HUMAN MEDICINAL PRODUCTS REGISTER

HUMAN MEDICINE REGISTERED PRODUCTS

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No. Registration No. Product Brand Name Generic Name Dosage Strength Dosage Form Pack Size Packaging Type Shelf Life Manufacturer's Name Manufacturer's Address Manufacturer Country Marketing Authorization Holder(MAH) Local Technical Representative(LTR) Registration Date Expiry Date
1 Rwanda FDA-HMP-MA-1575 D-TAM Tamsulosin and Dutasteride 0.4mg/ 0.5mg Tablets 3x10 Tablets ALU/ALU BLISTER 36 Months SKYBIOTECH LIFESCIENCES Pvt.Ltd Gut no.: 5, Gevrai tanda, Paithan road, Aurangabad (m.s.) INDIA STAR BIOTECH LIMITED STAR BIOTECH LIMITED 2024-08-17 2029-08-16
2 Rwanda FDA-HMP-MA-0604 D10 Glucose intravenous infusion BP 10%w/v 10%w/v Solution for infusion 500 ml & 250 ml Bottles LDPE Bottles 30 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL), ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12
3 Rwanda FDA-HMP-MA- 0519 D5 Glucose anhydrous 5.0% w/v 5.0% w/v Solution for infusion 500 ml & 250 ml Bottles LDPE bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04
4 Rwanda FDA-HMP-MA-1539 D5 GLUCOSE INTRAVENOUS INFUSION BP Solution for Infusion 500ml 60 Amanta Healthcare Limited India Amanta Healthcare Limited SUN ENTERPRISES LTD 2024-02-29 2029-02-26
5 Rwanda FDA-HMP-MA-1539 D5 Glucose Intravenous Infusion B.P 50G/LITRE Solution for Infusion 500ml Bottle LDPE bottles packed in a printed carton 60 Months AMANTA HEALTHCARE LIMITED Plot no: 876, N.H. No: 8, Hariyala, Kheda-387411, Gujarat, India INDIA AMANTA HEALTHCARE LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26
6 RWANDA-FDA24/HM/0628/0030 D5 500 GLUCOSE INTRAVENOUS INFUSION BP 5%w/v Solution for infusion. 1 x 500 mL 24 Months Tirupati Starch and Chemical Limited India Alfa Pharmaceuticals Limited AIVEEN (R) LTD 2025-10-16 2030-10-15
7 Rwanda FDA-HMP-MA-2182 D5 500ML Glucose Intravenous Infusion B.P 5%V/W INTRAVENOUS INFUSION 500ml &1000ml Plastic granules, Nipple Head Protective cap, Euro Head Cap 36 Months ACULIFE HEALTHCARE PVT. LTD Village- Sachana, Tal -Viramgam, District- Ahmedabad - 382 150 Gujarat, India INDIA ACULIFE HEALTHCARE PVT. LTD SUN ENTERPRISES LTD 2025-01-09 2030-01-08
8 Rwanda FDA-HMP-MA-0397 D50 Glucose Intravenous Infusion 50% W/V BP 50% W/V Solution for infusion 100ml Bottle Low density polyethylene bottles which are packed in baby cartons and then packed in mother cartons 24 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LIMITED (APDL), UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
9 Rwanda FDA-HMP-MA-1664 DACINAZOLE CREAM Miconazole nitrate BP 2%w/w CREAM 15 g Tube Aluminium tube 36 Months DAWA LIMITED Plot No: 7879/8, Baba Dogo road, Ruaraka, P.O Box 16633-00620, Nairobi –Kenya Kenya DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16
10 RWANDA-FDA25/HM/0077/0051 Daclavir Daclatasvir dihydrochloride 60 mg Film Coated Tablet 28's 24 Months European Egyptian Pharmaceutical Industries Km 25 Alexandria-Cairo Desert Road, Amriya, Alexandria. Egypt Egypt Dawood Pharma HELIOS PHARMA Ltd 2025-12-12 2030-12-11
11 Rwanda FDA-HMP-MA-1079 DACOF DRY COUGH SYRUP Diphenhydramine Hydrochloride BP 12.5mg + Dextromethophan Hybromide 6.5mg 12.5mg + 6.5 mg per 5ml Syrup 100 ml bottle Amber coloured bottle tightly closed with Aluminium cap/ label, unit box and measuring cap 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-04-20 2029-04-19
12 Rwanda FDA-HMP-MA-2329 DACOF EXPECTORANT SYRUP DIPHENHYDRAMINE HCL BP 14MG, AMMONIUM CHLORIDE BP 135.0MG, SODIUM CITRATE BP 57.0MG AND MENTHOL 1.1MG 14MG, 135.0MG, 57.0MG AND 1.1MG/5ml SYRUP 100ML BOTTLE AMBER COLOURED PET BOTTLES IN A UNIT BOX WITH LITERATURE INSERT INCLUDED 36 MONTHS DAWA LIMITED PLOT NO. 7879/8, BABA DOGO RD, RUARAKA. P.O. BOX 16633-00620. NAIROBI, KENYA KENYA DAWA LIMITED SUN ENTERPRISES LTD 2025-07-11 2030-07-10

Registered
13 Rwanda FDA-HMP-MA-1011 DACOF MUCOLYTIC SYRUP Each 5ml contains: Salbutamol (as sulphate) BP 2.0mg, Guaifenesin BP 100.0mg and Bromhexine HCl BP 4.0mg 2.0mg, 100.0mg & 4.0mg/5ml Syrup 100 ml Bottle PET bottle in a unit box along with a literature insert 36 Months DAWA LIMITED, Plot No.7879/8, Baba Dogo Road, Ruaraka, P.O Box 16633-00620, Nairobi-Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-02-23 2029-02-22
14 Rwanda FDA-HMP-MA-1076 DACOF PAEDIATRIC SYRUP Diphenhydramine hydrochloride BP 7.0mg and Sodium Citrate BP 28.5mg 7.0mg & 28.5mg per 5ml Syrup 100 ml Bottle Amber PET coloured bottle in a unit carton with a literature insert 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTREPRISES LTD 2024-04-20 2029-04-19
15 Rwanda FDA-HMP-MA-1665 DACOLD SYRUP Paracetamol BP, Pseudoephedrine HCl BP and Chlorphenamine Maleate BP 120MG/10MG/2MG SYRUP 100ml Bottle PET bottles in a unit box along with a literature insert 36 Months Dawa Limited Plot No.7879/8, Baba Dogo Road, Ruaraka, P.O.BOX 16633-00620 Nairobi, Kenya Kenya DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16
16 Rwanda FDA-HMP-MA-0058 DAFLON Esperidin (90 % Diosmin 10 % Of Flavonoids) 500 mg Tablets 30 Film-Coated Tablets ALUMINIUM/PVC BLISTER PACKS 36 Months SERVIER EGYPT INDUSTRIES (SEI), LES LABORATOIRES SERVIER INDUSTRIE, FRANCE 6th October City, 1 st Industrial Zone,12566, Giza A.R.E, EGYPT, 905, route de Saran, 45520 Gidy, FRANCE EGYPT, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2021-06-01 2026-06-01
17 Rwanda FDA-HMP-MA-1240 DAFLON 1000MG Micronised purified flavonoid fraction 1000 mg 1000 mg Film-coated tablet 30 tablets PVC Aluminium 48 Months SERVIER (IRELAND) INDUSTRIES LTD, Moneylands, Gorey Road, Arklow-Co. Wicklow, Y14 E284, Ireland IRELAND LES LABORATOIRES SERVIER KIPHARMA LTD 2024-05-06 2029-05-05
18 Rwanda FDA-HMP-MA-0226 DAFRACLAV ® 1000 MG BD Amoxicillin 875 mg - Clavulanic acid 125 mg 875mg & 125 mg Film-coated tablets 2x5 Tablets Alu/Alu blister 36 Months BILIM PHARMACEUTICALS, Çerkezköy Organize Sanayi Bölgesi, Karaa?aç Mh. 5. Sk. No.6, Kapakl?Tekirda?, 59510, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2023-05-12 2028-05-11
19 Rwanda FDA-HMP-MA-0227 DAFRACLAV ® 625 MG Amoxicillin 500 mg - Clavulanic acid 125 mg 500 mg & 125 mg Film-coated tablets 3x5 Tablets Alu/Alu blister 36 Months BILIM PHARMACEUTICALS, Çerkezköy Organize Sanayi Bölgesi, Karaa?aç Mh. 5. Sk. No.6, Kapakl?Tekirda?, 59510, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2023-05-12 2028-05-11
20 Rwanda FDA-HMP-MA-0193 DAFRACLAV® BD 200/28 MG Amoxicillin 200mg and Clavulanic acid 28mg 200mg and 28mg Powder for oral suspension 100 ml Bottle Amber coloured, type III glass bottle packed with a spoon 36 Months BILIM PHARMACEUTICALS, Çerkezköy Organize Sanayi Bölgesi, Karaa?aç Mh. 5. Sk. No.6, Kapakl?- Tekirda?, 59510, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2022-12-21 2027-12-20
21 Rwanda FDA-HMP-MA-0194 DAFRACLAV® BD 400/57MG Amoxicillin 400mg and Clavulanic acid 57mg 400mg and 57mg Powder for oral suspension 100 ml Bottle Amber coloured, type III glass bottle packed with a spoon 36 Months BILIM PHARMACEUTICALS, Çerkezköy Organize Sanayi Bölgesi, Karaa?aç Mh. 5. Sk. No.6, Kapakl?- Tekirda?, 59510, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2022-12-21 2027-12-20
22 Rwanda FDA-HMP-MA- 0658 DAFRAZOL® Omeprazole 20mg 20mg Capsules 14’s or 28’s, 7 capsules Alu/Alu blister. 2 or 4 blisters in a cardboard box 24 Months NOBEL ILAÇ San.ve Tic. A. ?, Sancaklar, Mah.Eski Akçakoca Cad. N°299, 811000 Düzce, Turkey TURKEY DAFRA PHARMA GmbH /SWITZERLAND SUN ENTERPRISES LTD 2023-12-02 2028-12-01
23 Rwanda FDA-HMP-MA-0974 DAFRAZOL® IV 42.6 mg of omeprazole sodium, corresponding to 40 mg of omeprazole 40 mg Powder for Solution for Injection 12 ml Vial and 10 ml Ampoule Transparent Glass powder vial Type I and Colourless Glass Solvent Ampoule Hydrolytic Class I 36 Months ANFARM HELLAS S.A, 61st km. Nat. Rd. Athens, Lamia, Schimatari Viotias, 32009, Greece GREECE DAFRA PHARMA GMbH SUN ENTERPRISES LTD 2024-02-26 2029-02-25
24 Rwanda FDA-HMP-MA-1406 DAPAVELDACTIN 10MG Dapagliflozin 10 mg 10 mg Film Coated Tablets 4 X 10 Tablets Alu/Alu Blister Pack. Such 4 blisters are packed in a carton along with package inserts. 24 Months LIPTIS FOR PHARMACEUTICALS AND MEDICAL PRODUCTS, Plot No. B/2, 6th industrial zone, 6th of October City, Egypt EGYPT LIPTIS FOR PHARMACEUTICAL AND MEDICAL PRODUCTS (S.A.E) GOODMAN INTERNATIONAL LTD (R) 2024-07-18 2029-07-17
