List of Human Medicines
List of Human Medicines
List of Human Medicines
16 TFDA0015/HM/0004 Combillin Ampicillin (As trihydrate ) & Cloxacillin (As Dawa Limited KENYA
sodium)
17 TFDA0015/HM/0048 Rifampicin and Isoniazid tablets Rifampicin + Isoniazid Macleods Pharmaceuticals INDIA
Limited
18 TFDA0015/HM/0148 Square zinc Zinc Sulphate Monohydrate Square Pharmaceuticals Limited Bangladesh
38 TFDA0015/HM/0512 Tasol GM Clobetasol Propionate + Miconazole Nitrate Centaur Pharmaceuticals Private INDIA
+ Gentamicin Sulphate Limited
39 TFDA0015/HM/0515 Sanaxone Plus - 1000 Ceftriaxone Sodium and Sulbactam Sance Laboratories Private INDIA
Sodium Limited
40 TFDA0016/HM/0002 Olopan Eye Drops Olopatadine Hydrochloride BEXIMCO PHARMACEUTICALS Bangladesh
LIMITED
49 TFDA0016/HM/0118 Varodipine Amlodipine Besilate Shin Poong Pharma Co. Ltd KOREA
54 TFDA0016/HM/0165 Prega 150 mg Pregabalin Capsules 150 mg Hetero Laboratories Limited INDIA
55 TFDA0016/HM/0166 Prega 75 mg Pregabalin Capsules 75 mg Hetero Laboratories Limited INDIA
57 TFDA0016/HM/0191 Bacip 200mg/100ml Infusion Ciprofloxacin Lactate USP Surge Laboratories Private PAKISTAN
Limited
62 TFDA0016/HM/0250 Irbis - HT 300/12.5 Irbesartan and Hydrochlorothiazide Tablets Hetero Laboratories Limited INDIA
82 TFDA0016/HM/0523 U-TRYP 100000 I.U Ulinastatin Bharat Serums and Vaccines INDIA
Limited
83 TFDA0016/HM/0541 Co- Arlumether Forte Artemether + Lumefantrine Astra Lifecare (India) Private INDIA
Limited
86 TFDA0016/HM/0583 Gaviscon Double Action Liquid sodium alginate + sodium bicarbonate Reckitt Benckiser Healthcare UK UNITED KINGDOM
Limited
87 TFDA0016/HM/0584 Gaviscon Liquid Sachets Sodium Alginate+Sodium Reckitt Benckiser Healthcare UK UNITED KINGDOM
Bicarbonate+Calcium Carbonate Limited
88 TFDA0016/HM/0586 Gaviscon Double Action Tablets Sodium Alginate+Sodium Reckitt Benckiser Healthcare UK UNITED KINGDOM
Bicarbonate+Calcium Carbonate Limited
90 TFDA0016/HM/0619 Tidact Clindamycin Hydrochloride Y.S.P Industries (M) SDN. BDH MALAYSIA
99 TFDA0017/HM/0020 Endulin VIAL Insulin Glardine (rDNA Origin) 100 IU/ml Mylan Pharmaceuticals Private INDIA
Injection Limited
100 TFDA0017/HM/0073 Bactigen Eye/ear Drops Gentamycin Sulphate FDC Limited INDIA
103 TFDA0017/HM/0103 Folic Acid Folic Acid Coral Laboratories Limited. INDIA
122 TFDA0017/HM/0250 Flutiform Formoterol Fumarate +Fluticasone Napp Pharmaceuticals limited UNITED KINGDOM
Propionate
123 TFDA0017/HM/0251 Flutiform Formoterol Fumarate +Fluticasone Napp Pharmaceuticals limited UNITED KINGDOM
Propionate
124 TFDA0017/HM/0258 Magna-biotic Amoxicillin + Clavulanic acid South Egypt Drug Industries EGYPT
Company
125 TFDA0017/HM/0270 Electral-Z Kit Oral Rehydration Salt/Zinc Sulfate Tablets FDC LIMITED INDIA
128 TFDA0017/HM/0321 Adsorbed Tetanus Vaccine Tetanus Toxoid Serum Institute of India Limited INDIA
139 TFDA0017/HM/0420 THEOFLEX - 500 Cefalexin Monohydrate Theon Pharmaceuticals Limited INDIA
142 TFDA0017/HM/0470 OSTEOTIDE Teriparatide Recombinant Human Virchow Healthcare Private INDIA
Parathyroid Hormone Limited
144 TFDA0017/HM/0474 Debridace Papain USP and Urea USP Virchow Healthcare Private INDIA
Limited
145 TFDA0017/HM/0475 CEFPO - 200 Cefpodoxime OMAN PHARMACEUTICAL OMAN
PRODUCTS Co.LLC
