The Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) Notice, 2019

1. This Notice may be cited as the Tanzania Food, Drugs and Cosmetics (List of Registered Medicines) Notice, 2018. Notification of approval

2. The list of registered medicines are as specified in the First, Second and Third Schedules to this Notice. _______ 1 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) SCHEDULES ______ TANZANIA FOOD AND DRUGS AUTHORITY LIST OF REGISTERED HUMAN MEDICINAL PRODUCTS FROM 1 ST JANUARY, 2018 TO 30TH JUNE, 2018 Produc t Streng th Registr ant Country Manufactu rer Dosa ge Form Product Name INN Name s Regis tratio n Num ber Manuf acture r's Count ry Registrant: A. Menarini Industrie Farmaceutiche Riunite S.R.L Fastum Ketoprofen Capsu les 50 mg 1 TAN 00,17 60 M01 A AMI ITALY A.Menarin i Manufactu ring Logistics and Services Registrant: Abacus Pharma Africa Limited 2 TZ 18 H 0115 Verzepa m Diazepam 3 TZ Expen 18 H 0098 Benzyl Penicillin 4 TZ 18 H 0090 5 TZ 18 H 0064 Cloxcin- 500 Cloxacillin Sodium Amoxyn - 500 Amoxycillin 6 TZ 18 H 0102 Fortiwin -4 Procaine Penicillin + Benzyl Penicillin 5 mg/ml Tanzani a 5,000, 000 IU Tanzani a 500 mg Tanzani a 500 mg Tanzani a 4 mega unit Tanzani a VERVE HUMAN CARE LABORA TORIES Reyoung Pharmaceu tical Company Limited Reyoung Pharmaceu tical Company Limited Reyoung Pharmaceu tical Company Limited Reyoung Pharmaceu tical Company Limited Soluti on for injecti on Powd er for soluti on for injecti on Powd er for soluti on for injecti on Capsu les Powd er for soluti on for injecti 2 ITAL Y INDI A CHIN A CHIN A CHIN A CHIN A Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) on INDI A INDI A INDI A INDI A EGYP T EGYP T Registrant: ACME Formulation Private Limited 7 TZ 18 H 0114 Orni - Flox Ofloxacin + Ornidazole Table ts 200 + 500 mg Registrant: Ajanta Pharma Limited INDIA ACME FORMUL ATION PRIVATE LIMITED 8 TZ 18 H 0015 9 TAN 09,08 5 P01B AJA TZ 18 H 0014 1 0 Rosucho l - 10 Rosuvastatin Calcium Artefan Artemether + Lumefantrine Table ts Table ts 10 mg 20 mg + 120 mg INDIA Ajanta Pharma Limited INDIA Ajanta Pharma Limited Rosucho l - 20 Rosuvastatin Table ts 20 mg INDIA Ajanta Pharma Limited Registrant: Amoun Pharmaceutical Industries Company S. A. E 1 1 1 2 TAN 00,24 73 M03 B AMO TAN 00,24 75 A11A AMO Roysan Tizanidine Haema Caps Ferrous fumerate equivalent to Iron BP + Folic Acid BP + Cyanocobalam in USP + Ascorbic Acid USP + Zinc Sulphate BP 4 mg EGYPT Amoun Pharmaceu tical Industries Company EGYPT Amoun Pharmaceu tical Industries Company 75 mg + 350 mg + 5 mg + 25 mg + 10 mg + 50 mg + 2 mg + 25 mg + 15 mg + 75 mg + 2 mg + 400 IU + 200 mg + 45 mg Table ts Capsu les, hard 3 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) + 15 mg 1 3 TAN 00,24 73 M03 B AMO Roysan Tizanidine Table ts 4 mg EGYPT Amoun Pharmaceu tical Industries Company EGYP T Registrant: Artemis Life Sciences 1 4 TZ 18 H 0097 ERTI 250 Erythromycin Stearate eq to Erythromycin Table ts 250 mg U.A.E S Kant Healthcare Limited INDI A Registrant: Astellas Pharma Proprietary Limited 1 5 TZ 18 H 0117 Mycami ne 100 Micafungin 1 6 TZ 18 H 0126 Mycami ne 50 Micafungin Soluti on For Infuss ion Soluti on For Infuss ion 100 mg 50 mg SOUT H AFRIC A SOUT H AFRIC A Astellas Pharma Tech Co. Ltd. Astellas Pharma Tech Co. Ltd. Registrant: Astra Lifecare (India) Private Limited 1 9 TZ 18 H 0003 Aspiclox Ampicillin + Cloxacillin Capsu les 250 + 250 mg 2 0 TZ 18 H 0021 Karvid

6.25 mg INDIA Astra Lifecare (India) Private Limited INDIA Astra lifecare (India) Private Limited INDIA Astra Lifecare (India) Private Limited IREL AND IREL AND INDI A INDI A INDI A 4 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Registrant: AstraZeneca United Kingdom Limited 2 2 2 3 TAN 00,22 94 A02B AST TAN 00,22 93 A02B AST Nexium Esomeprazole Magnesium Table ts 20mg Nexium Esomeprazole Table ts 40mg AstraZene ca AB. SWE DEN AstraZene ca AB. SWE DEN UNITE D KINGD OM UNITE D KINGD OM Registrant: ATCO Laboratories Limited 2 4 TZ 18 H 0009 Proloxin Ciprofloxacin Hydrochloride Registrant: Aurobindo Pharma Limited 2 5 TZ13 H046 Drox 250 Cefadroxil 2 6 2 7 2 8 TZ 18 H 0103 TZ 18 H 0031 TZ 18 H 0030 Glimsure 4 Glimsure 2 Glimsure 3 Glimepiride Glimepiride Glimepiride Ear/E ye Drops Powd er for Oral suspe nsion Table ts Table ts Table ts Registrant: Auronext Pharma Private Limited 2 9 TZ 18 H 0096 3 0 TZ 18 H 0096 Ertapik Ertapenem Monosodium Ertapik Ertapenem Monosodium Powd er for soluti on for injecti on Powd er for soluti on for injecti on 3 mg/ml PAKIS TAN ATCO Laboratori es Limited PAKI STAN 250mg /5ml INDIA Aurobindo Pharma Limited 4 mg INDIA Aurobindo Pharma Limited 2 mg INDIA Aurobindo Pharma Limited 3 mg INDIA Aurobindo Pharma Limited 1 g INDIA Auronext Pharma Private Limited 1 g INDIA Auronext Pharma Private Limited INDI A INDI A INDI A INDI A INDI A INDI A Registrant: Bafna Pharmaceuticals Limited 3 1 TZ 18 H 0049 Rosufast - 20 Rosuvastatin 20 mg INDIA Bafna Pharmaceu ticals INDI A Table t, Film- 5 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) coate d Limited Registrant: Beta Pharmaceuticals Limited Paraceta mol Paracetamol Soluti on 120 mg/5m l 3 2 TAN 00,13 57 A02A BET UNITE D KINGD OM Bell Sons & Company (Drugists) Limited UNIT ED KING DOM Registrant: Bharat Serums and Vaccines Limited 3 3 TZ 18 H 0018 3 4 TZ 18 H 0017 Endopro st Carboprost Tromethamine Inject ion 125 mcg INDIA Endopro st Carboprost Tromethamine Inject ion 250 mcg INDIA Registrant: Brookes Pharma Private Limited 3 5 TZ13 H161 Oxoferin Tetrachlorodec aoxide Soluti on