25 Rwanda FDA-HMP-MA-1479 DAPAVELDACTIN 5MG Dapagliflozin 5mg 5mg Film Coated Tablets 4x7 Tablets Alu-Alu blister pack. Such 4 blisters are packed in a carton along with package inserts 24 Months LIPTIS FOR PHARMACEUTICALS, Plot No. B/2, 6th Industrial Zone, 6th of October City, Egypt EGYPT LIPTIS FOR PHARMACEUTICAL AND MEDICAL PRODUCTS (S.A.E) GOODMAN INTERNATIONAL LTD (R) 2024-07-20 2029-07-19
26 Rwanda FDA-HMP-MA-1649 DAPAVELDACTIN PLUS 5/1000MG DAPAGLIFLOZIN/METFORMIN 5MG+1000MG Film Coated Tablets 4x7 tablets Al/ Transparent PVDC Strips 24 Months Liptis for Pharmaceuticals and Medical Products (S.A.E) Plot No. B/2, 6th Industrial Zone, 6th of October City, Egypt Egypt Liptis for Pharmaceuticals & Medical Products (S.A.E).Plot No. B/2, 6th Industrial zone, 6th of October City, Egypt.mahmoud.elaila@liptispharma.com Goodman International LTD (R) 2024-08-17 2029-08-16
27 Rwanda FDA-HMP-MA-2152 DAPIFLOZIN 10 DAPAGLIFLOZIN (AMORPHOUS) 5 MG 10 mg Tablets 3x10 tablets Alu Alu blister 36 Months Inventia Healthcare Limited F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East), Thane 421506, Maharashtra State, India India MEGA LIFESCIENCES(AUSTRALIA) PTY LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17
28 Rwanda FDA-HMP-MA-2146 DAPIFLOZIN 5 DAPAGLIFLOZIN (AMORPHOUS) 5 MG 5mg Tablets 3x10 tablets Alu Alu blister 36 months Inventia Healthcare Limited F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East), Thane 421506, Maharashtra State, India India MEGA LIFESCIENCES(AUSTRALIA) PTY LIMITED ABACUS PHARMA (A) LTD 2024-10-29 2029-10-28
29 Rwanda FDA-HMP-MA-0216 DAPIRING Dapivirine 25 mg 25 mg Flexible, off-white vaginal ring 1 ring and 3 rings Opaque 106 mm x 106 mm heat-sealed, metalized polyester pouches (FlexiFree™ 7153). Then 1 ring/carton or 3 rings/carton 60 Months QPHARMA AB, Agneslundsvägen 27, Malmö Sweden SWEDEN INTERNATIONAL PARTNERSHIP FOR MICROBICIDES INC. (IPM) SOUTH AFRICA NPC WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-01-25 2028-01-24
30 Rwanda FDA-HMP-MA-1190 DAPROFEN SUSPENSION Ibuprofen BP 100mg/5ml 100mg/5ml Oral suspension 60ml/ 100ml bottles Amber coloured PET bottles then in unit box 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-05-06 2029-05-05
31 Rwanda FDA-HMP-MA-0489 DAPZIN 10 Dapagliflozin 10mg 10mg Film-coated Tablets 3 x 10 Tablets ALU/ALU blister pack & carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-10-05 2028-10-04
32 Rwanda FDA-HMP-MA-0763 DAPZIN 10-M Dapagliflozin 10mg and Extended-Release Metformin Hydrochloride USP 500mg 10mg and 500mg Film coated tablets 3X10’s Tablets Alu/Alu blister pack. Such 3 blisters are packed in a printed outer carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29
33 Rwanda FDA-HMP-MA-0490 DAPZIN 10-M PLUS Dapagliflozin 10 mg / Metformin Hydrochloride USP 1000 mg 10 mg / 1000 mg Film-coated Tablets 3 x 10 Tablets ALU/ALU blister pack & carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-10-05 2028-10-04
34 Rwanda FDA-HMP-MA-0762 DAPZIN 5-M Dapagliflozin 5mg and Extended-Release Metformin Hydrochloride USP 500mg 5mg and 500mg Film coated tablets 3X10’s Tablets Alu/Alu blister pack. Such 3 blisters are packed in a printed outer carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29
35 Rwanda FDA-HMP-MA-0547 DAPZIN-5 TABLETS Dapagliflozin 5mg 5mg Film coated tablets 3x10’s tablets Alu/Alu blister pack. Such 3 blisters are packed in a printed carton with packing insert 24 Months MICRO LABS LIMITED, 92, SIPCOT, Industrial Complex, Hosur-635 126, Tamil Nadu, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-12-02 2028-12-01
36 Rwanda FDA-HMP-MA-1846 DARUNAVIR AND RITONAVIR TABLETS Darunavir and Ritonavir 800mg/100mg Tablets 60 Tablets and 180 Tablets HDPE CONTAINER 24 Months HETERO LABS LIMITED Unit III, 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIA. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
37 Rwanda FDA-HMP-MA-0988 DARUNAVIR AND RITONAVIR TABLETS Darunavir Ethanolate 400mg, Ritonavir 50mg 400mg/50mg Film coated tablets 30’s, 60’s, 120 Tablets HDPE Containers 24 Months HETERO LABS LIMITED, 22-110, IDA, Jeedimetla, Hyderabad-500 055, Telangana, India INDIA HETERO LABS LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-26 2029-02-25
38 Rwanda FDA-HMP-MA-0945 DARUNAVIR TABLETS 600 MG Darunavir amorphous 600mg 600mg Film coated tablets 60 Tablets HDPE container in child resistant plastic caps with pulp liners 38 mm and high-density polyethylene container 160cc with 38 mm neck 24 Months HETERO LABS LIMITED, Unit-III, Industrial Development Area (IDA) 22-110, IDA, Jeedimetla, Hyderabad-500 055, Telangana, India. INDIA HETERO LABS LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25
39 Rwanda FDA-HMP-MA-0086 DARUNAVIR)-600 Darunavir Ethanolate 600 mg Tablets Debossed With ‘Dnv’ On One Side And ‘600’ On Other Side 60 Tablets HDPE CONTAINER 24 Months CIPLA LIMITED Manufacturing Division At Plot D7- Bulk Drug II block &At Plot D27-API I Block, MIDC Industrial Area Kurkumbh Village; Taluka – Daund District – Pune (Maharashtra)- India INDIA CIPLA LIMITED/INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-08-05 2026-08-05
40 Rwanda FDA-HMP-MA-0085 DARUNAVIR-400 Darunavir Ethanolate 400 mg Tablets, Debossed With ‘Dnv’ On One Side And ‘400’ On Other Side 60 Tablets. HDPE CONTAINER 24 Months CIPLA LIMITED Manufacturing Division At Plot D7- Bulk Drug II block &At Plot D27-API I Block, MIDC Industrial Area Kurkumbh Village; Taluka – Daund District – Pune (Maharashtra)- India INDIA CIPLA LIMITED/INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-08-06 2026-08-06
41 Rwanda FDA-HMP-MA-2323 DASATINIB NEAPOLIS 70MG DASATINIB 70MG FILM COATED TABLETS 60 Tablets ALU/ALU BLISTER PACK 24 MONTHS NEAPOLIS PHARMA Road of Tunis, km 7-B.P.206, 8000 Nabeul, TUNISIA TUNISIA NEAPOLIS PHARMA KIPHARMA LTD 2025-06-19 2030-06-18

Registered
42 Rwanda FDA-HMP-MA-1834 DAWA PROM SYRUP Promethazine hydrochloride 5mg/5ml Syrup 60ml and 100ml Bottles AMBER COLOURED PET BOTTLES 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16
43 Rwanda FDA-HMP-MA-1176 DAWA – PROM TABLETS Promethazine Hydrochloride BP 25 mg 25 mg Film coated tablets 10x10 Tablets Alu-PVC blister pack 36 Months DAWA LIMITED. Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya. KENYA DAWA LIMITED SUN ENTERPRISES 2024-05-06 2029-05-05
44 Rwanda FDA-HMP-MA-1953 DAWA-CPM SYRUP CHLORPHENIRAMINE MALEATE 2MG/5ML SYRUP 60ml and 100ml Bottles PET Amber bottles 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya KENYA DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16
45 Rwanda FDA-HMP-MA-1610 DAWA-CPM TABLET Chlorpheniramine Maleate BP 4 mg Tablets 10x10 Tablets Aluminium foil/Clear PVC blister 36 Months Dawa Limited Plot No: 7879/8, Baba Dogo Road, Ruaraka; POBox 16633-00620, Nairobi, Kenya. Kenya Dawa Limited Sun Enterprises limited 2024-08-17 2029-08-16
46 Rwanda FDA-HMP-MA-1141 DAWACLOX POWDER FOR ORAL SOLUTION Cloxacillin (as sodium) BP 25mg/5ml 125mg/5ml Powder for oral solution 100 ml Bottle HDPE Bottle 24 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-04-21 2029-04-20
47 Rwanda FDA-HMP-MA-1441 DAWACLOX-250 Cloxacillin (as sodium) BP 250mg 250mg Hard gelatin capsules 10X10’s and 1000 capsules Alu-Alu Blister Pack, packed in printed unit carton /bulk pack of 1000’s packed in 1000CC HDPE container 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-07-20 2029-07-19
48 Rwanda FDA-HMP-MA-1758 DAWASTIN ORAL SUSPENSION Nystatin BP 100,000 IU/mL Suspension 30mL & 12mL Bottles AMBER COLORED GLASS BOTTLES 24 Months DAWA LIMITED Plot No.7879/8, Baba Dogo Road, Ruaraka. P.O. BOX 16633-00620 Nairobi, Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16
49 Rwanda FDA-HMP-MA-1669 DAWAVATE CREAM BETAMETHASONE VALEARATE BP 0.1% W/W CREAM 15 g Tube Collapsable Aluminium tube 36 Months DAWA LIMITED Plot No.7879/8, Baba Dogo Road, Ruaraka P.O.BOX 16633-00620, Nairobi, Kenya Kenya DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16
50 Rwanda FDA-HMP-MA-0299 DAZEL KIT Azithromycin Tablets 1g, Secnidazole Tablets 1g and Fluconazole Tablets 150mg 1g, 1g and 150mg Film coated tablets 4 tablets Alu/PVC-PvdC blister packed in printed carton along with pack insert. 36 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, 4 of 5 Maharashtra, India. INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
