL TABLETS USP 500MG | Antibiotics | DIAZEMOOR NIG LTD, VIRGINIA NDUBUEZE ONUABUCHI NDUBUEZE | Nectar Lifesciences Limited, Village Saidpura, Tehsil Dera Bassi, District Sahibzada Ajit Singh Nagar 140 507, Punjab, INDIA | Incompletete CTD Dossier Submission |
| 373 | MELIGLIPT M & Meglipt M Forte | Vildagliptin and Metformin Hydrochloride Tablets | Antidiabetic | HEALTHLINE LIMITED, ITUNU AJAYI Itunu Ajayi | Swiss Garnier Life sciences,21 â 23, Industrial Area, Mehatpur, Distt â Una, Himachal Pradesh – 174315 | Incompletete CTD Dossier Submission |
| 374 | KRISHAT OMEPRAZOLE SODIUM FOR INJECTION 40MG | OMEPRAZOLE SODIUM FOR INJECTION 40MG | Proton Pump Inhibitors (PPIs) | KRISHAT PHARMA INDUSTRIES LIMITED, KRISHAT PHARMA IND LTD BHARAT SHAH | MAANSHAN BBCA PHARMACEUTICAL CO. LTD.NO. 1503, MEISHAN ROAD, MAANSHAN ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, ANHUI PROVINCE, PEOPLE’S REPUBLIC OF CHINA | Incompletete CTD Dossier Submission |
| 375 | LUMINOR Eye drops | Brimonidine tartrate | Alpha-2 adrenergic agonists | Oskajay Nigeria Limited | Popular Pharmaceuticals Ltd. Factory: 164, Tongi Industrial Area, Monnunagor, Gazipur-1710, Bangladesh | Incompletete CTD Dossier Submission |
| 376 | RELIEXTRA | Diclofenac Sodium 50mg | Analgesic | Rick Rose Pharmaceuticals Limited | KGN PHARMACEUTICALS PVT. LTD.F-3/1, MIDC Tarapur, Boisar, Dist.: Palghar, 401506, Maharashtra, India | Incompletete CTD Dossier Submission |
| 377 | Sildenafil Citrate tablets BP 100 mg | Sildenafil Citrate tablets BP | Phosphodiesterase type 5 (PDE5) inhibitors | CARE CONA NIG LTD, IFY | LESANTO LABORATORIES PLOT NO. 9,10,11 &20, SURVEY NO. 53, PALGHAR (E) â 401 404, MAHARASHTRA, INDIA | Incompletete CTD Dossier Submission |
| 378 | Syntrexa 10mg | Dapagliflozin Tablets 10mg | Antidiabetic | Worldwide Commercial Ventures Ltd (WWCVL), Worldwide Commercial Ventures Limited | Cipla Ltd, Unit III, Plot No. L-139 to L-146, Verna Industrial Estate, Verna Salcette, Goa 403722 India | Incompletete CTD Dossier Submission |
| 379 | DEXTROMETHORPHAN HYDROBROMIDE SOFTGEL LOZENGES | DEXTROMETHORPHAN HYDROBROMIDE SOFTGEL LOZENGES | Antitussives (Cough Suppressants) | GENELO INVESTMENT LIMITED, UMENWA GODWIN NNANYELUGO UMENWA | GELNOVA LABORATORIES (INDIA) PVT. LTD,C-125, TTC INDUSTRIAL AREA, MAHAPE (PAWANE), NAVI MUMBAI-400703. MAHARASHTRA, INDIA | Incompletete CTD Dossier Submission |
| 380 | NATPENT | PENTAZOCINE | Opiod Analgesic | NATEX PHARMACEUTICALS LIMITED, James Ochiogu Chinonso Ochiogu | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | incompletete CTD Dossier Submission |
| 381 | Ibuprofen Suspension | Ibuprofen Suspension | Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | ALM DRUGMART PHARMACY LIMITED , ALM Drugmart Ngozi Obi | Nalis Pharmaceuticals Ltd, R67/68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State, Nigeria | Incompletete CTD Dossier Submission |
| 382 | Dr Clems Diclofenac Injection | Diclofenac Injection | Analgesic | Carrot Top Drugs Ltd, Chika Agughasi Jude Agughasi | OM BIOMEDIC PVT LTD, Plot No. 68, 69, 82 & 83, Sector-6A, IIE, Sidcul Distt. Haridwar, Uttarakhand, India | Incompletete CTD Dossier Submission |
| 383 | Avro Mist. Magnesium Trisilicate Suspension | Magnesium Trisilicate Dried,; Aluminium Hydroxide | Antacids | AVRO PHARMA LIMITED, ONWUEYI LEWACHI ONWUEYI | SKG-PHARMA LIMITED,7/9 Sapara Street, Ikeja, Lagos State, Nigeria | Incompletete CTD Dossier Submission |
| 384 | CEFTRIAXONE FOR INJECTION USP 1 GM | CEFTRIAXONE FOR INJECTION USP 1 GM | Antibiotics | GOLDEN HEALTHCARE LIMITED | ALLIAANCE BIOTECH, PLOT NO .440/3 VILLAGE-KATHA BABBI DIST -SOLAN (H.P)173205 | Incompletete CTD Dossier Submission |
| 385 | LINEZOL | LINEZOLID I.V INJECTION 200MG/100ML | Antibiotics | GLOBAL ORGANICS LIMITED, | Amanta Healthcare Ltd.Plot No. 876, N.H. No. 8, Hariyala, Kheda – 387411, Gujarat, India. | Incompletete CTD Dossier Submission |
| 386 | Pentazocine Injection BP 30mg/ml | Pentazocine BP 30 mg | Opiod Analgesic | PINNACLE HEALTH PHARMACEUTICAL & STORES LIMITED | Alpa Laboratories Limited 33/2 A.B Road, Pigdamber, Indore (MP) | Incompletete CTD Dossier Submission |
| 387 | PENTAZOCINE INJECTION BP 30MG/ML | PENTAZOCINE INJECTION BP 30MG/ML | Opiod Analgesic | PINNACLE HEALTH PHARMACEUTICAL & STORES LIMITED | M/S FARBE FIRMA PVT, LTD, PLOT NO. 1508, NEAR ATIQUE BAKERY, GIDC ESTATE, ANKLESHWAR-393002, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 388 | VASNAF 80 | Valsartan Tablets USP 80 mg | Antihypertensive | Afrigenerics Pharmaceuticals ltd | SWISS PHARMA PVT. LTD,3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382 445, Dist: Ahmedabad Gujarat State , India | Incompletete CTD Dossier Submission |
| 389 | ZIMBRANO | BRINZOLAMIDE + BRIMONIDINE | Antiglaucoma combination | ACTIVITY PHARMACEUTICAL CO. LTD | Lenus Lifecare Pvt.Ltd,Industrial Estate Plot NO.1,Chambaghat,Solan, Himachal Prdesh-173213,India | Incompletete CTD Dossier Submission |
| 390 | INJECTION PENTAZOCINE BP 30MG | PENTAZOCINE BP 30MG | Opiod Analgesic | LIORA HEALTHCARE LIMITED , CHISOM EZUMBA JESSICA EZUMBA | M/S FARBE FIRMA PVT LTD, PLOT NO 1508, NEAR ATIQUE BAKERY, GIDC ESTATE, ANKLESHWAR- 393002, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 391 | HEACH-H BENZHEXOL 5 MG | BENZHEXOL 5 MG | Anticholinergic | H-medlife-sciences limited, Desmond ihechukwu umunnakwe | SWISS PHARMA PVT. LTD.3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382445, Dist.: Ahmedabad. Gujarat State, | Incompletete CTD Dossier Submission |
| 392 | ASTAMOCIL 250mg Capsule | Amoxicillin 250mg Capsule | Antibiotics | Sam-Ace Limited, Alaba Olawoye Abiodun Olawoye | Sam-Ace Limited, Km 14, Gbongan-Ibadan Road, Akoda-Ede, Osun state | Incompletete CTD Dossier Submission |
| 393 | Clindamycin Capsules USP 300 mg | Clindamycin Capsules USP 300 mg | Antibiotics | AFRIGENERICS LIMITED, AFRIGENERICSLTD KAOSI Onyejekwe | MEDICO REMEDIES LTD. 7, 8 & 9, Dewan & sons udyog nagar, Lokmanya Nagar, Palghar, dist. thane â 401 404, Maharashtra. (INDIA) | Incompletete CTD Dossier Submission |
| 394 | KENZO PENTAZOCINE | PENTAZOCINE | Opiod Analgesic | KENZO PHARMACEUTICALS LIMITED, Kenzo Pharmaceutical Nig. Ltd JANE OGUOCHUKWU OKWUNZE | OM BIOMEDIC PVT LTD 1203 12 FLOOR SIR KRISHNA BLDG NEW LINK ROAD OPP LAXIMI INDS ESTATE NR FUN REBLUBLIC MALL ANDHERI WEST MUMBAL 400053 MAHARASTRA INDIA | Incompletete CTD Dossier Submission |
| 395 | PENTAZOCINE INJECTION BP 30 MG/ML | PENTAZOCINE INJECTION BP 30 MG/ML | Opiod Analgesic | JENILEVOX HEALTHCARE LTD , | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 396 | Pregabalin Capsules 300 mg | Pregabalin Capsules 300 mg | Anticonvulsant | OMMIC DAMIC PHARMACY NIGERIA LIMITED | SWISS PHARMA PVT. LTD. 3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382445, Dist.: Ahmedabad Gujarat State, India | Incompletete CTD Dossier Submission |
| 397 | NEBIVOLOL TABLETS 2.5 MG& 5 MG | NEBIVOLOL TABLETS 2.5 MG& 5 MG | Antihypertensive | NEW HEIGHTS PHARMA LTD, | STALLION LABORATORIES PVT. LTD.C1B-305,2, 3, 4 & 5, G.I.D.C. Kerala (Bavla) Dist: Ahmedabad, Gujarat, | Incompletete CTD Dossier Submission |
| 398 | Amlodipine, Valsartan, and hydrochlorothiazide tablets (10mg/320mg/25mg) | Amlodipine, Valsartan, and hydrochlorothiazide tablets (10mg/320mg/25mg) | Antihypertensive | BENAMADIN NIGERIA LIMITED | ENDURANCE HEALTHCARE PVT LTD, C-1B 305/2,3,4 & 5 G.I.D.C KERALA (BAVLA) DIST, AHMEDDABAD, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 399 | VILDAGLIPTIN 50 MG AND METFORMIN HYDROCHLORIDE 500 MG TABLETS VILDAGLIPTIN 50 MG AND METFORMIN HYDROCHLORIDE 850 MG TABLETS VILDAGLIPTIN 50 MG AND METFORMIN HYDROCHLORIDE 1000 MG TABLETS | VILDAGLIPTIN 50 MG AND METFORMIN HYDROCHLORIDE 500 MG TABLETS VILDAGLIPTIN 50 MG AND METFORMIN HYDROCHLORIDE 850 MG TABLETS VILDAGLIPTIN 50 MG AND METFORMIN HYDROCHLORIDE 1000 MG TABLETS | Antidiabetic | STERLING BIOPHARMA LTD , STERLING BIOPHARMA LTD | STALLION LABORATORIES PVT.LTD. C-1B 305/2, 3, 4& 5 G.I.D.C. KERALA (BAVLA), DIST. AHMEDABAD, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 400 | TRYPSIN AND CHYMOTRYPSIN TABLET | TRYPSIN AND CHYMOTRYPSIN TABLET | Proteolytic Enzymes | TUV VISKO PHARMACEUTICALS INDUSTRIES LIMITED | Visko Pharmacy Limited, 2 Uwala Street, Obeagu Ugwuaji Akwunanaw, Enugu State | Incompletete CTD Dossier Submission |
| 401 | Konis Artemether | Artemether 80mg + Lumefantrine 480mg tablets | Antimalaria | KONIS PHARMACEUTICAL LIMITED | LESANTO LABORATORIES, Address; Plot No 9, 10, 11 & 20 Survey No. 53, Palghar (E) – 401404, Maharashtra, India | Incompletete CTD Dossier Submission |
| 402 | PENTAZOCINE INJECTION BP 30MG/ML | PENTAZOCINE INJECTION BP 30MG/ML | Opiod Analgesic | ALL STAR BASE PHARM LIMITED | M/S FARBE FIRMA PVT, LTD, PLOT NO. 1508, NEAR ATIQUE BAKERY, GIDC ESTATE, ANKLESHWAR-393002, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 403 | AMLODIPINE, VALSARTAN AND HYDROCHLORTHIAZIDE TABLETS USP (10MG, 320MG/ 25MG) | AMLODIPINE, VALSARTAN AND HYDROCHLORTHIAZIDE TABLETS USP (10MG, 320MG/ 25MG) | Antihypertensive | BE-LEDFORTH LIMITED , BE-LEDFORTH LIMITED | ENDURANCE HEALTHCARE PVT LTD, C-1B 305/2,3,4 & 5 G.I.D.C KERALA (BAVLA) DIST, AHMEDDABAD, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 404 | VISTREC TABLET | DICLOFENAC/MISOPROSTOL | ANALgesic | VISKO PHARMACY LTD | AAN PHARMA PRIVATE LIMITED, 144/1 P2 VILLAGE GHODASAR 367110 AHMEDABAD DIST KHEDA GUJARATA INDIA | Incompletete CTD Dossier Submission |
| 405 | PENTAZOCINE INJECTION | PENTAZOCINE INJECTION BP 30MG/ML | Opiod Analgesic | DOM DIKE PHARMACEUTICAL COMPANY LIMITED | PHARMAX INDIA PVT.LTD.9, Kurla Industrial Estate, Off Narayan Nagar Ghatkopar (W), Mumbai – 400 086 Maharashtra State, India. | Incompletete CTD Dossier Submission |
| 406 | ALPHABETA-ARTEETHER INJECTION | ALPHABETA-ARTEETHER INJECTION | Antimalaria | G+M DE GREAT PHARMACEUTICALS LTD, | Alliance Biotech, of 440/3, Vill. Katha, Baddi, Distt.solan(H.P), INDIA | Incompletete CTD Dossier Submission |
| 407 | CEFUROXIME AXETIL TABLETS BP 500 MG | CEFUROXIME AXETIL TABLETS BP 500 MG | Antibiotics | Healthedge Pharmaceuticals & Beauty Co Ltd | AEVIAS HEALTHCARE, Survey No. 313/P2, Nedra- Chandravati Road, At. – Nedra, Ta. – Sidhpur, Dist. Patan-384151, Gujarat State, India. | Incompletete CTD Dossier Submission |
| 408 | CABERGOLINE TABLETS | CABERGOLINE TABLETS | Dopamine Receptor Agonists | TRUMEDIC PHARMACEUTICALS & STORES LTD | BHARAT PARENTERALS LTD, SURVEY NO 144-A JAROD SAMLAYA HARIPURA, DIST, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 409 | LOISVILDAMET 1000 | VILDAGLIPTIN 50MG; METFORMIN 1000MG | Antidiabetic | LOIS PHARMACEUTICALS &HEALTHCARE LTD | SHUKRA PHARMACEUTICALS, Plot No. 795, Rakanpur Sola-Santej Road, Ta. Kalol, Dist. Gandhinagar Gujarat, India | Incompletete CTD Dossier Submission |
| 410 | Ciprofloxacin 500 mg tablet | Ciprofloxacin 500 mg tablet | Antibiotics | CHRIS-EJIK PHARMACEUTICALS HEALTHCARE PRODUCTS LIMITED, Regulatory Officer TITUS DADA | MEDICO REMEDIES LTD. 7, 8 & 9, Dewan & Sons Udyog Nagar, Palghar, Dist. Thane, Maharashtra. INDIA | Incompletete CTD Dossier Submission |
| 411 | Artemether Injection 80mg/1 ml | Artemether | Antimalaria | Nancil Nigeria Ltd, Nancil Nigeria Ltd Adewale Sanni | East African (India) Overseas, 8 & 8A Pharmacity, Selaqui Dehradun India | Incompletete CTD Dossier Submission |
| 412 | CARBAMAZEPIN TABLETS BP 200 MG | CARBAMAZEPIN TABLETS BP 200 MG | Anticonvulsants | PROTRUST PHARMACY LIMITED, DAN OLUCHI UGBAH | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 413 | MEROPENEM INJECTION | MEROPENEM INJECTION | Antibiotics | G+M DE GREAT PHARMACEUTICALS LTD, EDWIN IKECHUKWU AZUGO | M/s. Kamla Lifesciences Ltd.G-84/1, Tarapur, MIDC, Boisar, District – Palghar-401506 india | Incompletete CTD Dossier Submission |
| 414 | Omeprazole Sodium for Injection 40mg with Sterilised water for injections 10ml | Omeprazole Sodium | Proton Pump Inhibitors (PPIs) | Noski Pharmaceuticals Limited, alfred okoye okoye Godfrey | Cisen Pharmaceutical Co.,Ltd.Tongji Tech Industry garden, Jining High&New Technology Industries Development Zone, Shandong, P.R.China | Incompletete CTD Dossier Submission |
| 415 | Ravelt | Cefuroxime Axetil USP 500mg | Antibiotics | CHUVET PHARMACEUTICAL AND ALLIED VENTURES LTD, TOBA JOHSON GABRIEL JOHNSON GABRIEL | SWISS PHARMA PVT. LTD 3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad _ 382445, Dist,: Ahmedabad, Gujarat State, India | Incompletete CTD Dossier Submission |
| 416 | TRANEXAMIC ACID 5OOMG | TRANEXAMIC ACID | Antifibrinolytics | ANNYGOD PHARMACEUTICAL CO. LIMITED, Leo CHUKWUMA OKAFOR | SCOTT-EDIL PHARMACIA LTD. UNIT-II, 21/22 EPIP PHASE 1 HARMAJRI, BADDI, DISTT. SOLAN (H.P.),173205, INDIA | Incompletete CTD Dossier Submission |
| 417 | ICOD SILDENAFIL | SILDENAFIL CITRATE 100MG USP | Phosphodiesterase type 5 (PDE5) inhibitors | ICOD PHARMACEUTICALS LIMITED, OKWU ONYINYE VERONICA | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 418 | Pentazocine | Pentazocine | Opiod Analgesic | Kessington Global Synergy Limited, Catherine .O. Kaosi Onyejekwe | FARBE FIRMA Pvt. Ltd.Plot no: 1508, G.I.D.C., Ankleswar Gujarat- 393 002, India. | Incompletete CTD Dossier Submission |
| 419 | Lidocaine And Adrenaline Injection BP | Lidocaine And Adrenaline Injection BP | Local anestheticVasoconstrictor | Liveforte Pharmacy and Sundries ltd, Tunde Adewale Philip Ikechukwu | PHARMAX INDIA PVT.LTD. 9, Kurla Industrial Estate, Ghatkopar (W), Mumbai – 400 086. | Incompletete CTD Dossier Submission |
| 420 | MEDIBOX PENTAZOCINE | PENTAZOCINE 30MG““““““““““““““ | Opiod Analgesic | JANE-MADOK PHARMACY AND WELLNESS CENTRE | NUCLEUS FORMULATION PVT. LTD.Plot no: 3484/3485, Phase-IV, G.I.D.C. Chhatral â 382729, Tal. Kalol, Dist. Gandhinagar, Gujarat, INDIA. | Incompletete CTD Dossier Submission |
| 421 | Eril 10mg Tablet | Empagliflozin 10mg | Antidiabetic | Fensyl MHP Consulting Limited | PharmEvo (Pvt) Limited, A-29, North Western Industrial Zone, Port Qasim, Karachi-75020, Pakistan. | Incompletete CTD Dossier Submission |
| 422 | KETAMINE INJECTION BP 50MG/ML | KETAMINE INJECTION | Dissociative Anesthetics | DORGLORY PHAARMACEUTICAL (NIG) LIMITED | MHJ PHARMACONCEPTS PRIVATE LIMITED, PLOT NUMBER 68 69 82 83 SCTOR 6A SIDCUL IIE IST. HARIDWAR UTTARAHN INDIA | Incompletete CTD Dossier Submission |
| 423 | ARTESAM INJECTION | ARTEMETHER 80MG/ML | Antimalaria | SAM PHARMACEUTICAL LIMITED | EAST AFRICAN (INDIA) OVERSEAS, UNIT 1-PLOT-1, PHARMACITY, SELAQUI, DEHRADUN-248011, UTTRAKHAND,INDIA | Incompletete CTD Dossier Submission |
| 424 | Paracetamol Injection 150mg/ml | Paracetamol Injection 150mg/ml | Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | MEDRAY PHARMACY LTD, | MAKCUR LABORATORIES LIMITED, 46/4-7, Dehgam Road, Zak Village, Tal.: Dehgam, Dist.: Gandhingar, Gujarat State, India. | Incompletete CTD Dossier Submission |
| 425 | SEVELAMER TABLET 400MG & 800MG | SEVELAMER TABLET 400MG & 800MG | Phosphate Binders | STALLION REMEDIES NIG LTD, | STALLION LABORATORIES PVT. LTD.,C1B 305/2,3,4,&5 G.I.D.C., KERALA (BAVLA) DIST: AHMEDABAD-382220, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 426 | Purity Grade Pentazocine Injection BP 30 mg/ml | Pentazocine Injection BP 30 mg/ml | Opiod Analgesic | Purity Grade pharmaceutical Ltd. | Merit Organic LTD, 2104/2/A, G.I.D.C , Sarigam, Bhilad-396 155, Gujarat . India | Incompletete CTD Dossier Submission |
| 427 | Gentamycin Injection 80 mg/2 Ml | Gentamycin Sulfate | Antibiotics | AIONS PHARMACEUTICAL LIMITED | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 428 | Zeyisima Pentazocine Injection BP 30 mg/ml | Pentazocine Injection BP 30 mg/m | Opiod Analgesic | Ezeyisi & sons pharmaceutical co. Ltd | Merit Organic LTD,2104/2/A, G.I.D.C, Sarigam, Bhilad-396 155, Gujarat . India | Incompletete CTD Dossier Submission |
| 429 | Empagliflozin 10mg and Metformin Hydrochloride 1000mg Tablet | Empagliflozin 10mg and Metformin Hydrochloride 1000mg Tablet | Antidiabetic | Espen Laboratories Limited | ECOMED PHARMA LTD,32, Chemical Lynson Avenue, Lagos-Abeokuta Expressway, Sango-Ota, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 430 | DOZYTEM | Artemether and Lumefantrine | Antimalaria | DOZAN PHARMACEUTICALS LIMITED | S.P PHARMACEUTICALS, G-19, & G-2/5 MIDC, Jalgaon, India | Incompletete CTD Dossier Submission |
| 431 | Ladfield Co-Amoxiclav 1.2g Injection | Co-Amoxiclav 1.2g Injection | Antibiotics | LADFIELD GLOBAL VENTURES | Shandong Xier kangtai Pharmaceutical Co., Ltd.Private Economy Garden, Xinyan Town, Yanzhou, Shandong, P. R. China | Incompletete CTD Dossier Submission |
| 432 | SILVAPEN INJECTION | BENZYLPENICILLIN SODIUM FOR INJECTION 1MG | Antibiotics | SILVER CROWN PHARMACY AND STORES LTD | REYOUNG PHARM.CO.LTD.NO. 1 RUIYANG ROAD, YIYUAN COUNTY, SHANDONG, P.R. CHINA | Incompletete CTD Dossier Submission |
| 433 | EMPAGLIFLOZIN | EMPAGLIFLOZIN 10 mg .25 mg film-coated tablets | Antidiabetic | Sai Sagar Pharma Limited | Endurance Healthcare Pvt. Ltd, C-1B, 305/2, 3, 4& 5, G.I.D.C. Kerala (Bavla), Dist.: Ahmedabad, Gujarat, India | Incompletete CTD Dossier Submission |