37.5/3 25 mg INDIA Registrant: Cadila Healthcare Limited Zolan 5 Zolmitriptan TRAMA ZAC P Tramadol + Paracetamol Catenol Atenolol Table ts Table t, Film- coate d Table ts 3 6 3 7 3 8 TZ 18 H 0120 TZ 18 H 0055 TAN 00,64 5 C01C CAH Registrant: Cadila Pharmaceuticals Limited 50 mg INDIA Cadila Healthcare Limited INDI A 3 9 TZ13 H043 Teli 80 Telmisartan 80mg INDIA INDI A Cadila Pharmaceu ticals Limited Table ts 6 Bharat Serums and Vaccines Limited Bharat Serums and Vaccines Limited Brookes Pharmaceu ticals Laboratori es (Pakistan) Limited Cadila Healthcare Limited Cadila Healthcare Limited INDI A INDI A PAKI STAN INDI A INDI A Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 4 0 TZ13 H042 Teli 40 Telmisartan 4 1 TZ13 H073 Teli H Telmisartan and Hydrochlorothi azide Registrant: Cipla Limited Table ts Table ts 40mg INDIA INDIA 40mg +

12.5m g 4 2 4 3 4 4 4 5 TZ 18 H 0094 TZ 18 H 0101 TZ13 H030 TZ 18 H 0042 Dolutegr avir Sodium Foracort 400 inhaler Efavir 600 Caspogi n 70 Dolutegravir Sodium Table ts 50 mg INDIA Formoterol + Budesonide Efavirenz Caspofungin 6 + 400 mcg/d ose 600mg INDIA INDIA 70 mg INDIA Aeros ol Inhale r Table ts Powd er for soluti on for injecti on Registrant: Cosmos Limited Cadila Pharmaceu ticals Limited Cadila Pharmaceu ticals Limited Cipla Limited Cipla Limited Cipla Limited Cipla Limited (Unit IX) INDI A INDI A INDI A INDI A INDI A INDI A Nycostat Nystatin Suspe nsion, Oral 10000 0 IU/ml KENY A Cosmos Limited KEN YA Painotab Caffeine + Paracetamol Caple ts 30 mg + 650 mg KENY A Cosmos Limited KEN YA Phenoba rbital Phenobarbital Table ts 30 mg KENY A Cosmos Limited KEN YA Salbut Salbutamol Table ts 4 mg KENY A Cosmos Limited KEN YA 4 6 4 7 4 8 4 9 TAN 00,13 80 D01A COS TAN 00,23 16 N02B COS TAN 00,13 78 N03A COS TAN 00,13 82 C06A COS Registrant: Dawa Limited 5 0 TZ 18 H 0125 Oracef Cefalexin Monohydrate Capsu les, hard 7 250 mg KENY A Dawa Limited KEN YA Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Registrant: Elys Chemical Industries Limited 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 TAN 00,17 95 D01A ELY TAN 00,17 97 C03C ELY TAN 00,18 00 R05A ELY TAN 00,17 94 A03B ELY TAN 00,23 29 A02A ELY TAN 00,17 96 D07A ELY TAN 00,17 78 D07A ELY TAN 00,14 00 P02X ELY TAN 00,13 98 J03B ELY Fungista t Miconazole Crea m 2 %w/w KENY A Frusemi de Frusemide Table ts 40 mg KENY A Cold Flu Caffeine + Chlorpheniram ine + Paracetamol + Phenylephrine Hyoscine Capsu les Table ts KENY A 400 mg + 30 mg + 4 mg + 5 mg 10 mg KENY A Bukol Alugel Elyvate Suspe nsion, Oral Oxethazaine BP + Dried Aluminium Hydroxide USP + Magnesium Hdrochloride USP Betamethasone Crea m KENY A 250 mg/5m l + 120 mg/5m l

0.1 %w/w KENY A Elycort Hydrocortisone Crea m 1 % w/w KENY A Alprim Sulfamethoxaz ole+Trimethop rim Table ts 400 mg + 80 mg KENY A Alprim Sulfamethoxaz ole+Trimethop rim Suspe nsion, Oral KENY A 200 mg/5m l + 40 mg/5m l 8 KEN YA KEN YA KEN YA KEN YA KEN YA KEN YA KEN YA KEN YA KEN YA Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 6 0 6 1 6 2 6 3 6 4 6 5 6 6 6 7 6 8 TAN 00,19 75 R03A ELY TAN 00,18 01 D07A ELY TAN 00,17 84 N02B ELY TAN 00,17 80 H02A ELY TAN 00,19 76 D04A ELY TAN 00,13 99 A07A ELY TAN 00,17 93 D07X ELY TAN 00,17 91 M01 A ELY TAN 00,19 71 A11E ELY Ventosal Salbutamol Table ts 4 mg KENY A Elyvate Betamethasone Crea m 01 % w/w KENY A Elymol Paracetamol Table ts 500 mg KENY A Predniso lone Prednisolone Table ts 5 mg KENY A CIPI-M Chlorpheniram ine Table ts 4 mg KENY A Lyfe Elyclob G Glucose Anhydrous BP + Sodium Chloride BP + Potassium Chloride BP + Sodium Citrate Dihydrate BP Beclomethason e + Clotrimazole + Gentamycin Ibufen Ibuprofen KENY A Powd er for Oral soluti on 135 g + 26 g + 15 g + 29 g Crea m Table ts