51 Rwanda FDA-HMP-MA-2331 DAZOLE CREAM CLOTRIMAZOLE BP 1.0% w/w Cream for external use only 20GM CREAM TUBE COLLAPSIBLE ALUMINUM TUBES IN A UNIT CARTON WITH A LITERATURE INSERT 36 MONTHS DAWA LIMITED PLOT NO. 7879/8, BABA DOGO RD, RUARAKA. P.O. BOX 16633-00620. NAIROBI, KENYA KENYA. DAWA LIMITED SUN ENTERPRISES LTD 2025-07-11 2030-07-10

Registered
52 Rwanda FDA-HMP-MA-2197 DECLOPHEN FAST Diclofenac Potassium 50 mg Granules for Oral Solution 10x2g LDPE-AL-LDPE-Paper 24 Months PHARCO PHARMACEUTICALS KM 31, Alexandria-Cairo Desert Road, Amriya, Alexandria, Egypt. EGYPT PHARCO PHARMACEUTICALS Le Medical Ltd 2025-02-04 2030-02-03
53 Rwanda FDA-HMP-MA-0282 DECLOT Warfarin Sodium USP 5mg 5mg Uncoated tablets 100’s tablets HDPE container 24 Months MACLEODS PHARMACEUTICALS LIMITED, 304, Atlanta Arcade, Marol Church road, Andheri (East), India INDIA MACLEODS PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11
54 Rwanda FDA-HMP-MA-1435 DEEP HEAT SPRAY Methyl salicylate 1% w/w, Ethyl salicylate 5% w/w, 2-hydroxyethylsalicylate 5% w/w and methyl nicotinate 1.6% w/w 1% w/w, 5% w/w, 5% w/w and 1.6% w/w Aerosol topical spray 150 ml (100g) x1 Container Tinplate aerosol container packed in a box 36 Months COLEP LAUPHEIM Gmbh & Co. KG Fockestraße 12, 88471, Laupheim Germany GERMANY THE MENTHOLATUM COMPANY LIMITED SUN ENTERPRISES LTD 2024-07-20 2029-07-19
55 Rwanda FDA-HMP-MA-0241 DEEXA Dexamethasone Sodium Phosphate Injection USP, 4 mg/ml 4 mg/ml Solution for injection 10 X 10 X 2 ml Ampoules in blister pack 2ml transparent glass ampoule. Such 10 ampoules are packed in blister pack. Such 10 blisters are packed in Plain white inner with packaging insert 36 Months LINCOLN PHARMACEUTICALS LIMITED Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
56 Rwanda FDA-HMP-MA-0173 DEEXA Dexamethasone Sodium Phosphate USP 0.1 % 0.001 Ophthalmic drops, clear colourless solution 10 ml bottle Plastic dropper bottle 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13
57 Rwanda FDA-HMP-MA-1256 DEFAL 30MG Deflazacort 30mg 30mg Tablets 10 Tablets Blister made of PVC and aluminium-PVC foil 60 Months FAES FARMA, S.A, Máximo Aguirre 14-48940 Leioa (Biscay) Spain SPAIN FAES FARMA, S.A GOMHS LTD 2024-05-06 2029-05-05
58 Rwanda FDA-HMP-MA-1220 DEFAL 6MG TABLETS Deflazacort 6 mg 6 mg Tablets 20 Tablets Blister made of PVC and aluminium-PVC 60 Months FAES FARMA, S.A Máximo Aguirre 14-48940 Leioa (Biscay) Spain SPAIN FAES FARMA, S.A. GOMHS LTD 2024-05-06 2029-05-05
59 Rwanda FDA-HMP-MA-1217 DEFAL DROPS Deflazacort 22.75mg/ml 22.75mg/ml Oral drops suspension 13 ml Bottle Amber glass container of 20 ml with a cap with aluminium seal 36 Months FAES FARMA, S.A Máximo Aguirre 14-48940 Leioa (Biscay) Spain SPAIN FAES FARMA, S.A., SPAIN GOMHS LTD 2024-05-06 2029-05-05
60 Rwanda FDA-HMP-MA-0428 DELASED CHESTY COUGHS NON-DROWSY Each 5ml contain Guaifenesin Ph. Eur 100 mg, Menthol 1.1mg. Each 5ml contain 100 mg, 1.1mg Syrup 100 ml Bottles Amber glass bottles 36 Months REGAL PHARMACEUTICALS LIMITED. Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
61 Rwanda FDA-HMP-MA- 0836 DELASED CHESTY COUGHS SYRUP Diphenidramine HCL BP 14.0 mg, Ammonium chloride BP 135.0 mg, Sodium Citrate BP 57.0 mg, Menthol BP 1.1mg 14.0 mg, 135.0 mg, 57.0 mg, 1.1mg Syrup 100 ml Bottle Amber Glass bottle packed in a corrugated box/carton 36 Months REGAL PHARMACEUTICALS LTD, Plot No. 7879/18, Off Baba Dogo Road, Ruaraka; Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LIMITED 2024-02-09 2029-02-08
62 Rwanda FDA-HMP-MA-0429 DELASED DRY COUGH SYRUP Each 5ml contain Diphenhydramine HCl BP 14mg, Dextromethorphan HBr BP 6.5mg, Sodium Citrate BP 57mg, Menthol BP 2mg Each 5ml contain 14mg, 6.5mg, 57mg, 2mg Syrup 100 ml Bottles Amber glass bottles 36 Months REGAL PHARMACEUTICALS LIMITED. Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
63 Rwanda FDA-HMP-MA-1297 DELASED DRY COUGHS (NON-DROWSY) SYRUP Dextromethorphan HBr 7.5mg/5ml 7.5mg/5ml Syrup 100ml bottles Amber 100ml glass bottles with Roll-On-Pilfer-Proof (ROPP) Caps 36 Months REGAL PHARMACEUTICALS LTD, Plot No:7879/18. Off Baba Dogo Road, Ruaraka P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06
64 Rwanda FDA-HMP-MA-0430 DELASED PAEDIATRIC SYRUP Each 5ml contain Diphenhydramine HCI BP 7 mg, Sodium citrate 28.5mg, Menthol 0.55 mg Each 5ml contain 7 mg, 28.5mg, 0.55 mg Syrup 100 ml Bottles Amber glass bottles 36 Months REGAL PHARMACEUTICALS LIMITED. Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
65 Rwanda FDA-HMP-MA-1005 DEPAKINE 200 MG Sodium Valproate 200mg 200mg Film Coated Tablets 40 Tablets Polypropylene tubes 36 Months SANOFI WINTHROP INDUSTRIES, Sanofi Winthrop Industrie– Ambare-1, rue de la Vierge ambares et Lagrave 33565 carbon blanc Cedex, France. FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LIMITED 2024-02-23 2029-02-22
66 Rwanda FDA-HMP-MA-1007 DEPAKINE 200 MG/ML Sodium Valproate 200 mg/ml 200 mg/ml Oral Solution Syrup 40 ml Bottle Amber Glass Type III Brown Bottles closed with a polypropylene child-proof cap 36 Months SANOFI WINTHROP INDUSTRIES, Sanofi Winthrop Industrie Ambare-1, rue de la Vierge ambares et Lagrave 33565 carbon blanc Cedex, France. FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LIMITED 2024-02-23 2029-02-22
67 Rwanda FDA-HMP-MA-1006 DEPAKINE 500 MG Depakine 500 mg 500 mg Film Coated Tablets 30 Tablets Polypropylene tubes 36 Months SANOFI WINTHROP INDUSTRIES, Sanofi Winthrop Industrie Ambare-1, rue de la Vierge ambares et Lagrave 33565 carbon blanc Cedex, France. FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LIMITED 2024-02-23 2029-02-22
68 Rwanda FDA-HMP-MA-0600 DEPAKINE 57.64 SYRUP Sodium Valproate (57.64 mg/ml) 57.64 mg/ml Syrup 150 ml Bottle Amber glass bottle (type III) of 150 mL closed with child-proof cap with a polyethylene (PE) seal. 36 Months UNITHER LIQUID MANUFACTURING, 1-3 allée de la Neste Z.I d’En Sigal 31770 Colomiers - France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-10-13 2028-10-12
69 Rwanda FDA-HMP-MA-1028 DEPAKINE CHRONO 500MG Sodium Valproate + Valproic Acid 500mg 500mg Tablets 30 tablets Polypropylene tube secured by a Polyethylene stopper containing a desiccant 36 Months SANOFI WINTHROP INDUSTRIE-AMBARES, 1, Rue de la Vierge Ambares et Lagrave 33565 Carbon Blanc Cedex, France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-02-28 2029-02-27
70 Rwanda FDA-HMP-MA-0348 DEPO-PROVERA Medroxyprogesterone Acetate 150mg/ml 150mg/ml Suspension for subcutaneous injection 25’s Pre-filled disposable syringe Pre-filled disposable syringe 60 Months Pfizer Manufacturing Belgium, Address: Rijksweg 12, 2870 PUURS, Belgium BELGIUM PFIZER LABORATORIES LIMITED/KENYA GILMED LIMITED 2023-07-08 2028-07-07
71 Rwanda FDA-HMP-MA-0063 DERISE-25 DARBEPOETIN ALFA 25MCG/0.42ML SOLUTION FOR INJECTION 1ML 1 ML PREFILLED SYRINGE BARREL WITH NEEDLE, 1 ML PLUNGER STOPPER AND 1 ML PLUNGER ROD 36 Months HETERO BIOPHARMA LIMITED Sy. No. 458 (part), TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (Disrtict)-509 301, Telangana State, India INDIA HETERO BIOPHARMA LIMITED BION PHARMA GROUP 2021-06-01 2026-06-01
72 Rwanda FDA-HMP-MA-0064 DERISE-40 DARBEPOETIN ALFA 40MCG/0.4ML SOLUTION FOR INJECTION 1ML 1 ML PREFILLED SYRINGE BARREL WITH NEEDLE, 1 ML PLUNGER STOPPER AND 1 ML PLUNGER ROD 36 Months HETERO BIOPHARMA LIMITED Sy. No. 458 (part), TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (Disrtict)-509 301, Telangana State, India INDIA HETERO BIOPHARMA LIMITED BION PHARMA GROUP 2021-06-01 2026-06-01
73 Rwanda FDA-HMP-MA-0608 DERIVA AQUEOUS GEL Adapalene 0.1% w/w 0.1% w/w Gel Printed aluminum collapsible tube of 15 g Printed aluminum collapsible tube of 15 g packed in a paper carton 36 Months GLENMARK PHARMACEUTICALS LIMITED, Plot No. E-37, 39, D-Road, Midc, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-10 2028-12-09
74 Rwanda FDA-HMP-MA-1146 DERMAZINE CREAM Silver Sulfadiazine USP 1.0% w/w 1.0% w/w Cream 15 gm & Collapsible aluminium tube in a unit carton with a literature insert 36 Months DAWA LIMITED, Plot No: 7879/8, Baba Dogo Road, Ruaraka, P.O Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-04-27 2029-04-26