| 434 | Alprazolam Tablets USP 0.5mg | Alprazolam Tablet 0.5mg | Benzodiazepines | UGOLAB PRODUCTIONS LTD. | ASTAMED HEALTHCARE (i) PVT.LTD.PLOT NO. 2 & 3 PHASE II, GENESIS INDUSTRIAL COMPLEX, KOLGAON, PALGHAR-401404 MAHARASHTRA STATE INDIA | Incompletete CTD Dossier Submission |
| 435 | ProstaEase | Tamsulosin Hydrochloride | Alpha-1 Adrenoceptor Blockers | BRIDGECARE PHARMACEUTICALS LIMITED | Wellrick Pharmaceuticals Pvt. Ltd.C 207, Titanium Business Park, Near Makarba Underbridge, Makarba, Ahmedabad, Gujarat – 380051, India. | Incompletete CTD Dossier Submission |
| 436 | LEVOFLOXACIN TABLET USP 500MG | LEVOFLOXACIN TABLET USP 500MG | Antibiotics | SUZ PHARMACEUTICALS LTD | IMPULSE PHARMA PVT. LTD, : J-201, J-202/1, MIDC TARAPUR, BOISAR DIST. PALGHAR â 401506, MASHARASHTRA STATE INDIA | Incompletete CTD Dossier Submission |
| 437 | CIPROFLOXACIN HYDROCHLORIDE 500mg | CARLOS CIPROFLOXACIN 500mg TABLET | Antibiotics | CARLOS PHARMACEUTICAL LIMITED | CARLOS PHARMACEUTICALLIMITED, KM 15 Goodluck Jonathan Bye Pass, Ayade Industrial Park Calabar, Cross River State | Incompletete CTD Dossier Submission |
| 438 | Amitriptyline Hydrochloride Tablets BP 25mg | Amitriptyline Hydrochloride BP 25mg | Antidepressant | SJS LIFE SCIENCES LTD | McW HEALTHCARE PRIVATE LIMITED. 286, 287 A, 287B, Sector E, Industrial area, Sanwer Road, Indore (M.P.), INDIA | Incompletete CTD Dossier Submission |
| 439 | Pentazocine Injection BP 30mg/ml | PENTAZOCINE INJECTION | Opiod Analgesic | PARIN PHARMACEUTICAL LIMITED | M/S FARBE FIRMA, Plot No: 1508, Near Atique Bakery, GIDC Estate, Ankleshwar-393002, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 440 | AMLODIPINE, VALSARTAN AND HYDROCHLORTHIAZIDE | AMLODIPINE, VALSARTAN AND HYDROCHLORTHIAZIDE | Antihypertensive | GOLDEN REMEDIES LIMITED | ENDURANCE HEALTHCARE PVT LTD, C-1B 305/2,3,4 & 5 G.I.D.C KERALA (BAVLA) DIST, AHMEDDABAD, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 441 | Artemether Injection 80 mg/Ml | Artemether | Antimalaria | AIONS PHARMACEUTICAL LIMITED | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 442 | REMOLTablet | Paracetamol Tablets | Analgesic | REMG PHARMACEUTICALS LIMITED | REMG PHARMACEUTICALS LIMITED, 2, FOGO CLOSE, OFF OLAMBE ROAD, AKUTE, IFO L.G.A. OGUN STATE | Incompletete CTD Dossier Submission |
| 443 | ArtesunateInjection 120mg | Artesunate | Antimalaria | Novaklin pharmaceutical Nigeria limited | Pharmax India pvt limited, No. 9, Kurla Industrial Estate, off Lal Hahadur Shashtri Marg., Ghatkopar (W) Mumbai 400086, | Incompletete CTD Dossier Submission |
| 444 | UGOFRANIL | Clomipramine Hydrochloride Tablet 25mg | Antidepressant | UGOLAB PRODUCTIONS LTD. | OSAKA PHARMACEUTICALS PVT. LTD, OLD N.H. NO. 8, AT & POST-SANKARDA-391350. DIST VADODARA GUJARAT INDIA | Incompletete CTD Dossier Submission |
| 445 | EMPALINA 10/5 TABLETS | 10 mg Empagliflozin and 5 mg Linagliptin | Antidiabetic | STANDARD GENERICS LIMITED | BEXIMCO PHARMACEUTICALS LTD.,126, KATHALDIA, AUCHPARA, TONGI, 1711, GAZIPUR, BANGLADESH | Incompletete CTD Dossier Submission |
| 446 | GABATAB | PREGABALIN 75MG BP | Anticonvulsant | DIGITALL HEALTHCARE LIMITED | LARK LABOTARORIES (INDIA) LTD.SP-1192E RIICO INDUSTRIAL AREA, PHASE âIV, BHIWADI, (RAJ.) 301019 | Incompletete CTD Dossier Submission |
| 447 | KAVIAN CEFTRIAXONE INJECTION | CEFTRIAXONE | Antibiotics | KAVIAN PHARMACEUTICALS NIG. LTD | SHANDONG XIER KANGTAL PHARMA LTD | Incompletete CTD Dossier Submission |
| 448 | Methocarbamol Tablets 500 mg | Methocarbamol | Muscle Relaxant | NEESAN PHARMACEUTICAL LTD | Blutris Healthcare Pvt Ltd, Survey No. 1229, Kherpur- Chandarda Road, Nr. DPS School Village: Rajpur, Taluka: Kadi Dist: Mehsana, Gujarat 384440 | Incompletete CTD Dossier Submission |
| 449 | HEALTHMAL 80/480MG Tablet | Artemether 80 mg & Lumefantrine 480 mg Tablets | Antimalaria | CCglobalcure Pharmaceutical Company Limited | JFL LIFESCIENCES LTD. Plot No. 615, G.I.D.C Kerala (Bavla), City: Kerala (Bavla) – 382245, Dist: Ahmedabad, Gujarat, India | Incompletete CTD Dossier Submission |
| 450 | Pregabalin Capsule 300mg | Pregabalin BP | Anticonvulsant | SIDOM PHARMACY IND. LIMITED | ASTAMED HEALTHCARE (I) PVT LTD, Plot No. 2 & 3, Phase II, Genesis Ind. Complex, Kolgaon, Taluka: Palghar – 401404, District ; Thane, India. | Incompletete CTD Dossier Submission |
| 451 | MIDALAM | Midazolam injection BP 15mg/3ml, (5mg/ml) | Benzodiazepines | RESTORE HEALTHCARE LIMITED | KWALITY PHARMACEUTICALS LTD.NAG KALAN, MAJITHA ROAD, AMRITSAR (143601)- INDIA | Incompletete CTD Dossier Submission |
| 452 | METHOCARBAMOL TABLETS | METHOCARBAMOL TABLETS | Muscle Relaxant | TRUMEDIC PHARMACEUTICALS & STORES LTD | CIRON DRUGS PHARMA LTD, UDYOG NAGAR PALGHAR, INDIA | Incompletete CTD Dossier Submission |
| 453 | Ciprofloxacin & Tinidazole | Ciprofloxacin & Tinidazole | Antibiotics/Antimicrobials | Asenka Global Pharmaceuticals Ltd | Ratnatris Pharmaceuticals Pvt. Ltd, Survey No. 416, At.- Indrad, Ta.- Kadi, Dist.- Mehsana-382715, Gujarat, India | Incompletete CTD Dossier Submission |
| 454 | SOLTEN 40MG 10ML INJECTION | OMEPRAZOLE SODIUM | Proton Pump Inhibitors (PPIs) | UNICURE PHARMACEUTICAL LIMITED | HARBIN MEDISAN PHARMACEUTICAL LIMITED, LANXI ECONOMIC DEVELOPMENT ZONE, SUIHUA CITY, HEILONGJIANG PROVINCE | Incompletete CTD Dossier Submission |
| 455 | Pentazocine injection BP 30mg/ml | Pentazocine | Opiod Analgesic | NONSEC HEALTHCARE PHARMA LTD | FARBE FIRMA, Plot No 1508 GIDC, Ankleshwar, Dist Bharuch -393002, Gujarat, India | Incompletete CTD Dossier Submission |
| 456 | CEERABZOLE (RABEPRAZOLE SODIUM CAPSULES, 20MG) | RABEPRAZOLE SODIUM CAPSULES, 20MG | Proton Pump Inhibitors (PPIs) | SUNNY CEE PHARMACY & STORES LTD | TOWA PHARMA PVT LTD MFG. SITE-JALIYANAMATH VILLAGE, SURVEY NO-17, DEHGAM RAKHIYAL ROAD, TA.- DEHGAM, DIST. GANDHINAGAR-382315 GUJARAT (INDIA) | Incompletete CTD Dossier Submission |
| 457 | Artemether Injection 80 mg/ml | Artemether | Antimalaria | BIN KHALIFA PHARMACEUTICAL LTD | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 458 | VILDAGLIPTIN & METFORMIN HYDROCHLORIDE 50MG/850MG | VILDAGLIPTIN & METFORMIN HYDROCHLORIDE | Antidiabetic | SOCIETY FOR FAMILY HEALTH | CENTURION LABORATORIES PVT LTD, Plot No P-2, Savali Bio-Tech park, At – Manjusar, Tal -Savali, Dist – Vadodara, Gujarat, India | Incompletete CTD Dossier Submission |
| 459 | CEFTRIAXONE FOR INJECTION USP 1 GM | CEFTRIAXONE | Antibiotics | T.P DRUGS LIMITED | ALLIAANCE BIOTECH, PLOT NO .440/3 VILLAGE-KATHA BABBI DIST -SOLAN (H.P)173205 | Incompletete CTD Dossier Submission |
| 460 | Griseofulvin 500mg Tablet | Griseofulvin | Antifungal | DailySun Industries Limited | Daily Sun Pharmaceutical Co. Limited, Plot 3 & 4 Tomori industrial etate off idiroko road ota ogun state | Incompletete CTD Dossier Submission |
| 461 | APIXABAN 5MG | APIXABAN | Anticoagulant | PHARMA ETHICS LTD. | HOF PHARMACEUTICALS LTD.SURVEY NO. 211-4/5/6, PIPAN VILLAGE, SANAND-BAVLA ROAD, SANAND, AHMEDABAD, GUJARAT-382110, INDIA. | Incompletete CTD Dossier Submission |
| 462 | DILAZOL EXTRA CAPSULES | Omeprazole BP 20 mg (as enteric coated pellets), Domperidone BP 10 mg (as coated pellets) | Proton Pump Inhibitors (PPIs) | STANDARD GENERICS LIMITED | SHUKRA PHARMACEUTICALS LTD, Plot No. 795, Rakanpur Sola-Santej Road, Ta. Kalol, Dist. Gandhinagar (Gujarat) | Incompletete CTD Dossier Submission |
| 463 | GYNOFER TABLET | Tinidazole BP 500mg, Miconazole Nitrate BP 100 mg, Neomycin Sulphate BP 20 mg | Antimicrobial/Antifungal/Antibiotic | ITATS PHARMACIA LIMITED | Centaur Pharmaceutical Pvt. Ltd, Plant-I, Plot No.3,5B, 2C Tivim Industrial Estate, Karaswada, Mapusa, Goa-403 526, INDIA | Incompletete CTD Dossier Submission |
| 464 | Liamdel Delflox 500 mg | (Levofloxacin Tablets USP 500 mg) | Antibiotics | LIAMDEL PHARMACEUTICAL LIMITED | SANGHARSH LIFECARE PVT. LTD.C/8, Sardar Estate, Ajwa Road, Vadodara-390019, Gujarat, India | Incompletete CTD Dossier Submission |
| 465 | PENTAZOCINE INJECTION | PENTAZOCINE | Opiod Analgesic | ANISUN PHARM. CO. LTD | FAR BEFIRMA, PLOT NO1508 , GIDC ESTATE, ANKLESHWAR, GUJARAT 393002, INDIA | Incompletete CTD Dossier Submission |
| 466 | Pentazocin injection bp 30 mg/ml | Pentazocine | Opiod Analgesic | Sitawell Pharmacy ltd | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 467 | Vadis Co-trimoxazole Tablet | C0-trimoxazole tablet | Antibiotics | FIRST VADIS PHARMACEUTICAL INDUSTRIAL LTD | FIRST VADIS PHARMACEUTICAL INDUSTRIES LIMITED, PLOT IN/2 PHASE 2 EXTENTION, EMENE INDUSTRIAL LAYOUT, ENUGU STATES | Incompletete CTD Dossier Submission |
| 468 | BONGRA | AMITRIPTYLINE TABLETS BP 25 MG | Antidepressant | CHIMEXBON INTERNATIONAL COMPANY LIMITED | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 469 | KATIPROST EYE DROP | BIMATOPROST & TIMOLOL MALEATE | Prostaglandin analogNon-selective beta-blocker | Kayhelt Pharma Limited | CIRON DRUGS & PHARMACEUTICALS PVT LTD,N-118, N-119, N-113, MIDC, TARAPUR, BOISAR, DIST THANE-401 406, MAHARASHTRA, INDIA | Incompletete CTD Dossier Submission |
| 470 | PROCAINE PENICILLIN | PROCAINE PENICILLIN | Antibiotics | PHARMA-LINE HEALTHCARE G.D.W LTD | Shandong Xier Kangtai Pharmaceutical Co., Ltd. Private Economy Garden, Xinyan Town, China | Incompletete CTD Dossier Submission |
| 471 | MEROPENEM INJECTION | MEROPENEM | Antibiotics | ASHFORT PHARMACEUTICAL LTD | M/s. Kamla Lifesciences Ltd.G-84/1, Tarapur, MIDC, Boisar, District – Palghar-401506 india | Incompletete CTD Dossier Submission |
| 472 | LUMETHER FORTE | ARTEMETHER 80MG-LUMEFANTRINE 480MG | Antimalaria | JANE-MADOK PHARMACY AND WELLNESS CENTRE | NUCLEUS FORMULATION PVT. LTD.PLOT No. 3484/3485, Phase IV, GIDC Chhatral 382729 , Tal. Kalol, Dist. Gandhinagar, Gujarat, INDIA. | Incompletete CTD Dossier Submission |
| 473 | ARTESUNATE INJECTION 120 MG | Artesunate 120 mg | Antimalaria | KAL-G PHARMACY AND STORES LTD. | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 474 | CYTALON 1000 | Cytarabine 1000MG/10ML | Antimetabolites | L’PACEMAKER PHARMACEUTICALS | Celon Laboratories Pvt. Ltd. #2, ALEAP Industrial Estate, Near Pragatinagar, Gajularamaram, Medchal District, Hyderabad- 500 072 | Incompletete CTD Dossier Submission |
| 475 | Fortelog | Triamcinolone Acetonide Injection BP | Corticosteroids | Liveforte Pharmacy and Sundries ltd | PHARMAX INDIA PVT. LTD. 9, Kurla Industrial Estate, Ghatkopar (W), Mumbai – 400 086 | Incompletete CTD Dossier Submission |
| 476 | Gentamicin Injection 2ml:80mg | Gentamicin Injection | Antibiotics | Noski Pharmaceuticals Limited | Cisen Pharmaceutical Co.,Ltd.Hai Chuan Road, Jining High & New Technology Ind. Development Zone, Jining, Shandong Province | Incompletete CTD Dossier Submission |
| 477 | OLHOTEM 0.5%W/V EYEDROP | TIMOLOL MALEATE USP 5MG | Ocular Antihypertensive | GREENLIFE PHARMACEUTICALS LTD | FDC LIMITED, B-8, MIDC INDUSTRIAL AREA WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA | Incompletete CTD Dossier Submission |
| 478 | Pentazocine Injection BP 30 mg/ml | Pentazocine | Opiod Analgesic | Rick Rose Pharmaceuticals Ltd | FarbeFirma, Plot number 1508, GIDC Estate, Ankleshwar- 393002 | Incompletete CTD Dossier Submission |
| 479 | PENTAZOCINE INJECTION BP 30MG/ML | Pentazocine | Opiod Analgesic | SUZ PHARMACEUTICALS LTD | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 480 | Pentazocine | Pentazocine | Opiod Analgesic | FAIREST PHARMA & COSMETICS LTD | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 481 | PENTAZOCINE INJECTION | Pentazocine | Opiod Analgesic | KIMTO HEALTHCARE LTD | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 482 | PENTAZOCINE INJECTION 30MG | Pentazocine | Opiod Analgesic | SENATOR POM PHARMACEUTICAL &GEN ENT LTD | ENDURANCE HEALTHCARE PVT.LTD, C-1B 305/2,3,4&5 GIDC, KARALA (BAVLA) DIST AHMEDABAD 383 220, GUJARAT, INDIA | incompletete CTD Dossier Submission |
| 483 | CEFTRIAXONE AND SULTBACTAM For Injection 1.5G | CEFTRIAXONE AND SULTBACTAM | Antibiotics | SOUGHTOUT HEALTHCARE LTD | Endurance Healthcare PVT. LTD 3709, G.I.D.C., Phase IV, VATVA AHMEDABAD 382 445, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 484 | DAPIX | DAPAGLIFLOZIN | Antidiabetic | BEZIK PHARMA LTD | WELLRICK PHARMACEUTICAL PVT LTD, SURVEY NUMBER 807/002,NEAR ETHICRO INDUSTRIES,KADIDISTRICT,GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 485 | PENTAZOCIN INJECTION BP 30MG/ML | Pentazocine | Opiod Analgesic | JOVIEX HEALTHCARE LTD | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 486 | PENTAZOCIN INJECTION BP 30MG/ML | Pentazocine | Opiod Analgesic | CRIO PHARMACEUTICAL LTD | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 487 | Phytomenadione Injection BP (Vitamin K1) | Phytomenadione Injection BP (Vitamin K1) | Antihemorrhagics/Fat-soluble vitamins | Novaklin pharmaceutical Nigeria limited | Pharmax India pvt limited, No. 9, Kurla Industrial Estate, off Lal Hahadur Shashtri Marg., Ghatkopar (W) Mumbai 400086, | Incompletete CTD Dossier Submission |
| 488 | HANBET ARTEETHER INJECTION | α â β ARTEETHER | Antimalaria | Hanbet Pharmaceuticals Ltd | MAKCUR LABORATORIES LIMITED, 46/4-7, Dehgam Road, Zak Village, Tal.: Dehgam, Dist.: Gandhingar, Gujarat State, India. | Incompletete CTD Dossier Submission |
| 489 | Alprazolam Tablets USP 0.5mg | Alprazolam | Antidepressant | SEEMARK PHARMACY NIG. LTD | ASTAMED HEALTHCARE (I)PVT. LTD, PLOT NO. 2 & 3 PHASE II, GENESIS INDUSTRIAL COMPLEX, KOLGAON, PALGHAR -401404, MAHARASHTRA STATE (INDIA) | Incompletete CTD Dossier Submission |
| 490 | VIKING AZITHROMYCIN | Azithromycin | Antibiotics | VIKING PHARMACEUTICALS LTD | RHYDBURG PHARMACEUTICALS LTD, C 2 & 3, S.I.E.L, SELAQUI, DEHRADUN, UTTARAKHAND, INDIA | Incompletete CTD Dossier Submission |
| 491 | CEFIXIME 400MG | CEFIXIME 400MG | Antibiotics | Healthedge Pharmaceuticals & Beauty Co Ltd | SANGHARSH LIFECARE PVT LTD, A-503 SOLITAIRE COPORATE PARK NR, DIVYABHASKAR, S’G HIGHWAY MAKARBA AHMEDABAD 380015 | Incompletete CTD Dossier Submission |
| 492 | MEROSTAL | MEROPENEM INJECTION 500MG & 1000MG | Antibiotics | STALLION REMEDIES NIG LTD | STALLION LABORATORIES PVT. LTD.,Plot no – 10, Survey No.- 151, Inside Varmora Plastech, P.O – Vasna Chancharwadi, Bavla-Changodar Highway, Ahmedabad, Gujarat 382213 | Incompletete CTD Dossier Submission |
| 493 | Atavarone 250 mg/100 mg Granules | Atovaquone 250 mg; Proguanil Hydrochloride 100 mg | Antimalaria | Espen Laboratories Limited | Espen Laboratories Limited, Plot 32, Lynson Chemical Avenue, KM 38, Lagos-AbeoKuta Expressway, Sango Ota, Ogun State | Incompletete CTD Dossier Submission |
| 494 | ZAHIFRANIL TABLET | CLOMIPRAMINE TABLET | Antipsychotics | ZASAN LIFE SCIENCE VENTUES LTD | ZAHIDI PHARMACEUTICALS PVT LTD, J-1601/10, 3RD PHASE, ROAD NO 17, G.I.D.C.. UMARGAON-396171. DIST VALSAD, GUJRAT INDIA | Incompletete CTD Dossier Submission |
| 495 | PRENEU 82.5MG TABLET | Pregabalin 82.5mg | Anticonvulsant | Pheni Pharma Nigeria Limited | Nabiqasim Industries (PVT) Ltd17/24 Korangi Industrial Area,Karachi-Pakistan | Incompletete CTD Dossier Submission |
| 496 | SIPTIL | SITAGLIPTIN TABLETS USP 50 MG, 100MG | Antidiabetic | Sai Sagar Pharma Limited | ENDURANCE HEALTHCARE PVT LTD.C-1B, 305/2, 3, 4& 5, G.I.D.C. Kerala (Bavla), Dist.: Ahmedabad, Gujarat, India | Incompletete CTD Dossier Submission |
| 497 | XFIN | CEFTRIAXONE SODIUM USP | Antibiotics | XCEL PHARMACEUTICAL LTD. | XCEL PHARMACEUTICAL LTD , 9 olowogbowo street, Ilupeju Lagos, Nigeria | Incompletete CTD Dossier Submission |
| 498 | OBIGOD PENTAZOCINE | PENTAZOCINE INJECTION | Opiod Analgesic | OBIGOD PHARMACEUTICALS LTD | MERIT ORGANICS LTD, PLOT NO , 2104/2/A G.I.D.C SARIGAM BHILAD, DIST VALSAD 396155 INDIA | Incompletete CTD Dossier Submission |
| 499 | Artemether 20mg-Lumefantrine 120mg Tablet | Artemether, Lumefantrine | Antimalaria | JEHYSON HEALHTCARE LIMITED | JEHYSON HEALTHCARE LIMITED, Km 78, Lagos-Expressway Apomu Village, Ewekoro LGA Ogun state | Incompletete CTD Dossier Submission |
| 500 | SAROXIME | Cefuroxime | Antibiotics | SAOCO PHARMACEUTICS LTD | SHAMSHREE LIFESCIENCES LTD,Plot No. 11, Industrial Area, Katha- Bhatolikalan, Baddi 173205 (H.P), India | Incompletete CTD Dossier Submission |
| 501 | MALVEN VILDAGLIPTIN 50MG AND METFORMIN HYDROCHLORIDE 100OMG TABLETS | VILDAGLIPTIN 50MG AND METFORMIN HYDROCHLORIDE 100OMG TABLETS | Antidiabetic | Malven medics international company limited | SHUKRA PHARMACEUTICALS LIMITED D, R(GUJARAT),795, RAKANPUR SOLA SANTEJ ROAD, TA KALOL DIST GANDHINAGER(GUJARAT), INDIA | Incompletete CTD Dossier Submission |
| 502 | CLOTOVER | RIVAROXABAN 10MG | Anticoagulant | BIOGENERICS NIGERIA LIMITED | Actoverco Pharmaceutical Company, No. 79, 4th Golestan Blvd., Baharestan Industrial City. Karaj, Iran | Incompletete CTD Dossier Submission |
| 503 | Artesunate Injection | Artesunate | Antimalaria | Alivio Pharmacy & Store Nigeria Limited. | ALPA LABORATORIES LIMITED, 33/2 A.B ROAD, PIGDAMBER, INDORE (MP) , INDIA | Incompletete CTD Dossier Submission |
| 504 | Lifeline artemether and lumefantrine | Artemether and Lumefantrine | antimalaria | Total wellness Resources Nigeria Ltd | IMPULSE PHARMA PVT. LTD.J-201, J-202/1, MIDC Tarapur, Boisar Dist. Palghar – 401506, India | Incompletete CTD Dossier Submission |