0.025 % w/w + 1 %w/w + 0.2 % w/w 200 mg KENY A KENY A KENY A Vitamin B Complex Thiamine + Riboflavine + Nicotinamide Table ts 11 mg + 115 mg + 165 mg 9 KEN YA KEN YA KEN YA KEN YA KEN YA KEN YA KEN YA KEN YA KEN YA Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 6 9 7 0 7 1 7 2 7 3 7 4 TAN 00,15 84 J01F ELY TAN 00,17 77 P01X ELY TAN 00,17 86 P01A ELY TAN 00,17 83 P02X ELY TAN 00,19 73 P02X ELY TAN 00,17 98 J01F ELY Elocin dry syrup Erythromycin Syrup 125mg /5 ml KENY A Elyzole Albendazole Table ts 200 mg KENY A Elogyl Metronidazole Table ts 200 mg KENY A Elyzole Albendazole Suspe nsion, Oral 200 mg/5m l KENY A Vumtrex Levamisole Table ts 40 mg KENY A Elocin Erythromycin Table ts 25 mg KENY A Elys Chemical Industries Limited Elys Chemical Industries Limited Elys Chemical Industries Limited ELYS CHEMIC AL INDUSTR IES LTD Elys Chemical Industries Limited Elys Chemical Industries Limited Registrant: Emcure Pharmaceutical Limited 7 5 TZ 18 H 0050 7 6 7 7 TAN 00,25 59 A11J HAR TAN 00,25 55 B03A EMC Instgra Dolutegravir Sodium Caloshel l Calcium + Cholecalciferol Orofer Iron (III) Hydroxide Polymatose Complex Table t, Film- coate d Table ts Syrup 10 50 mg INDIA INDIA INDIA 1250 mg + 250 IU 50 mg/5m l Emcure Pharmaceu ticals Limited Emcure Pharmaceu ticals Limited Emcure Pharmaceu ticals Limited KEN YA KEN YA KEN YA KEN YA KEN YA KEN YA INDI A INDI A INDI A Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Registrant: Esapharma s.r.l. 7 8 7 9 TZ 18 H 0129 TZ 18 H 0109 Oranvate Gel Clobetasol Propionate Lemonv ate Cream Clobetasol Propionate Gel Gel

0.5 mg/g ITALY Esapharma s.r.l. ITAL Y ITALY Esapharma s.r.l. ITAL Y Registrant: Eva Pharma for Pharmaceuticals and Medical Appliances 8 0 TZ 18 H 0065 Virecta 100 mg Sildenafil Citrate Table ts 100mg EGYPT Eva EGYP T SWIT ZERL AND SWIT ZERL AND FRAN CE Pharma for Pharmaceu ticals and Medical Appliances F.Hoffman -La Roche Ltd. F.Hoffman -La Roche Limited Galenical Bulk Production F.Hoffman -La Roche Limited CENEXI S.A.S SWIT ZERL AND FRAN CE Registrant: F.Hoffman-La Roche Limited Mabther a SC Mabther a SC Dormicu m Hercepti n Dormicu m Rituximab Rituximab Midazolam Trastuzumab Midazolam 8 1 8 2 8 3 8 4 8 5 TZ 18 H 0111 TZ 18 H 0112 TAN 08,00 6 N04B F.H TZ13 H064 TAN 08,00 7 N04B F.H Inject ion Inject ion Soluti on for injecti on Powd er Soluti on for injecti on 1600 mg 1400 mg 50mg/ 10ml SWITZ ERLA ND Tanzani a SWITZ ERLA ND 150mg SWITZ ERLA ND SWITZ ERLA ND 15mg/ 3ml Registrant: FDC Limited 8 6 8 7 8 8 TAN 00,14 10 S01A FDC TZ 18 H 0107 TZ 18 H 0107 Pyricort Dexamethason e + Gentamycin Eye Drops

0.1%w /v INDIA FDC Limited INDI A Lanatopr ost Eye Drops Lanatopr ost Eye Drops Latanoprost Soluti on

0.005 %w/v INDIA FDC Limited FDC Limited INDI A INDI A Registrant: Galentic Pharma (India) Private Limited 11 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Netravir eye ointment 8 9 TAN 00,41 06 S01D GAL Acyclovir Oint ment 30 mg/g INDIA Galentic Pharma (India) Pvt, Ltd. INDI A Registrant: Getz Pharma Private Limited 9 0 TZ 18 H 0047 SOLIFE N Solifenacin Succinate Table ts 5 mg PAKIS TAN Registrant: GlaxoSmithKline Pharmaceutical Kenya Limited 9 1 9 2 9 3 9 4 9 5 TAN 00,10 77 D07A GLA TAN 08,05 9 J01D GSK TAN 08,05 9 J01D GSK TAN 08,05 8 J01D GSK TAN 00,34 8 J01C SKB Betnovat e cream Betamethasone Crea m

0.1 %w/w KENY A Proxime xa Cefuroxime Suspe nsion, Oral 125 mg/5m l KENY A Proxime xa Cefuroxime Suspe nsion, Oral 125 mg/5m l KENY A Proxime xa Cefuroxime Suspe nsion, Oral 250 mg/ml KENY A Augment in Amoxicillin + Clavulanate Table ts KENY A 500 mg + 125 mg Getz Pharma Private Limited GlaxoSmit hkline Operations (UK) Limited GlaxoSmit hkline Operations (UK) Limited GlaxoSmit hkline Operations (UK) Limited GlaxoSmit hkline Operations (UK) Limited GlaxoSmit hKline Limited Registrant: Glenmark Pharmaceuticals Limited 9 6 TZ13 H071 Ibicar Beclomethason e Inhale r 200Mc g Registrant: Guilin Pharmaceutical Shanghai Co. Limited 9 7 TZ 18 H 0104 Gucefor Cefuroxime Sodium 750 mg Powd er for soluti on for injecti on 12 INDIA Glenmark Pharmaceu ticals Limited CHINA Reyoung Pharmaceu tical Company Limited PAKI STAN UNIT ED KING DOM UNIT ED KING DOM UNIT ED KING DOM UNIT ED KING DOM UNIT ED KING DOM INDI A CHIN A Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 9 8 TZ 18 H 0048 Zathenza Benzathine Penicillin

2.4 MIU Powd er for soluti on for injecti on Registrant: Guilin Pharmaceuticals Company Limited 9 9 TZ 18 H 0004 G - Cospe Sulfadoxine + Pyrimethamine Table ts 500 + 25 mg CHINA Reyoung Pharmaceu tical Company Limited GUILIN PHARMA CEUTICA L COMPAN Y Limited Registrant: Hastand Export Marketing Private Limited Betacort N Betamethasone + Neomycin Crea m 1 0 0 TAN 00,21 2 D07C AUR 0064 %w/w + 05 % w/w INDIA Aurochem Pharmaceu ticals (I) Pvt. Limited Registrant: Hebei Oriental Pharma Import and Export Corporation 1 0 1 TZ 18 H 0085 Baceftri Ceftriaxone Sodium 1 0 2 TZ 18 H 0084 BA- WATER Sterilized Water for Injection 1 0 3 TZ 18 H 0083 BA- WATER Sterilized Water for Injection Powd er for soluti on for injecti on Soluti on Inject ion 1 g CHINA Reyoung Pharmaceu tical Company Limited 5 ml CHINA Shijiazhua ng No.4 Pharmaceu tical Co. Limited 10 ml CHINA Shijiazhua 1 0 4 TZ 18 H 0082 Ba-DNS Glucose + Sodium Chloride Inject ion