148 TFDA0017/HM/0479 Cefovex 500 Cefuroxime Axetil Oman Pharmaceutical Products SULTANATE OF
Co., LLC OMAN
156 TFDA0017/HM/0571 INFUMOX CV 156.25 Amoxicillin + Clavulanic acid INFUGEN PHARMA PVT. LTD. INDIA
161 TFDA0017/HM/0619 Dolutegravir, Lamivudine & Lamivudine + Tenofovir Disoproxil Aurobindo Pharma Limited Tanzania
Tenofovir Disoproxil Fumarate Fumarate + Dolutegravir
Tablets
162 TFDA0017/HM/0631 NEO-GABA 75 Pregabalin Capsules 75 mg United Pharmaceutical Mfg. Co. JORDAN
Limited
167 TFDA0017/HM/0667 Vemlidy Tenofovir Alafenamide Gilead Sciences, Inc United States of
America
168 TFDA0017/HM/0684 LISOF ledipasvir 90mg/sofosbuvir 400mg Hetero Labs Limited INDIA
173 TFDA0017/HM/0711 BREATHEZY- L (10/5) Montelukast Sodium MSN LABORATORIES PRIVATE INDIA
LIMITED
181 TFDA0017/HM/0735 Gabix 100 Gabapentin Getz Pharma Private Limited PAKISTAN
182 TFDA0017/HM/0736 Gabix 300 Gabapentin Getz Pharma Private Limited PAKISTAN
184 TFDA0017/HM/0746 AZIBERG 500 Azithromycin Dihydrate Sunberg Life Science Private INDIA
Limited
185 TFDA0017/HM/0749 AZIBERG 250 Azithromycin Dihydrate Sunberg Life Science Private INDIA
Limited
186 TFDA0017/HM/0754 Miconax cream Miconazole nitrate ALPHACEUTICALS LIMITED UNITED KINGDOM
194 TFDA0017/HM/0799 IMOX 250 DT Amoxicillin trihydrate IPCA Laboratories Limited INDIA
223 TFDA0018/HM/0049 MANTAZOL CREAM Isoconazole Nitrate + Diflucortolone PharmactiveIlac San.ve Tic.A.S/ TURKEY
Valerate Tekirdag
233 TFDA0018/HM/0098 GYNOGEN HP 75 IU Human menopausal gonadotropin (HMG) SANZYME (P) Limited. INDIA
or Menotrophin 75IU
237 TFDA0018/HM/0107 Zoledronic Acid Amring zoledronic acid AMRING FARMA S.R.L Romania
239 TFDA0018/HM/0122 cetacaf Paracetamol + Caffeine Astra lifecare (India) Private INDIA
Limited
245 TFDA0018/HM/0182 Rabishield - 100 Rabies Human Monoclonal Antibody Serum Institute of India Private INDIA
Limited
251 TFDA0018/HM/0212 Dolutegravir/Lamivudine/Tenofo Dolutegravir Sodium Lamivudine Tenofovir Cipla Ltd INDIA
vir Disoproxil Fumarate Disoproxil Fumarate
262 TFDA0018/HM/0250 Sodium Chloride Injection Sodium Chloride ALPHACEUTICALS LIMITED UNITED KINGDOM
263 TFDA0018/HM/0251 Glucose Injection Anhydrous Glucose ALPHACEUTICALS LIMITED UNITED KINGDOM
269 TFDA0018/HM/0286 VAGID - 100 Clotrimazole Bliss GVS Pharma Limited INDIA
270 TFDA0018/HM/0287 VAGID - 200 Clotrimazole Bliss GVS Pharma Limited INDIA
271 TFDA0018/HM/0288 VAGID 500 Clotrimazole Bliss GVS Pharma Limited INDIA
273 TFDA0018/HM/0298 ONCHOFIN 250 Terbinafine Hydrochloride Aurobindo Pharma Limited INDIA
274 TFDA0018/HM/0307 MALAKANT Sulfadoxine + Pyrimethamine Skant Health care Limited INDIA
275 TFDA0018/HM/0308 MALAKANT JUNIOR Sulfadoxine & Pyrimethamine Skant Health care Limited INDIA
DISPERSIBLE
276 TFDA0018/HM/0311 PACSITA 500 Capecitabine USP Aurobindo Pharma Limited INDIA
285 TFDA0018/HM/0363 Rifampicin 150 mg + Isoniazid 75 Rifampin + Isoniazid + Pyrazinamide + Lupin Limited INDIA
mg + Ethambutol 275 mg + Ethambutol
Pyrazinamide 400 mg
286 TFDA0018/HM/0365 Rifampicin 150 mg + Isoniazid 75 Rifampicin + Isoniazid Lupin Limited INDIA
mg
287 TFDA0018/HM/0374 Salboget Salbutamol Sulphate Getz Pharma (Pvt) Limited PAKISTAN
290 TFDA0018/HM/0383 URSOCOL 150 Ursodeoxycholic Acid Sun Pharmaceuticals Industries INDIA
Limited.