| 505 | Xcept 10mg Tablet | Rivaroxaban 10mg | Anticoagulant | Fensyl MHP Consulting Limited | PharmEvo (Pvt) Limited, A-29, North Western Industrial Zone, Port Qasim, Karachi-75020, Pakistan. | Incompletete CTD Dossier Submission |
| 506 | CEFUROXIME AXETIL TABLETS USP 250MG & 500MG | CEFUROXIME AXETIL | Antibiotics | Right Remedies Limited | ENDURANCE HEALTHCARE PVT.LTD, 3709, G.I.D.C., PHASE IV, VATVA City: AHMEDABAD 382 445, Gujarat State, India | Incompletete CTD Dossier Submission |
| 507 | PENTAZOCINE INJECTION | Pentazocine | Opiod Analgesic | CHYNA PHARMACEUTICAL LTD | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 508 | SYNUCIA TABLETS | Etoricoxib 120mg | Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | ZORYA PHARMACEUTICALS NIGERIA LTD | UNICOR PHARAMTECH LLP, SURVEY No 273/1/1 VILLAGE, NATIONA HIGHWAY 8A, GANDHIDHAM – MUNDRA, TALUKA, OPPOSITE SURYA ROSHNI LIMITED COMPANY, BHUVAD, ANJAR, GUJARAT 370130 | Incompletete CTD Dossier Submission |
| 509 | Sildenafil Citrate | Sildenafil Citrate | Phosphodiesterase type 5 (PDE5) inhibitors | JETSTREAM LIMITED | SPENSUS PHARMACEUTICAL PVT LTD.Unit No.1, Survey No.284, Beside Niva Nutrifoods LLP, Dhanali Road Mehsana, Ahmedabad – Patan Highway Rd, Ganeshpura, Gujarat 382705 | Incompletete CTD Dossier Submission |
| 510 | Artemether 80mg and Lumefantrine 480mg Tablets | Artemether and Lumefantrine | Antimalaria | Therap Pharmaceuticals | CENTURION LABORATORIES PVT.LTD.Plot No: P-2, Savali, Bio-Tech Park, At – Manjusar, Tal – Savali, Dist. – Vadodara, 391775, INDIA. | Incompletete CTD Dossier Submission |
| 511 | Easycare Gentamicin Sulfate Injection | Gentamicin Sulfate | Antibiotics | Easy-care Pharmaceuticals Limited | Guizhou Tiandi Pharmaceutical Co.,Ltd, No.6 Baokang Road,Hongxing Pharmaceutical Indutrial Park,Dingxiao Town,Xingyi City Qianxiânan Bouyei and Miao Autonomous Prefecture,Guizhou Province,China | Incompletete CTD Dossier Submission |
| 512 | NECPRO-TN | Ciprofloxacin + Tinidazole | Antibiotics | Mekbenny Health Services Limited | Relax Biotech Pvt Limited, 862/1, GIDC Makarpura, Vadodara – 390010, India | Incompletete CTD Dossier Submission |
| 513 | CEVINAF | CEFIXIME USP 400 MG | Antibiotics | HOMMAGE INTERNATIONAL SERVICES LIMITED | MEDICO REMEDIES LIMITED,7, 8 & 9, Dewan and Sons Udyog Nagar, Lokmanya Nagar, Palghar (West), Dist., Palghar, Maharashtra – 401404 | Incompletete CTD Dossier Submission |
| 514 | Artesunate Injection | Artesunate Injection | Antimalaria | AIONS PHARMACEUTICAL LIMITED | ALPA LABORATORIES LIMITED,33/2 A.B. Road, Pigdamber. Indore. Madhya Pradesh 453446 | Incompletete CTD Dossier Submission |
| 515 | PENTAZOCINE INJECTION | PENTAZOCINE | Opiod Analgesic | VAXORA LIMITED, Ogbonnia Nwafor Peter Igboko | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 516 | Artemether 80 mg and Lumefantrine 480 mg Tablets | Artemether and Lumefatrine | Antimalaria | NAFRO PHARMA NIGERIA LIMITED, Kayode GBENGA ONI | Cubit Lifesciences LLP, Plot No. 39-40, Ozone Industrial Park, At. & post: Kerala- Bhayla Near. Kerala G.I.D.C, Taluka: Bavla, Dist.: Ahmedabadâ382220 Gujarat India. | Incompletete CTD Dossier Submission |
| 517 | AMLODIPINE, VALSARTAN AND HYDROCHLORTHIAZIDE | AMLODIPINE, VALSARTAN AND HYDROCHLORTHIAZIDE | Antihypertensive | GOLDEN REMEDIES LIMITED, Chidimma Okafor NA Okafor | ENDURANCE HEALTHCARE PVT LTD, C-1B 305/2,3,4 & 5 G.I.D.C KERALA (BAVLA) DIST, AHMEDDABAD, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 518 | PENTAZOCINE INJECTION | PENTAZOCINE HYDROCHLORIDE | Opiod Analgesic | SCION GLOBA LIMITED, SEUN MOSES PETER MOSES PETER | OM BIOMEDIC PVT. LTD, 1203,12TH FLOOR,SRI KRISHA BLDG,NEW LINK ROAD OPP LAXMI INDS ESTATE,NR,FUN REPUBLIC MALL,ANDHERI(WEST),MUMBAI-40005,MAHArashtra,india. | Incompletete CTD Dossier Submission |
| 519 | Artesunate Injection | Artesunate | Antimalaria | Nancil Nigeria Ltd | East African (India) Overseas, Plot 1, Pharmacity, Selaqui, Dehradun-248011 (INDIA) | Incompletete CTD Dossier Submission |
| 520 | CODIOLAD 80 TABLETS | VALSARTAN 80MG TABLETS | Antihypertensive | LADFIELD GLOBAL RESOURCES LTD | M/S Globela Pharma Pvt. Ltd.PLOT NO. 357-358, G. I. D. C., SACHIN, SURAT â 394 230, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 521 | Spironolactone Tablets | Spironolactone Tablets | Antihypertensive | NEESAN PHARMACEUTICAL LTD | Blutris Healthcare Pvt Ltd, Survey No. 1229, Kherpur- Chandarda Road, Nr. DPS School Village: Rajpur, Taluka: Kadi Dist: Mehsana, Gujarat 384440 | Incompletete CTD Dossier Submission |
| 522 | PENTACOZINE INJECTION | PENTACOZINE | Opiod Analgesic | AFFLUENT DRUGS LIMITED | FARBE FIRMA PVT LTD, Plot no: 1508, Near Atique Bakery, G.I.D.C. Estate, Ankleswar – 393002 Gujarat, India | Incompletete CTD Dossier Submission |
| 523 | ITANAF 200 (ITRACONAZOLE CAPSULES BP 200 MG) | Itraconazole BP 200mg | Antifungal | AFRIGENERICS DRUGS LIMITED | SWISS PHARMA PVT. LTD. 3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382445, Dist: Ahmedabad Gujarat State, India. | Incompletete CTD Dossier Submission |
| 524 | VILPHAC 200MG TABLET | OFLOXACIN | Antibiotics | UNICURE PHARMACEUTICAL LIMITED | UNICURE PHARMACEUTICAL LIMITED, Ikofa Village, Lagos-Benin Expressway, Ijebu-Ode, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 525 | LUMITIDE 40MG TABLET | FUROSEMIDE | Antihypertensive | UNICURE PHARMACEUTICAL LIMITED | UNICURE PHARMACEUTICAL LIMITED, Ikofa Village, Lagos-Benin Expressway, Ijebu-Ode, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 526 | LECTAX 500MG TABLET | LEVOFLOXACIN | Antibiotics | UNICURE PHARMACEUTICAL LIMITED | UNICURE PHARMACEUTICAL LIMITED, Ikofa Village, Lagos-Benin Expressway, Ijebu-Ode, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 527 | Felpack | Piroxicam | Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | Espen Laboratories Limited | ECOMED PHARMA LTD, Plot 32, Lynson Chemical Avenue, KM 38, Lagos-AbeoKuta Expressway, Sango Ota, Ogun State | Incompletete CTD Dossier Submission |
| 528 | LOFIX 500MG TABLET | CIPROFLOXACIN HYDROCHLORIDEU | Antibiotics | UNICURE PHARMACEUTICAL LIMITED | UNICURE PHARMACEUTICAL LIMITED, Ikofa Village, Lagos-Benin Expressway, Ijebu-Ode, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 529 | ACITEN 20MG CAPSULE | OMEPRAZOLE | Proton Pump Inhibitors (PPIs) | UNICURE PHARMACEUTICAL LIMITED | UNICURE PHARMACEUTICAL LIMITED, Ikofa Village, Lagos-Benin Expressway, Ijebu-Ode, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 530 | MeCureâs Chlorpheniramine 4mg Capsules | Chlorpheniramine Maleate 4mg Capsules | Antihistamine | MECURE INDUSTRIES LIMITED | MeCure Industries PLC, Plot 6, Block H, Oshodi Industrial Scheme, Oshodi, Lagos State | Incompletete CTD Dossier Submission |
| 531 | Nosdrine Plus Tablet | Loratadine + Pseudoephedrine Hydrochloride | Antihistamine | DRUGFIELD PHARMACEUTICALS LIMITED | Drugfield Pharmaceuticals Limited, Lynson Chemical Avenue Km 38, Lagos-Abeokuta Expressway, Sango Ota, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 532 | FIDSON CIPROFLOXACIN TABLETS 500mg | CIPROFLOXACIN HYDROCHLORIDE TABLETS USP 500mg | Antibiotics | FIDSON HEALTHCARE LTD | FIDSON HEALTHCARE PLC , KM 38, LAGOS-ABEOKUTA EXPRESSWAY, SANGO-OTA, OGUN STATE | Incompletete CTD Dossier Submission |
| 533 | LADFIELD CO-AMOXICLAV INJECTION 1.2g | 1g Amoxicillin and 200mg Clavulanic acid (Co-Amoxiclav) Injection 1.2g | Antibiotics | LADFIELD GLOBAL RESOURCES LTD | Shandong Xier Kangtai Pharmaceutical Co., Ltd.Private Economy Garden, Xinyan Town, Yanzhou city, Shangdong P. R. China | Incompletete CTD Dossier Submission |
| 534 | Ibucap Night Capsules | Ibuprofen and Diphenhydramine Citrate Capsules 200mg / 38mg | Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)/Antihistamine | SHALINA HEALTHCARE NIGERIA LIMITED | SHALINA HEALTHCARE NIGERIA LIMITED, Block 3B, Westerner Industrial Avenue, OA Lagos-Ibadan Expressway, Isheri, IFO Local Government Area Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 535 | Floxsafe 400 | MOXIFLOXACIN TABLETS 400 mg | Antibiotics | PHILLIPS PHARMACEUTICALS (NIGERIA) LIMITED | MSN Laboratories Private Limited, Formulations Division, Unit-II, Sy No.1277 & 1319 to 1324, Nandigama (Villlage & Mandal), Rangareddy District, Telangana Pin Code – 509 228, India. | Incompletete CTD Dossier Submission |
| 536 | ZOMTU 4 mg/5 ml concentrated solution for IV infusion | zoledronic acid monohydrate 4 mg/5 ml concentrated solution for IV infusion | Bisphosphonates | PHARAON HEALTHCARE NIGERIA LIMITED | Onko Ä°laç Sanayi ve Ticaret A.Å, GOSB 1700 Sokak, No:1703 Ãayırova / Kocaeli/ TURKEY | Incompletete CTD Dossier Submission |
| 537 | OXATU-S 100mg/20ml Concentrated Solution for IV Infusion | oxaliplatin 100mg/20ml Concentrated Solution for IV Infusion | Antineoplastic | PHARAON HEALTHCARE NIGERIA LIMITED | Onko Ä°laç Sanayi ve Ticaret A.Å, Gebze Organize Sanayi Bölgesi, 1700 Sokak, No:1703 Ãayırova, Kocaeli/ TURKEY | Incompletete CTD Dossier Submission |
| 538 | MALNET SP TABLET | Sulfadoxine 500mg and Pyrimethamine 25mg Tablet | Antimalaria | FIDSON HEALTHCARE LTD | FIDSON HEALTHCARE PLC, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, OTA, OGUN STATE | Incompletete CTD Dossier Submission |
| 539 | IRONTU 100 mg/ 5ml Vial Containing Solution for IV Infusion | irinotecan hydrochloride trihydrate 20mg/ml Vial Containing Solution for IV Infusion | Topoisomerase I inhibitor. | PHARAON HEALTHCARE NIGERIA LIMITED | Onko Ä°laç Sanayi ve Ticaret A.Å, GOSB 1700 Sokak, No:1703 Ãayırova / Kocaeli/ TURKEY | Incompletete CTD Dossier Submission |
| 540 | IRITERO | IRINOTECAN HYDROCHLORIDE INJECTION 100MG/5ML | Topoisomerase I inhibitor. | HETERO LABS NIG LTD | HETERO LABS LIMITED UNIT VI APIIC FORMULATION SEZ , SURVEY N0 440&441 POLEPALLY VILLAGE JADCHERLA MANDAL MAHABOOB NAGAR (DIST)-509301 TELANGANA INDIA | Incompletete CTD Dossier Submission |
| 541 | SOLTEN 40MG/10ML INJECTION | OMEPRAZOLE SODIUM | Proton Pump Inhibitors (PPIs) | UNICURE PHARMACEUTICAL LIMITED | HARBIN MEDISAN PHARMACEUTICAL LIMITED, LANXI ECONOMIC DEVELOPMENT ZONE, SUIHUA CITY, HEILONGJIANG PROVINCE | Incompletete CTD Dossier Submission |
| 542 | MOVFOR | MOLNUPIRAVIR CAPSULES 200MG | Antiviral | HETERO LABS NIG LTD | HETERO LABS LIMITED, UNIT V, TSIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR DISTRICT, TELANGANA STATE, INDIA | Incompletete CTD Dossier Submission |
| 543 | BRYXO | Brimonidine tartrate | Glaucoma Agents | GENERIX GLOBAL INVESTMENT LTD | Popular Pharmaceuticals Ltd. Address: 164, Tongi Industrial Area, Tongi, Gazipur-1711, Bangladesh | Incompletete CTD Dossier Submission |
| 544 | LOFIX 500MG | CIPROFLOXACIN SODIUM 500MG | Antibiotics | UNICURE PHARMACEUTICAL LIMITED | UNICURE PHARMACEUTICAL LIMITED, Ikofa Village, Lagos-Benin Expressway, Ijebu-Ode, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 545 | ACITEN 20MG | OMEPRAZOLE 20MG | Proton Pump Inhibitors (PPIs) | UNICURE PHARMACEUTICAL LIMITED | UNICURE PHARMACEUTICAL LIMITED, Ikofa Village, Lagos-Benin Expressway, Ijebu-Ode, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 546 | DAMOXEN 500 mg capsule | Amoxicillin Trihydrate | Antibiotics | Daily Need Industries Limited | Daily Need Industries Limited, Plot 9 & 10, Daily Need Lane, Off Ladipo Street, Oshodi Industrial Scheme, Matori â Lagos | Incompletete CTD Dossier Submission |
| 547 | MEDIRAN | TELMISARTAN ; CHLORTHALIDONE | Antihypertensive | NEMEL PHARMACEUTICALS IND. LIMITED | NEMEL PHARMACEUTICALS LIMITED , PLOT 35 EMENE INDUSTRIAL LAYOUT | Incompletete CTD Dossier Submission |
| 548 | Dolutegravir, Lamivudine and Tenofovir Alafenamide Tablets 50/300/25 mg | Dolutegravir, Lamivudine and Tenofovir Alafenamide Tablets 50/300/25 mg | Antiviral | ONIFAM LABORATORIES LTD | Lupin Limited , Plot No. 6A1, 6A2 , Sector-17, Special Economic Zone, MIHAN Notified Area, Nagpur, Maharashtra-4411 08, India. | Incompletete CTD Dossier Submission |
| 549 | SILVAROXIME 500MG TABLET | CEFUROXIME AXETIL 500MG TABLET | Antibiotics | SILVER CROWN PHARMACY AND STORES LTD | REYOUNG PHARM.CO.LTD.NO. 1 RUIYANG ROAD, YIYUAN COUNTY, SHANDONG, P.R. CHINA | Incompletete CTD Dossier Submission |
| 550 | Bedaquiline Tablets 100 mg | Bedaquiline | Anti-Tuberculosis | ONIFAM LABORATORIES LTD | Lupin Limited, A-28/1, MIDC, Chikalthana, Chhatrapati Sambhajinagar – 431210- Maharashtra | Incompletete CTD Dossier Submission |
| 551 | Krishat Fluconazole Tablet | Fluconazole Tablet | Antifungal | KRISHAT PHARMA INDUSTRIES LIMITED | KRISHAT PHARMA INDUSTRIES LIMITED, KM 15, LAGOS IBADAN EXPRESSWAY, IBADAN, OYO STATE, NIGERIA. | Incompletete CTD Dossier Submission |
| 552 | DRULATAN PLUS EYE DROPS | LATANOPROST 0.005% W/V, TIMOLOL MALEATE 0.68% W/V | Prostaglandin Analog/Ocular Antihypertensive | DRUGFIELD PHARMACEUTICALS LIMITED | Drugfield Pharmaceuticals Limited, Lynson Chemical Avenue Km 38, Lagos-Abeokuta Expressway, Sango Ota, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 553 | Cerazette 75 mcg film-coated tablets. | Desogestrel 75mcg | Progestin | Pharmasymbiosis Ltd. | N. V. Organon, Kloosterstraat 6 5349 AB Oss Netherland | Incompletete CTD Dossier Submission |
| 554 | XYTICA EYE DROPS | TRAVOPROST USP 0.004%W/V | Prostaglandin Analog | FIDSON HEALTHCARE LTD | FIDSON HEALTHCARE PLC, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, OTA, OGUN STATE | Incompletete CTD Dossier Submission |
| 555 | PROLLERG EYE DROPS | NAPHAZOLINE 0.05%W/V & ZINC SULPHATE 0.25%W/V EYE DROPS | Ocular Decongestant and Astringent | FIDSON HEALTHCARE LTD | FIDSON HEALTHCARE PLC, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, OTA, OGUN STATE | Incompletete CTD Dossier Submission |
| 556 | GABAPENTIN CAPSULES USP | GABAPENTIN | Anticonvulsant | Excel Charis Pharmaceutical chemical ltd | Hab Pharmaceuticals and Research Ltd, 10, Pharmacity, Selaqui, Dehradun, Uttarakhand – 248011 | Incompletete CTD Dossier Submission |
| 557 | Gobesunate | Artesunate 50mg and Amodiaquine Hydrochloride 150mg | Antimalaria | Goben Pharmacy Limited | Health Care Formulations Pvt. Ltd.C/8, Sardar Estate. Ajwa Road, Vadodara-390019, Gujarat, India | Incompletete CTD Dossier Submission |
| 558 | CEFIXO 400 | CEFIXIME TABLETS USP 400MG | Antibiotics | ESMERO PHARMACEUTICAL LIMITED | Health Care Formulations Pvt. Ltd.C/8, Sardar Estate. Ajwa Road, Vadodara-390019, Gujarat, India | Incompletete CTD Dossier Submission |
| 559 | Dailiclav 625 mg Tablet | Amoxicillin Trihydrate and Potassium Clavulanate | Antibiotics | Daily Need Industries Limited | Daily-Need Industries Limited, Plot 9&10 Daily-need Lane, Off Ladipo Street, Oshodi Scheme Industrial Estate, Matori, Lagos | Incompletete CTD Dossier Submission |
| 560 | Dailiclox 500 mg Capsule | Ampicillin and Cloxacillin Capsule 500 mg | Antibiotics | Daily Need Industries Limited | Daily-Need Industries Limited, Plot 9&10 Daily-need Lane, Off Ladipo Street, Oshodi Scheme Industrial Estate, Matori, Lagos | Incompletete CTD Dossier Submission |
| 561 | DAMOXEN 500 mg capsule | Amoxicillin trihydrate | Antibiotics | Daily Need Industries Limited | Daily-Need Industries Limited, Plot 9&10 Daily-need Lane, Off Ladipo Street, Oshodi Scheme Industrial Estate, Matori, Lagos | Incompletete CTD Dossier Submission |
| 562 | ODIZAT HCT | AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE | Antihypertensive | BEZIK PHARMA LTD | AVANTIKA MEDEX PVT LTD, PLOT NO. J8 TO J11 GALLOPS INDUSTRIAL PARK 2 NATIONAL HIGH WAY 8A, VASNA CHACHARWADI AHMEDABAD, 382213 | Incompletete CTD Dossier Submission |
| 563 | Telmisartan 80mg and Amlodipine 10 mg Tablets | Telmisartan 80mg and Amlodipine 10 mg Tablets | Antihypertensive | BOCHEPHARM NIGERIA LIMITED | Celogen Generics Pvt. Ltd.Plot No. 646/1&2, Agrawal Industrial Estate, Somnath Temple Road, Dabhel, Daman – 396 210, U.T. India | Incompletete CTD Dossier Submission |
| 564 | PARAZOX PLUS TABLET | Aceclofenac 100mg +Paracetamol 500mg + Chlorzoxazone 250mg | Non-Steroidal Anti-Inflammatory Drug (NSAID)/ Analgesics | ARTEMIS LABORATORIES LIMITED | Artemis laboratories limited,Plot 4, Block 4, Ogun State Housing Corporation & Industrial Estate, Ota, Ogun State, Nigeria. | Incompletete CTD Dossier Submission |
| 565 | ARTEFEN SUSPENSION | IBUPROFEN BP | Non-Steroidal Anti-Inflammatory Drug (NSAID) | ARTEMIS LABORATORIES LIMITED | Artemis laboratories limited,Plot 4, Block 4, Ogun State Housing Corporation & Industrial Estate, Ota, Ogun State, Nigeria. | Incompletete CTD Dossier Submission |
| 566 | Vancomycin | Vancomycin | Antibiotics | CONFIDENCE PHARMACEUTICALS LIMITED | ABIPHARM LLC, 3319 Tsilkani, Mtskheta district, Georgia | Incompletete CTD Dossier Submission |
| 567 | CEFUROXIME | Cefuroxime Sdium | Antibiotics | CONFIDENCE PHARMACEUTICALS LIMITED | ABIPHARM LLC, 3319 Tsilkani, Mtskheta district, Georgia | Incompletete CTD Dossier Submission |
| 568 | TRAMADOL HYDROCHLORIDE INJECTION 100MG/2ML | TRAMADOL HYDROCHLORIDE INJECTION 100MG/2ML | Opioid Analgesic | F-DUMSOM NIG LTD | STALLION LABOURATORIES PVT. LTD, PLOT 1508, GIDC, ANKLESHWAR. DIST BHARUCH GUJARAT INDIA | Incompletete CTD Dossier Submission |