0.9 + 5 % Registrant: Hetero Laboratories Limited Alzer 5 Donepezil Hydrochloride Table ts 5 mg INDIA Hetero 1 0 5 1 0 6 TZ 18 H 0072 TZ 18 H 0091 Darunavi r Darunavir Table ts 400 mg 13 ng No.4 Pharmaceu tical Co. Limited CHINA Shijiazhua ng No.4 Pharmaceu tical Co. Limited Labs Limited (UNIT V) INDIA Hetero Labs Limited CHIN A CHIN A INDI A CHIN A CHIN A CHIN A CHIN A INDI A INDI A Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Registrant: Hetero Labs Limited TZ 18 H 0093 Dolutegr avir 1 0 7 Registrant: Hovid Bhd Dolutegravir Sodium Table ts 50 mg INDIA Hetero Labs Limited INDI A TZ13 H041 1 0 8 Registrant: Immacule Lifesciences Private Limited Tramadol Hydrochloride Pengesic SR Tablet Table ts 100mg MALA YSIA Hovid Bhd MAL AYSI A Imreb Rabeprazole 1 0 9 TZ 18 H 0010 Lyop hilize d Inject ion 20 mg INDIA Immacule Lifescienc es Private Limited Registrant: Indchemie Health Specialities Private Limited 1 1 0 TZ 18 H 0011 Zenoxim - 500 Cefuroxime Axetil Table ts 500 mg INDIA Alkem Laboratori es Limited Registrant: Indi Pharma Private Limited Clincin Clindamycin Gel 1% w/v INDIA 1 1 1 TAN 07,31 1 J01F IND Registrant: Indoco Remedies Limited Cloben Beclomethason e + Clotrimazole Crea m ATM 200 Nosic Azithromycin Doxylamine + Pyridoxine Suspe nsion, Oral Table ts Flamar- mx Diclofenac + Chlorzoxazone + Paracetamol Table ts INDIA INDIA INDIA INDIA

0.025 % w/w + 1 %w/w 200 mg/5 ml 10 mg + 10 mg 50 mg + 250 mg + 325 mg 1 1 2 1 1 3 1 1 4 1 1 5 1 1 6 TAN 00,24 57 D01A IND TZ13 H154 TAN 00,23 44 A04A IND TAN 00,23 49 M01 A IND TZ 18 H 0113 Metchek 850 Metformin Hydrochloride Table ts 850 mg INDIA Indoco Remedies Limited INDI A 14 INDI A INDI A INDI A INDI A INDI A INDI A INDI A Indi Pharma Private Limited Indoco Remedies Limited (Plant I) Indoco Remedies Limited Indoco Remedies Limited (Plant I) Indoco Remedies Limited (Plant I) Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) Table ts 40/12. 5 mg INDIA GN. NO. 21 (Contd) TZ13 H054 1 1 7 Flamgen Methyl Salicylate + Mephenesin + Methyl Nicotinate Registrant: Intas Pharmaceuticals Limited 1 1 8 1 1 9 1 2 0 1 2 1 1 2 2 TZ 18 H 0061 TZ 18 H 0060 Rovas 5 Rosuvastatin Rovas 10 Rosuvastatin TZ13 H020 Sartel- 40H TZ 18 H 0059 Rovas 20 Telmisartan and Hydrochlorothi azide Rosuvastatin Heligo kit Clarithromycin + Lansoprazole + Tinidazole TAN 00,21 54 A02B INT Registrant: IPCA Laboratories Limited TZ 18 H 0008 Rapiclav 250 DT TZ13 H025 Lumerax 80/480 1 2 3 1 2 4 Amoxicillin and Clavulanate Potassium Artemether and lumefantrine Crea m Table ts Table ts Table t, Film- coate d Table ts Table ts Table ts Registrant: Laboratories and Allied Limited Kemoxyl Amoxicillin trihydrate Letrax Levamisole 1 2 5 1 2 6 TAN 00,41 28 J01H LAB TAN 00,41 29 Powd er for Oral soluti on Table ts 15 INDIA INDI A Indoco Remedies Limited (Plant I) 8% w/w + 5% w/w + 1% w/w + 2% w/w 5 mg INDIA 10 mg INDIA 20 mg INDIA INDIA INDIA INDIA 250 mg + 30 mg + 500 mg 250 +

62.5 mg 80mg + 480mg 125 mg/5m l KENY A 40 mg KENY A Intas Pharmaceu ticals Limited Intas Pharmaceu ticals Limited Intas Pharmaceu ticals Limited Intas Pharmaceu ticals LIMITED Intas Pharmaceu ticals Limited IPCA Laboratori es Limited IPCA Laboratori es Limited Laboratori es and Allied Limited Laboratori es and Allied INDI A INDI A INDI A INDI A INDI A INDI A INDI A KEN YA KEN YA Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) P02X LAB TAN 00,26 20 P02X PHD TZ13 H072 1 2 7 1 2 8 Natoa Mebendazole Suspe nsion, Oral 100 mg/5m l KENY A Ferrolic - LF Tablets Albendazole Table ts KENY A 200mg +

0.40m g Registrant: Lincoln Pharmaceuticals Limited Vivian Diclofenac Table ts 50 mg INDIA Dermofu lvin Griseofulvin Table ts 500 mg INDIA TINI- 500 Tinidazole Table ts 500 mg INDIA LCT Kit VAST- 10 Lansoprazole 30mg + Tinidazole 500mg + Clarithromycin 250mg Atorvastatin Calcium Table ts Table ts INDIA 30 + 250 + 500 mg 10 mg INDIA Clotrilin V Clotrimazole Crea m 2 %w/w INDIA VAST- 20 Atorvastatin Calcium Table ts 20 mg INDIA Teterous Tetracycline Capsu les 250 mg INDIA 1 2 9 1 3 0 1 3 1 1 3 2 1 3 3 1 3 4 1 3 5 1 3 6 TAN 00,20 01 N02B LIN TAN 00,20 00 J03C LIN TZ 18 H 0119 TZ 18 H 0108 TZ 18 H 0127 TAN 00,19 98 D01A LIN TZ 18 H 0025 TAN 00,19 99 J01A Limited Laboratori es and Allied Limited Laboratori es and Allied Limited Lincoln Pharmaceu ticals Limited Lincoln Pharmaceu ticals Limited Lincoln Pharmaceu ticals Limited Lincoln Pharmaceu ticals Ltd Lincoln Pharmaceu ticals Limited Lincoln Pharmaceu ticals Limited Lincoln Pharmaceu ticals Limited Lincoln Pharmaceu ticals Limited KEN YA KEN YA INDI A INDI A INDI A INDI A INDI A INDI A INDI A INDI A 16 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) LIN TZ 18 H 0052 TAN 00,41 36 J03C LIN TZ 18 H 0051 TZ 18 H 0106 1 3 7 1 3 8 1 3 9 1 4 0 Timolin Timolol Maleate Norzole Norfloxacin + Tinidazole Ophth almic Soluti on Table ts