75 Rwanda FDA-HMP-MA-0513 DERMIDEX CREAM Miconazole Nitrate BP 2% w/w 2% w/w Cream 15g tube Aluminium tube with a white cap and packed in unit cartons 36 Months REGAL PHARMACEUTICALS LTD, P.O BOX 44421- 00100 GPO, NAIROBI, KENYA KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-09-11 2028-09-10
76 Rwanda FDA-HMP-MA-0521 DERMOBACTER Benzalkonium chloride solution 0.985 g corresponding to Benzalkonium chloride 0.500 g/chlorhexidine digluconate solution 1.065 g corresponding to chlorhexidine digluconate 0.200 g 0.985 g/1.065 g Viscous liquid 125 ml, 300 ml bottles Brown PVC Bottles with a stopper (white PE) 12 Months INNOTHERA CHOUZY, Rue René Chantereau, Chouzy-Sur-Cisse 41150, Valloire-Sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL MEDIASOL PHARMACEUTICAL DEPOT LTD 2023-10-13 2028-10-12
77 Rwanda FDA-HMP-MA-0065 DERMOFIX Sertaconazole Nitrate 2%/ 20mg/g Cream Tube TUBE LINED WITH A LACQUER OF EPOXIDE & PHENOLIC RESINS, CAP MADE OF HDPE 36 Months FERRER INTERNACIONAL, S.A Joan Buscalla 1-9-08173-Sant Cugat del Valles (Barcelona), Spain SPAIN FERRER INTERNACIONAL, S.A GOMHS LTD 2021-06-01 2026-06-01
78 Rwanda FDA-HMP-MA-0806 DESLOR 5 MG Desloratadine 5mg 5mg Film coated tablets 15 tablets Box, placed in PVC-Aluminum blisters of 15 tablets each. 36 Months LES LABORATOIRES MÉDIS, BP 206 Km 7-Nabeul, 8000 Nabeul, Tunisia. TUNISIA LES LABORATOIRES MÉDIS KIPHARMA LTD 2024-01-15 2029-01-14
79 Rwanda FDA-HMP-MA-0211 DESLORA-DENK 5MG Desloratadine 5mg 5mg Film-coated tablets 10x10 Tablets PVC/Aclar - aluminium blister pack 24 Months DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-21 2027-12-20
80 Rwanda FDA-HMP-MA-0775 DESLORASTAL Desloratadine syrup 2.5mg/5ml 2.5mg/5ml Oral Liquid Syrup 60 ml Bottle Amber-coloured PET Bottle 24 Months STALLION LABORATORIES PRIVATE LIMITED. Unit-1Plot No. C-1B, 305/2,3,4&5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad-382 220, Gujarat, India INDIA STALLION LABORATORIES PVT. LTD SUN ENTERPRISES LTD 2024-01-30 2029-01-29
81 Rwanda FDA-HMP-MA-1666 DESLORASTAL DESLORATADINE 5MG TABLETS 3x10 Tablets Alu-Pvc blister pack 36 Months STALLION LABORATORIES PVT. LTD C-1B, 305/2, 3, 4 & 5 G.I.D.C. Kerala (Bavla), Dist.: Ahmedabad, Gujarat, India INDIA STALLION LABORATORIES PVT Ltd SUN ENTERPRISES LTD 2024-08-17 2029-08-16
82 Rwanda FDA-HMP-MA-1719 DEXAMED EYE/EAR DROPS Dexamethasone Sodium Phosphate USP 0.1%W/V EYE/EAR DROPS 10mL plastic droppers CLEAR PLASTIC DROPPERS CONTAINED IN A UNIT BOX 24 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16
83 Rwanda FDA-HMP-MA-1654 DEXAMETHASONE MEDIS DEXAMETHASONE PHOSPHATE 4MG/ML INJECTABLE SOLUTION 50 ampoules of 1ml Glass Ampoules 36 Months Les Laboratoires Médis Route de Tunis, Km7-B.P.206, 8000 Nabeul, Tunisia Tunisia Les Laboratoires Médis, Tunisia KIPHARMA LTD 2024-08-17 2029-08-16
84 Rwanda FDA-HMP-MA-1752 DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION USP Dexamethasone sodium phosphate USP 0.1 % w/v Eye Drops 1×10 mL HDPE BOTTLE 36 Months MERIT ORGANICS LTD. Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD. SUN ENTERPRISES LTD 2024-08-17 2029-08-16
85 Rwanda FDA-HMP-MA-2079 DEXO Dexamethasone Sodium Phosphate USP 4mg/ml Solution for injection 2ml Ampoule Amber Ampoule 24 Months KILITCH DRUGS (INDIA) LTD 37/39, Ujagar Industrial Estate, W.T.Patil Marg, Deonar, Mumbai- 400 088, Maharashtra INDIA INDIA KILITCH DRUGS (INDIA) LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16
86 Rwanda FDA-HMP-MA-1962 DIAFORMINE 1000 METFORMIN BP 1000MG TABLETS 3x10 Tablets Aluminium/PVC foil 36 month Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16
87 Rwanda FDA-HMP-MA-1963 DIAFORMINE 500 METFORMIN BP 500MG TABLETS 3x10 Tablets Aluminium/ PVC foil 36 Months Bliss GVS Pharma Limited Address: Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16
88 Rwanda FDA-HMP-MA-1923 DIAFORMINE 850 METFORMIN BP 850MG TABLETS 3x10 Tablets Aluminium & PVC foil. 24 Months Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 , India India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16
89 Rwanda FDA-HMP-MA-0499 DIAPRIDE PLUS 2 Glimepiride USP 2 mg and Metformin Hydrochloride BP 500 mg sustained release 2 mg and 500 mg Uncoated bi-layered sustained release tablets 3X10 tablets ALU/ PVC Blisters. Such 3 Blisters are packed in a printed outer carton along with a pack insert 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10
90 Rwanda FDA-HMP-MA-2273 DIARTEM IG ADULT DIHYDROARTEMISININ/ PIPERAQUIN 120MG/960MG TABLETS 3 tablets per blister Aluminium laminate/ Aluminium foil blisters 36 Months BLISS GVS PHARMA LTD Plot 10, 11-A, 12; Survey No. 38/1, dewan Udyog Nagar, Aliyali, Palghar, District- Thane -401404. INDIA IMEX PHARMA Mediasol Pharmaceutical Depot Ltd 2025-05-12 2030-05-11
91 Rwanda FDA-HMP-MA-0952 DIAZAC 10 Dapagliflozin IH 10mg 10 mg Film Coated Tablets 3x10 Tablets Alu-PVC/PVDC Blister. 3 such blisters packed in a printed carton along with pack insert 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA(A) LTD 2024-02-26 2029-02-25
92 Rwanda FDA-HMP-MA-0951 DIAZAC 5 Dapagliflozin 5 mg 5 mg Film Coated Tablets 3x10 Tablets Alu-PVC/PVDC Blister. 3 such blisters packed in a printed carton along with pack insert. 24 Months AJANTA PHARMA LIMITED, Z/103/A, Dahej SEZ II, Bharuch-392 130, Dist. Bharuch, Gujarat State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA(A) LTD 2024-02-26 2029-02-25
93 Rwanda FDA-HMP-MA-1786 DICARD Sacubitril and valsartan 24.30 mg/25.70mg Tablets 3x10 Tablets ALU/PVC BLISTER 24 Months COSMOS LIMITED Rangwe Road; Off Lunga Road, Industrial Area, P. O. Box 41433, Gpo 00100 - Nairobi, Kenya. KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16
94 Rwanda FDA-HMP-MA-1701 DICLO-DENK 100 RECTAL DICLOFENAC SODIUM 100MG SUPPOSITORIES 10 suppositories PVC/PVDC/PE foil 36 month Haupt Pharma Wülfing GmbH Bethelner Landstr. 18 31028 Gronau Germany DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Germany ETS CONTINENTAL Depot Pharmaceutique 2024-08-17 2029-08-16
95 Rwanda FDA-HMP-MA-2281 DICLO-DENK 100 RETARD DICLOFENAC SODIUM 100MG PROLONGED-RELEASE TABLETS 10 or 100 tablets PVC/PVDC/Aluminium blister 36 months DENK PHARMA GmbH & Co. KG Prinzregentenstr. 79, 81675 München Production site: Göllstr.1, 84529 Tittmoning Germany DENK PHARMA GmbH & Co. KG, Germany HERILY-AGENCE DE MARKETING LTD 2025-05-12 2030-05-11
96 Rwanda FDA-HMP-MA-1142 DICLOFENAC 100 Diclofenac sodium 100 mg 100 mg Suppositories 2x 5 suppositories Blister strips of composite foil made of PVC laminated low-density polyethylene (LD-PE) 36 Months FULTON MEDICINALI S.p.A., Via G. Marconi n. 28/9-20044, Arese Milan– Italy ITALY FULTON MEDICINALI S.P.A. UBIPHARM-RWANDA LTD 2024-04-27 2029-04-26
97 Rwanda FDA-HMP-MA-2214 DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG/3ML SOLUTION FOR INJECTION 1 or 5 ampoules Colourless neutral glass ampoules, glass type I 24 Months LEK PHARMACEUTICALS D.D. Verovškova ulica 57 1526 Ljubljana Slovenia SLOVENIA Sandoz GmbH SURGIPHARM (RWANDA) LTD 2025-02-04 2030-02-03
98 RWANDA-FDA23/HM/0116/0020 Diclofenac Sodium injection DICLOFENAC SODIUM 75MG PER 3ML Liquid for Injection 10x10's 36 Months REYOUNG PHARMACEUTICAL CO., Ltd. No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R. China China Reyoung Pharmaceutical Co., Ltd SUN ENTERPRISES LTD 2026-02-05 2031-02-04
99 Rwanda FDA-HMP-MA-2270 DICLOKANT-50 Diclofenac Sodium BP 50 mg TABLETS 10x10 Tablets Alu-PVC blister 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-10-10 2029-10-09
100 Rwanda FDA-HMP-MA-0816 DICLOMOL EC 50 Diclofenac Sodium BP 50 mg 50 mg Enteric-coated tablets 10x10 Tablets PVC/Aluminium foil blister 36 Months WIN-MEDICARE PVT. LTD. Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29
101 Rwanda FDA-HMP-MA-0815 DICLOMOL PLUS Diclofenac Sodium BP 50 mg and Paracetamol BP 500 mg 50 mg and 500 mg Tablets 10x10 Tablets PVC/Aluminium foil blister 36 Months WIN-MEDICARE PVT. LTD. Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29
102 Rwanda FDA-HMP-MA-0817 DICLOMOL SR Sustained release tablets of Diclofenac Sodium 100 mg 100 mg Film coated tablets 10x10 Tablets Clear PVC rigid film and Aluminum foil 0.25mm 36 Months WIN-MEDICARE PVT. LTD. Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29