| 569 | CHLORAMPHENICOL EYE OINTMENT BP 1% W/W STERILE | CHLORAMPHENICOL | Antibiotics | FIDSON HEALTHCARE LTD | CURIS LIFESCIENCES PRIVATE LIMITED, PF-23 Sanand, GIDC II, Sanand, Ahmedabad-363020, GUJARAT (INDIA) | Incompletete CTD Dossier Submission |
| 570 | TENELIGLIPTIN TABLETS | TENELIGLIPTIN TABLETS 20MG & 40MG | Antidiabetic | FIDSON HEALTHCARE LTD | STALLION LABORATORIES PVT. LTD, C-1B 305/2, 3, 4 & 5 G.I.D.C. Kerala (Bavla), Dist. Ahmedabad, Gujarat, India. | Incompletete CTD Dossier Submission |
| 571 | QUININE | QUININE DIHYDROCHLORIDE INJECTION 600MG/2ML | Antimalaria | FIDSON HEALTHCARE LTD | FIDSON HEALTHCARE PLC, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, OTA, OGUN STATE | Incompletete CTD Dossier Submission |
| 572 | EMXAMIC INJECTION | Tranexamic acid Injection BP | Antifibrinolytic | EMBASSY PHARMACEUTICAL AND CHEM.LTD | M/S LABORATE PHARMACEUTICALS , 51, Industrial Area Gondpur, Paonta Sahib, Distt. Sirmour, Himachal Pradesh, INDIA H.O.: E-11, Indl. Area, Panipat – 132103 | Incompletete CTD Dossier Submission |
| 573 | Enhertu 100 mg powder for concentrate for solution for infusion | trastuzumab deruxtecan | Antibody-Drug Conjugates (ADCs) | ASTRAZENECA NIGERIA LIMITED | Baxter Oncology GmbH, Kantstrasse 2, 33790 Halle/Westfalen, Germany | Incompletete CTD Dossier Submission |
| 574 | PROLLERG EYE DROPS | NAPHAZOLINE 0.05%W/V & ZINC SULPHATE 0.25%W/V EYE DROPS | Ocular Decongestant and Astringent | FIDSON HEALTHCARE LTD | FIDSON HEALTHCARE PLC, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, OTA, OGUN STATE | Incompletete CTD Dossier Submission |
| 575 | PROIST EYE DROPS | HYPROMELLOSE 0.3% W/V | Ocular Lubricant | FIDSON HEALTHCARE LTD | FIDSON HEALTHCARE PLC, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, OTA, OGUN STATE | Incompletete CTD Dossier Submission |
| 576 | XYTICA EYE DROPS | TRAVOPROST USP 0.004%W/V | Antiglaucoma Agent | FIDSON HEALTHCARE LTD | FIDSON HEALTHCARE PLC, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, OTA, OGUN STATE | Incompletete CTD Dossier Submission |
| 577 | ZOMTU 4 mg/5 ml concentrated solution for IV infusion | zoledronic acid monohydrate 4 mg/5 ml concentrated solution for IV infusion | Nitrogenous bisphosphonate | PHARAON HEALTHCARE NIGERIA LIMITED | Onko Ä°laç Sanayi ve Ticaret A.Å, GOSB 1700 Sokak, No:1703 Ãayırova / Kocaeli/ TURKEY | Incompletete CTD Dossier Submission |
| 578 | IRONTU 100 mg/ 5ml Solution for IV Infusion | irinotecan hydrochloride trihydrate 20 mg/ml | Topoisomerase I inhibitor | PHARAON HEALTHCARE NIGERIA LIMITED | Onko Ä°laç Sanayi ve Ticaret A.Å, GOSB 1700 Sokak, No:1703 Ãayırova / Kocaeli/ TURKEY | Incompletete CTD Dossier Submission |
| 579 | OXATU-S 100mg/20ml Concentrated Solution for IV Infusion | Oxaliplatin 100 mg/20ml Concentrated Solution for IV Infusion | Antineoplastic | PHARAON HEALTHCARE NIGERIA LIMITED | Onko Ä°laç Sanayi ve Ticaret A.Å, GOSB 1700 Sokak, No:1703 Ãayırova / Kocaeli/ TURKEY | Incompletete CTD Dossier Submission |
| 580 | Valubabe Paracetamol Syrup | Paracetamol Syrup 120mg/5ml | Analgesic | VALUECARE PRODUCT LTD | Daily-Need Industries Limited, Plot 9&10 Daily-need Lane, Off Ladipo Street, Oshodi Scheme Industrial Estate, Matori, Lagos | Incompletete CTD Dossier Submission |
| 581 | TRAMADOL 100mg CAPSULES | Tramadol Hydrochloride B.P 100mg | Opiod Analgesic | ALM DRUGMART PHARMACY LIMITED | Nalis Pharmaceuticals Ltd, R67-68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State | Incompletete CTD Dossier Submission |
| 582 | NALIS LORATADINE 10 MG TABLETS | LORATADINE 10 MG TABLETS | Antihistamine | FOCHIZZ DRUGS PHARMACY LIMITED | Nalis Pharmaceuticals Ltd, R67-68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State | Incompletete CTD Dossier Submission |
| 583 | BGCEF | Ceftriaxone Sodium and Sulbactam Injection | Antibiotics | BG PHARMA & HEALTHCARE LIMITED | OM BIOMEDIC PVT. LTD. 1203, 12th Floor, Sri Krishna Bldg, New Link Road, Opp Laxmi Inds Estate, Nr. Fun Republic Mall, Andheri (West), Mumbai – 400053, Maharashtra, India. | Incompletete CTD Dossier Submission |
| 584 | FLUCAZYLA | Fluconazole | Antifungal | OZYFAVOUR PHARMACEUTICAL NIGERIA LTD. | KGN PHARMACEUTICALS PVT. LTD.F-3/1, MIDC Tarapur, Boisar, Dist.: Palghar, 401506, Maharashtra, India | incompletete CTD Dossier Submission |
| 585 | CHUPET BENZATHINE BENZYLPENICILLIN INJECTION | BENZATHINE BENZYLPENICILLIN | Antibiotics | CHUPET PHARMACEUTICAL COMPANY LIMITED | REYOUNG PHARMACEUTICAL CO LTD, NO 1 RUIYANG ROAD YIYUAN COUNTY SHANDONG PROVINCE P. R. CHINA | Incompletete CTD Dossier Submission |
| 586 | Valocam 100mg/5ml oral suspension | Ibuprofen 100mg/5ml Oral Suspension | Non-Steroidal Anti-Inflammatory Drug (NSAID) | VALUECARE PRODUCT LTD | Daily-Need Industries Limited, Plot 9&10 Daily-need Lane, Off Ladipo Street, Oshodi Scheme Industrial Estate, Matori, Lagos | Incompletete CTD Dossier Submission |
| 587 | ENOXAPARIN SODIUM INJECTION | ENOXAPARIN SODIUM | Anticoagulant | BOLFORT PHARMACEUTICAL LIMITED | MAKUR LABORATORY LIMITED, 46/4-7 VILLAGE ZAK NEAR CANAL GUJARAT INDIA | Incompletete CTD Dossier Submission |
| 588 | Artelum SG | Artemether 80mg; Lumefantrine 480mg | Antimalaria | May & Baker Nigeria Plc | Asoj Soft Caps PVT Ltd, Asoj, Baroda-Halol Highway, Dist. Baroda – 391 510. Gujarat | Incompletete CTD Dossier Submission |
| 589 | Diazepam Tablet 5 mg | Diazepam B.P 5mg | Benzodiazepines | FOCHIZZ DRUGS PHARMACY LIMITED | Nalis Pharmaceuticals Ltd, R67-68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State | Incompletete CTD Dossier Submission |
| 590 | CHRISVENT AZITHROMYCIN TABLETS 500MG | Azithromycin Tablets USP 500mg) | Antibiotics | CHRISVENT PHARMACEUTICAL LTD | M/s. IMPULSE PHARMA PVT. LTD.J-201, J-202/1 , MIDC Tarapur, Boisar, Dist. Palghar – 401506, Maharashtra State, India. | Incompletete CTD Dossier Submission |
| 591 | GLOBAL YOUNG Nystatin | Nystatin Ny | Polyene Antifungal | GLOBAL YOUNG PHARMA LTD | ENICAR PHARMACEUTICALS PVT. LTD , Plot J-214, 215, 216, MIDC Tarapur Boisar, Tal Palghar Dist, Thane, Tarapur-401506, INDIA | Incompletete CTD Dossier Submission |
| 592 | APPAMIDE PLUS (TROPICAMIDE & PHENYLEPHRINE HYDORCHLORIDE OPHTHALMIC SOLUTION | TROPICAMIDE & PHENYLEPHRINE HYDORCHLORIDE OPHTHALMIC SOLUTION | Mydriatic and Cycloplegic Agent | CEDAR VILLE LIMITED | Appasamy Ocular Devices (P) Ltd, Plot No. 74 âD, Katha, Baddi Distt. Solan Himachal Pradesh- 173205 India | Incompletete CTD Dossier Submission |
| 593 | PATBLESS Artesunate Injection 120 mg | Artesunate | Antimalaria | PATBLESS PHARMACEUTICAL LTD | PHARMAX INDIA PVT. LTD , 9, KURLA INDUSTRIAL ESTATE, NARAYAN NAGAR, NETAJI PALKER ROAD, GHATKOPER (W), MUMBAI – 400086, MAHARASHTRA. | Incompletete CTD Dossier Submission |
| 594 | Dolutegravir Tablet 50mg | Dolutegravir | Antiviral | Strides Life sciences Limited | Strides Pharma Science Limited,No 36/7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore, India | Incompletete CTD Dossier Submission |
| 595 | OMEPEP | OMEPRAZOLE FOR INJECTION 40MG | Proton Pump Inhibitors (PPIs) | SAM PHARMACEUTICAL LIMITED | EAST AFRICAN (INDIA) OVERSEAS, PLOT NO. 1, PHARMACITY, SELAQUI, DEHRADUN-248011 | Incompletete CTD Dossier Submission |
| 596 | ANOFAST TABLET | Aceclofenac / Chlorzoxazone / Paracetamol | Analgesic | Osworth Nigeria Limited | May & Baker Nigeria Plc, 1 May & Baker Avenue Off Idiroko Road Ota Ogun State | Incompletete CTD Dossier Submission |
| 597 | Lumacee Powder for Oral Suspension | Artemether 20 mg & Lumefantrine 120 mg Powder for Oral Suspension | Antimalaria | CEEMIKE PHARMACEUTICAL CO. LTD | ASTAMED HEALTHCARE (I) PVT. LTD, 2 & 3, Genesis Industrial Complex, Phase-II, Kolgaon, Palghar, Thane, Maharashtra, INDIA | Incompletete CTD Dossier Submission |
| 598 | Dalat Suspension 400 mg | Albendazole 400mg Suspension | Benzimidazole | Daily Need Industries Limited | Daily-Need Industries Limited, Plot 9&10 Daily-need Lane, Off Ladipo Street, Oshodi Scheme Industrial Estate, Matori, Lagos | Incompletete CTD Dossier Submission |
| 599 | ARTEMETHER 20 MG AND LUMEFANTRINE 120 MG TABLETS & ARTEMETHER 80 MG AND LUMEFANTRINE 480MG TABLETS | ARTEMETHER 20 MG AND LUMEFANTRINE 120 MG TABLETS & ARTEMETHER 80 MG AND LUMEFANTRINE 480MG TABLETS | Antimalaria | CRISTABEN PHARMA NIG LTD. | STALLION LABORATORIES PVT. LTD.C-1B 305/2, 3, 4& 5, G.I.D.C, KERALA (BAVLA), DIST. AHMEDABAD, GUJARAT, INDIA. | Incompletete CTD Dossier Submission |
| 600 | BRIDGEFENAC TABLETS | Diclofenac Sodium BP-Misoprostol USP (As 1% HPMC Dispersion) | Non-Steroidal Anti-Inflammatory Drug (NSAID) | BRIDGECARE PHARMACEUTICALS LIMITED | Amoli Organics Private Limited, G.I.D.C., Vapi,State-Gujarat, INDIA PIN-396195 India | Incompletete CTD Dossier Submission |
| 601 | Sartem (20/120mg) | Artemether/Lumefantrine | Antimalaria | Savannah Pharmaceuticals Nigeria Limited | Evans Baroque Limited, Agbara Industrial Estate, Km 32, Lagos-Badagry Expressway, Agbara, Ogun State, Nigeria. | Incompletete CTD Dossier Submission |
| 602 | Feccox Omeprazole Capsules 20mg | Omeprazole Capsules 20mg | Proton Pump Inhibitors (PPIs) | FECCOX PHARMACY AND GENERAL ENTERPRISES LIMITED | Nalis Pharmaceuticals Ltd, R67-68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State | Incompletete CTD Dossier Submission |
| 603 | Diafuroxime caplet 500mg | Cefuroxime Axetil 500mg | Antibiotics | Diamond healthcare limited | Miraflash Nigeria Limited, 2-8 Success Estate, Off Brent Field Avenue ,Oke-Afa, Magboro Ogun State | Incompletete CTD Dossier Submission |
| 604 | LISINOPRIL TABLETS BP 10 MG | LISINOPRIL | Antihypertensive | Ireka gpt pharmaceutical | LESANTO LABORATORIES, 4-5-6, Om Sai Karan Palace, Eksar Road, Borivali (W), Mumbai – 400 091. INDIA. | Incompletete CTD Dossier Submission |
| 605 | Ciprofloxacin 500mg Tablets | Ciprofloxacin | Antibiotics | ALM DRUGMART PHARMACY LIMITED | Nalis Pharmaceuticals Ltd, R67-68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State | Incompletete CTD Dossier Submission |
| 606 | OBIGOD Ceftriaxone for intravenous injection 1g | Ceftriaxone for intravenous injection 1g | Antibiotics | OBIGOD PHARMACEUTICALS LTD | MERIT ORGANICS LIMITED, PLOT NO 2104/2/A, GIDC, SARIGAM, BHILAD, DIST- VALSAD- 396155, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 607 | EASYCARE | PENTAZOCINE INJECTION BP 30 MG/ML | Opiod Analgesic | Easy-care Pharmaceuticals Limited | MERIT ORGANICS LIMITED, PLOT NO 2104/2/A, GIDC, SARIGAM, BHILAD, DIST- VALSAD- 396155, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 608 | MAZTAPEN | Tapentadol Capsules 100mg | Opiod Analgesic | Okeymazi Pharmaceutical Limited | JASH PHARMA PVT. LTD.Plot No. 143/144, Surat SEZ, Near Sachin Railway Station, Sachin, Surat | Incompletete CTD Dossier Submission |
| 609 | Biomedical Paracetamol drop | Paracetamol | Analgesic | Biomedical Limited | Biomedical Limited, 1, Ohimege street Industrial Estate | Incompletete CTD Dossier Submission |
| 610 | ARIUM 50 INJECTION | Atracurium Besylate Injection USP 50mg/5mL | Non-Depolarizing neuromuscular blocker | L’PACEMAKER PHARMACEUTICALS | CELON LABORATORIES PVT LTD, Plot No-3, ALEAP Industrial Estate, Gajularamaram(V), Quthbullapur(M), elangana – Medchal – Malka 500090, INDIA | Incompletete CTD Dossier Submission |
| 611 | TOPSEA CHLORAMPHENICOL CAPSULES 250 MG | CHLORAMPHENICOL CAPSULES 250 MG | Antibiotics | TOPSEA STANDARD PHARMACEUTICAL COMPANY LTD | ALPA LABORATORIES LIMITED, 33/2 A.B Road, Pigdamber, Indore (MP)-India | Incompletete CTD Dossier Submission |
| 612 | GRATEM 80/480 TABLETS | Artemether 80 mg; Lumefantrine 480 mg Tablets | Antimalaria | Grandcure pharmaceuticals limited | SHUKRA PHARMACEUTICALS LTD, Plot No. 795, Rakanpur Sola-Santej Road, Ta. Kalol, Dist. Gandhinagar (Gujarat) | Incompletete CTD Dossier Submission |
| 613 | Dalat 400 mg Tablet | Albendazole 400mg Tablet | Benzimidazole | Daily Need Industries Limited | Daily-Need Industries Limited, Plot 9&10 Daily-need Lane, Off Ladipo Street, Oshodi Scheme Industrial Estate, Matori, Lagos | Incompletete CTD Dossier Submission |
| 614 | ZURESI-5 | Diazepam Tablet 5mg | Benzodiazepines | VCA American Pharmaceuticals Limited | EVERGREEN AND MORNING STAR INDUSTRIAL COMPLEX, NDIOWERI VILLAGE, ORLU IMO STATE, NIGERIA. | Incompletete CTD Dossier Submission |
| 615 | PERMESOP PLUS | ESOMEPRAZOLE 40MG + DOMPERIDONE 30MG | Proton Pump Inhibitors (PPIs) | REALS PHARMACEUTICAL LTD | STALLION LABORATORIES PVT.LTD. C-1B, 305/2, 3, 4&5, G.I.D.C. KERALA (BAVLA), DIST.: AHMEDABAD, GUJARAT, INDIA. 8. Marketing authorisa | Incompletete CTD Dossier Submission |
| 616 | Grohe arthemether 80/480 | Artemether 80mg & Lumefantrine 480mg | Antimalaria | GROHE PHARMACEUTICALS LIMITED | AR Lifescience , 819/B rakanpur IndI. area, Tal. kalol, Dist. Gandhinagar,Gujrat. | Incompletete CTD Dossier Submission |
| 617 | Grohe arthemether 20/120 | Artemether 20 mg and Lumefantrine 120 mg Tablets | Antimalaria | GROHE PHARMACEUTICALS LIMITED | AR Lifescience , 819/B rakanpur IndI. area, Tal. kalol, Dist. Gandhinagar,Gujrat. | Incompletete CTD Dossier Submission |
| 618 | ARTORSTAT 20 TABLETS | ATORVASTATIN CALCIUM USP 20MG | HMGCo-A Reductase Inhibitor | BLESSED ASSURANCE PHARMACEUTICALS LTD | MEDIWIN PHARMACEUTICALS , 128/A, PHASE I & II, G.I.D.C., NARODA AHMEDABAD – 382330, INDIA | Incompletete CTD Dossier Submission |
| 619 | LEVOFAST 500 TABLETS | LEVOFLOXACIN USP 500MG | Antibiotics | BLESSED ASSURANCE PHARMACEUTICALS LTD | MEDIWIN PHARMACEUTICALS , 128/A, PHASE I & II, G.I.D.C., NARODA AHMEDABAD – 382330, INDIA | Incompletete CTD Dossier Submission |
| 620 | FRANK-LOIS PREGABALIN CAPSULES 300MG | PREGABALIN BP 300MG | Anticonvulsant | FRANK LOIS PHARMACEUTICAL NIG. LTD | HEALTH CARE FORMULATIONSPVT. LTD. C/8, SARDAR ESTATE, AJWA ROAD, VADODARA 390019, INDIA | Incompletete CTD Dossier Submission |
| 621 | TOPSEA PREGABALIN CAPSULES 300 MG | Pregabalin BP | Anticonvulsant | TOPSEA STANDARD PHARMACEUTICAL COMPANY LTD | ALPA LABORATORIES LIMITED, 33/2 A.B Road, Pigdamber, Indore (MP)-India | Incompletete CTD Dossier Submission |
| 622 | ONDAVA Tablets | Levofloxacin; Ornidazole | Antibiotics | Solid Accord Ltd | East African (India) Overseas 1, Pharmacity, Selaqui, Dehradun -248011 (INDIA) | Incompletete CTD Dossier Submission |
| 623 | Gentamicin Sulfate Injection | Gentamicin Sulfate | Antibiotics | Easy-care Pharmaceuticals Limited | Guizhou Tiandi Pharmaceutical Co.,Ltd, No.6 Baokang Road,Hongxing Pharmaceutical Indutrial Park,Dingxiao Town,Xingyi City Qianxiânan Bouyei and Miao Autonomous Prefecture,Guizhou Province,China | Incompletete CTD Dossier Submission |
| 624 | CLICKMAL 80/480 MG TABLETS | Artemether 80 mg And Lumefantrine 480 mg Tablets PhI | Antimalaria | CLICK HEALTH PHARMACYLTD, | KGN PHARMACEUTICALS PVT. LTD. F-3/1, MIDC Tarapur, Boisar, Dist.: Palghar, 401506, Maharashtra, India | Incompletete CTD Dossier Submission |
| 625 | VINCO FORTIFIED PROCAINE PENICILLIN FOR INJECTION 4MEGA | FORTIFIED PROCAINE PENICILLIN FOR INJECTION 4MEGA | Antibiotics | VINCO PHARM. NIG. LTD. | Shanxi Shuguang Pharmaceutical Co., Ltd. No.1, Kangle St., Qi County, Jinzhong City, Shanxi Province, P.R. Of China | Incompletete CTD Dossier Submission |
| 626 | Fluconazole 150 mg Capsule | Fluconazole 150 mg Capsule | Antibiotics | PIVOT PHARMACY LTD | AâRAF (PVT Ltd) , 23-Km, Raiwind Road Lahore â Pakistan | Incompletete CTD Dossier Submission |
| 627 | KNOX ARTESUNATE INJECTION | Artesunate Injection 60 mg & 120mg | Antimalaria | KNOX PHARMACEUTICALS LTD | Systochem Laboratories Limited,B-75 , Roop Nagar Indl . Area Loni , Ghaziabad-201102 (UP) | Incompletete CTD Dossier Submission |
| 628 | ASTEMAL TABLET | ARTHEMETHER 80MG LUMEFANTRINE 480MG | Antimalaria | Asterra Pharmaceuticals Limited | UNIZA LIFECARE PVT LTD Sr. No. 919/7 (Old Survey no. 404), Kadi-Detroj Road, Balasar, Tal- Kadi, Dist- Mehsana- 382715, Gujrat, India. | Incompletete CTD Dossier Submission |
| 629 | TELMISIN TABLET | Telmisartan Tablet USP 40 mg | Antihypertensive | Generics and Specialities Limited | Lincoln Pharmaceuticals Ltd, Trimul Estate, AT and Post Khatraj, Tal Kalol, Dist. Gandhinagar, Gujarat, India | Incompletete CTD Dossier Submission |
| 630 | FLUCOSEAL 200 CAPSULES | Fluconazole Capsules BP 200 mg | Antibiotics | Globelink Investments & Resources Development Company ( Pharmaceuticals sales Division) | SHUKRA PHARMACEUTICALS LTD, Plot No. 795, Rakanpur Sola-Santej Road, Ta. Kalol, Dist. Gandhinagar (Gujarat) | Incompletete CTD Dossier Submission |
| 631 | NEMETHER INJECTION | Artermether injection 40MG/1ml | Antimalaria | CHUPET PHARMACEUTICAL COMPANY LIMITED | TIANJIN KINGYORK GROUP HUBEI TIANYAO PHARM CO. LTD, NO 99, HANJIANG BEI ROAD, XIANGYANG CITY, HUBEI PROVINCE, CHINA. | Incompletete CTD Dossier Submission |
| 632 | OMEPRAZOLE INJECTION 40MG | OMEPRAZOLE 40MG | Proton Pump Inhibitors (PPIs) | DE LATEST PHARMACY AND GNERAL SUPPLY LTD | FARBE FIRMA, Plot number 1508, GIDC Estate, Ankleshwar- 393002 INDIA | Incompletete CTD Dossier Submission |