0.5 %w/v INDIA INDIA 400 mg + 600 mg Binafin Terbinafine Hydrochloride Crea m 1% INDIA KLARO -500 Clarithromycin Table ts 500 mg INDIA Lincoln Parenteral Limited Lincoln Pharmaceu ticals Limited Lincoln Pharmaceu ticals Limited Lincoln Pharmaceu ticals Limited Registrant: M.J. Biopharm Private Limited Azyth Cefepime 1 4 1 1 4 2 TZ13 H053 Teico- 1000 TZ 18 H 0128 Azithromycin Dihydrate Capsu les, hard Powd er for soluti on for injecti on Powd er for soluti on for injecti on Registrant: Macleods Pharmaceuticals Limited TZ 18 H 0066 Teico- 500 Cefepime 1 4 3 250 mg 1000m g INDIA M.J Biopharm Limited INDIA M.J Biopharm Limited 500mg INDIA M.J Biopharm Limited 1 4 4 1 4 5 TZ 18 H 0056 TZ 18 H 0038 Isoniazid Isoniazid Table ts 300 mg Febumac 80 Febuxostat Table ts 80 mg Registrant: Medley Pharmaceuticals Limited INDIA Macleods Pharmaceu ticals Limited INDIA Macleods Pharmaceu ticals Limited 17 INDI A INDI A INDI A INDI A INDI A INDI A INDI A INDI A INDI A Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) TZ13 H013 Motinor m 1 4 6 Domperidone Syrup Registrant: Medopharm Private Limited 1 4 7 TZ 18 H 0089 Cledomo x 625 Table t, Film- coate d 5 mg/5m l INDIA Medley Pharmaceu ticals Limited INDI A 500 + 125 mg INDIA Medophar m Private Limited INDI A Registrant: Mega Lifesciences (Australia) Proprietary Company Limited 1 4 8 1 4 9 1 5 0 1 5 1 1 5 2 TZ13 H045 Ligaba 150 Pregabalin Capsu les 150mg AUSTR ALIA TZ13 H044 Ligaba 75 Pregabalin Capsu les 75mg AUSTR ALIA TZ 18 H 0012 TZ13 H100 PANFO R SR- 1000 Metformin Hydrochloride Table ts 1000 mg AUSTR ALIA CILZEC Telmisartan Table ts 80mg AUSTR ALIA TZ13 H111 Cilzec Plus Telmisartan Table ts 40mg/

12.5m g AUSTR ALIA INDI A INDI A INDI A INDI A INDI A MSN Laboratori es Private Limited (Formulati ons Division), MSN Laboratori es Private Limited (Formulati ons Division), Inventia Healthcare Private Limited MSN Laboratori es Private Limited (Formulati ons division) MSN Laboratori es Private Limited (Formulati ons division) 18 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 1 5 3 1 5 4 TZ13 H110 Kipel 5 Montelukast Table ts 5mg AUSTR ALIA TZ13 H109 Kipel 4 Montelukast 4 mg AUSTR ALIA Table ts, Chew able INDI A INDI A MSN Laboratori es Private Limited (Formulati ons division) MSN Laboratori es Private Limited (Formulati ons division) Registrant: Mega Lifesciences Public Company Limited 19 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) TZ13 H004 1 5 5 Prenatal Multivitamins and trace elements Capsu les, soft 20 THAIL AND THAI LAN D Mega Lifescienc es Public Company Limited Vitami n A Palmit ate 4,000. 00 IU, Vitami n D3

400.00 IU, Vitami n B1 (Thia mine Mono nitrate ) 2.00 mg, Vitami n B2 (Ribof lavin)

10.00 mg, Vitami n B6 (Pyrid oxine Hydro chlorid e) 2.00 mg, Calciu m Pantot henate

0.25 mg, Vitami n C (Ascor bic Acid) Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd)

100.00 mg, Vitami n E (Toco pheryl Acetat e)

20.00 mg, Coppe r (as Coppe r Sulpha te) 0.5 mg, Iodine (as Potassi um Iodide ) 0.05 mg, Magne sium (as Magne sium Sulpha te)

1.00 mg, 21 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Manga nese (as Manga nese Sulpha te)

0.10 mg, Potassi um (as Potassi um Sulpha te)