103 Rwanda FDA-HMP-MA-1604 DICLOREN TABLETS Diclofenac Sodium BP 50 mg Tablets 10x10 Tablets Aluminium/PVC blister strip 24 Months RENE INDUSTRIES LTD Plot No.680, Kamuli, Kireka, Kampala, Uganda. India Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16
104 Rwanda FDA-HMP-MA-2307 DICLOSWISS Diclofenac Sodium 25mg/3ml Solution for injection 10 x 3 ml Ampoules Plain glass ampoules 36 Months SWISS PARENTERALS LTD 808, 809 & 810, Kerala Industrial Estate, GIDC, Nr. Bavla, Dist: Ahmedabad-382220, Gujarat, India INDIA SWISS PARENTERALS LTD Pharmaceutical and Medical Supplies Society Limited 2025-05-12 2030-05-11
105 Rwanda FDA-HMP-MA-1765 DICYNONE Etamsylate 250mg/2ml Solution for Injection 4 x 2 ml Ampoules TYPE I GLASS AMPOULE 60 Months DELPHARM Dijon,6 boulevard de l'europe 21800 Quetinyl,France FRANCE OM PHARMA SA KIPHARMA LTD 2024-08-17 2029-08-16
106 Rwanda FDA-HMP-MA- 1371 DICYNONE Etamsylate 500mg 500 mg Hard Gelatin Capsules 20 Capsules Lacquered aluminium and PVC/PVDC foils, housed in cardboard box 36 Months OM PHARMA SA Rue du Bois-du-Lan 221217 Meyrin,Switzerland SWITZERLAND OM PHARMA SA, SWITZERLAND KIPHARMA LTD 2024-05-18 2029-05-17
107 Rwanda FDA-HMP-MA-2047 DIFENASOL DICLOFENAC SODIUM 0.1% Eye drops solution 5ml LDPE Bottle in a cardboard box. 36 Months Ahlcon Parenterals (India) Ltd Ahlcon Parenterals (India) Ltd Address: SP 918, Phase III Bhiwadi 301019 Rajasthan, India Tel: +91 (01493) 225304,305,306,307 INDIA Exphar SA H&H Pharma Ltd 2024-09-30 2029-09-29
108 Rwanda FDA-HMP-MA-1432 DIGOXIN INJECTION BP Digoxin BP 0.25 mg/ml 0.25 mg/ml Solution for injection 5 Ampouls of 2 ml Amber USP type I Ampoules 36 Months CIRON DRUGS AND PHARMACEUTICALS PVT. LTD, N-118, N-119, N-113, Midc. Tarapur, Boisar, Dist, Thane-401506, Maharashtra, India INDIA CIRON DRUGS & PHARMACEUTICALS PVT. LTD RENE PHARMACY (R) LTD 2024-07-20 2029-07-19
109 Rwanda FDA-HMP-MA-1824 DIKON Diclofenac Sodium 75mg/3ml Injection 3x10x10 GLASS VIAL 36 Months REYOUNG PHARMACEUTICALS CO, LTD No.1 Ruiyang Road, Yiyuan Country, Zibo City, Shandong Province, P. R. China CHINA FARMASINO CO, LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16
110 Rwanda FDA-HMP-MA-1973 Dilconeurine Tablet VITAMIN B1 (Thiamine HCl), VITAMIN B6 (Pyridoxine HCl) & VITAMIN B12 (Cyanocobalamine) 100mg, 100mg & 100mcg Tablets 10x10 Tablets ALU-PVDC blister 36 Months CCL Pharmaceuticals (Pvt.) Ltd 62-Industrial Estate, Kot Lakhpat, Lahore-54770 ,Pakistan Pakistan CCL Pharmaceuticals (Pvt.) Ltd Depot Pharmaceutique Le Medical 2024-08-17 2029-08-16
111 Rwanda FDA-HMP-MA-1311 DILINCT DRY COUGH SYRUP Dextromethorphan hydrobromide 15 mg / 5 ml 15 mg / 5 ml Syrup 50ml, 100 ml and 200 ml bottles Labelled amber glass bottles with 28 mm Medropp Generic Cap and placed in a printed carton 24 Months ADCOCK INGRAM HEALTHCARE (PTY) LIMITED, Corner Axel Drive and Baksteen Road, Clayville, Olifantsfontein, Johannesburg, 1665, Republic of South Africa SOUTH AFRICA ADCOCK INGRAM HEALTHCARE (PTY) LIMITED, SOUTH AFRICA SURGIPHARM (RWANDA) LIMITED 2024-05-16 2029-05-15
112 Rwanda FDA-HMP-MA-0593 DINAC GEL Diclofenac Diethylamine BP, 1.16% 0.0116 Gel 20gm Tube Collapsible Aluminium Tube 36 Months S KANT HEALTHCARE LTD. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12
113 Rwanda FDA-HMP-MA-1330 DIOCLAV 1G Amoxicillin Trihydrate 875mg + Potassium Clavulanate 125mg 875mg, 125mg Film Coated Tablets 5 ×2 tablets Alu-Alu foil laminated with LDPE 24 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO.(SAOC), Street No. 15, Rusayl Industrial Area, Muscal Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO.(SAOG) SUN ENTERPRISES LTD 2024-05-18 2029-05-17
114 Rwanda FDA-HMP-MA-0914 DIOCLAV 625 MG Amoxicillin trihydrate 500mg and Clavulante Potassium 125mg 500mg and 125mg Film coated tablets 7x2 Tablets Alu-Alu foil laminated with LDPE. These strips in a carton 36 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), P.O Box 120, Rusayl, Postal code 124, Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), SULTANATE OF OMAN SUN ENTERPRISES LTD 2024-02-22 2029-02-21
115 Rwanda FDA-HMP-MA-1670 DIPARA DICLOFENAC SODIUM BP + PARACETAMOL BP 50MG/500MG TABLETS 10x10 Tablets Alu-PVC Blister Pack 36 Months STALLION LABORATORIES PVT. LTD C-1B, 305/2, 3, 4 & 5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad-382 220, Gujarat, India India STALLION LABORATORIES PVT Ltd GLAXO PHARMA WHOLESALE LTD 2024-08-17 2029-08-16
116 Rwanda FDA-HMP-MA-1501 DISLEP 25MG LEVOSULPIRIDE 25MG TABLET 20 Tablets Aluminum/PVC/PVDC blisters packed in a carton box with literature insert 60 Months DOPPEL FARMACEUTICI S.R.L., Via Volturno, 48, Quinto de’ Stampi, 20089 ROZANO (MI), Italy ITALY Ferrer Internacional, S.A. GOMHS Ltd 2024-07-27 2029-07-26
117 Rwanda FDA-HMP-MA-1216 DISTEM TABLETS Methocarbamol 380mg & Paracetamol 300mg 380mg /300mg Tablet 50 tablets PVC- Aluminium blister pack 60 Months FAES FARMA, S.A Máximo Aguirre 14-48940 Leioa (Biscay) Spain SPAIN FAES FARMA, S.A., SPAIN GOMHS LTD 2024-05-06 2029-05-05
118 Rwanda FDA-HMP-MA-1458 DNS Sodium Chloride 0.9% w/v and Anhydrous Glucose 5.0% w/v 0.9% w/v and 5.0% w/v Solution for Intravenous (IV) Infusion 250mL and 500 mL Bottles Low Density Polyethylene plastic bottles overwrapped with a protective plastic pouch made of biaxially oriented polyethylene 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono. P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2024-07-20 2029-07-19
119 Rwanda FDA-HMP-MA-1178 DNS 500 ML Sodium Chloride (0.9%w/v) & Glucose (5%w/v) (0.9%w/v) & (5%w/v) Intravenous solution 500 ml Bottle Bottle made of Plastic granule and Protective cap. 36 Months ACULIFE HEALTHCARE PRIVATE LIMITED, Sachana, Taluka: Viramgam, District: Ahmedabad, 382150, Gujarat, India INDIA ACULIFE HEALTHCARE PRIVATE LIMITED SUN ENTERPRISES LTD 2024-05-06 2029-05-05
120 Rwanda FDA-HMP-MA-2169 DOBATAF-3 Dolutegravir, Emtricitabine and Tenofovir Alafenamide 50 mg/200 mg/25 mg TABLETS 30’s & 90’s HDPE Container 24 Months APL HEALTHCARE LIMITED Unit- IV), (Formerly known as Aurobindo Pharma Limited, Unit-X) Plot No.16, APIIC , Multi Products SEZ,Menakuru Village, Naidupeta Mandal Tirupati District, Andhra Pradesh INDIA Aurobindo Pharma Limited PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2025-01-09 2030-01-08
121 Rwanda FDA-HMP-MA-1807 DOBESIL Calcium Dobesilate Monohydrate Capsules 500 mg Capsules 5 x 10’s Capsules Alu /PVDC Blister 36 Months Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2024-08-17 2029-08-16
122 Rwanda FDA-HMP-MA-2327 DOBESIL H CREAM 30 GRM CALCIUM DOBESILATE 0.5 %, LIDOCAINE 3.0 % W/W, HYDROCORTISONE ACETATE 0.25 % W/W & ZINC OXIDE 5.0 % 0.5 %, 3.0 % W/W, 0.25 % W/W & 5.0 % CREAM 30G TUBE ALUMINIUM TUBE OF 30G 24 MONTHS AUROCHEM LABORATORIES (I) PVT LTD 58, PALGHAR TALUKA, INDUSTRIAL CO.-OP. ESTATE LTD. PALGHAR-401 404, DISTRICT THANE, MAHARASHTRA, INDIA INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2025-07-11 2030-07-10

Registered
123 Rwanda FDA-HMP-MA-0717 DOCETAXEL Docetaxel, 80mg/8ml 80mg/8ml Solution for infusion Vial of 8ml Clear type I glass vial of 8ml with rubber stopper and Aluminum crimp cap, with or without a protective plastic overwrap (OnkoSafe) 24 Months FAREVA UNTERACH GmbH, Mondseestrasse 11 4866 Unterach, AUSTRIA AUSTRIA SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14
124 Rwanda FDA-HMP-MA-0718 Docetaxel Docetaxel, 20mg/2ml 20mg/2ml Solution for infusion Vial of 8ml Clear type I glass vial of 8ml with rubber stopper and Aluminum crimp cap, with or without a protective plastic overwrap (OnkoSafe) 24 Months FAREVA UNTERACH GmbH, Mondseestrasse 11 4866 Unterach, AUSTRIA AUSTRIA SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14
125 Rwanda FDA-HMP-MA-1801 DOCETAXEL IMPACT Docetaxel 100 unit/ml Solution for injection 7 ml Vial CLEAR GLASS (TYPE I) VIAL 24 Months SANOFI-AVENTIS DEUTSCHLAND GmbH INDUSTRIEPARK HOCHST-BRUNINGSTRABE 50,65926 FRANKFURT AM MAIN GERMANY SANOFI-AVENTIS DEUTSCHLAND GmbH KIPHARMA LTD 2024-08-17 2029-08-16
126 Rwanda FDA-HMP-MA-1232 DOCETAXEL IMPACT 80MG/4ML Docetaxel 80mg/4ml 80mg/4ml solution for infusion 7 ml Vial Glass vials 36 Months SANOFI-AVENTIS DEUTSCHLAND GmbH, Industriepark Höchst, 65926 Frankfurt am Main, Germany GERMANY SANOFI-AVENTIS SOUTH AFRICA (PVT) LTD. KIPHARMA LTD. 2024-05-06 2029-05-05