| 633 | LINCOMYCIN 500MG CAPSULE | LINCOMYCIN HYDROCHLORIDE CAPSULES 500MG | Antibiotics | CHANNEL PHARMACEUTICALS LIMITED | JIANGSU HUAYANG PHARMACEUTICAL CO.,LTD, NO.21 CHANGJIANG ROAD SIYANG COUNTY JIANGSU, CHINA | Incompletete CTD Dossier Submission |
| 634 | DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | Non-Steroidal Anti-Inflammatory Drug (NSAID) | GLOBAL YOUNG PHARMA LTD | FREDUN PHARMACEUTICALS LIMITED, 14, 15 , 16 , ZORABIAN INDUSTRIAL PREMISES, VEOOR, PALGHAR,- 4041404, INDIA | Incompletete CTD Dossier Submission |
| 635 | IBUPROFEN 400MG | IBUPROFEN | Non-Steroidal Anti-Inflammatory Drug (NSAID) | NIGERIAN AIR FORCE DRUG MANUFACTURING UNIT | NIGERIAN AIRFORCE DRUG MANUFACTURING UNIT LTD, SAM ETHNAN AIRFORCE BASE IKEJA LAGOS NIGERIA | Incompletete CTD Dossier Submission |
| 636 | Cefotaxime for Injection 1.0g | Cefotaxime | Antibiotics | Nesher Healthcare Ltd | Reyoung Pharmaceutical Co., Ltd,No.1 Ruiyang Road, Yiyuan County, Shandong Province | Incompletete CTD Dossier Submission |
| 637 | LUMACEE TABLETS | Artemether & Lumefantrine Tablet | Antimalaria | CEEMIKE PHARMACEUTICAL CO. LTD | ASTAMED HEALTHCARE (I) PVT. LTD, 2 & 3, Genesis Industrial Complex, Phase-II, Kolgaon, Palghar, Thane, Maharashtra, INDIA | Incompletete CTD Dossier Submission |
| 638 | ANNVAN | PROPOFOL INJECTION | Sedative-Hypnotic Agent | Annie Pharma Limited | NAPROD LIFE SCIENCE PVT. LTD.G= 17/1 MIDC, TARACUP, BOISAR,PALGHAR-401 506, MAHARASHTRA, INDIA | Incompletete CTD Dossier Submission |
| 639 | MALARI_EGYPT 20/120 MG | Artemether 20 mg And Lumefantrine 120 mg Tablets | Antimalaria | LIFE NET CARE LIMITED | KGN PHARMACEUTICALS PVT.LTDF-3/1, MIDC TARAPUR,BOISAR, DIST., Palghar,401506 Maharashtra,INDIA , | Incompletete CTD Dossier Submission |
| 640 | ST-RAY AZITHROMYCIN TABLETS | AZITHROMYCIN TABLETS USP 500 MG | Antibiotics | SIMPEC PHARMACEUTICAL LIMITED | HEALTH CARE FORMULATIONS PVT LTD, C/8, Sardar Estate, Ajwa Road, Vadodara- 390019, INDIA | Incompletete CTD Dossier Submission |
| 641 | XYDAP TABLETS 10MG | DAPAGLIFLOZIN TABLETS 10MG | Antidiabetic | Med 365 Limited | RATNATRIS PHARMACEUTICALS. PVT. LTD.Survey No. 416, At.- Indrad, Ta.- Kadi, Dist.- Mehsana-382715, Gujarat, India | Incompletete CTD Dossier Submission |
| 642 | KING JOE PREGABALIN 300 MG | PREGABALIN CAPSULES BP | Anticonvulsant/ Analgesic | KINGJOE STANDARD PHARMACEUTICAL LIMITED | Health Care Formulations Pvt. Ltd, C-8/1, Ajwa Rd, Sardar Estate, Sayaji Park Society, Vadodara, Gujarat 390019, India | Incompletete CTD Dossier Submission |
| 643 | Delstrigo | Doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg of equivalent to 245 mg of tenofovir disoproxil | Antiviral | MSD IDEA Pharmaceuticals Nig. Ltd | MSD International GmbH, Ballydine, Kilsheelan, Clonmel, Country Tipperary Ireland | Incompletete CTD Dossier Submission |
| 644 | OFLOXACIN TABLETS USP 400 MG | Ofloxacin USP | Antibiotics | SUITELIFE PHARMACEUTICAL LIMITED | Alpa Laboratories Limited, 33/2 A.B Road, Pigdamber, Indore (MP)-India Pin Code- 453446 | Incompletete CTD Dossier Submission |
| 645 | PREMARTEM 80/480 TABLETS | Artemether 80mg, Lumefantrine 480mg | Antimalaria | PRECIOUS TRUST PHARMA. LIMITED | PROTECH BIOSYSTEMS PVT. LTD, Bhagwanpur, Roorkee Distt. Haridwar, Uttarakhand INDIA | Incompletete CTD Dossier Submission |
| 646 | Rusovas | Rusovas, 10 mg, film-coated tablet: each film-coated tablet contains 10 mg of rosuvastatin, as rosuvastatin calcium. | HMGCo-A Reductase Inhibitor | MITAKA TRADE COMPANY NIGERIA LIMITED | GALENIKA AD BEOGRAD,BatajniÄki drum b.b., Belgrade, Republic of Serbia | Incompletete CTD Dossier Submission |
| 647 | ERVINAC | Diclofenac Sodium Delayed-Release Tablets USP 50 mg | Non-Steroidal Anti-Inflammatory Drug (NSAID) | ERVINA PHARMACEUTICAL LIMITED | SAITECH MEDICARE PVT. LTD.Village Kheri, Trilokpur Road, Kala amb-173030, Distt. Sirmour (H.P.), India. | Incompletete CTD Dossier Submission |
| 648 | Ajas Diclofenac Tablet | Diclofenac Potassium Tablets | Non-Steroidal Anti-Inflammatory Drug (NSAID) | Ajadons Pharmacy Nig. Ltd. | Claroid Pharmaceuticals Pvt. Ltd, Survey No. 217/P, Opp. Gurukul English Medium School, Kamod, Satpanth Mandir, Pirana Rd, TA, Ahmedabad-3824205, India | Incompletete CTD Dossier Submission |
| 649 | ANOFAST TABLET | Aceclofenac / Chlorzoxazone / Paracetamol | Non-Steroidal Anti-Inflammatory Drug (NSAID)/ Analgesics | May & Baker Nigeria Plc | May & Baker Nigeria Plc, 1 May & Baker Avenue Off Idiroko Road Ota Ogun State | Incompletete CTD Dossier Submission |
| 650 | KALTHER SUSPENSION | Artemether 180mg + Lumefantrine 1080mg Suspension | Antimalaria | PUSHKAL PHARMACEUTICAL LIMITED | S KANT HEALTHCARE LIMITED.1802-1805, G.I.D.C., Phase-III, Vapi-396195, Gujarat. M. L. No.: G-1344 | Incompletete CTD Dossier Submission |
| 651 | RELIEXTRA | Diclofenac Sodium Tablets 50 mg | Non-Steroidal Anti-Inflammatory Drug (NSAID) | RICK ROSE PHARMACEUTICALS LTD | KGN PHARMACEUTICALS PVT. LTD.F-3/1, MIDC Tarapur, Boisar, Dist.: Palghar, 401506, Maharashtra, India | Incompletete CTD Dossier Submission |
| 652 | ANNKET | Ketamine Hydrochloride Injection | NMDA Receptor Antagonist | Annie Pharma Limited | SHUKRA PHARMACEUTICAL LIMITED, Plot No. 795, Rakanpur Sola-Santej Road, Ta. Kalol, Dist. Gandhinagar Gujarat, India | Incompletete CTD Dossier Submission |
| 653 | TraVost Eye Drop | Travoprost and Timolol Maleate Eye Drops | Ophthalmic Antiglaucoma Combination | Prov Amati Healthcare Company Limited | KWALITY PHARMACEUTICALS LTD, Nahan Road, Paonta Sahib, Dist â Sirmour, Himachal Pradesh â 173025 India | Incompletete CTD Dossier Submission |
| 654 | Fluphenazine Decanoate Injection BP (25mg/ml) | Fluphenazine Decanoate BP | Antipsychotic | KATARI PHARMACY & STORES LTD | PHARMAX (INDIA) PVT.LTD. 9, Kurla Industrial Estate, Ghatkopar (W), Mumbai – 400 086. | Incompletete CTD Dossier Submission |
| 655 | VENTROX SF INHALER | SALMETEROL AND FLUTICASONE PROPIONATE INHALER 25+125 MCG/DOSE | Bronchodilator and Corticosteroid | CHANNEL PHARMACEUTICALS LIMITED | MEDISOL LIFE SCIENCE PVT. LTD,228, Pragati Industrial Estate, N. M. Joshi Marg, Lower Parel (E) Mumbai, 400 011, India | Incompletete CTD Dossier Submission |
| 656 | PENTAZOCINE INJECTION | PENTAZOCINE INJECTION | Opiod Analgesic | EVERGREEN MORNING STAR PHARCEUTICAL IND. LTD. | FARBE FIRMA Pvt. Ltd.Plot no: 1508, G.I.D.C., Ankleswar Gujarat- 393 002, India. | Incompletete CTD Dossier Submission |
| 657 | TRIADAIT-SB | CEFTRIAXONE AND SULBACTAM FOR INJECTION 1.5G | Antibiotics | DAITECH PHARMACEUTICALS LTD | Kilitch Drugs (India) Ltd, C-301/2 M.I.D.C, T.T.C Industrial Area, Pawane Navi | Incompletete CTD Dossier Submission |
| 658 | Basamol | Paracetamol | Analgesic | Biomedical Limited | Biomedical Ltd, 1, Ohimege street Industrial Estate Gaa-Imam Ilorin | Incompletete CTD Dossier Submission |
| 659 | REFLEEFTRA | DICLOFENAC SODIUM BP | Non-Steroidal Anti-Inflammatory Drug (NSAID) | DUKELINN PHARMACY & STORES LTD. | KGN PHARMACEUTICALS PVT. LTD.F-3/1, MIDC Tarapur, Boisar, Dist.: Palghar, 401506, Maharashtra, India | Incompletete CTD Dossier Submission |
| 660 | Pregabalin Capsules BP 75 mg | Pregabalin BP 75 mg | Anticonvulsant | EKO LIFESCIENCE NIGERIA LIMITED | Lucent Biotech Limited, Factory; 165/3, Nalhera, Anantpur Puhana, Roorkee Dist: Haridwar -247667, Uttarakhand, India. | Incompletete CTD Dossier Submission |
| 661 | Diclofenac Potassium Tablets | Diclofenac Potassium 50mg | Non-Steroidal Anti-Inflammatory Drug (NSAID) | AKSO PHARMACEUTICAL NIGERIA LIMITED | FRONT Pharmaceutical PLC, Economic and Technical Development Zone, Xuancheng, China | Incompletete CTD Dossier Submission |
| 662 | Zoline 500 Tablets | Levofloxacin Tablets 500 mg | Antibiotics | SARATHI IMPEX PROFESSIONAL LTD | BDA HEALTHCARE PVT. LTD, Plot No.: B-1, 2, 3, Near Gov. ITI MIDC, Parseoni â 441105, Taluka: Parseoni, District: Nagpur, M.S., India | Incompletete CTD Dossier Submission |
| 663 | KOBINAX TABLET | METHOCARBAMOL TABLET USP 500 MG | Skeletal Muscle Relaxant | BICHAN PHARMACEUTICALS LIMITED | Ciron Drugs Pharmaceutical LTD Plot No 35-37, 43-45 CFC-B, Diwan Udyog Nagar, Aliyali, Palghar, Thane 401404 Maharashtra state, India | Incompletete CTD Dossier Submission |
| 664 | Gloatem Forte Softgel | Artemether and Lumefantrine | Antimalaria | GLOBAL HEALTHCARE LIMITED | Vital Health Care PVT Ltd, Plot No. 1416-18 & 1507, GIDC Estate, phase11 Vap-396195 Gujarat India | Incompletete CTD Dossier Submission |
| 665 | Meflotin Tablet | Mefloquine | Antimalaria | Espen Laboratories Limited | Ecomed Pharma Limited, Plot 32, Lynson Chemical Avenue, KM 38, Lagos-AbeoKuta Expressway, Sango Ota, Ogun State | Incompletete CTD Dossier Submission |
| 666 | SUKKA | Diclofenac Potassium Tablets 50 mg | Non-Steroidal Anti-Inflammatory Drug (NSAID) | WE-CURE MEDIK PHARMACEUTICAL LTD | Jash Pharma Pvt. Ltd.Plot No 143/144, Surat Special Economic Zone, Station Road, Sachin, Surat-394230, Gujarat, India | Incompletete CTD Dossier Submission |
| 667 | CEENOPRIL (LISINOPRIL TABLETS BP 10 MG) | LISINOPRIL TABLETS BP 10 MG | Antihypertensive | SUNNY CEE PHARMACY & STORES LTD | TOWA PHARMA PVT. LTD, JALIYANAMATH VILLAGE, SURVEYNO-17, DEHGAM RAKHIYAL ROAD, TA.- DEHGAM,DIST. GANDHINAGAR-382315 GUJARAT (INDIA) | Incompletete CTD Dossier Submission |
| 668 | CEERABZOLE (Rabeprazole Sodium Capsule 20mg) | Rabeprazole Sodium Capsule 20mg | Proton Pump Inhibitors (PPIs) | SUNNY CEE PHARMACY & STORES LTD | TOWA PHARMA PVT. LTD, JALIYANAMATH VILLAGE, SURVEYNO-17, DEHGAM RAKHIYAL ROAD, TA.- DEHGAM,DIST. GANDHINAGAR-382315 GUJARAT (INDIA) | Incompletete CTD Dossier Submission |
| 669 | Pregabalin Capsules 300 mg | Pregabalin | Anticonvulsant | SIRBACO PHARMACY LTD | ALPA LABORATORIES LIMITED, 33/2 A.B Road, Pigdamber, Indore (MP)-India | Incompletete CTD Dossier Submission |
| 670 | ELSEANAC 50(DICLOFENAC SODIUM 50MG) | DICLOFENAC SODIUM 50MG | Non-Steroidal Anti-Inflammatory Drug (NSAID) | ELSEA GRAND PHARMACEUTICAL AND CHEMICAL INDUSTRIES LIMITED | CORAL LABORATORIES LIMITED, 3B, PATANWALA COMPOUND OPP. SHREYAS CINEMA, L.B.S, MARG, GHATKOPAR(WEST), MUMBIA-400086 INDIA | Incompletete CTD Dossier Submission |
| 671 | PENTAZOCINE INJECTION | PENTAZOCINE | Opiod Analgesic | DERM PHARMACEUTICAL LIMITED | ALPA LABORATORIES LIMITED, 33/2 A.B Road, Pigdamber, Indore (MP)-India | Incompletete CTD Dossier Submission |
| 672 | EMPAGLOZIN DUO | Empagliflozin and Metformin Hydrochloride | Antidiabetic | Espen Laboratories Limited | ECOMED PHARMA LTD, 32, Chemical Lynson Avenue, Lagos-Abeokuta Expressway, Sango-Ota, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 673 | Diclofenac Sodium Tablet 50 mg | Diclofenac Sodium | Non-Steroidal Anti-Inflammatory Drug (NSAID) | makki pharmaceuticals limited | SURMOUNT LABORATORIES PVT. LTD.,A-2/4003, GIDC Ind. Estate, Ankleshwar-393002, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 674 | Sasklofen | Diclofenac Potassium | Non-Steroidal Anti-Inflammatory Drug (NSAID) | Sastek Mega Pharmaceutical and Chemical Company Nigeria | M/s. Impulse Pharma Pvt. Ltd.J-201, J-202/1, MIDC Tarapur, Boisar, Dist-Palghar 401 506, Maharashtra State, India | Incompletete CTD Dossier Submission |
| 675 | TRIADAIT | CEFTRIAXONE USP 1G | Antibiotics | DAITECH PHARMACEUTICALS LTD | Kilitch Drugs (India) Ltd, C-301/2 M.I.D.C, T.T.C Industrial Area, Pawane Navi | Incompletete CTD Dossier Submission |
| 676 | AZITHROMYCIN TABLETS USP 500 MG | AZITHROMYCIN TABLETS USP 500 MG | Antibiotics | makki pharmaceuticals limited | SURMOUNT LABORATORIES PVT. LTD, A-2/4003, GIDC Ind. Estate, Ankleshwar-393002, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 677 | Heirtraxone Inj | Ceftriaxone for Injection USP 1000 mg | Antibiotics | FOSEN PHARMACEUTICALS LIMITED | Protech Biosystems Pvt. Ltd.145, 146, PACE CITY I, SECTOR 37, GURUGRAM, HARYANA 122018, INDIA | Incompletete CTD Dossier Submission |
| 678 | SOBIO EYE DROPS | Sodium Cromoglicate BP | Mast Cell Stabilizer | I Globe Pharma Ltd | FDC Limited, B-8, MIDC Industrial Area, Waluj, Aurangabad- 431 136, Maharashtra State, India | Incompletete CTD Dossier Submission |
| 679 | Loperamide Capsules BP 2 mg | Loperamide Capsules BP 2 mg | Antidiarrheal | CUREALL IMPEX NIGERIA LIMITED | SSM Formulation Pvt. Ltd.11/1, Ashti (Rith) Hinganghat, Maharashtra, 442301 India. | Incompletete CTD Dossier Submission |
| 680 | Maxef | Ceftriaxone Sodium U.S.P.) | Antibiotics | Osbud Pharmacy and Stores ltd | Indus Pharma (Pvt.) Ltd. Plots no. 26-27 & 63-67, Sector- 27, Korangi Industrial Area, Karachi, 74900, Pakistan. | Incompletete CTD Dossier Submission |
| 681 | Dyclo | Diclofenac Analgesic | Non-Steroidal Anti-Inflammatory Drug (NSAID) | Osbud Pharmacy and Stores ltd | Indus Pharma (Pvt.) Ltd. Plots no. 26-27 & 63-67, Sector- 27, Korangi Industrial Area, Karachi, 74900, Pakistan. | Incompletete CTD Dossier Submission |
| 682 | ST-RAY | LOSARTAN TABLETS 100 MG | Antihypertensive | SIMPEC PHARMACEUTICAL LIMITED | M/s. Health Care Formulations Pvt. Ltd.C/8, Sardar Estate, Ajwa Road Vadodara-390019, Gujarat. India | Incompletete CTD Dossier Submission |
| 683 | PENTAZOCINE INJECTION | PENTAZOCINE | Opiod Analgesic | MELOXION PHARMACEUTICALS LIMITED | FARBE FIRMA PVT LTD, Plot No: 1508, Near Atique Bakery, GIDC Estate, Ankleshwar-393002, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 684 | PENTAZOCINE INJECTION | PENTAZOCINE | Opiod Analgesic | NUGENIX PHARMACEUTICALS LIMITED | FARBE FIRMA PVT LTD, Plot No: 1508, Near Atique Bakery, GIDC Estate, Ankleshwar-393002, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 685 | CFX (Ciprofloxacin 500mg Tablets) | Ciprofloxacin 500mg Tablets | Antibiotics | FECCOX PHARMACY AND GENERAL ENTERPRISES LIMITED | Nalis Pharmaceuticals Ltd, R67-68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State | Incompletete CTD Dossier Submission |
| 686 | Tranexamic Acid Injection BP 500 mg/5 mL | TRANEXAMIC ACID INJECTION BP | Antifibrinolytic | CHINARE ANI PHARMACEUTICAL LTD | Protech Biosystems Pvt. Ltd.Bhagwanpur, Roorkee, Distt. Haridwar, Uttarakhand, INDIA | Incompletete CTD Dossier Submission |
| 687 | TADA_EGPT | Tadalafil 10mg | :Phosphodiesterase-5 (PDE5) inhibitor | LIFE NET CARE LIMITED | KGN PHARMACEUTICALS PVT.LTD, F-3/1, MIDC TARAPUR,BOISAR, DIST., Palghar,401506 Maharashtra,INDIA , | Incompletete CTD Dossier Submission |
| 688 | AKENOCID | ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE & DEGLYCYRRHIZINATED LIQUORICE | Antacid/Antigas agent/Mucosal Protective | AKESTAR PHARMACEUTICAL LTD | Sunrise Remedies PVT LTD, Block No. 2244, AT & Post-Santej, Tal-Kalol, Dist- Gandhinagar-382721, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 689 | CEFOPAR 200MG CAPSULE | CEFPODOXIME PROXETIL 200MG | Antibiotics | LAIDER INTERNATIONAL (W.A) LIMITED | MIRAFLASH NIGERIA LIMITED, 2-8 SUCCESS ESTATE, OFF BRENTFIELD AVE, OKE-AFA, MAGBORO, OGUN STASTE, NIGERIA | Incompletete CTD Dossier Submission |
| 690 | RICAM SYRUP | CETIRIZINE HYDROCHLORIDE 5MG/5ML | Antihistamine | Phamatex Nigeria Limited | Hovid Bhd. 121, Jalan Tunku Abdul Rahman, 30010 Ipoh, Perak, Malaysia. | Incompletete CTD Dossier Submission |
| 691 | DICLOFENAC POTASSIUM TABLETS 50MG | DICLOFENAC POTASSIUM | Non-Steroidal Anti-Inflammatory Drug (NSAID) | Krismediks Nigeria Ltd | JASH PHARMA PRIVATE LIMITED, PLOT NO 143 AND 144, SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, SURAT 394230 | Incompletete CTD Dossier Submission |
| 692 | REBOZOL TABLETS | BENZHEXOL HYDROCHLORIDE BP 5MG | Antimuscarinic / Anticholinergic | UC-REBOK INVESTMENT LIMITED | McCoy Pharma Pvt.Ltd, S-12,MIDC TARAPUR, DIST-PALGHAR, MAHARASHTRA | Incompletete CTD Dossier Submission |
| 693 | OMEPRAZOLE FOR INJECTION 40 MG | OMEPRAZOLE FOR INJECTION 40 MG | Proton Pump Inhibitors (PPIs) | DANMALIKI PHARMACEUTICAL COMPANY & GEN. ENT. LTD | Noronic Pharmaceuticals Pvt. Ltd.Block No. 763/2, Chadasana road, Near Torrent Pharma, Opp., Gayatri Dairy, Ta-Kadi, Dist: Mehsana, (Guj), India. | Incompletete CTD Dossier Submission |
| 694 | WITZER PREGABALIN CAPSULES 300MG | PREGABALIN | Anticonvulsant | WITZER pHARMACEUTICALS NIGERIA LIMITED | Alpa Laboratories Limited 33/2 A.B Road, Pigdamber, Indore (MP) | Incompletete CTD Dossier Submission |
| 695 | DREIVE | Sildenafil 100 mg, Dapoxetine 60 mg | Phosphodiesterase type 5 (PDE5) Inhibitor | ITATS PHARMACIA LIMITED | Halewood Laboratories Pvt Ltd. 319, Phase-II, G.I.D.C., Vatva, Ahmedabad-382445. | Incompletete CTD Dossier Submission |
| 696 | SOBIKMATEM-DS TABLETS | Artemether 80 mg &Lumefantrine 480 mg Tablets | Antimalaria | BARNAETO PHARMACY LTD. | IMPULSE PHARMA PVT. LTD. J-201, J-202/1, MIDC Tarapur, Boisar Dist. Palghar – 401506 India | Incompletete CTD Dossier Submission |
| 697 | MALARI_EGYPT 80/480MG | Artemether 80 mg &Lumefantrine 480 mg Tablets | Antimalaria | EXCELLENT PORT COMPANY LIMITED | KGN PHARMACEUTICALS PVT.LTD, F-3/1, MIDC TARAPUR,BOISAR, DIST., Palghar,401506 Maharashtra,INDIA , | Incompletete CTD Dossier Submission |