0.05m g, Zinc (as Zinc Sulpha te) monoh ydrate

0.15 mg Registrant: Merck Proprietary Limited TZ13 H177 Glucoph age Metformin Hydrochloride Table ts 1000 mg TZ13 H137 Glucoph age Metformin Hydrochloride Table ts 500 mg 1 5 6 1 5 7 Merck Sante s.a.s. FRAN CE Merck Sante s.a.s. FRAN CE SOUT H AFRIC A SOUT H AFRIC A Registrant: Moraf Pharmaceuticals LTD 22 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 1 5 8 TZ 18 H 0028 1 5 9 TZ 18 H 0027 AMLOB ERG 10 Amlodipine Besylate Table ts 10 mg Tanzani a AMLOB ERG 5 Amlodipine Besylate Table ts 5 mg Tanzani a Registrant: MSD (Pty) Limited 1 6 0 1 6 1 TAN 00,25 56 R06A ESS TZ 18 H 0118 Aerius Desloratadine Table ts 5 mg Singulair 4 mg Montelukast Sodium Granu les 4 mg SOUT H AFRIC A SOUT H AFRIC A Registrant: MSN Laboratories Private Limited (Formulations division) THE MADRAS PHARMA CEUTICA LS THE MADRAS PHARMA CEUTICA LS Schering Plough Laboratori es N.V MSD (Pty) Limited 1 6 2 TZ 18 H 0026 Dapoxe m 60 Dapoxetine Hydrochloride Table ts TZ13 H181 Breathez y 10 Montelukast Table ts TZ13 H117 Pregasaf e Pregabalin Capsu les 1 6 3 1 6 4 60 mg INDIA MSN Laboratori es Private Limited (Formulati ons Division), 10mg INDIA MSN Laboratori es Private Limited (Formulati ons Division), 75 mg INDIA MSN Laboratori es Private Limited (Formulati ons Division), INDI A INDI A BELG IUM SOUT H AFRI CA INDI A INDI A INDI A Registrant: Mylan Laboratories Limited 23 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 1 6 5 1 6 6 1 6 7 1 6 8 1 6 9 1 7 0 TAN 08,01 3 J05A MAT TAN 08,01 2 J05A MAT TAN 08,00 9 J05A MAT TAN 08,01 6 J05A MAT TAN 08,01 1 J05A MAT TAN 08,01 0 J05A MAT Lopinavi r/Ritona vir Lopinavir + Ritonavir Table ts 200mg + 150mg INDIA Mylan Laboratori es Limited Abacavir Sulphate Abacavir Sulfate Table ts 300mg INDIA Mylan Laboratori es Limited Tenofovir + Emtricitabine Table ts 300mg + 200mg INDIA Mylan Laboratori es Limited Nevirapine Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Fumarate + Lamivudine Table ts Table ts 200mg INDIA Mylan Laboratori es Limited 300mg INDIA Mylan Laboratori es Limited Table ts 300mg +300m g INDIA Mylan Laboratori es Limited Tenofovi r Disoprox il Fumarat e/ Emtricita bine Nevirapi ne Tenofovi r Disoprox il Fumarat e Tenofovi r Disoprox il Fumarat e/ Lamivud ine Registrant: Napp Pharmaceuticals limited 1 7 1 TZ 18 H 0100 Flutifor m Formoterol and fluticasone Inhale r 250/10 mcg Registrant: Naprod Life Sciences Pvt Limited. Fisons Limited UNITE D KINGD OM TZ13 H019 1 7 2 4 - Epeedo - 50 Epirubicin Registrant: Nectar Lifesciences Limited Lyop hilize d Inject ion 24 50 mg INDIA Naprod Life Sciences Private Limited INDI A INDI A INDI A INDI A INDI A INDI A UNIT ED KING DOM INDI A Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 1 7 3 TZ 18 H 0013 FIXINE CT 400 Cefixime Table ts 100 mg/5m l INDIA Nectar Lifescienc es Limited - UNIT VI Registrant: Novo Nordisk Production S.A.S INDI A DEN MAR K DEN MAR K DEN MAR K DEN MAR K DEN MAR K DEN MAR K GER MAN Y 100 IU/ml FRAN CE 100 IU/ml FRAN CE 100 units/ ml 100 units/ ml FRAN CE FRAN CE 100 IU/ml FRAN CE 100 IU/ml FRAN CE 200 g/L SWITZ ERLA ND Novo Nordisk A/S Novo Nordisk A/S Novo Nordisk A/S Novo Nordisk A/S Novo Nordisk A/S Novo Nordisk A/S Octapharm a Production sgesellscha ft Deutschlan d mbH 10 g INDIA Panacea Biotech Limited INDI A 1 7 4 TZ 18 H 0131 Human Insulin - Insultard Human Insulin 1 7 5 TZ 18 H 0130 Human Insulin - Actrapid Human Insulin 1 7 6 TZ 18 H 0135 1 7 7 TZ 18 H 0134 1 7 8 TZ 18 H 0133 1 7 9 TZ 18 H 0132 Human Insulin - NovoRa pid FlexPen NovoMi x 30 FlexPen Human Insulin - Mixtard 30 Human Insulin - Levemir Flexpen Insulin aspart Insulin aspart Human Insulin Insulin Detemir Registrant: Octapharma AG 1 8 0 TZ 18 H 0079 Albunor m 20 Albumin Registrant: Panacea Biotec Limited Livoluk Lactulose TZ13 H114 1 8 1 Registrant: Pfizer Laboratories Limited Suspe nsion for injecti on Suspe nsion for injecti on Soluti on for injecti on Suspe nsion for injecti on Suspe nsion for injecti on Soluti on for injecti on Soluti on for injecti on Soluti on, Oral 25 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Lipitor Atorvastatin Table ts 10mg KENY A 1 8 2 TAN 00,93 0 B04A WAR Registrant: Pharmed Limited 1 8 3 TZ 18 H 0123 1 8 4 TZ 18 H 0123 Synezze Cetirizine hydrochloride Soluti on Synezze Cetirizine hydrochloride Soluti on 5 mg/5m l 5 mg/5m l Tanzani a Tanzani a Registrant: Reckitt Benckiser Healthcare UK Limited 1 8 5 TZ 18 H 0039 Nurofen Cold & Flu Ibuprofen + Pseudoephedri ne Table ts 230 mg 1 8 6 TZ 18 H 0037 1 8 7 TZ 18 H 0032 nurofen Ibuprofen Capsu les, soft 400 mg nurofen Ibuprofen Table ts 400 mg UNITE D KINGD OM UNITE D KINGD OM UNITE D KINGD OM Pfizer manufactur ing Deutschlan d GmbH Aurochem Laboratori es India Private Limited Aurochem Laboratori es India Private Limited Reckitt Benckiser Healthcare Internation al Limited Reckitt Benckiser Healthcare Internation al Limited Reckitt Benckiser Healthcare Internation al Limited GER MAN Y INDI A INDI A UNIT ED KING DOM UNIT ED KING DOM UNIT ED KING DOM Registrant: Remedica Limited Alopron Allopurinol Table ts 300 mg CYPR US Remedica Limited CYPR US 1 8 8 TAN 00,26 32 G04B REM Registrant: Rena Exports 1 8 9 TZ 18 H 0122 Triaf - Inj 1g Ceftriaxone 1 g INDIA CHIN A REYOUN G PHARMA CEUTICA L CO., LIMITED Powd er for soluti on for injecti on 26 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Registrant: Riva Pharma S.A.E Rivaclox Ampicillin + Cloxacillin Suspe nsion, Oral 1 9 0 TAN 00,26 37 J01C RIP Registrant: Rotexmedica GmbH Arzneimittelwerk Oxytocin Oxytocin TZ13 H065 1 9 1 Registrant: S K Age Exports Soluti on for injecti on 125 mg/5m l + 125 mg/5m l 5 Units / ml EGYPT Riva Pharma S.A.E EGYP T GERM ANY Rotexmedi ca GmbH Arzneimitt elwerk GER MAN Y Ciprokan t Ciprofloxacin Hydrochloride Table ts 500 mg INDIA Proprano lol Propranolol Table ts 40 mg INDIA MYGR A Sildenafil Citrate Table ts 100 mg INDIA SilverKa nt Silver Sulfadiazine Crea m

1.0%w /w INDIA S Kant Healthcare Limited INDI A S Kant Healthcare Limited INDI A S Kant Healthcare Limited S Kant Healthcare Limited INDI A INDI A 1 9 2 1 9 3 1 9 4 1 9 5 TAN 00,96 1 J01K SKT TAN 08,02 0 C01C S K TZ 18 H 0002 TAN 08,10 9 J03C S K Registrant: Salama Pharmaceuticals Limited 1 9 6 TZ 18 H 0046 1 9 7 TZ 18 H 0086 Panacid 40 Pantoprazole sodium CEFIPY M Cefipime 1 9 8 TZ 18 H 0074 BSV- HUMO G 75 HP Menotropins 40 mg Tanzani a INDI A ACME Formulatio n Private Limited 1 g Tanzani a 75 IU Tanzani a CHIN A INDI A REYOUN G PHARMA CEUTICA L CO., LIMITED Bharat Serums and Vaccines Limited Table t, Enteri c Coate d Powd er for soluti on for injecti on Inject ion 27 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 1 9 9 TZ 18 H 0045 Tiniz 500 Tinidazole 2 0 0 TZ 18 H 0073 HUCOG 5000 HP Chorionic Gonadotrophin Table t, Film- coate d Inject ion 500 mg Tanzani a 5000 IU Tanzani a 2 0 1 2 0 2 2 0 3 2 0 4 2 0 5 2 0 6 2 0 7 2 0 8 2 0 9 TZ 18 H 0054 TZ 18 H 0099 TZ 18 H 0053 TZ 18 H 0053 TZ 18 H 0024 TZ 18 H 0023 TZ 18 H 0105 TZ 18 H 0124 TZ 18 H 0088 Folix 5 Folic Acid Table ts 5 mg Tanzani a Fibronex 500 Tranexamic acid Ramivas c 2.5 Ramipril Ramivas c 2.5 Ramipril CARDIT OR-20 Atorvastatin Calcium Table t, Film- coate d Capsu les, hard Capsu les, hard Table ts 500 mg Tanzani a