127 Rwanda FDA-HMP-MA-1595 DOL-P TABLET Tramadol and Paracetamol 37.5 mg/325 mg Tablets 1x10 Tablets Alu/Alu Blister 24 Months Genix Pharma (Pvt) Ltd 44, 45B, Korangi Creek Road, Karachi. Pakistan Pakistan Genix Pharma (Pvt) Ltd Bonte Pharma 2024-08-17 2029-08-16
128 Rwanda FDA-HMP-MA-1969 DOLIMEX 1000 PARACETAMOL BP 1000MG POWDER FOR ORAL SOLUTION 8 Sachets of 4g Glassin paper + Aluminium + LDPE Laminated foil 24 months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane - 401404, India India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16
129 Rwanda FDA-HMP-MA-1970 DOLIMEX 500 PARACETAMOL BP 500MG POWDER FOR ORAL SOLUTION 12 Sachet of 4g Glassin paper + Aluminium + LDPE laminated foil 24 months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane - 401404, India India IMEX PHARMA, Maurice KIPHARMA LTD 2024-08-17 2029-08-16
130 Rwanda FDA-HMP-MA-1305 DOLIMEX SUPPOSITORIES 250 MG Paracetamol BP 250mg 250 mg Suppositories 2 Strip of 5 Suppositories Polyvinyl Chloride / Polyethylene (PVC/PE) foil packed in monocarton. 36 Months BLISS GVS PHARMA LTD, Plot 10, 11-A, 12 Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, District-Thane – 401404, INDIA. INDIA IMEX PHARMA, MAURITIUS MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-05-16 2029-05-15
131 Rwanda FDA-HMP-MA-0558 DOLIMEX ® PERF Paracetamol for Injection 10mg/ml 10mg/ml Solution for injection 100ml flexible bag Flexible bag 24 Months CARELIDE Rue Michel Raillard 59420 Mouvaux, France. FRANCE IMEX PHARMA KIPHARMA LTD 2023-10-05 2028-10-04
132 Rwanda FDA-HMP-MA-1971 DOLIMEX-200 PARACETAMOL BP 200MG POWDER FOR ORAL SOLUTION 12 Sachets of 4 g Glassin paper + Aluminium + LDPE laminated foil 24 months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane - 401404, India India IMEX PHARMAAdresse : Rose Belle Building, Unit 3 – Rose Belle Business ParkPays : MauriceE-Mail : contact@imex-group.frTéléphone : 00 230 628 0973 KIPHARMA LTD 2024-08-17 2029-08-16
133 Rwanda FDA-HMP-MA-2076 DOLIMEX-300 PARACETAMOL BP 300MG POWDER FOR ORAL SOLUTION 12 Sachet of 4g Sachet of laminated foil (Glassin paper + Aluminium + LDPE). 24 Months Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 INDIA India IMEX PHARMA, Maurice KIPHARMA LTD 2024-08-17 2029-08-16
134 Rwanda FDA-HMP-MA-0603 DOLIPRANE 2.4% SUSPENSION Paracetamol, 24 mg/ml 24 mg/ml Suspension 100ml Bottle Amber glass (type III) bottles sealed with a childproof screw cap and tamper-evident ring. 24 Months A. NATTERMANN & Cie. GmbH, Nattermannallee 1 50829 Köln, Germany GERMANY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-10-13 2028-10-12
135 Rwanda FDA-HMP-MA- 0682 DOLOACT GEL Ketoprofen BP 2.50 % w/w and Capsicum Oleoresin USP 0.25 % w/w 2.50 % w/w and 0.25 % w/w Gel 30g gel Tube Aluminiun tube 24 Months AUROCHEM LABORATORIES (I) PVT LTD, 8, Palghar Taluka Ind. Co-op. Est. Ltd. Palghar-401 404, India INDIA OCHOA LABORATORIES, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09
136 Rwanda FDA-HMP-MA-1072-R1 DOLOWIN Aceclofenac 100mg 100mg Tablets 3x10 Tablets Alu/Alu Blister Pack. Such 3 blisters are in a carton along with a package insert 36 Months MICRO LABS LIMITED No 92, Sipcot, Industrial Complex, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25
137 Rwanda FDA-HMP-MA-0692 DOLOWIN-PLUS Aceclofenac 100mg and Paracetamol 500mg 100mg and 500mg Film-coated tablets 1x10’s Tablets Alu/PVC blister pack 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29
138 Rwanda FDA-HMP-MA-0767 DOLOWIN-SR Aceclofenac 200mg 200mg Film-coated sustained release tablets 3x10’s Tablets Alu/Alu blister pack. Such 3 blisters are packed in carton along with pack insert. 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29
139 Rwanda FDA-HMP-MA-1716 DOLUTEGRAVIR Dolutegravir 50mg Tablets 30’s, 60’s & 90 Tablets HDPE 48 Months MICRO LABS LIMITED Plot No. S-155 to S-159 & N1, Phase III & IV, Verna Industrial Estate, Verna INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICAL (RWANDA) LIMITED 2024-08-17 2029-08-16
140 Rwanda FDA-HMP-MA-0048 DOLUTEGRAVIR (AS SODIUM), LAMIVUDINE, TENOFOVIR DISOPROXIL Dolutegravir (As Sodium), Lamivudine, Tenofovir Disoproxil Fumarate 50 mg, 300 mg, 300 mg Film Coated Tablet 30 And 90 Tablets WHITE HDPE CONTAINER 24 Months CIPLA LIMITED Cipla Goa Unit VII and (Unit VII PD II) Address: Plot No. S- 103 to S- 105, S-107 to S-112 & L-147, L-147/1 to L147/3, L-147/A & L-138, Verna Industrial Estate, Verna, Salcette, Goa – 403 722, India INDIA CIPLA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-03-17 2026-03-17

Grace Period
141 RwandaFDA-HMP-MA-0485 DOLUTEGRAVIR (SODIUM) / LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Dolutegravir (sodium)/ lamivudine/ tenofovir disoproxil fumarate 50mg/ 300mg/ 300mg 50mg/ 300mg/ 300mg Film coated tablets 30’s and 90 Tablets HDPE Bottles 24 Months CELLTRION PHARM, INC. 82, 2 sanda-ro, Ochangeup, Cheongwon-gu, Cheonju-si, Chung-cheongbukdo, Republic of Korea REPUBLIC OF KOREA CELLTRION, INC. KIPHARMA LTD 2023-09-06 2028-09-05
142 Rwanda FDA-HMP-MA-0619 DOLUTEGRAVIR 50 MG FILM-COATED TABLETS Dolutegravir (as dolutegravir sodium) 50 mg 50 mg Film-coated tablets 30 tablets and 90 tablets 50 cc white HDPE Bottle 24 Months CIPLA LIMITED, Indore Unit-IV Plot: No.9, 10 and 15, Indore Special Economic Zone, Phase II, Pithampur, District Dhar, India INDIA CIPLA LIMITED, INDIA PHILLIPS PHARMACEUTICALS RWANDA LTD 2023-12-02 2028-12-01
143 Rwanda FDA-HMP-MA-1164 DOLUTEGRAVIR 50MG TABLETS Dolutegravir Sodium 50 mg 50 mg Film coated Tablets 30 & 90 tablets HDPE Bottles 24 Months LAURUS LABS LIMITED (UNIT II), Plot No.19,20 & 21, Western sector, APSEZ, Atchutapuram Mandal, Vasakhapatnam district, Andhra Pradesh, 531011, India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-04-20 2029-04-19
144 Rwanda FDA-HMP-MA-2236 DOLUTEGRAVIR AND LAMIVUDINE TABLETS DOLUTEGRAVIR AND LAMIVUDINE 50 mg/ 300 mg TABLETS 30 TABLETS and 90 TABLETS HDPE Bottles 24 Months CIPLA LIMITED Goa (Unit-VII) and (Unit VII- PD II), Plot No. S- 103 to S- 105, S-107 to S-112, L-147, L-147/1 to L-147/3, L-147/A & L- 138, Verna Industrial Estate, Verna, Salcette, Goa – 403 722 India CIPLA LIMITED Phillips Pharmaceuticals (Rwanda) Ltd 2025-02-04 2030-02-03
145 1074-Rwanda FDA-2019-R1 DOLUTEGRAVIR SODIUM Dolutegravir Sodium 50mg Tablets 30 Tablets HDPE BOTTLE 36 Months AUROBINDO PHARMA LIMITED Unit-III, Survey No. 313, Bachupally village, Bachupallapur Mandal, Ranga Reddy District (A.P), INDIA INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16
146 Rwanda FDA-HMP-MA-2172 DOLUTEGRAVIR SODIUM 50MG, LAMIVUDINE USP 300 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG DOLUTEGRAVIR SODIUM, LAMIVUDINE USP, TENOFOVIR DISOPROXIL FUMARATE 50 MG, 300 MG, 300 MG TABLETS 30 TABLETS; 90 TABLETS and 180 TABLETS HDPE container 36 Months CIPLA LTD Goa Unit VII, Unit VII PD II Plot No. S-103 to S-105, S-107 to S-112 & L-147, L-147/1 to L-147/3, L-147/A & L-138 Verna Industrial Estate, Verna, Salcette, Goa – 403 722 INDIA CIPLA LTD PHILIPS PHARMACEUTICALS (RWANDA) LTD 2025-01-09 2030-01-08
147 Rwanda FDA-HMP-MA-0259 DOLUTEGRAVIR SODIUM TABLET FOR ORAL SUSPENSION (DISPERSIBLE TABLETS) 10MG Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets) 10mg 10mg Tablet for Oral Suspension (Dispersible Tablets) 90 tablets HDPE container packed in a carton along with pack insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, Distt. Solan, Himachal Pradesh, 174101, India. INDIA MACLEODS PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11
148 Rwanda FDA-HMP-MA- 0968 DOLUTEGRAVIR SODIUM TABLETS 50MG Dolutegravir Sodium 50 mg 50 mg Film coated tablets 30 Tablets HDPE container packed in a carton along with pack Insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam. Daman, PIN – 396210 India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25
149 Rwanda FDA-HMP-MA-0106 DOLUTEGRAVIR SODIUM, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 50/300/300MG Dolutegravir Sodium 50, Lamivudine 300 And Tenofovir Disoproxil Fumarate 300mg 50/300/300mg Biconvex, Film Coated Tablets Debossed With “C” On One Side & Plain On Other Side 30 & 90 Tablet HDPE BOTTLE 24 Months CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED Address: Plot 1-7, pt Ring Road, Luzira Industrial Park, Uganda UGANDA CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED, SURGIPHARM (RWANDA) LTD 2022-03-22 2027-03-22