| 698 | DICLOFENAC POTASSIUM TABLETS 50MG | DICLOFENAC POTASSIUM TABLETS 50MG | Non-Steroidal Anti-Inflammatory Drug (NSAID) | Abiskata Pharmaceuticals Limited | JASH PHARMA PRIVATE LIMITED, PLOT NO 143 AND 144, SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, SURAT 394230 | Incompletete CTD Dossier Submission |
| 699 | DICLOFENAC POTASSIUM TABLETS 50MG | DICLOFENAC POTASSIUM | Non-Steroidal Anti-Inflammatory Drug (NSAID) | Solpharm Chemical Industries Limited | JASH PHARMA PRIVATE LIMITED, PLOT NO 143 AND 144, SPECIAL ECONOMIC ZONE, NEAR SACHIN RAILWAY STATION, SACHIN, SURAT 394230 | Incompletete CTD Dossier Submission |
| 700 | ALFLURANE INHALATION | Isoflurane for Inhalation 250mL. | Volatile liquid anesthetic | ALPHA PHARMACY & STORES LIMITED | Lunan Better Pharmaceutical Co., Ltd.No 243, Yinqueshan Road, Linyi City, Shandong Province, People’s Republic of China | Incompletete CTD Dossier Submission |
| 701 | GRAFENAC DICLOFENAC POTTASIUM 50MG TABLETS | DICLOFENAC POTASSIUM 50MG | Non-Steroidal Anti-Inflammatory Drug (NSAID) | GRAVITAS PHARMACEUTICAL COMPANY LIMITED | TOWA PHARMA PRIVATE LIMITED MFG. SITE-JALIYANAMATH VILLAGE, SURVEY NO-17, DEHGAM RAKHIYAL ROAD, TA.-DEHGAM, DIST. GANDHINAGAR-382315 GUJARAT (INDIA | Incompletete CTD Dossier Submission |
| 702 | CETAXIMERICH INJECTION | Cefotaxime Sodium for Injection | Antibiotics | PAMACURE PHARMACEUTICAL LTD | Sinopharm Weiqida Pharmaceutical Co., Ltd, Pharmaceutical Industrial Park, Economic & Technological Development Zone, Datong, Shanxi, China | Incompletete CTD Dossier Submission |
| 703 | EUDORA TRAMADOL 50MG CAPSULE | TRAMADOL 50MG | Opiod Analgesic | Eudora Pharmaceutical Industries ltd | REAGAN REMEDIES LTD, 24 MUSA YARADUA DRIVE, NEW OWERRI, IMO STATE | Incompletete CTD Dossier Submission |
| 704 | CAROMAL SOFT GEL | Artemether Lumefantrine | Antimalaria | Peton Pharmaceutical Nig. Ltd | INDO RAMA ENGINEERS, Plot no. 9, Vill. Rampur Jattan, SH 2, Kala Amb, Himachal Pradesh 173030, | Incompletete CTD Dossier Submission |
| 705 | DEXAMETHASONE TABLETS | Dexamethasone BP 0.5Mg | Steriod | JOMIA PHARMACEUTICAL LTD | FLOURISH PHARMA, 24E, Goa-IDC, DAMAN IND ESTATE SOMANTH, DABHEL (U.T):396215 | Incompletete CTD Dossier Submission |
| 706 | TOBRAMYCIN & DEXAMETHASONE EYE DROPS | TOBRAMYCIN USP 0.3%W/V USP + DEXAMETHASONE 0.1%W/V | Antibiotic/Corticosteroid | FIDSON HEALTHCARE LTD | FIDSON HEALTHCARE PLC,KM 38, LAGOS-ABEOKUTA EXPRESSWAY, OTA, OGUN STATE | Incompletete CTD Dossier Submission |
| 707 | EUDORA DECONGESTANT TABLETS | Pseudoephedrine hydrochloride 60.0 mg, hydrochloride 2.5 mg | Alpha- and Beta-Adrenergic Agonist/ Nasal Decongestant | Eudora Pharmaceutical Industries ltd | REAGAN REMEDIES LTD, 24 MUSA YARADUA DRIVE, NEW OWERRI, IMO STATE | Incompletete CTD Dossier Submission |
| 708 | EL-CEF INJECTION 1G | Ceftriaxone Sodium for Injection | Antibiotics | PAMACURE PHARMACEUTICAL LTD | Sinopharm Weiqida Pharmaceutical Co., Ltd, Pharmaceutical Industrial Park, Economic & Technological Development Zone, Datong, Shanxi, China | Incompletete CTD Dossier Submission |
| 709 | MATHERMA | Artemther 80mg &Lumefantrine 480mg | Antimalaria | JIMMI-WELL INTERNATIONAL COMPANY LIMITED | AVEO PHARMACEUTIALS PVT LTD, PLOT NO. C/13 MIDC TARAPUR INDUSTRIAL AREA PALGHAR THANE MAHARASHTRA 401 506 INDIA | Incompletete CTD Dossier Submission |
| 710 | KOLDJET | Diclofenac Potassium B.P 100mg | Non-Steroidal Anti-Inflammatory Drug (NSAID) | Nalis Pharmaceuticals Limited | Nalis Pharmaceuticals Ltd, R67-68 Nekede-Naze Industrial Clusters, Nekede, Owerri, Imo State | Incompletete CTD Dossier Submission |
| 711 | Caffeine Citrate 10mg/ml Solution for Injection | Caffeine Citrate 10mg/ml Solution for Injection | CNS stimulant | ALPHA PHARMACY & STORES LIMITED | Macarthys Laboratories Limited T/A Martindale Pharma, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom | Incompletete CTD Dossier Submission |
| 712 | Temerit Tablet | Nebivolol 5mg | Antihypertensive | PHILLIPS PHARMACEUTICALS (NIGERIA) LIMITED | Menarini Von Heyden GmbH .Menarini Von Heyden GmbH Leipziger Strasse 7-13, 01097 Dresden, Germany | Incompletete CTD Dossier Submission |
| 713 | XITHON 500 | Azithromycin Tablets USP 500mg | Antibiotics | C.H.M.S Limited | INNOVA CAPTAB LIMITED, 1281/1, Hilltop Industrial Estate, Near EPIP Phase-I, Jharmajri, Baddi – 173205 (H.P.) India. | Incompletete CTD Dossier Submission |
| 714 | Meropen 1000 | Meropenem USP (Sterile) | Antibiotics | CHINARE ANI PHARMACEUTICAL LTD | Protech Biosystems Pvt. Ltd.314, 3RD FLOOR, WELLDONE TECH PARK, SOHNA ROAD GURGAON, SECTOR- 48, HARYANA, INDIA. | Incompletete CTD Dossier Submission |
| 715 | DICLOFENAC SODIUM TABLET 50MG | DICLOFENAC SODIUM | Non-Steroidal Anti-Inflammatory Drug (NSAID) | HUGO HEALTH CARE LIMITED | SURMOUNT LABORATORIES PRIVATE LIMITED, Plot No A-2/4003, GIDC Ind. Estate, Ankleshwar-393002, Gujarat, India | Incompletete CTD Dossier Submission |
| 716 | OMACEF 500 | CEFUROXIME 500 | Antibiotics | GREAT OMACO PHARMACY LIMITED | ASSOCIATED BIOTECH, KISHANPURA, GURU MAJRA ROAD, BADDI, THE. NALAGAR DISTT. SOLAN (H.P), INDIA. | Incompletete CTD Dossier Submission |
| 717 | TRAMADOL HYDROCHLORIDE INJECTION 100 MG/2 ML | TRAMADOL HYDROCHLORIDE INJECTION 100 MG/2 ML | Opiod Analgesic | HEALTHTRUST PHARMACY AND STORES | STALLION LABORATORIES PVT. LTD.C-1B 305/2, 3, 4& 5, G.I.D.C, KERALA (BAVLA), DIST. AHMEDABAD, GUJARAT, INDIA. | Incompletete CTD Dossier Submission |
| 718 | EMPAGLIFLOSIN WITH METFORMIN TABLET | EMPAGLIFLOSIN WITH METFORMIN TABLET | Antidiabetic | NEW HEIGHTS PHARMACEUTICALS LTD | STALLION LABORATORIES PVT. LTD.C-1B 305/2, 3, 4& 5, G.I.D.C, KERALA (BAVLA), DIST. AHMEDABAD, GUJARAT, INDIA. | Incompletete CTD Dossier Submission |
| 719 | KINEXA 10mg | RIVAROXABAN | Direct Oral Anticoagulants (DOACs) | BIOGENERICS NIGERIA LIMITED | Beximco Pharmaceuticals Ltd. 126, Kathaldia, Auchpara, Tongi-1711, Gazipur, Bangladesh | Incompletete CTD Dossier Submission |
| 720 | EUROCEF 500 | CEFUROXIME AXETIL | Antibiotics | EUROMED LIMITED | MEDIWIN PHARMACEUTICALS, 128/A, PHASE -1 & 11, G.I.D.C, NARODA, AHMEDABAD- 382330, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 721 | Chy Azithromycin | Azithrornycin Tablets USP 500 mg | Antibiotics | CHY-GOZZY GLOBAL CONCEPT NIGERIA LIMITED | Surmount Laboratories Private Limited Plot No. A-2/4003 & A-1/4010, Near Crystal Chokdi, GIDC Industrial Estate, Ankleshwar-Gujarat, India- 393 002 | Incompletete CTD Dossier Submission |
| 722 | ARTESUNATE FOR INJECTION 120MG|VIAL | ARTESUNATE 120MG | Antimalaria | TALLIS PHARMACEUTICALS COMPANY NIG LTD | KAMLA LIFESCIENCES LTD, G 84|1, TARAPUR, MIDC, BOISAR, DISTRICT PALGHAR 401506 | Incompletete CTD Dossier Submission |
| 723 | Faslodex | Fulvestrant | Selective Estrogen Receptor Degrader (SERD) | ASTRAZENECA NIGERIA LIMITED | VETTER PHARMA-FERTIGUNG GMBH & CO KG Address: SCHUETZENSTRASSE 87 AND 99-101, RAVENSBURG, D-88212, GERMANY | Incompletete CTD Dossier Submission |
| 724 | LYFETRAN POWDER FOR INJECTION | CEFTRIAXONE SODIUM 1GM | Antibiotics | HAYAH HEALTHCARE LIMITED | INJECTCARE PARENTERALS PVT LTD , Plot No. 130, Silvassa Road, GIDC, Vapi â 396 195, Gujarat, India. | Incompletete CTD Dossier Submission |
| 725 | Artinat 120 | Combipack Artesunate Injection 120 mg, Sodium Bicarbonate Injection BP 5.0 % w/v and Sodium Chloride Injection BP 0.9 % w/v | Antimalaria | Generics and Specialities Limited | Lincoln Pharmaceuticals Ltd, Trimul Estate, AT and Post Khatraj, Tal Kalol, Dist. Gandhinagar, Gujarat, India | Incompletete CTD Dossier Submission |
| 726 | VALSARTAN AND HYDROCHLORTHIAZIDE TABLETS USP (10 mg/25 mg) | VALSARTAN AND HYDROCHLORTHIAZIDE TABLETS USP | Antihypertensive | GOLDEN REMEDIES LIMITED | ENDURANCE HEALTHCARE PVT LTD, C-1B 305/2, 3, 4& 5 G.I.D.C. KERALA (BAVLA), DIST. AHMEDABAD, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 727 | Pbxone 2 | Ceftriaxone for Injection USP 2g | Antibiotics | PANGENE BIOTECH PVT LTD | East African (India) Oversea, Unit I â Plot No. 1, Pharmacity, Selaqui, Dehradun-248011 UTTARAKHAND (INDIA) | Incompletete CTD Dossier Submission |
| 728 | LYFETRAN-SL POWDER FOR INJECTION | Ceftriaxone 1g & Sulbactam 500 mg | Antibiotics | HAYAH HEALTHCARE LIMITED | INJECTCARE PARENTERALS PVT LTD, Plot No. 130, Silvassa Road, GIDC, Vapi â 396 195, Gujarat, India. | Incompletete CTD Dossier Submission |
| 729 | TRAMADOL HYDROCHLORIDE INJECTION 100 MG/2 ML | TRAMADOL HYDROCHLORIDE INJECTION 100 MG/2 ML | Opiod Analgesic | SAVOCENT PHARMA LTD | STALLION LABORATORIES PVT. LTD.C-1B 305/2, 3, 4& 5, G.I.D.C, KERALA (BAVLA), DIST. AHMEDABAD, GUJARAT, INDIA. | Incompletete CTD Dossier Submission |
| 730 | MAYGLOW NYSTATIN | Nystatin Oral Suspension USP 1,00,000IU/ml | Antifungal | MAY GLOW PHARM LIMITED | DUPEN LABORATORIES PVT. LTD, C/1-49 & 36, Degam Road, Industrial Township, Vapi–396 195,Gujarat. Dist. ValsadIndia. | Incompletete CTD Dossier Submission |
| 731 | Solivo Tablet 500 mg | Naproxen 500 mg & Esomeprazole 20 mg | Non-Steroidal Anti-Inflammatory Drug (NSAID)/Proton Pump Inhibitors | NAXOS HEALTHCARE LTD | Healthcare Pharmaceuticals Limited.Gazariapara, Rajendrapur, Gazipur-1703, Bangladesh | Incompletete CTD Dossier Submission |
| 732 | SEVOTROY 250 | Sevoflurane USP | Volatile liquid anesthetic | Vista International Limited | Troikaa Pharmaceuticals Ltd, Sara Industrial Estate, Selaqui, Dehradun-248197, Uttarakhand, India | Incompletete CTD Dossier Submission |
| 733 | Eila (Pentazocin Injection BP 30mg/ml) | Pentazocine Injection BP 30 mg/ml | Opiod Analgesic | VCA American Pharmaceuticals Limited | FARBE FIRMA Pvt. Ltd.Plot no: 1508, G.I.D.C., Ankleswar Gujarat- 393 002, India. | Incompletete CTD Dossier Submission |
| 734 | PREGABALIN (75 MG) & METHYLCOBALAMIN (750 MCG) CAPSULES | PREGABALIN AND METHYLCOBALAMIN | Neuropathic Pain Reliever and NutritionalSupplement | RESTORE HEALTHCARE LIMITED | ALLIAANCE BIOTECH,440/3 VILL KATCHA BADDI SOLAN (H.P) 172 205 INDIA | Incompletete CTD Dossier Submission |
| 735 | FOSFO-200 | FLUCONAZOLE 200MG | Antifungal | VIXA PHARMACEUTICALS CO. LTD | KREMOINT PHARMA PRIVATE LIMITED, D 59/60, Additional Ambemath MIDC., Ambemath (E). Dist.: Thane-421506, Maharashtra, India | Incompletete CTD Dossier Submission |
| 736 | FECCOX | GENTAMYCIN | Antibiotics | FECCOX PHARMACY AND GENERAL ENTERPRISES LTD | GUIZHOU TIANDI PHARMACEUTICAL COMPANY LIMITED,NO 6 BAOKANG ROAD, YILONG HONGXING PHARMACEUTICAL PARK, QIANXI’NAN BUYI AND MIAO AUTONOMOUS PREFECTURE, GUIZHOU PROVINCE CHINA, CHINA | Incompletete CTD Dossier Submission |
| 737 | GABAPENTIN CAPSULES USP | GABAPENTIN CAPSULES USP | Anticonvulsant | excel charis pharmaceutical chemical ltd | Hab Pharmaceuticals & Research Ltd.,10, Pharmacity, Selaqui, Dehradun, Uttarakhand – 248011, India | Incompletete CTD Dossier Submission |
| 738 | DOZISCAN | Gadopentetate Dimeglumine | Gadolinium-based contrast agent (GBCA) | Dozie and Dozie’s Pharm Nig Ltd | Beliu, No 3, Shuiyuan West Road, Miyun District, Beijing, China | Incompletete CTD Dossier Submission |
| 739 | CLOMIPHENE TABLETS | Clomiphene Citrate USP 50 mg | Selective Estrogen Receptor Modulator (SERM) | FAIRFIELD PHARMA LTD | Swiss Pharma Pvt. Ltd.,Plot No.3709, GIDC, Phase-IV, Vatva, City â Ahmedabad â 382 445, Dist. â Ahmedabad, Gujrat State, India | Incompletete CTD Dossier Submission |
| 740 | Cefepime Injection | Cefepime for Injection USP 1 g | Antibiotics | Genex Life Sciences Limited | ZEISS PHARMACEUTICALS PVT. LTD, At Plot No. 72, EPIP â I, Jharmajari, Baddi, Distt. Solan, (H.P.), India. | Incompletete CTD Dossier Submission |
| 741 | PARACETAMOL INJECTION | Paracetamol 150mg/ml | Analgesic | OLINT GLOBAL PHARMACY | Farbe Firma Pvt. Ltd., Plot No. 1508, GIDC Estate, Ankleshwar, 393 002, Gujarat, India | Incompletete CTD Dossier Submission |
| 742 | JEPRAZ-D CAPSULES | Omeprazole IR 20 mg and Domperidone SR 30 mg | Proton Pump Inhibitors (PPIs) | SJS LIFE SCIENCES LTD | VIRJO HEALTHCARE PVT. LTD. PLOT NO. 84, SMART INDUSTRIAL PARK, PITHAMPUR, MP, INDIA | Incompletete CTD Dossier Submission |
| 743 | Mimident | LIDOCAINE | Sodium Channel Blocker | QUAYLE MEDICALS NIGERIA LIMITED | kwality Pharmaceuticals Pvt Ltd, 6th Mile Stone Village | Incompletete CTD Dossier Submission |
| 744 | ORINMARC | Latanoprost Ophthalmic Solution | Prostaglandin Analogues | Marcson Healthcare Ltd | CORAL LABORATORIES LTD.5, 6 Khokhani Industrial Complex No.2, Sativali, Vasai (E), Thane – 401 208. INDIA | Incompletete CTD Dossier Submission |
| 745 | KETAMINE HYDROCHLORIDE INJECTION BP 50MG/ML | KETAMINE HYDROCHLORIDE | Dissociative General Anesthetic | SHREE ALOE PHARMACEUTICAL LIMITED | M/S Farbe Firma, Plot Number 1508, GIDC Estate, Ankleshwar | Incompletete CTD Dossier Submission |
| 746 | FERROKAM INJECTION | Iron Sucrose Injection BP 20 mg/ml | Polynuclear iron(III)-hydroxide in sucrose | T.P DRUGS LIMITED | M/S. Kamla Lifesciences Ltd.Plot no.G-84/1, Tarapur M.I.D.C, Boisar-401 506, Tal. & Dist. Palghar, Maharashtra, India | Incompletete CTD Dossier Submission |
| 747 | JARDY – MET TABLET 5MG/500MG | Empagliflozin, Metformin | Antidiabetic | CCL LIFESCIENCES NIGERIA LIMITED | CCL PHARMACEUTICALS (PVT) LTD, 62 KOTLAKH PAT INDUSTRIAL ESTATE PAKISTAN | Incompletete CTD Dossier Submission |
| 748 | VADIS CO-TRIMOXAZOLE TABLETS | SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG | Antimalaria | FIRST VADIS PHARMACEUTICAL INDUSTRIAL LTD | FIRST VADIS PHARMA IND. LTD, PLOT IN/2 PHASE EMENE ENUGU | Incompletete CTD Dossier Submission |
| 749 | DICLOWOOD TABLETS | DICLOFENAC POTASSIUM TABLETS USP 50MG | Non-Steroidal Anti-Inflammatory Drug (NSAID) | HALEWOOD LABORATORIES PVT LTD | HALEWOOD LABORATORIES PVT.LTD. Plot no 319, G.I.D.C. Phase II Vatva, Ahmedabad, Gujarat, India | Incompletete CTD Dossier Submission |
| 750 | MCFORIS PREGABALIN CAPSULES | PREGABALIN 300MG | Anticonvulsant | MC FORIS PHARMACEUTICALS LTD | ALPA LABORATORIE LTD, 33/2 A.B ROAD, PIGDAMBER, INDORE, INDIA | Incompletete CTD Dossier Submission |
| 751 | ARTESUNATE FOR INJECTION 120 MG | ARTESUNATE 120MG | Antimalaria | ZENITH BIOTECH LIMITED | ALLIAANCE BIOTECH, VILL. KATHA, BADDI, DISTT. SOLAN (H.P. INDIA | Incompletete CTD Dossier Submission |
| 752 | Ceftriaxone Sodium and Sulbactam Sodium for Injection | Ceftriaxone Sodium and Sulbactam Sodium for Injection | Antibiotics | ABOVE ONLY PHARMACEUTICALS LIMITED | DAFFODILLS PHARMACEUTICAL LTD, Jawahar Nagar, Rohta Road, Meerut-250001, Uttar Pradesh (India | Incompletete CTD Dossier Submission |
| 753 | OVUFEN | CLOMIPHENE CITRATE USP | Selective Estrogen Receptor Modulator (SERM) | DIGITALL HEALTHCARE LIMITED | LARK LABOTARORIES (INDIA) LTD.SP-1192E RIICO Industrial Area, Phase âIV, Bhiwadi, (RAJ.) 301019 INDIA | Incompletete CTD Dossier Submission |
| 754 | Metal forte | Artemether/ Lumefantrine | Antimalaria | GREAT OMACO PHARMACY LIMITED | S.K MEDICINE LIMITED (ASSOCIATED BIOTECH), VILLAGE KISHANPURA,GURUMAJRA ROAD,NALAGARH ROAD,BADDI,DISTT. SOLAN(HP.), INDIA | Incompletete CTD Dossier Submission |
| 755 | ANIRTE FORTE TABLETS | ARTEMETHER 80MG & LUMENFANTRINE 480MG | Antimalaria | ANISUN PHARMACEUTICAL CO NIG LTD. | M/s IMPULSE PHARMA PVT. LTD..J-201,J-202/1, MIDC TARAPUR BOISAR DIST. PALGHAR 401506, MAHARASTRA STATE, INDIA | Incompletete CTD Dossier Submission |
| 756 | MYSROTEC DICLOFENAC SODIUM 75 MG & MISOPROSTOL 200 MCG TABLETS | DICLOFENAC SODIUM 75 MG & MISOPROSTOL 200 MCG TABLETS | Non-Steroidal Anti-Inflammatory Drug (NSAID) | E LIFE APEX PHARMACY COMPANY LIMITED | HEALTH CARE FORMULATIONS PVT LTD, C/8, Sardar Estate, Ajwa Road, Vadodara- 390019, INDIA | Incompletete CTD Dossier Submission |
| 757 | Iohexol | Dozhexol | Anticholinergics | Dozie and Dozie’s Pharm Nig Ltd | Beliu, No 3, Shuiyuan West Road, Miyun District, Beijing, China | Incompletete CTD Dossier Submission |
| 758 | IMOXCLAV 1000MG TABLET | Amoxicillin875mg &Clavulanic Acid125 mg Tablets USP | Antibiotics | CHRIS-EJIK PHARMACEUTICALS HEALTHCARE PRODUCTS LIMITED | MEDICEF PHARMA, PLOT NO: 28, 29 & 48 EPIP, PHASE-1, JHARMAJRI, BADDI, DIST. SOLAN (H.P), INDIA | Incompletete CTD Dossier Submission |
| 759 | Sita-Met Tablet 50/500mg | Sitagliptin Phosphate monohydrate â¦.50mg Metformin HClâ¦â¦â¦..500mg | Antidiabetic | CCL LIFESCIENCES NIGERIA LIMITED | CCL PHARMACEUTICALS (PVT) LTD, 62 KOTLAKH PAT INDUSTRIAL ESTATE PAKISTAN | Incompletete CTD Dossier Submission |
| 760 | ANTALGIQ | PIROXICAM | Non-Steroidal Anti-Inflammatory Drug (NSAID) | UNILINK PHARMACEUTICAL LTD | UNILINK PHARMA PVT LTD, A-19, SIDCO Industrial Estate, Alathur, Thriuporur â 603 110, India. | Incompletete CTD Dossier Submission |
| 761 | BOND IBUPROFEN SUSPENSION | IBUPROFEN | Analgesic | BOND CHEMICAL INDUSTRIES LIMITED | BOND CHEMICAL INDUSTRIES LIMITED | Incompletete CTD Dossier Submission |
| 762 | BONACILLIN 500MG CAPSULES | AMPICILLIN TRIHYDRATE CAPSULE | Antibiotics | BOND CHEMICAL INDUSTRIES LIMITED | BOND CHEMICAL INDUSTRIES LIMITED | Incompletete CTD Dossier Submission |
| 763 | VICORDIA 5mg | Ivabradine Hydrochloride | (HCN) channel blocker | Oculus Pharmacare Limited | PHARMATHEN INTERNATIONAL S.A, Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece | Incompletete CTD Dossier Submission |