292 TFDA0018/HM/0407 PULMOFIRST 62.5 Bosentan Tablets MSN LABORATORIES PRIVATE INDIA
LIMITED
293 TFDA0018/HM/0410 PULMOFIRST 125 Bosentan Tablets MSN LABORATORIES PRIVATE INDIA
LIMITED
296 TFDA0018/HM/0446 Fungoal Cream Clobetasol Kremoint Pharma Pvt. Ltd INDIA
297 TFDA0018/HM/0457 Emtricitabine and Tenofovir Emtricitabine and Tenofovir Disoproxil Laurus Labs Limited
Disoproxil Fumarate tablets Fumarate
298 TFDA0018/HM/0472 GACET-250 Paracetamol (Acetaminophen) Bliss GVS Pharma Limited INDIA
302 TFDA0018/HM/0485 BUPILIN HEAVY Bupivacaine Hydrochloride Lincoln Pharmaceuticals Limited INDIA
308 TFDA0018/HM/0532 Glycopyrronium Bromide Glycopyrronium bromide Macarthys Laboratories Limited UNITED KINGDOM
T/A Martindale Pharmaceuticals
309 TFDA0018/HM/0536 RABEMAC Rabeprazole SRS Life Sciences Pvt Ltd Singapore
310 TFDA0018/HM/0541 TIVICAY Dolutegravir Sodium GSK Pharmaceuticals Kenya Ltd KENYA
311 TFDA0018/HM/0542 TIVICAY Dolutegravir Sodium GSK Pharmaceuticals Kenya Ltd KENYA
320 TFDA0018/HM- Xtandi Enzalutamide Astellas Pharma( PTY) Limited SOUTH AFRICA
JAP/0628
322 TFDA0018/HM/0672 MICROGYNON ED Levonorgestrel and ethinylestradiol Bayer East Africa Limited KENYA
323 TFDA0018/HM/0681 DARUNAVIR TABLETS 600 MG Darunavir Laurus Labs Limited. INDIA
324 TFDA0018/HM/0682 DARUNAVIR TABLETS 400 MG Darunavir Laurus Labs Limited. INDIA
325 TFDA0018/HM/0683 DARUNAVIR TABLETS 800 MG Darunavir Laurus Labs Limited
333 TFDA0018/HM/0784 AUKETAB Amoxicillin trihydrate & Potassium North China Pharmaceutical CHINA
Clavulanate Co.Limited
338 TFDA0018/HM/0844 STAVANCE 1 Vancomycin Hydrochloride USP Hetero Labs Limited INDIA
339 TFDA0018/HM/0845 STAVANCE 500 Vancomycin Hydrochloride USP Hetero Labs Limited INDIA
340 TFDA0018/HM/0847 Tenofovir Disoproxil Fumarate Tenofovir and Lamivudine Hetero Labs Limited INDIA
and Lamivudine
341 TFDA0018/HM/0870 Efavirenz, Lamivudine & Efavirenz, Lamivudine & Tenofovir Cipla Ltd INDIA
Tenofovir Disoproxil Fumarate Disoproxil Fumarate
Tablets 600/300/300 mg
342 TFDA0018/HM/0871 Efavirenz/Lamivudine/Tenofovir Efavirenz, Lamivudine & Tenofovir Cipla Ltd INDIA
Disoproxil Fumarate Disoproxil Fumarate
600mg/300mg/300mg
343 TFDA0018/HM/0872 Asthamol Salbutamol Sulphate PRINCE PHARMACEUTICALS CO. Tanzania
LTD
345 TFDA0019/HM/0007 Tramadol Denk 200 mg Retard Tramadol Hydrochloride Denk Pharma GmbH & Co. KG GERMANY
346 TFDA0019/HM/0008 Tramadol Denk 100mg Retard Tramadol Hydrochloride Denk Pharma GmbH & Co. KG GERMANY
351 TFDA0019/HM/0208 Dolutegravir, Lamivudine and Dolutegragravir + Emtricitabine + Tenofovir Aurobindo Pharma Limited INDIA
Tenofovir Disoproxil Fumarate Alafenamide
352 TFDA0019/HM/0304 Betaserc 24 Betahistine Dihydrochloride Abbott Laboratories S.A (Pty) Ltd. SOUTH AFRICA