150 1075-Rwanda FDA-2019-R1 DOLUTEGRAVIR SODIUM/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE-50/ 300/300 Dolutegravir Sodium, Lamivudine, Tenofovir Disoproxil Fumarate 50mg, 300mg, 300mg Tablets 30 Tablets HDPE BOTTLE 36 Months AUROBINDO PHARMA LIMITED Unit-III, Survey No. 313, Bachupally village, Bachupallapur Mandal, Ranga Reddy District (A.P), INDIA INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16
151 Rwanda FDA-HMP-MA-0245 DOLUTEGRAVIR TABLETS 50MG Dolutegravir Sodium 50mg 50mg Film-coated tablets 30 Tablets 40cc white HDPE Container with 33mm polypropylene child resistant Cap 24 Months STRIDES PHARMA SCIENCE LIMITED, KRS Gardens Tablet Block 36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk, Bengaluru – 562 106 INDIA INDIA STRIDES PHARMA SCIENCE LIMITED, India SUN ENTERPRISES LTD 2023-05-12 2028-05-11
152 Rwanda FDA-HMP-MA-0349 DOLUTEGRAVIR TABLETS 50MG Dolutegravir 50mg 50mg Film Coated Tablets 30 tablets HDPE bottles 36 Months MYLAN LABORATORIES LIMITED Plot no: 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase-II, Sector-III, Pithampur – 454775 Dist. Dhar (MP) India. INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2023-07-08 2028-07-07
153 Rwanda FDA-HMP-MA-2008 Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets 50 mg / 200 mg / 25 mg Dolutegravir, Emtricitabine and Tenofovir Alafenamide 50 mg / 200 mg / 25 mg Tablets 30’s HDPE container, 100’s HDPE container HDPE container 24 months M/s. Hetero Labs Limited Unit-III, 22-110, IDA, Jeedimetla, Hyderabad - 500055, Telangana India Hetero Labs Limited Sun Enterprises Limited 2024-08-17 2029-08-16
154 Rwanda FDA-HMP-MA-0935 DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR ALAFENAMIDE TABLETS Dolutegravir Sodium, Lamivudine and Tenofovir Alafenamide Fumarate 50 mg/300 mg/25 mg 50 mg/300 mg/25 mg Film Coated Tablets 30 Tablets, 90 Tablets and 180 Tablets HDPE Bottles 30 Months LAURUS LABS LIMITED, (Unit-II), Plot No: 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam District, Andhra Pradesh, 531011-India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2024-02-26 2029-02-25
155 Rwanda FDA-HMP-MA-2112 Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate 50 mg / 300 mg / 300 mg Tablets 30’s, 90’s & 180 Tablets HDPE Bottle 36 Months MICRO LABS LIMITED Address: Plot No. S-155 to S-159 & N1, Phase III & IV, Verna Industrial Estate, Verna Salcette Goa – 403722 India MICRO LABS LIMITED Wessex Pharmaceuticals (Rwanda) Ltd 2024-10-18 2029-10-17
156 Rwanda FDA-HMP-MA-1936 DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET 50MG,300MG & 300MG DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 50MG+300MG+300MG TABLETS 30’s,60’s,90’s,180 Tablets 120cc,200cc,300cc and 400cc Round Opaque White HDPE Bottles 24 Months LUPIN Limited Unit 1, Plot No. 6A1, 6A2, Sector-17, Special Economic Zone, MIHAN Notified Area, Nagpur, Maharashtra-4411 08 India LUPIN Limited Aiveen (R) Ltd 2024-08-17 2029-08-16
157 Rwanda FDA-HMP-MA-0937 DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE Dolutegravir sodium 50 mg, Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg 50mg/300mg/300mg Film coated tablets 30 Tablets and 90 Tablets 30 tablets in white opaque 100 cc HDPE bottles filled with 1gm silica gel canister closed with 38 mm child resistant closures. 90 Tablets: white opaque 250 cc hdpe bottles filled with 1gm silica gel canister closed with 53 mm child resistant closures 24 Months LAURUS LABS LIMITED, (Unit-Il), Plot No: 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam District, and Andra Pradesh, India. 531011-India. INDIA LAURUS LABS LIMITED, INDIA CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2024-02-26 2029-02-25
158 Rwanda FDA-HMP-MA-0261 DOLUTEGRAVIR/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE 50/300/300MG TABLETS Dolutegravir sodium/Lamivudine USP/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg 50mg/300mg/300mg Film coated tablets 30, 90, 100, & 180 tablets HDPE containers and CT Closure with 3x3 gm silica sachets in carton with leaflet 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N 2, Village Theda P.O. Lodhi Majra, Tehsil Baddi Dist.: Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11
159 Rwanda FDA-HMP-MA-1257 DOM R CAPSULES Rabeprazole Sodium 20 mg & Domperidone 30 mg 20 mg & 30 mg Hard Gelatin Capsules 10 Capsules Alu/Alu Blister 24 Months CORONA REMEDIES PRIVATE LIMITED, Village Jatoli, Post Office - Oachghat, Tehsil Solan, Dist. Solan, Himachal Pradesh – 173223 India INDIA I-CARE PHARMA LIMITED AIVEEN (R) LTD 2024-05-06 2029-05-05
160 Rwanda FDA-HMP-MA-1276 DOPAMET TABLETS Methyldopa BP 250 mg 250 mg Film Coated Tablets 1000 Tablets and 10x10 tablets Jar pack & Blister pack 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06
161 Rwanda FDA-HMP-MA-1950 DOXIL-100 DOXYCYCLINE BP 100MG TABLETS 10x10 Tablets ALU/PVC BLISTER 36 Months MAXTAR BIO-GENICS K. No. 705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - 173205 India INDIA MAXTAR BIO-GENICS SUN ENTEPRISES LTD 2024-08-17 2029-08-16
162 Rwanda FDA-HMP-MA-0535 DOXORUBICIN HYDROCHLORIDE Doxorubicin hydrochloride 2mg/ml 2mg/ml Concentrate solution for infusion 1 Vial Type I amber glass vial, closed with rubber stoppers and subsequently sealed with aluminium crimp caps. 24 Months FAREVA UNTERACH GmbH, Mondseestraße 11, 4866 Unterach, Austria. AUSTRIA SANDOZ GmbH, Kundl SURGIPHARM (RWANDA) LTD 2023-10-05 2028-10-04
163 Rwanda FDA-HMP-MA-0701 DOXY 200 Doxycycline monohydrate 200mg 200mg Tablets 8 Tablets Blister (PVC-Aluminium) of 8 tablets in a cardboard box 36 Months GRACURE PHARMACEUTICALS LIMITED, E- 1105, Industrial Area, Phase-III BHIWADI, PIN-301019 Dist. Alwar, Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2024-01-08 2029-01-07
164 Rwanda FDA-HMP-MA-2158 DOXY CAPSULES DOXYCYCLINE 100MG CAPSULES 10 x 10 Tablets Alu / PVC blister packs 36 Months LABORATORY & ALLIED LIMITED Plot No:209/10349, Opposite Sameer Business Park, Mombasa road, Kenya KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-10-18 2029-10-17
165 Rwanda FDA-HMP-MA-0520 DOXY-DENK 100 Doxycycline 100 mg 100 mg Tablets 20 tablets PVC/PE/PVDC/aluminium blisters 36 Months ARTESAN PHARMA GmbH & Co. KG Wendlandstr. 1, 29439 Lüchow Production site: Wendlandstr. 1, 29439 Lüchow, Germany GERMANY DENK PHARMA GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-10-13 2028-10-12
166 Rwanda FDA-HMP-MA-0396 DOXY-DENK 200 Doxycycline 200mg 200mg Film-coated tablets 8 film-coated tablets PVC/PE/PVDC/aluminium blisters 18 Months DENK PHARMA GmbH & Co. KG Address: Göllstr.1 84529 Tittmoning Country: Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-08-24 2028-08-23
167 Rwanda FDA-HMP-MA-2297 DREZ OINTMENT IODINATED, PROVIDONE & METRONIDAZOLE OINTMENT 5%, 5% & 1% OINTMENT 10g & 30g Amber Glass Bottle 24 Months STEDMAN PHARMACEUTICALS PVT. LTD C-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur 603 110, Tamil Nadu, Country: INDIA INDIA STEDMAN PHARMACEUTICALS PVT. LTD ESCORTS PHARMACEUTICALS (RWANDA) Limited 2025-05-12 2030-05-11
168 Rwanda FDA-HMP-MA-2298 DREZ POWDER IODATED, PROVIDONE & METRONIZADOLE POWDER 5%, 5% & 1% POWDER 10g HDPE Bottle 24 Months STEDMAN PHARMACEUTICALS PVT. LTD C-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur 603 110, Tamil Nadu, Country: INDIA INDIA STEDMAN PHARMACEUTICALS PVT. LTD ESCORTS PHARMACEUTICALS (RWANDA) Limited 2025-05-12 2030-05-11
169 Rwanda FDA-HMP-MA-2296 DREZ SOLUTION IODATED, PROVIDONE & METRONIZADOLE SOLUTION 30ML/100ML/500ML SOLUTION 30ML Amber Glass Bottle 24 Months STEDMAN PHARMACEUTICALS PVT. LTD C-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur 603 110, Tamil Nadu, Country: INDIA INDIA STEDMAN PHARMACEUTICALS PVT. LTD ESCORTS PHARMACEUTICALS (RWANDA) Limited 2025-05-12 2030-05-11
170 Rwanda FDA-HMP-MA-2074 DREZ-V GEL MICONAZOLE NITRATE & METRONIDAZOLE GEL 2%, 1% GEL 30 g and 5 g tubes Aluminium tubes & Applicator packed in a carton 24 Months STEDMAN PHARMACEUTICALS PVT. LTD C-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur 603 110, Tamil Nadu, INDIA INDIA STEDMAN PHARMACEUTICAL, PVT. LTD ESCORTS PHARMACEUTICALS LTD 2024-08-17 2029-08-16