| 764 | BONDIC | Diclofenac Potassium | Non-Steroidal Anti-Inflammatory Drug (NSAID) | BON PLEASANT PHARMACEUTICAL COMPANY LIMITED | MCCOY PHARMA PVT. LTD, S 12, MIDC, TARAPUR, BOISAR THANE-401506, MAHARASHTRA STATE, INDIA | Incompletete CTD Dossier Submission |
| 765 | VELMID | MIDAZOLAM BP | Benzodiazepine | DORGLORY PHARMACY NIG. LTD | VELLINTON HEALTH CARE, TRILOKPUR ROAD VILL- RAMPUR JATTAN, KALA-AMB PIN 173030, DISTT- SIRMUR (HP) INDIA | Incompletete CTD Dossier Submission |
| 766 | BONACILLIN 250MG CAPSULES | AMPICILLIN TRIHYDRATE CAPSULE | Antibiotics | BOND CHEMICAL INDUSTRIES LIMITED | BOND CHEMICAL INDUSTRIES LIMITED | Incompletete CTD Dossier Submission |
| 767 | ORTACTA 15MG | Rivaroxaban | Anticoagulant | Oculus Pharmacare Limited | COMBINO PHARM MALTA, LTD, HF60 Hal Far Industrial Estate Hal Far BBG3000 MALTA | Incompletete CTD Dossier Submission |
| 768 | DUOFENAC | Diclofenac Potassium Tablets 50 mg | Non-Steroidal Anti-Inflammatory Drug (NSAID) | JIMMI-WELL INTERNATIONAL COMPANY LIMITED | M/s. AVEO PHARMACEUTIALS PVT LTD , PLOT NO. C/13, MIDC TARAPUR INDUSTRIAL AREA, PALGHAR THANE MAHARASHTRA 401 506 INDIA | Incompletete CTD Dossier Submission |
| 769 | ACCUTAS | Bromelain and Crystaline Trypsin tablets | Proteolytic Enzymes | PHARMACY PLUS LTD | STALLION LABORATORIES PVT. LTD. C1B-305,2, 3, 4 & 5, G.I.D.C. Kerala (Bavla) Dist: Ahmedabad, Gujarat, | Incompletete CTD Dossier Submission |
| 770 | MOZARTEM 20MG/120MG SUSPENSION | Artemether 20 mg & Lumefantrine 120 mg | Antimalaria | Lemon Drugs Trading | M/s. LESANTO LABORATORIES, PLOT NO 9, 10, 11 & 20 SURVEY NO 53, NEAR RAILWAY BRIDGE, MANOR ROAD, PALGHAR (EAST) PALGHAR H.O. DIST. THANE 401404 MAHARASHTRA, INDIA | Incompletete CTD Dossier Submission |
| 771 | RALVET AMPICILLIN AND CLOXACILLIN | Ampicillin And Cloxacillin | Antibiotics | VETHY PHARMACEUTICAL AND ALLIED VENTURES LTD | SWISS PHARMA PVT. LTD,3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382 445, Dist: Ahmedabad Gujarat State , India | Incompletete CTD Dossier Submission |
| 772 | Loratadine Tablets USP 10 mg | Loratadine USP | Antihistamine | CHY-GOZZY GLOBAL CONCEPT NIGERIA LIMITED | Surmount Laboratories Private Limited, A-2, 4003, GIDC, Estate, Anklesvar INA, Ankleshwar, Gujarat 393001, India | Incompletete CTD Dossier Submission |
| 773 | VERST AZITHROMYCIN TABLETS | Azithromycin Tablets | Antibiotics | VATICAN PHARMA CONSULT LIMITED | WINTECH PHARMACEUTICALS LTD.Office No. 2 & 3, 3rd floor, Broadway Shopping Centre, Dr. Ambedkar Road, Dadar T.T. Mumbai- 400014, India. | Incompletete CTD Dossier Submission |
| 774 | RALVET AMLODIPINE | Amlodipine | Antihypertensive | MASRICH PHARMACEUTICAL AND ALLIED VENTURES LTD | SWISS PHARMA PVT. LTD,3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382 445, Dist: Ahmedabad Gujarat State , India | Incompletete CTD Dossier Submission |
| 775 | Velmetia- M Tablet 50/1000mg | Sitagliptin (as phosphate monohydrate) â¦â¦â¦.. 50mg and Metformin hydrochloride â¦â¦â¦â¦..â¦â¦â¦1000mg | Antidiabetic | FENN PHARMACEUTICALS LIMITED | MAXITECH PHARMA (PVT) LTD.Plot No. E-178, S.I.T.E. Super Highway, Phase II, Karachi | Incompletete CTD Dossier Submission |
| 776 | RALVET DICLOFENAC | Diclofenac Potassium | Non-Steroidal Anti-Inflammatory Drug (NSAID) | MASRICH PHARMACEUTICAL AND ALLIED VENTURES LTD | SWISS PHARMA PVT. LTD,3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382 445, Dist: Ahmedabad Gujarat State , India | Incompletete CTD Dossier Submission |
| 777 | PRE-MAX CAPSULE 75mg (Pregabalin) | PREGABALIN 75MG | Anticonvulsant | FENN PHARMACEUTICALS LIMITED | MAXITECH PHARMA (PVT) LTD, Plot No. E-178, S.I.T.E. Super Highway, Phase II, Karachi, PAKISTAN. | Incompletete CTD Dossier Submission |
| 778 | ZAHIDICORT | TRIAMCINOLONE ACETONIDE | Synthetic Corticosteroid | MASAN PHARMACEUTICAL LIMITED | ZAHIDIS ENTERPRISE, Office No-4, Ground Floor, 106 Kanchwala Building, Plot No-13, Keshavji Naik Road, Chinch Bunder, Mumbai – 400009, Maharashtra, India P) | Incompletete CTD Dossier Submission |
| 779 | ZAHITIS-60 | ARTESUNATE INJECTION | Antimalaria | MASAN PHARMACEUTICAL LIMITED | ZAHIDIS ENTERPRISE, Office No-4, Ground Floor, 106 Kanchwala Building, Plot No-13, Keshavji Naik Road, Chinch Bunder, Mumbai – 400009, Maharashtra, India P) | Incompletete CTD Dossier Submission |
| 780 | RALVET AMOXICILLIN AND CLAVULANATE | Co-Amoxiclav | Antibiotics | Chuvet Pharmaceutical and Allied Ventures LTD | SWISS PHARMA PVT. LTD,3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382 445, Dist: Ahmedabad Gujarat State , India | Incompletete CTD Dossier Submission |
| 781 | MARLEY | CIMETIDINE INJECTION | H2-receptor antagonist | MARLEYSHREE PHARMACEUTICAL NIGERIA LIMITED | TianJin KingYork Group HuBei TianYao Pharmaceutical Co., Ltd.99, Hanjiang Bel ,Xiangyang, Hubei, China. | Incompletete CTD Dossier Submission |
| 782 | CATAPHINI 50 | DICLOFENAC POTASSIUM USP 50MG | Non-Steroidal Anti-Inflammatory Drug (NSAID) | PHINIFARMS PHARMACEUTICAL COMPANY LTD | M/s. MacCoy Pharma Pvt. Ltd.,S 12, MIDC, TARAPUR, BOISAR THANE, 401506 MAHARASHTRA STATE, INDIA., INDIA | Incompletete CTD Dossier Submission |
| 783 | AKOM | ARTEMETHER Ph. Int. | Antimalaria | EFFINNIA HEALTH PHARM. COMPANY LIMITED | BROOKS LABORATORIES LTD.Village Kishanpura, Nalagarh Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh (174101), India | Incompletete CTD Dossier Submission |
| 784 | ENTHOTWC TABLETS (DICLOFENAC SODIUM 75 MG & MISOPROSTOL 200 MCG ) | DICLOFENAC SODIUM 75 MG & MISOPROSTOL 200 MCG TABLETS | Non-Steroidal Anti-Inflammatory Drug (NSAID)/Prostaglandin E1 analogue | ENVOLVE PHARMACEUTICAL LIMITED | HEALTH CARE FORMULATIONS PVT LTD, C/8, Sardar Estate, Ajwa Road, Vadodara- 390019, INDIA | Incompletete CTD Dossier Submission |
| 785 | EPI-Tears Ophthalmic solution | Dextran & Hydroxy propyl methyl cellulose | Ophthalmic lubricant | Elmarine Pharmaceutical Ltd | Egyptian International Pharmaceutical Industries CO. A.R.E 10th of Ramadan City â Industrial Zone B1 | Incompletete CTD Dossier Submission |
| 786 | FLUMOX VIAL 500MG & 1G | AMOXYCILLIN SODIUM , FLUCLOXACILLIN SODIUM | Antibiotics | Elmarine Pharmaceutical Ltd | Egyptian International Pharmaceutical Industries CO. A.R.E 10th of Ramadan City â Industrial Zone B1 | Incompletete CTD Dossier Submission |
| 787 | Benzhexol Tablets BP 5 MG | Benzhexol Hydrochloride (Trihexyphenidyl Hydrochloride) | Antimuscarinic agent | NONSEC PHARMACEUTICALS LTD | M/S. MACCOY PHARMA PVT. LTD.Plot No. S-12, MIDC, Tarapur, Boisar, Palghar, Dist. Palghar, Tarapur-410506, India | Incompletete CTD Dossier Submission |
| 788 | Pentazocin Injection | Pentazocine Injection BP 30mg/ml | Opiod Analgesic | Right Care Drugs Limited | M/s FARBE FIRMA Pvt Ltd, Plot No: 1508, Near Atique Bakery, GIDC Estate, Ankleshwar-393002, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 789 | TIMUK EYE DROPS | TIMOLOL EYE DROPS BP 0.5% W/V | Antibiotics | Medicrown Nigeria Limited pharmaceuticals | M/s. KAMLA LIFESCIENCES LTD, Plot no.G-84/1, Tarapur M.I.D.C, Boisar-401 506, Tal. & Dist. Palghar, Maharashtra, India.. | Incompletete CTD Dossier Submission |
| 790 | DYCLOSA 50 | Diclofenac sodium tablets 50 mg | Non-Steroidal Anti-Inflammatory Drug (NSAID) | PRAIPEC PHARMACEUTICAL LIMITED | Merit Organics Ltd, 509, Western Edge I, Western Express Hwy, Food Corporation of India Warehouse, Borivali East, Mumbai, Maharashtra 400066, India | Incompletete CTD Dossier Submission |
| 791 | SODIVAL | Betamethasone and Neomycin Eye/ Ear Drops | Corticosteroids/Antibiotics | Fanyval Vision limited | ALPA LABORATORIES LIMITED, 33/2 A.B Road, Pigdamber, Indore (MP)-India | Incompletete CTD Dossier Submission |
| 792 | Gentamicin Eye Drops BP 0.3% w/v | Gentamicin Eye | Antibiotics | EST PHARMACEUTICAL NIGERIA LIMITED | M/s. KAMLA LIFESCIENCES LTD, Plot no.G-84/1, Tarapur M.I.D.C, Boisar-401 506, Tal. & Dist. Palghar, Maharashtra, India.. | Incompletete CTD Dossier Submission |
| 793 | OSICOXIB 60 | ETORICOXIB TABLETS 60 MG | Selective cyclooxygenase-2 (COX-2) inhibitor | DE-ZUBIK PHAMACEUTICAL LTD | Globela Pharma Pvt. Ltd, 357-358, Sachin G.I.D.C, Surat, Gujarat, India-394230. | Incompletete CTD Dossier Submission |
| 794 | PREGAFYL 300 | Pregabalin BP | Anticonvulsant | PILLARS PHARMACEUTICALS NIGERIA LIMITED | SWISS PHARMA PVT. LTD,3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382 445, Dist: Ahmedabad Gujarat State , India | Incompletete CTD Dossier Submission |
| 795 | LEVOFLOXACIN TABLETS | Levofloxacin Tablets USP 500mg | Antibiotics | DON-J PHARMACY LTD | ZOTA HEALTHCARE LTD, Plot No: 169, Surat Special Economy Zone, Nr. Sachin Railway Station, Sachin, Surat-394 230, Gujarat, India. | Incompletete CTD Dossier Submission |
| 796 | DICLOFENAC POTASSIUM BP 50MG | DICLOFENAC POTASSIUM | Non-Steroidal Anti-Inflammatory Drug (NSAID) | AL PHARMA LTD | ALPA LABORATORIES LIMITED, 33/2 A.B Road, Pigdamber, Indore (MP)-India | Incompletete CTD Dossier Submission |
| 797 | Pentazocine Injection BP 30 mg/ml | Pentazocine | Opiod Analgesic | MIGHTY FAVOUR PHARMACEUTICAL LTD, | M/s. IMPULSE PHARMA PVT. LTD. J-201, J-202/1, MIDC Tarapur, Boisar Dist. Palghar – 401506 INDIA | Incompletete CTD Dossier Submission |
| 798 | Jessy Amlodipine Tablet | Amlodipine Tablet | Antihypertensive | JESSY PHARMACEUTICAL COMPANY LIMITED | Jessy pharmaceutical company limited, 13B Acme road ogbaegbe industrial layout ikeja Lagos | Incompletete CTD Dossier Submission |
| 799 | Chlorphenamine Maleate Capsules 4 mg | Chlorphenamine Maleate | Antihistamine | BARI PHARMACY NIG. LTD | Claroid Pharmaceuticals Pvt. Ltd, Survey No. 217/P, Opp. Gurukul English Medium School, Kamod, Satpanth Mandir, Pirana Rd, TA, Ahmedabad-3824205, India | Incompletete CTD Dossier Submission |
| 800 | GYNOFER TABLET | Tinidazole BP | Nitroimidazole Antimicrobial | AL-TINEZ PHARMACEUTICALS LTD | CENTAUR PHARMACEUTICAL PVT. LTD, PLANT -1,PLOT N0 3 TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA,GOA -403 526 INDIA | Incompletete CTD Dossier Submission |
| 801 | Artemether and Lumefantrine Tablets 80/480 mg | Artemether and Lumefantrine Tablets 80/480 mg | Antimalaria | THERAP PHARMACEUTICALS LIMITED | CENTURION REMEDIES PVT.LTD. Plot No. G/5, G/6, B.I.D.C., Gorwa, Vadodara-390016, INDIA | Incompletete CTD Dossier Submission |
| 802 | PENICILLIN – V | PENICILLIN – V | Antibiotics | CHRIS NELB PHARMACEUTICAL NIG. LTD. | NORTH CHINA PHARMACEUTICAL CO., LTD.NO 388, HEPING EAST ROAD, SHIJIAZHUANG, CHINA. | Incompletete CTD Dossier Submission |
| 803 | Synomal | α-β Arteether Injection | Antimalaria | SYNMEDIC SPECIALTY LIMITED | PHARMAX INDIA PVT. LTD.9 Kurla Industrial Estate, Netaji Palkar Road, Narayan Nagar, Ghatkopar West, Mumbai-400086, INDIA | Incompletete CTD Dossier Submission |
| 804 | JOMIFENAC TABLETS | Diclofenac potassium BP 50 mg | Non-Steroidal Anti-Inflammatory Drug (NSAID) | RKJ PHARMACEUTICALS LTD | M/s. IMPULSE PHARMA PVT. LTD.J-201, J-202/1 , MIDC Tarapur, Boisar, Dist. Palghar – 401506, Maharashtra State, India. | Incompletete CTD Dossier Submission |
| 805 | Marcllerg | Antazoline Hydrochloride, Tetryzoline Hydrochloride eye drop | Ophthalmic Anti-allergic and Decongestant | Marcson Healthcare Ltd | CORAL LABORATORIES LTD.5, 6 Khokhani Industrial Complex No.2, Sativali, Vasai (E), Thane – 401 208. INDIA | Incompletete CTD Dossier Submission |
| 806 | PHILO | CHLORAMPHENICOL 250MG | Antibiotics | A.NWAEZE PHARM. CO., LTD | LIAONING HUARUI UNION PHARMACEUTICAL CO., LTD. YUANQU ROAD NO 1, TONGYUANPU ECONOMIC DEVELOPMENT ZONE DANDONG CITY, LIAONING PROVINCE, CHINA. | Incompletete CTD Dossier Submission |
| 807 | TRAMADOL CAPSULES 100MG | Tramadol hydrochloride 100mg | Opiod Analgesic | BARNAETO PHARMACY LTD. | Astamed Healthcare (I) Pvt. Ltd.Plot No.2&3, Phase-II, Genesis Ind. Complex, Kolgaon, Palghar-401404, Maharashtra, India | Incompletete CTD Dossier Submission |
| 808 | FUROPAN 750 | Cefuroxime for Injection USP, 750 mg | Antibiotics | PANGENE BIOTECH PVT LTD | East African (India) Overseas, Unit I â Plot No. 1, Pharmacity, Selaqui, Dehradun-248011 UTTARAKHAND (INDIA) | Incompletete CTD Dossier Submission |
| 809 | CEFTRIAXONE SODIUM AND SULBATAM SODIUM AND STERILE WATER FOR INJECTION | CEFTRIAXONE SODIUM AND SULBATAM SODIUM AND STERILE WATER FOR INJECTION | Antibiotics | CHRIS NELB PHARMACEUTICAL NIG. LTD. | NORTH CHINA PHARMACEUTICAL CO., LTD.NO 388, HEPING EAST ROAD, SHIJIAZHUANG, CHINA. | Incompletete CTD Dossier Submission |
| 810 | CHLORAMPHENICOL 250MG | CHLORAMPHENICOL 250MG | Antibiotics | VELLOUSLIFE PHARMACEUTICAL LIMITED | LIAONING HUARUI UNION PHARMACEUTICAL CO., LTD. YUANQU ROAD NO 1, TONGYUANPU ECONOMIC DEVELOPMENT ZONE DANDONG CITY, LIAONING PROVINCE, CHINA. | Incompletete CTD Dossier Submission |
| 811 | BRYXO | BRIMONIDINE EYE DROPS | Alpha-2 adrenergic agonists | GENERIX GLOBAL INVESTMENT LTD | Popular Pharmaceuticals Ltd. Address: 164, Tongi Industrial Area, Tongi, Gazipur-1711, Bangladesh | Incompletete CTD Dossier Submission |
| 812 | PURITY GRADE LISINOPRIL | LISINOPRIL | Antihypertensive | Purity Grade pharmaceutical Ltd. | LESANTO LABORATORIES, 4-5-6, Om Sai Karan Palace, Eksar Road, Borivali (W), Mumbai – 400 091. INDIA. | Incompletete CTD Dossier Submission |
| 813 | CHIMEXBON ARTESUNATE INJECTION 60MG | EACH VIAL CONTAINS: ARTESUNATE 60 MG THE PACK CONTAINS: 1 ML AMPOULE OF SODIUM BICARBONATE IN1JECTION BP 5 % W/V 5 ML AMPOULE OF SODIUM CHLORIDE INJECTION BP 0.9 % W/V | Antimalaria | CHIMEXBON INTERNATIONAL COMPANY LIMITED | ALPA LABORATORIES LIMITED, 33/2 A.B Road, Pigdamber, Indore (MP)-India | Incompletete CTD Dossier Submission |
| 814 | DUTASIN CAPSULES | TAMSULOSIN HYDROCHLORIDE 0.4MG, DUTASTERIDE 0.5MG | Alpha-1 Blocker/5-Alpha Reductase Inhibitor | EMBASSY PHARMACEUTICAL AND CHEM.LTD | AR LIFESCIENCES, 819/B, Industrial Area, Rakanpur, Santej, Ta. Kalol, Dist-Gandhinagar, Gujarat-382721, INDIA | Incompletete CTD Dossier Submission |
| 815 | CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3 % W/V | CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3 % W/V | Antibiotics | Priya Pharmaceutical Nig Ltd | KAMLA LIFESCIENCES LIMITED,G-84/1, TARAPUR MIDC, BOISAR DIST-PALGHAR MAHARASHTRA 401506 INDIA | Incompletete CTD Dossier Submission |
| 816 | AXARTEM 20/120 Powder for Oral Suspension | Artemether 20mg + Lumefantrine 120mg | Antimalaria | AXION PHARMACEUTICALS LTD | Saitech Medicare Pvt. Ltd, Trilokpur Road, Kala Amb 173030 Dist-Sirmaur, H.P. India | Incompletete CTD Dossier Submission |
| 817 | Salucan Combo | Secnidazole 1000 mg Tablets; Fluconazole 150 mg Capsules; Clotrimazole Vaginal Gel 15 g | Nitroimidazole/Antifungal/Imidazole | Solid Accord Ltd | Ciron Drugs Pharmaceutical Pvt Ltd, C-1101/1102, Lotus Corporate Park, Graham Firth Steel Compound, Jay Coach Junction, Western Express Highway, Goregaon (East), Mumbai â 400 063. | Incompletete CTD Dossier Submission |
| 818 | NEXTPHARM ARTESUNATE INJECTION | ARTESUNATE 120MG | Antimalaria | NEXTPHARMA DRUG COMPANY LIMITED | M/S. KAMLA LIFESCIENCES LTD, G-84/1, TARAPUR, MIDC, BOISAR, DISTRICT-PALGHAR 401506 INDIA. | Incompletete CTD Dossier Submission |
| 819 | ACICROF-P | ACECLOFENAC 100MG AND PARACETAMOL 500MG TABLET | Non-Steroidal Anti-Inflammatory Drug (NSAID)/Analgesic | CIFAX EXIM LIMITED | ASSOCIATED BIOTECH VILL-KISHANPURA, GURUMAJRA ROAD, BADDI, TEH, NALAGARH, DIST. SOLAN-174 101 (H.P). INDIA | Incompletete CTD Dossier Submission |
| 820 | EZETRAM 100mg capsule | Tramadol Hydrochloride Capsules 100 mg | Opiod Analgesic | EZECHUKS PHARM . CO.LTD | LESANTO LABORATORIES, Plot No. 9, 10, 11 & 20, Survey No. 53, Manor Road, Near Railway Bridge, Palghar (E), Thane-401404, Maharashtra, India | Incompletete CTD Dossier Submission |
| 821 | ROEYZNAC | Diclofenac Potassium BP | Non-Steroidal Anti-Inflammatory Drug (NSAID) | ROEYZN PHARMACEUTICAL LIMITED | KESAR PHARMA (P) LTD, Plot Survey No.50-P/2, At Village, Bileshwarpura, Po Chhatral-382729. Tal.Kalol, Dist. Gandhinagar | Incompletete CTD Dossier Submission |
| 822 | VEEWCIN REDNESS + IRRITATION RELIEF EYE DROPS | TETRAHYDROZOLINE HYDROCHLORIDE USP 0. 5 MG/ML | Selective Alpha-1 Adrenegic Receptor Agonist | PATRICKLINGO PHARMACEUTICALS LIMITED | DIARA INTERNATIONAL , Samajdeep Chs Ltd, B/602, Jamnadas Adukia Lane, opp. Seasons Hotel, Ghanshyam Nagar, Jethava Nagar, Kandivali West, Mumbai, Maharashtra 400067 | Incompletete CTD Dossier Submission |
| 823 | GABCEL – 300 | Pregabalin Capsule 300 mg | Anticonvulsant | excel charis pharmaceutical chemical ltd | Hab Pharmaceuticals & Research Ltd, 10, Pharmacity, Selaqui, Dehradun, Uttarakhand – 248011, India | Incompletete CTD Dossier Submission |
| 824 | MAMCAP | OXYTETRACYCLINE 250MG | Antibiotics | M.M.H KANO LTD | JIANGXI XIERKANGTAI PHARMACEUTICAL CO LTD, NORTH ZONE, HIGH NEW-TECH INDUSTRIAL ZONE, PINGXIANG | Incompletete CTD Dossier Submission |
| 825 | CEPHTA INJECTION | Ceftriaxone 1g Injection | Antibiotics | HEALTH HUB PHARMACY & STORE LTD | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd, Luoqi Road, Linyi High andNew Technology Industries Development Zone, Shandong Province, PR China | Incompletete CTD Dossier Submission |