2.5 mg Tanzani a 20 mg Tanzani a CARDIT OR-10 Atorvastatin Calcium Table ts 10 mg Tanzani a Irivisc DS Carmellose Sodium Soluti on

1.0 %w/v Tanzani a Zyflo 10 Alfuzosin Table ts 10 mg Tanzani a CEROX Cefuroxime Sodium 750 mg Tanzani a Soluti on for injecti on 28 INDI A INDI A INDI A INDI A INDI A INDI A INDI A INDI A INDI A INDI A INDI A ACME Formulatio n Private Limited Bharat Serums and Vaccines Limited ACME Formulatio n Private Limited ACME Formulatio n Private Limited ACME Formulatio n Private Limited ACME Formulatio n Private Limited ACME Formulatio n Private Limited ACME Formulatio n Private Limited Indoco Remedies Limited (Plant II) ACME Formulatio n Private Limited Scott Edil Advanced Research Laboratori es & Education Limited Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Cefipym Cefepime 2 1 0 TZ 18 H 0087 1000 mg Tanzani a Powd er for soluti on for injecti on Registrant: Sance Laboratories Private Limited Sandox - 200 Cefpodoxime Proxetile Table ts 200 mg INDIA Sanaxon e - 1000 Cefriaxone Sodium 1000 mg INDIA 2 1 1 2 1 2 TZ 18 H 0121 TZ 18 H 0043 INDI A INDI A INDI A Scott Edil Advanced Research Laboratori es & Education Limited Sance Laboratori es Private Limited Sance Laboratori es Private Limited Registrant: Sandoz GmbH 2 1 3 TZ 18 H 0080 Amoxici llin 250mg Amoxicillin 250 mg AUSTR ALIA Sandoz GmbH, Kundl AUST RIA Registrant: SERUM INSTITUTE OF INDIA LTD 2 1 4 TAN 00,26 40 J06B SER SII Tetanus Antitoxi n Tetanus Antitoxin Vacci ne 1500 IU/ml INDIA INDI A Serum Institute of India Limited Registrant: Shanghai Dahua Pharmaceutical Company Limited 75 mg CHINA Shanghai 2 1 5 TZ 18 H 0110 LEVOP LANT Levonorgestrel Sub- derma l Impla nt Powd er for soluti on for injecti on Table t, Dispe rsible Registrant: Shayana Healthcare Private Limited 2 1 6 TZ 18 H 0095 SHAFG RA Sildenafil Citrate Table ts 100 mg INDIA 29 CHIN A INDI A Dahua Pharmaceu tical Company Limited Lincoln Pharmaceu ticals Limited Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 2 1 7 TZ 18 H 0001 SHAFG RA-50 Sildenafil Citrate Table ts 50 mg INDIA Registrant: Square Pharmaceuticals Limited 2 1 8 TZ 18 H 0092 Dexonex C Eye/ Ear drop Dexamethason e + Chlorpheniram ine Maleate Ear/E ye Drops Registrant: Strides Shasun Limited 1 + 5 mg Bangla desh 2 1 9 TZ 18 H 0016 Nofong Terbinafine Hydrochloride Crea m

1.0 %w/w INDIA Virso Sofosbuvir TZ 18 H 0040 2 2 0 Registrant: Sun Pharmaceutical Industries Limited Table ts 400 mg INDIA 90 mg INDIA 1 mg INDIA 60 mg INDIA Etocoxx Etoricoxib Toba DM Sterile Eye Drop Etocoxx Tobramycin + Dexamethason e Etoricoxib Table ts Optha lmic Suspe nsion Table ts Etocoxx Etoricoxib Table ts 120 mg INDIA Irovel Irbesartan Table ts 150 mg INDIA Starval HCT 80 + 12.5 Valsartan + Hydrochlorothi azide Table ts INDIA 80 mg+

12.5 mg Registrant: Sunberg Life Science Private Limited 30 2 2 1 TZ 18 H 0007 2 2 2 TZ 18 H 0044 2 2 3 TZ 18 H 0006 2 2 4 TZ 18 H 0005 TAN 08,08 7 C01E SUN TZ13 H017 2 2 5 2 2 6 INDI A Lincoln Pharmaceu ticals Limited Square Pharmaceu ticals Limited BAN GAL ADES H INDI A INDI A INDI A INDI A INDI A INDI A INDI A INDI A The Madras Pharmaceu ticals Strides Shasun Limited Sun Pharmaceu tical Industries Limited Sun Pharmaceu tical Industries Limited Sun Pharmaceu tical Industries Limited Sun Pharmaceu tical Industries Limited Sun Pharmaceu tical Industries Limited Sun Pharmaceu ticals Industries Limited Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) 2 2 7 TZ 18 H 0116 PREGA BA 75 Pregabalin Capsu les 75 mg INDIA INDI A THE MADRAS PHARMA CEUTICA LS Registrant: Swiss Parenterals Limited Clincina Clindamycin 2 2 8 TZ 18 H 0029 Soluti on for injecti on 600 mg/4m l INDIA Swiss Parenterals Limited INDI A Registrant: SYNMEDIC LABORATORIES 2 2 9 TZ 18 H 0081 SYNAT OR 20 Atorvastatin Calcium Table ts 20 mg INDIA Registrant: TCS CO; LTD 2 3 0 TZ 18 H 0019 Cefmdin e Cefriaxone Sodium