171 Rwanda FDA-HMP-MA-1674 DT-ZINC ZINC SULPHATE 10 MG DISPERSIBLE TABLETS 10x10 Tablets PVC/PVDC Aluminum foil blister 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India India AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16
172 Rwanda FDA-HMP-MA-0256 DUOCETZ Paracetamol 325mg & Tramadol Hydrochloride 37.5mg 325mg & 37.5mg Film-coated tablets 3 x 10 film-coated tablets ALU-PVC/PVDC blisters packed in a cardboard carton along with a pack insert 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LTD 515/1 MOO 4, SOI 8, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280. Thailand THAILAND MEGA LIFE SCIENCES PUBLIC COMPANY LTD, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
173 Rwanda FDA-HMP-MA-0231 DUOSKIN® CREAM Isoconazole nitrate 10mg/g (1%) and Diflucortolone valerate 1mg/g (0.1%) 10mg/g (1%) and 1mg/g (0.1%) Cream 15 g Lacquered aluminium tube closed with a HDPD screw-cap 36 Months BILIM ILAÇ SANAYI VE TICARET A.?. (BILIM PHARMACEUTICALS), GOSB, 1900 Sokak N°1904, 41480 Gebze – Kocaeli,Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2023-05-12 2028-05-11
174 Rwanda FDA-HMP-MA-0478 DUOTRAV EYE DROPS Travoprost, 40 micrograms/ml and Timolol mareate 6.8 mg/ml 40 micrograms/ml and 6.8 mg/ml Eye Drops Suspension 5 ml Bottle LDPE bottle with dispensing plug 24 Months S.A. ALCON-COUVREUR N.V., Rijksweg 14 B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23
175 Rwanda FDA-HMP-MA-0255 DUOVIR Lamivudine and Zidovudine 150 /300mg 150 /300mg Film-coated tablets 60 Tablets HDPE container 42 Months CIPLA LIMITED, Goa Unit VII, Plot No. S- 103 to S -105, S- 107 to S-112 & L-147 to L-147-1; Goa Unit III & IV, Plot No. L-139 to L -146; Verna Industrial Estate, Verna, Salcette, Goa 403722; Indore Unit IV, Plot No. 9, 10 & 15, Indore Special Economic Zone, Phase II, Pithampur, District Dhar, Pin Code: 454775, Madhya Pradesh, I, India INDIA CIPLA LIMITED, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-10-05 2028-10-04
176 RwandaFDA-HMP-MA-1868 DUPHALAC 200ML LACTULOSE 66.50% SYRUP 200 ml and 1000 ml HDPE 24 Months ABBOTT LABORATOIRES LTD Veerweg 12 8121 AA Olst The Netherlands. NETHERLANDS ABBOTT LABORATOIRES B.V SUN ENTERPRISES LTD 2024-08-17 2029-08-16
177 Rwanda-FDA-HM-1878 DUPHASTON DYDROGESTERONE 10MG TABLET This medicine is presented as flm-coated tablets. Box of 20 Strips made of PVC and aluminium. 60 Months Abbott Biologicals B.V Veerweg 12 8121 AA Olst Netherlands ABBOTT LABORATOIRES B.V LTD/ITALY Veerweg 12,81 21 AA O1st The NetherlandsTel: 0031-570-568211Fax: 0031-570-562899 SUN ENTERPRISES LTD 2024-08-17 2029-08-16
178 Rwanda FDA-HMP-MA-0742 DURART 600 Darunavir Ethanolate 600mg 600mg Film coated tablets 60 Tablets High Density Polyethylene (HDPE) bottle 36 Months MYLAN LABORATORIES LIMITED, Plot No. H-12 and H-13, MIDC, Waluj Industrial Area, Aurangabad-431136, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2024-01-05 2029-01-04
179 Rwanda FDA-HMP-MA-2114 DURART 800 Darunavir Tablets 800 mg Tablets 1x30 Tablets Aluminium induction 36 Months MYLAN LABORATORIES LIMITED Plot No. H-12 and H-13), MIDC, Waluj Industrial Area, Aurangabad-431136. Maharashtra India MYLAN LABORATORIES LIMITED Pyramid Pharma Limited 2024-10-18 2029-10-17
180 RwandaFDA-HMP-MA-1879 DUSPATALIN MEBEVERINE 200MG CAPSULES 30’s ALU/PVC BLISTER 36 Months ABBOTT BIOLOGICALS BV Abbott Biologicals B.V. Veerweg 12 8121 AA Olst The Netherlands NETHERLANDS ABBOTT BIOLOGICALS BV), Olst, TheNetherlands SUN ENTERPRISES LTD 2024-08-17 2029-08-16
181 Rwanda FDA-HMP-MA-2315 DUTASOLIN TAMSULOSINE + DUTASTERIDE 0.4MG+0.5MG Capsules 3x10 capsules ALU-ALU BLISTERS 36 Months GLOBELA PHARMA PVT. LIMITED PLOT NO. 358, ROAD NO. 3, SACHIN -GIDC., SURAT, 394230, GUJARAT INDIA INDIA GLOBELA PHARMA PVT. LIMITED AFRIPHARM LTD 2025-07-11 2030-07-10
182 RWANDA-FDA23/HM/0438/0010 DUTASOLIN TAMSULOSINE + DUTASTERIDE 0.4MG+0.5MG Capsules 3x10 capsules 36 Months PELLTECH HEALTH CARE PVT. LTD. India Globela Pharma Private Limited AFRIPHARM LTD 2025-09-23 2030-09-22
183 Rwanda FDA-HMP-MA-0516 DUXCOSPAN Hyoscine butyl bromide 10 mg tablets 10 mg Film-coated tablets 10 x 10 Tablets PVC/Aluminium blisters 36 Months UNIVERSAL CORPORATION LIMITED, Club Road, Plot No. 13777 P.O Box 1748-00902, Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED, KENYA SUN ENTERPRISES LIMITED 2023-10-13 2028-10-12
184 Rwanda FDA-HMP-MA-0637 DYGLI-100 Sitagliptin Tablets USP 100 100 mg Film coated tablets 3x10’s Tablets Alu/Alu blister pack (printed Aluminium foil/Sliver Base Foil). Such 3 blisters are packed in a printed carton with packing insert 24 Months BAFNA PHARMACEUTICALS LTD., Unit II, No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052. India. INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2023-12-02 2028-12-01
185 Rwanda FDA-HMP-MA-0636 DYGLI-50 Sitagliptin Tablets USP 50 50 mg Film coated tablets 3x10’s Tablets Alu/Alu blister pack (printed Aluminium foil/Sliver Base Foil). Such 3 blisters are packed in a printed carton with packing insert 24 Months BAFNA PHARMACEUTICALS LTD., Unit II, No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052. India. INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2023-12-02 2028-12-01
186 Rwanda FDA-HMP-MA-1775 DYGLI– M Sitagliptin Phosphate USP + Metformin Hydrochloride BP 50mg /1000 mg Tablets 3x10 Tables Alu/Alu Printed Aluminum foil / Alu/Alu base foil 24 Months BAFNA PHARMACEUTICALS LTD. No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052. India Tel: 0091 – 44 - 26320366 INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2024-08-17 2029-08-16
187 RwandaFDA-HMP-MA-1875 DYNACORT 30MG DEFLAZACORT 30MG TABLET 3 x 10’s ALU/PVC BLISTER 36 Months SKYBIOTECH LIFE SCIENCES PVT LTD Factory: Gut no.5, Gevrai Tanda, Paithan road, Aurangabad (M.S) India INDIA GALAXYPHARMACEUTICALSBuilding No. 36, Gala No. 2, 3, 4A, Kopar, Purna, Bhiwandi, Thane -421302, Mumbai (Maharashtra) INDIA;Telephone No: 022-49719061/022-49718955Email: info@galaxy-pharmaceuticals.com / md@galaxy-pharmaceuticals.com STAR BIOTECH RWANDA 2024-08-17 2029-08-16
188 RWANDA FDA-HMP-MA-1895 DYNACORT SUSPENSION Deflazacort Suspension 60ml 36 M/S SKYBIOTECH LIFESCIENCES PVT. LTD India STAR BIOTECH RWANDA 2029-08-16
189 RwandaFDA-HMP-MA-1895 DYNACORT SUSPENSION DEFLAZACORT 6MG/5ML SUSPENSION 60ml Amber Glass Bottle 36 Months M/s. Skybiotech Life sciences Pvt.Ltd. Gut no.5, Gevrai Tanda, Paithan road, Aurangabad (M.S) India. INDIA GALAXYPHARMACEUTICALSBuilding No. 36, Gala No. 2, 3, 4A, Kopar, Purna, Bhiwandi, Thane -421302, Mumbai (Maharashtra) INDIA;Telephone No: 022-49719061/022-49718955Email: info@galaxy-pharmaceuticals.com / md@galaxy-pharmaceuticals.com STAR BIOTECH RWANDA 2024-08-17 2029-08-16
190 Rwanda FDA-HMP-MA-1857 DYNACORT-18 DEFLAZACORT,18MG 18 mg Tablets 3 x 10’s tablets Alu-Alu Blister pack 36 months. SKYBIOTECH LIFE SCIENCES PVT LTD : Gut no.5, Gevrai Tanda, Paithan road, Aurangabad (M.S) India. India Star Biotech Limited 1st floor, Prestige House, Rwandex, Kigali-Rwanda Telephone: (+250) 785377688 / (+250) 787229914 Email: shantilal.bhanderi@yahoo.com STAR BIOTECH RWANDA 2024-08-17 2029-08-16
191 Rwanda FDA-HMP-MA-1001 DYNACORT-6 TABLETS Deflazacort 6 mg tablets 6mg Tablets 3 X 10 Tablets Alu-Alu blister and such blisters packed in a carton along with product insert 36 Months SKY BIOTECH LIFE SCIENCES PVT. LTD, Gut no.5, Gevrai Tanda, Paithan road, Aurangabad (M.S) India INDIA GALAXY PHARMACEUTICALS LTD, INDIA STAR BIOTECH LIMITED 2024-02-26 2029-02-25
192 Rwanda FDA-HMP-MA-1517 DYNAMOGEN ORAL SOLUTION ARGININE ASPARTATE 2.50% ORAL SOLUTION 20 drinkable ampoules of 10ml PVC/PVDC/PE material in amber colour with printed text in white colour in a carton box with package insert 12 Months FAES PHARMA SA Máximo Aguirre 14-48940 Leioa (Biscay) Spain Spain FAES PHARMA SA, GOMHS Ltd 2024-07-27 2029-07-26
193 Rwanda FDA-HMP-MA-0606 DYSEN FORTE TABLET Secnidazole, 1000 mg tablet 1000 mg Film coated tablet 2 tablets Alu-PVC blister pack. Each blister of is packed in printed carton 48 Months NABIQASIM INDUSTRIES (PVT) LTD. Factory:17/24, Korangi Industrial Area, Karachi-Pakistan Pakistan NABIQASIM INDUSTRIES (PVT) LTD AFRI HEALTH CARE LTD 2023-10-13 2028-10-12