| 826 | REAGAN TRAMADOL 100MG CAPSULE | TRAMADOL 100MG | Opiod Analgesic | Reagan Remedies Ltd | REAGAN REMEDIES LTD, 24 MUSA YARADUA DRIVE, NEW OWERRI, IMO STATE | Incompletete CTD Dossier Submission |
| 827 | REAGAN TRAMADOL 50MG CAPSULE | TRAMADOL 50MG | Opiod Analgesic | Reagan Remedies Ltd | REAGAN REMEDIES LTD, 24 MUSA YARADUA DRIVE, NEW OWERRI, IMO STATE | Incompletete CTD Dossier Submission |
| 828 | DOPILLA | Pseudoephedrine Hydrochloride USP, Triprolidine Hydrochloride USP | Sympathomimetic nasal decongestant/Antihistamine | PILLARS PHARMACEUTICALS NIGERIA LIMITED | SWISS PHARMA PVT. LTD,3709, G.I.D.C. Phase IV, Vatva, City: Ahmedabad â382 445, Dist: Ahmedabad Gujarat State , India | Incompletete CTD Dossier Submission |
| 829 | Pentazocine Injection BP 30 mg/ml | Pentazocine | Anticonvulsant | PATRICKLINGO PHARMACEUTICALS LIMITED | Merit Organic LTD, 2104/2/A, G.I.D.C , Sarigam, Bhilad-396 155, Gujarat . India | Incompletete CTD Dossier Submission |
| 830 | Pentazocine Injection BP 30 mg/ml | Pentazocine | Anticonvulsant | SKIN PHARM NIGERIA LIMITED | BHARAT PARENTERALS LIMITED, Plot No- 144 & 146, Jarod-Samilyala Road, Vill. Haripura, Ta. Savli, Dist- Baroda, Gujarat, INDIA | Incompletete CTD Dossier Submission |
| 831 | EMEFILM-4 | Ondansetron Hydrochloride Orally Disintegrating Strips 4 mg | Selective serotonin 5-HT3 receptor antagonist | PHILLIPS PHARMACEUTICALS (NIGERIA) LIMITED | Shilpa Therapeutics Pvt Ltd, Plot No. 118, Phase III, IDA, Cherlapally Hyderabad-500 051, INDIA | Incompletete CTD Dossier Submission |
| 832 | ANIMOL CAPSULES | DICLOFENAC POTASSIUM B.P 50MG | NSAID | ANISUN PHARMACEUTICAL CO NIG LTD. | M/s IMPULSE PHARMA PVT. LTD..J-201 J-202/1 MIDC TARAPUR BOISAR DIST PAL;GHAR 401506 MAHARASTRA STATE INDIA | Incompletete CTD Dossier Submission |
| 833 | Tadalong 20 mg | Tadalafil 20 mg | Phosphodiesterase Type5 (PDE5) Inhibitor | EXCELLENT PORT COMPANY LIMITED | Al Andalous for Pharmaceutical Industries.Part No. 7/1/A, 6th Industrial Zone, 6th of October City, Giza â Egypt | Incompletete CTD Dossier Submission |
| 834 | ONDANSETRON INJECTION USP 2 MG/ML | ONDANSETRON | Antiemetic | IDEAL HEALTH PHARMACY AND STORES LTD | Ciron Drugs & Pharmaceuticals Pvt. Ltd., N-118,118/1, 119, 119/1, 119/2, 113 MIDC, TARAPUR, BIOSAR, PALGHAR 401506 MAHARASHTRA STATE, INDIA | Incompletete CTD Dossier Submission |
| 835 | PLUMAL | ARTEMETER 20MG + LUMENFANTRINE 120MG TABLET | Antimalaria | UNICURE PHARMACEUTICAL LIMITED | UNICURE PHARMACEUTICAL LIMITED, Ikofa Village, Lagos-Benin Expressway, Ijebu-Ode, Ogun State, Nigeria | Incompletete CTD Dossier Submission |
| 836 | Tadalafil 5 mg + Tamsulosin HCL 0.4 mg | Tadalafil 5 mg + Tamsulosin HCL 0.4 mg | Phosphodiesterase Type5 (PDE5) Inhibitor | BAISC PHARMACUTICAL & HERBAL HEALTHCARE LTD. | BASE MEDICO PVT. LTD.Survey No. 570, Village Tundav, Tal. Savli, Dist. Vadodara – 391775, Gujarat, India. | Incompletete CTD Dossier Submission |
| 837 | SACUBITRIL VALSARTAN TABLETS 50MG, 100MG AND 200 MG | SACUBITRIL VALSARTAN TABLETS 50MG, 100MG AND 200 MG | Antihypertensive | ROCKFORTH PHARMACY & STORES LTD | STALLION LABORATORIES PVT. LTD. C1B-305,2, 3, 4 & 5, G.I.D.C. Kerala (Bavla) Dist: Ahmedabad, Gujarat, | Incompletete CTD Dossier Submission |
| 838 | MELTON DICLOFENAC SODIUM INJECTION | DICLOFENAC SODIUM 75MG | Non-Steroidal Anti-Inflammatory Drug (NSAID) | MELTON PHARMACEUTICAL NIG. LTD | ANHUI CHENGSHI PHARMACEUTICAL CO. LTD.NO. 5068, HUAISHANG ROAD, BENGBU, ANHUI PROVINCE, CHINA. | Incompletete CTD Dossier Submission |
| 839 | EMICOLD TABLETS | Paracetamol, Phenylephrine Hydrochloride, Chlorphenamine Maleate and Caffeine Tablets | Analgesic/Antihistamine | EMINENT DRUGS AND PHARMACEUTICAL LIMITED | IMPULSE PHARMA PVT. LTD. J-201, J-202/1 , MIDC Tarapur, Boisar Dist. Palghar -401506 India | Incompletete CTD Dossier Submission |
| 840 | MELTER ARTEMETHER INJECTION | ARTEMETHER 80MG/1ML | Antimalaria | MELTON PHARMACEUTICAL NIG. LTD | ANHUI CHENGSHI PHARMACEUTICAL CO. LTD, NO. 5068, HUAISHANG ROAD, BENGBU, ANHUI PROVINCE, CHINA.. | Incompletete CTD Dossier Submission |
| 841 | SILDENAFIL CITRATE AND DAPOXETINE TABLETS | SILDENAFIL CITRATE AND DAPOXETINE TABLETS 100+60 MG | Phosphodiesterase Type5 (PDE5) Inhibitor | THERAP PHARMACEUTICALS LIMITED | CENTURION REMEDIES PVT.LTD.Plot No. G/5, G/6, B.I.D.C., Gorwa, Vadodara-390016, INDIA. | Incompletete CTD Dossier Submission |
| 842 | EBECEF-SB | Ceftriaxone Sodium & Sulbactam Sodium | Antibiotics | Elbe Pharma Nig Ltd | SWISS PARENTERALS LTD, Plot No, 402, 412-414, Kerala GIDC, City: Bavla, Ahmedabad-382220, Gujarat, India | Incompletete CTD Dossier Submission |
| 843 | BONACILLIN DRY SYRUP | AMPICILLIN TRIHYDRATE DRY SYRUP | Antibiotics | BOND CHEMICAL INDUSTRIES LIMITED | BOND CHEMICAL INDUSTRIES LIMITED | Incompletete CTD Dossier Submission |
| 844 | INDAPAMIDE PROLONGED-RELEASE TABLETS BP 1.5 MG | INDAPAMIDE PROLONGED-RELEASE TABLETS BP 1.5 MG | Antihypertensive | PHARMACY PLUS LTD | STALLION LABORATORIES PVT. LTD. C1B-305,2, 3, 4 & 5, G.I.D.C. Kerala (Bavla) Dist: Ahmedabad, Gujarat, | Incompletete CTD Dossier Submission |
| 845 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENED RELEASE TABLETS (5/500, 5/1000 & 10/500, 10/1000) | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENED RELEASE TABLETS (5/500, 5/1000 & 10/500, 10/1000) | Antidiabetic | PEAKPHARM NIGERIA LIMITED | STALLION LABORATORIES PVT. LTD. C1B-305,2, 3, 4 & 5, G.I.D.C. Kerala (Bavla) Dist: Ahmedabad, Gujarat, | Incompletete CTD Dossier Submission |
| 846 | ALIVIOTEC 75 Tablets | Diclofenac sodium & Misoprostol | Non-Steroidal Anti-Inflammatory Drug (NSAID)/Synthetic Prostaglandin Analogue | ALIVIO PHARMACY & STORE NIGERIA LIMITED, LOUIS ifeanyi R. | NANDESARI DRUGS AND PHARMACEUTICALS PVT. LTD.,Plot No. A1 – 167 & 168, G.I.D.C., Nandesari, Vadodara – 391 340 Dist. Vadodara, Gujarat. India | Incompletete CTD Dossier Submission |
| 847 | PINNACLE LOPERAMIDE | LOPERAMIDE HYDROCHLORIDE CAPSULES USP 2 MG | Antidiarehea | PINNACLE HEALTH PHARMACEUTICAL & STORES LIMITED, Amaka Ubajekwe CLEMENTINA UBAJEKWE | GLOBELA PHARMA PVT LTD.PLOT NO. 357-358, G. I. D. C., SACHIN, SURAT â 394 230, GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 848 | HYFRESH OPHTHALMIC SOLUTION | SODIUM HYALURONATE 0.2% W/V OPHTHALMIC SOLUTION | Viscosupplementation Agent | ASSENE-LABOREX LIMITED, ASSENE-LABOREX LIMITED CHINYEREM AMUZIE | JAMJOOM PHARMACEUTICAL COMPANY, PLOT NO. ME 1:3, PHASE 5, INDUSTRIAL CITY, JEDDAH, KINGDOM OF SAUDI ARABIA | Incompletete CTD Dossier Submission |
| 849 | TERMINEX INJECTION 4.5 | Piperacillin & Tazobactam for Injection USP 4.5g | Antibiotics | Aquatix Pharmaceutical Limited, Aquatix Pharmaceutical Limited Ajokpaoghene Onaidhe | ZEISS PHARMACEUTICALS PVT LTD, Plot No. 72, EPIP â 1, JHARMAJRI, BADDI, DISTT. SOLAN (H.P) | Incompletete CTD Dossier Submission |
| 850 | Nifedipine Extended Release Tablets USP 20 mg ; 30mg | Nifedipine Extended Release Tablets USP 20 mg ; 30mg | Antihypertensive | BAISC PHARMACUTICAL & HERBAL HEALTHCARE LTD., Divyesh Patel EMMANUEL Izuegbu | Base Medico Pvt. Ltd., Survey No. 570, Village Tundav, Tal. Savli, Dist. Vadodara – 391775, Gujarat, India | Incompletete CTD Dossier Submission |
| 851 | Ciprofloxacin Tablets USP 500 mg | Ciprofloxacin Tablets USP 500 mg | Antibiotics | CHIRUSH PHARMA NIGERIA LIMITED | ASTAMED HEALTHCARE (I) PVT. LTD.2 & 3, Genesis Industrial Complex, Phase-II, Kolgaon, Palghar, Thane, Maharashtra, INDIA | Incompletete CTD Dossier Submission |
| 852 | DAPAGLIFLOZIN TABLETS 5 MG & 10 MG | DAPAGLIFLOZIN TABLETS 5 MG & 10 MG | Antidiabetic | PEAKPHARM NIGERIA LIMITED | STALLION LABORATORIES PVT. LTD. C1B-305,2, 3, 4 & 5, G.I.D.C. Kerala (Bavla) Dist: Ahmedabad, Gujarat, | Incompletete CTD Dossier Submission |
| 853 | BIOTHROMYCIN SUSPENSION | ERYTHROMYCIN ESTOLATE | Antibiotics | BIORAJ PHARMACEUTICALS LTD | BIORAJ PHARMACEUTICALS LTD, No. 405 Kaiama Road, Ilorin, Kwara State.S | Incompletete CTD Dossier Submission |
| 854 | Combofusiv | Paracetamol/Ibuprofen | Analgesic | Golden Gazelle Nigeria Ltd. | Pharma Bavaria Internacional (PBI) Portugal, Unipessoal Lda., Viela da Beloura, nº 6, Lj 19, 2710-693 Sintra, Portugal | Incompletete CTD Dossier Submission |
| 855 | Jevostat 500mg Tablet | Levofloxacin 500mg Tablet | Antibiotics | JESSY PHARMACEUTICAL COMPANY LIMITED | Jessy pharmaceutical company limited, 13B Acme road ogbaegbe industrial layout ikeja Lagos | Incompletete CTD Dossier Submission |
| 856 | CHEMIMYCIN INJECTION | Clindamycin Injection USP 150 mg/ml (2 ml) | Antibiotics | WELLNESS FOREVER MEDICARE LIMITED | Bharat Parenterals Ltd., Survey No. 144 – A, Jarod Samlaya Road, Village: Haripura, Tal. Savli, Dist.- Vadodara â 391520, Gujarat, India. | Incompletete CTD Dossier Submission |
| 857 | Drenoxol 30 mg/10 ml syrup (ampoules) | Ambroxol 30mg/10ml syrup (ampoules) | Mucolytic Agent | FAES FARMA NIGERIA LIMITED | Faes Farma Portugal, S.A., Rua Elias Garcia, 28 2700-327 Amadora | Incompletete CTD Dossier Submission |
| 858 | NORBALOG | TRIAMCINOLONE ACETONIDE | Corticosteriod | NORBARC PHARMACEUTICAL | SWISS PARENTERALS LTD, Plot No, 402, 412-414, Kerala GIDC, City: Bavla, Ahmedabad-382220, Gujarat, India | Incompletete CTD Dossier Submission |
| 859 | CEDOCLAV DS | Cefuroxime and Clavulanate Potassium Oral Suspension 156.25 mg | Antibiotics | De-Still pharmacy Ltd | Maxmed Life Sciences PVT Ltd,Plot No-54 & 55, Sector-llDC, SIDCUL, Rudrapur, Udhamsingh Nagar, Uttarakhand, lndia. | Incompletete CTD Dossier Submission |
| 860 | BROMOCRIPTINE TABLET | BROMOCRIPTINE | Dopamine Receptor Agonists | Smart Way Pharma, Ltd. | OCTOBER PHARMA, PLOT 190, INDUSTRIAL ZONE, 6TH OCTOBER CITY, EGYPT | Incompletete CTD Dossier Submission |
| 861 | AZITHROMYCIN TABLETS USP 500 MG | AZITHROMYCIN TABLETS USP 500 MG | Antibiotics | ccglobalcure pharmaceutical company limited | AVEO PHARMACEUTICALS PVT. LTD. | Incompletete CTD Dossier Submission |
| 862 | ALIVIOREX CAPSULES | Rabeprazole Sodium (EC) and Domperidone (SR) | Proton Pump Inhibitors (PPIs) | ALIVIO PHARMACY & STORE NIGERIA LIMITED | Naxcure Healthcare Pvt. Ltd. SURVEY NO.-889/1,B/H CHADASANA ONGC, CHADASANA-JHULASAN ROAD, AT & POST.- JHULASAN, TA.- KADI, DIST.- MEHSANA-382705 GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 863 | Oxytetracycline Capsules | Oxytetracycline | Antibiotics | MANFES PHARMACEUTICAL COMPANY LIMITED | Jiangxi Xierkangtai Pharmaceutical Co., LTD, NORTH ZONE, HIGH- NEW TECHNOLOGY INDUSTRIAL ZONE, PINGXIANG, JIANGXI, CHINA | Incompletete CTD Dossier Submission |
| 864 | IG AKUMA GENTAMYCIN INJECTION 80MG/2ML | GENTAMYCIN SULFATE INJECTION | Antibiotics | I.G AKUMA DIVINE PHARMACEUTICALS LTD. | TianJin KingYork Group HuBei TianYao Pharmaceutical Co., Ltd.No.99, HanJiang Bei Road, XiangYang City, HuBei Province, China. | Incompletete CTD Dossier Submission |
| 865 | EMITIFED TABLETS | Chlorphenamine Tablets BP 4mg | Antihistamine | EMINENT DRUGS AND PHARMACEUTICAL LIMITED | Impulse Pharma Pvt. Ltd. J-201, J-202/1, Maharashtra Industrial Development Corporation Tarapur, Dist. Palghar, Boisar 401506, India | Incompletete CTD Dossier Submission |
| 866 | ISOFLURANE INHALATION SOLUTION | Isoflurane | Inhalation General Anesthetics | Smart Way Pharma, Ltd. | ACDIMA INTERNATIONAL TRADING, Plot No. 41 – 6th Industrial Zone Extension – 6th October – Egypt | Incompletete CTD Dossier Submission |
| 867 | GABAPREF CAPSULES | PREGABALIN CAPSULES 75 MG | Anticonvulsant | PREFERRED DRUGS NIGERIA LIMITED. | FREDUN PHARMACEUTICALS LIMITED, 14, 15 , 16 , ZORABIAN INDUSTRIAL PREMISES, VEOOR, PALGHAR,- 4041404, INDIA | Incompletete CTD Dossier Submission |
| 868 | Oxynide Eye Drops | Brimonidine Tartrate | Selective Alpha-2 Adrenegic Receptor Agonist | Fanyval Vision limited | ALPA LABORATORIES LTD, 118,INDUSTRIAL ESTATE APAPA-OSHODI. AMUWO-ODOFIN, LAGOS, LAGOS | Incompletete CTD Dossier Submission |
| 869 | ARTESUNATE FOR INJECTION 120 MG/VIAL | ARTESUNATE FOR INJECTION 120 MG/VIAL | Antimalaria | Priya Pharmaceutical Nig Ltd | M/s. Kamla Lifesciences Ltd, G-84/1, Tarapur, MIDC, Boisar, District-Palghar 401506 | Incompletete CTD Dossier Submission |
| 870 | LYNSUNATE FORTE SOFTGEL | ARTEMETHER 80MG AND LUMEFANTRINE 480MG | Antimalaria | LYN-EDGE PHARMACEUTICALS LTD | SOFTGEL HEALTHCARE PRIVATE LTD, SURVEY NO. 20/1, VANDALUR-KELAMBAKKAM ROAD, PUDUPAKKAM VILLAGE, KANCHEEPURAM DISTRICT, TAMIL NADU-603103 | Incompletete CTD Dossier Submission |
| 871 | Plannor 1.5mg tablet | Levonorgestrel tablets BP 1.5mg | Progestin | SOCIETY FOR FAMILY HEALTH | ACME FORMULATION PVT LTD, Ropar Road Nalagarh, Distt. Solan, Himachal Pradesh â 174101 India | Incompletete CTD Dossier Submission |
| 872 | FAMASTEO TABLETS | Diclofenac Potassium Tablets 50 mg | Non-Steroidal Anti-Inflammatory Drug (NSAID) | BRANDS PHARM AND GENERAL ENTERPRISE | IMPULSE PHARMA PVT. LTD, J-201, J-202/1 MIDC TARAPUR BOISAR DIST-PALGHAR, 401506 MAHARASHTRA STATE INDIA | Incompletete CTD Dossier Submission |
| 873 | Pentazocine Injection | Pentazocine Injection BP 30mg/mL | Opiod Analgesic | DON-J PHARMACY LTD | M/s. Farbe Firma, Plot number 1508, GIDC Estate, Ankleshwar- 393002 | Incompletete CTD Dossier Submission |
| 874 | NOMESARTAN â 50 HCTZ | Losartan Potassium and Hydrochlorothiazide Tablets USP | Antihypertensive | Nomedi Pharmaceuticals Limited | CORAL LABORATORIES LTD.Plot No.57/1 (16), Bhenslore, Dunetha, Nani Daman-396 210, India | Incompletete CTD Dossier Submission |
| 875 | AFROFRANIL | Clomipramine Tablets 25 mg | Antidepressant | ccglobalcure pharmaceutical company limited | AVEO PHARMACEUTICALS PVT. LTD.Plot No C/13, Tarapur, Industrail area, MIDC, Biosar, Dist. Palghar-401506. | Incompletete CTD Dossier Submission |
| 876 | Advumet 1000/50mg | Metformin 1000mg + Vildagliptin 50mg | Antidiabetic | Advantage Pharmaceuticals Limited | Salud Care (India) PVT. Ltd. D-10, Signature II, Sarkhej Sanad Cross Road, Sarkhej, Ahmedabad, Gujarat, India | Incompletete CTD Dossier Submission |
| 877 | MALANTER DS SOFT GEL CAPSULES | ARTEMETHER 80MG, LUMEFANTRINE 480MG | Antimalaria | NKOYO CHEMIST LTD | BRIYOSIS SOFT CAPS PVT. LTDS.R No. 176/1-1, Opp. L K India, Jarod-Rasulabad Road, At & Post: Jarod, Dist: Vadodara. | Incompletete CTD Dossier Submission |
| 878 | Advumet 1000/50mg | Metformin 1000mg + Vildagliptin 50mg | Antidiabetic | Advantage Pharmaceuticals Limited | Salud Care (India) PVT. Ltd. D-10, Signature II, Sarkhej Sanad Cross Road, Sarkhej, Ahmedabad, Gujarat, India | Incompletete CTD Dossier Submission |
| 879 | MALANTER DS SOFT GEL CAPSULES | ARTEMETHER 80MG, LUMEFANTRINE 480MG | Antimalaria | NKOYO CHEMIST LTD | BRIYOSIS SOFT CAPS PVT. LTDS.R No. 176/1-1, Opp. L K India, Jarod-Rasulabad Road, At & Post: Jarod, Dist: Vadodara. | Incompletete CTD Dossier Submission |
| 880 | Artemis Artesunate Injection | Artesunate for Injection (Sterile) | Antimalaria | ARTEMIS LIFE SCIENCES NIGERIA LIMITED | East African (India) Overseas, Unit I â Plot No. 1, Pharmacity, Selaqui, Dehradun-248011 UTTARAKHAND (INDIA) | Incompletete CTD Dossier Submission |
| 881 | IGXIN | POLYMYXIN B FOR INJECTION USP 500,000 UNITS | Antibiotics | IGNITE PHARMA NIGERIA LIMITED | GUFIC BIOSCIENCES LIMITED, UNIT-2, SURVEY NO.171, N.H. NO,8, Nr. GRID, KABILPORE-396424, NAVSARI,GUJARAT, INDIA | Incompletete CTD Dossier Submission |
| 882 | OCUREST-AH EYE DROPS | Phenylephrine Hydrochloride BP | Selective Alpha-1 Adrenegic Receptor Agonist | AL-TINEZ PHARMACEUTICALS LTD | CENTAUR PHARMACEUTICAL PVT. LTD, PLANT -1,PLOT N0 3 TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA,GOA -403 526 INDIA | Incompletete CTD Dossier Submission |
| 883 | GYNOFER TABLET | Tinidazole BP | Imidazole | XCEL PHARMACEUTICAL LTD. | CENTAUR PHARMACEUTICAL PVT. LTD, PLANT -1,PLOT N0 3 TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA,GOA -403 526 INDIA | Incompletete CTD Dossier Submission |
| 884 | EUVRIL | Metronidazole 500MG+ Clotrimazole 100MG + Lactobacillus Pessaries 25MG | Antimicrobial/Imidazole | VIXA PHARMACEUTICALS CO. LTD | SAMRUDH PHARMACARE PVT. LTD, G 16/2 & 3, MIDC, Tarapur, Boisar, Tal. & Dist. Palghar, 401506., India | Incompletete CTD Dossier Submission |
| 885 | FEXONA ARTESUNATE INJECTION 120MG | ARTESUNATE INJECTION | Antimalaria | Fexona Pharmaceutical Co Ltd | Zee Laboratories Ltd, Behind 47, Industrial Area, Paonta Sahib – 173025, Himachal Pradesh, India | Incompletete CTD Dossier Submission |
| 886 | PENTAMAX (Pentazocine Injection BP) | PENTAZOCIN INJECTION BP | Opiod Analgesic | ENVOLVE PHARMACEUTICAL LIMITED | SHUKRA PHARMACEUTICALS LTD, Plot No. 795, Rakanpur Sola-Santej Road, Ta. Kalol, Dist. Gandhinagar Gujarat, India | Incompletete CTD Dossier Submission |
| 887 | Â Â Metamizole Injection 100 mg/mL | Â Metamizole | Non-opiod Analgesic | Allstarbase Pharmaceutical Ltd, Onitsha, Anambra State, Nigeria | discontinue registration of metamizole or dipyrone formulations due to the risks associated with product safety (i.e agranulocytosis) |