1.0 g Tanzani a Powd er for soluti on for injecti on Registrant: TROIKAA PHARMACEUTICALS LIMITED 1%w/v INDIA SYNMED IC LABORA TORIES FUREN PHARMA CEUTICA L GROUP COMPAN Y LIMITED. Troikaa Pharmaceu ticals Limited TZ13 H112 Troypof ol Propofol 2 3 1 Registrant: Unichem Laboratories Limited Corvadil Amlodipine Besylate MPLify 20 Tadalafil Corvadil Amlodipine TZ13 H049 TZ 18 H 0022 TZ13 H050 2 3 2 2 3 3 2 3 4 Emul sion for Inject ion Table ts Table ts Table ts 5 mg 20 mg 10 mg INDIA Unichem Laboratori es Limited INDIA Unichem Laboratori es Limited INDIA Unichem Laboratori es Limited Registrant: Vital Healthcare Private Limited 2 3 5 TAN 00,24 29 R03A VIT Vitaphyl line Aminophylline Inject ion 25 mg/ml INDIA Vital Healthcare Private Limited 31 INDI A CHIN A INDI A INDI A INDI A INDI A INDI A Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Registrant: Y.S.P Industries (M) SDN. BDH 2 3 6 2 3 7 2 3 8 2 3 9 TZ 18 H 0077 TZ 18 H 0067 TZ 18 H 0078 TZ 18 H 0077 Paracetamol Poro Supposit ory Voren Plus Gel Diclofenac Sodium Paracetamol Paracetamol Poro Supposit ory Poro Supposit ory Supp ositor ies Gel Supp ositor ies Supp ositor ies 125 mg MALA YSIA 10 mg/g MALA YSIA 250 mg 125 mg MALA YSIA MALA YSIA Y.S.P Industries (M) SDN. BHD Y.S.P Industries (M) SDN. BHD Y.S.P Industries (M) SDN. BHD Y.S.P Industries (M) SDN. BHD MAL AYSI A MAL AYSI A MAL AYSI A MAL AYSI A TANZANIA FOOD AND DRUGS AUTHORITY LIST OF REGISTERED VETERINARY PHARMACEUTICAL FROM 1 ST JANUARY, 2018 TO 30TH JUNE, 2018 S/ N Registr ation Numbe r Product Name INN Name Dosage Form Product Strength Registr ant Countr y Manufact urer Manufac turer's Country

2.37 g INDIA Ashish INDIA Registrant: Ashish Life Science Private Limited 1 TZ 18 V 0001 Diminas hish Plus Diminazen e + Phenazone granule s for injectio n Registrant: Bajuta International (T) Limited 2 TZ 18 V 0004 Bacolisti n Colistin 10% Tanzan ia Water Solubl e Powde r Life Science Private Limited Hebei Yuanzhe ng Pharmac eutical Co. Limited CHINA Registrant: Ceva Biomune (BIOMUNE COMPANY) 3 TZ 18 V 0005 N/A Vectorm une HVT NDV & Rispens Live, Frozen Vaccin e 2474 + 1206 PFU United States of Americ a Ceva Biomune (BIOMU NE COMPA United States of America 32 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) NY) 4 TZ 18 V 0005 N/A Vectorm une HVT NDV & Rispens Registrant: Ceva Sante Animale Live, Frozen Vaccin e 2474 + 1206 PFU United States of America United States of Americ a Ceva Biomune (BIOMU NE COMPA NY) 5 TZ 18 V 0006 6 TAN 00,252 5 J01A CEV 7 TZ 18 V 0008 8 TZ 18 V 0007 CEVAC CORY MUNE 7K Tenaline 20% LA Cevac CORY MUNE 4 k CEVAC VITAB RON L N/A Emulsi on

0.5 ml FRAN CE Ceva Phylaxia HUNGA RY 20 % w/v FRAN CE Ceva Sante Animale FRANC E

5.5/3.3 ml FRAN CE Ceva Phylaxia HUNGA RY Oxytetracy cline N/A N/A Solutio n for injectio n suspen sion vaccin e live, freeze- dried vaccin e Registrant: Kela Laboratoria N.V Amprolium Powde 20%w/w BELGI Amproli um 20% 9 TAN 00,262 4 P01X PHE Genta 10% r for Oral solutio n Gentamicin Solutio 1 0 1 1 1 2 TAN 00,194 9 J01K PHE TAN 00,258 0 J01F KEL TAN 00,193 7 J01K KEL Tylokel 20 Tylosine Tartrate Albendazol e Albenzo le 10% Suspensi on UM 100000 IU/ml BELGI UM 200 mg/ml BELGI UM 100 mg/ml BELGI UM Kela Laborato ria N.V Kela Laborato ria N.V Kela Laborato ria N.V Kela Laborato ria N.V BELGIU M BELGIU M BELGIU M BELGIU M n for injectio n Solutio n Suspen sion, Oral 33 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Amproli um 20% Amprolium Powde Oligovit MULTIVI TAMIN 1 3 1 4 TAN 00,258 3 P01X KEL TAN 08,071 A11A KEL 200 mg/g BELGI UM Kela Laborato ria N.V BELGIU M BELGI UM Kela Laborato ria N.V BELGIU M 2mg/ml +01mg/ ml +50,000 IU/ml +25000I U/ml +0056m g/ml+ 1mg/ml + 0010mg/ ml+ 4mg/ml + 10mg/ml + 2mg/ml +5mg/m l + 01mg/ml +01mg/ ml +002mg /ml + 1mg/ml +5mg/m l + 5mg/ml 1050/2.3 6 mg/g MORO CCO M.C.I Sante Animale MOROC CO 10% MORO CCO 10% MORO CCO M.C.I Sante Animale M.C.I Sante Animale MOROC CO MOROC CO r for Oral solutio n Emulsi on for Injecti on Powde r for solutio n for injectio n Suspen sion, Oral Suspen sion, Oral 34 Registrant: M.C.I Sante Animale 1 5 TZ 18 V 0003 AZADI M Diminazine diaceturate 1 6 Oxfendazol e TZ 18 V 0002 PARAN THIC 10% PARAN THIC 10% Registrant: Norbrook Kenya Limited TZ 18 V 0002 Oxfendazol e 1 7 Tanzania Food, Drugs and Cosmetics (List of Registered Human and Veterinary Medicinal Products and Withdrawn Medicinal Products) GN. NO. 21 (Contd) Multijec t IMM TAN 00,131 8 J01J NOR Neomycin + Prednisolo ne + Procaine Penicillin + Streptomyc in Suspen sion, Oral 20 mg/g + 20 mg/g + 20 mg/g + 20 mg/g KENY A Norbroo k Laborato ries Limited NORTH ERN IRELAN D Opticlox Cloxacillin Ointme Alamyci n LA Oxytetracy cline nt Solutio n for injectio n 167 % w/w KENY A 216 %w/v KENY A Dichloroph en Ointme nt

0.55%w/ w KENY A Norbroo k Milking Salve Alamyci n LA Oxytetracy cline Noroclo x DC Cloxacillin Solutio n for injectio n Suspen sion, Oral 300 mg/ml KENY A 500mg KENY A Norbroo k Laborato ries Limited Norbroo k Laborato ries Limited Norbroo k Kenya Limited Norbroo k Laborato ries Limited Norbroo k Laborato ries Limited NORTH ERN IRELAN D NORTH ERN IRELAN D KENYA NORTH ERN IRELAN D NORTH ERN IRELAN D 1 8 1 9 2 0 2 1 2 2 2 3 TAN 00,132 7 S01A NOR TAN 00,439 1 J01A NOR TAN 08,080 D08A NOR TAN 00,194 5 J01A NOR TAN 00,132 4 J01H NOR Dar es Salaam, ………………, 2018 ADAM M. FIMBO Director General 35