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-1972 T-Sar Tablet 40mg Telmisartan BP 40mg Tablets 3x10 Tablets Alu-Alu blisters 24 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
2 RWANDA-FDA25/HM/0295/0048 Tacrocord 0.5 Tacrolimus Capsules USP 0.5 mg Capsules 24 Months Concord Biotech Limited India Prisma Pharma FZE PRAFIN RWANDA LTD 2025-12-12 2030-12-11
3 RWANDA-FDA25/HM/0300/0034 Tacrocord 1 TACROLIMUS USP 1 mg Capsules 24 Months Concord Biotech Limited India Prisma Pharma FZE PRAFIN RWANDA LTD 2025-10-16 2030-10-15
4 Rwanda FDA-HMP-MA-1759 TACROVATE FORTE OINTMENT Tacrolimus Ointment 0.1% w/w Ointment 10 grams LAMI TUBE 24 Months AUROCHEM LABORATORIES (I) PVT. LTD. 333, Gundecha Ind. Complex, Akurli Rd, Kandivali East Mumbai - 400 101, India INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2024-08-17 2029-08-16
5 Rwanda FDA-HMP-MA-0941 TADAFORCE Tadalafil USP 20mg 20mg Film coated tablets 1× 4 Tablets PVC/ALU Blister 36 Months AKUMS DRUGS AND PHARMACEUTICALS LTD, Plot no. 19,20 & 21, Sector-6A, IIE., SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED, INDIA. AIVEEN RWANDA LTD 2024-02-21 2029-02-20
6 Rwanda FDA-HMP-MA-0283 TADALIN-20 Tadalafil 20 mg 20 mg Film coated tablets 4 tablets ALU-PVC Blister packed in a printed baby Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
7 Rwanda FDA-HMP-MA-1112 TALIMUS 0.1% Tacrolimus Ointment 0.1% w/w 0.1% w/w Ointment 10 g tube Laminated tube along with Pack Insert 36 Months AJANTA PHARMA LIMITED, Mirza, Palashbari Road, Vill-Kokjhar, Kamrup(R), Guwahati, Assam-781128, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19
8 Rwanda FDA-HMP-MA-1351 TAMBALGIC Tramadol 37.5mg and Paracetamol 325mg 37.5 mg, 325mg Film Coated Tablets 2 x 10 Tablets Alu-Alu Pack, Packed in Printed and Laminated Carton 48 Months WEST-COAST PHARMACEUTICAL WORKS LTD, F.P. No17 & 16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad- 382481. Gujarat State (India) INDIA WEST-COAST PHARMACEUTICAL WORKS LTD DOLI PHARMA 2024-05-18 2029-05-17
9 Rwanda FDA-HMP-MA-0640 TAMCONTIN 0.4 CONTROLLED RELEASE TABLETS Tamsulosin Hydrochloride BP 0.4 mg 0.4 mg Enteric coated tablets 10x10’s Tablets Aluminium strips made up of printed Aluminium foil and plain foil 24 Months MODI-MUNDIPHARMA PRIVATE LIMITED, Modipuram -250110 Uttar Pradesh, India INDIA MODI-MUNDIPHARMA PVT. LTD SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01
10 Rwanda FDA-HMP-MA-0471 TAMOXIFEN Tamoxifen citrate 20mg 20mg Film coated tablet 30 Tablets Aluminium - Aluminium blister 36 Months SALUTAS PHARMA GmbH, Otto-von-GuerickeAllee 139179 Barleben Germany GERMANY SANDOZ GmbH BIOCHEMIESTRASSE SURGIPHARM (RWANDA) LTD 2023-09-06 2028-09-05
11 RWANDA-FDA25/HM/0100/0038 Tamsumac 0.4 TAMSULOSIN HYDROCHLORIDE USP 0.4 MG Hard Gelatin Capsules 36 Months Macleods Pharmaceuticals limited India MACLEODS PHARMACEUTICALS LTD AIVEEN (R) LTD 2025-10-16 2030-10-15
12 Rwanda FDA-HMP-MA-0156 TASIGNA 200MG Nilotinib hydrochloride monohydrate 200mg 200mg Hard gelatin capsules 28’s, 40’s, 112(4x28), 120(3x40), 392(14x28) capsules PVC/PVDC/Alu Blister multiple packs 36 Months NOVARTIS PHARMA STEIN AG, Schaffhauserstrasse 4332 Stein, Switzerland SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20
13 Rwanda FDA-HMP-MA-0447 TAVIN-EM Tenofovir Disoproxil Fumarate 300mg & Emtricitabine 200 mg 300mg & 200 mg Film coated tablets 30 tablets HDPE bottle 24 Months EMCURE PHARMACEUTICALS LTD, Plot No. P1 & P2, I.T.B.T. Park, Phase II, M.I.D.C. Hinjawadi, Pune – 411057, India. INDIA EMCURE PHARMACEUTICALS LTD, ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
14 Rwanda FDA-HMP-MA-2223 TAZOGARD PIPERACILLIN + TAZOBACTAM 400mg/500mg Powder for Injection 30 ml Vial USP type III Glass vial 36 Months AKUMS DRUGS & PHARMACEUTICALS LTD Plot No. 2, 3, 4 & 5, Sector-6B, IIE, Sidcul, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED AIVEEN (R) LTD 2025-02-04 2030-02-03
15 RWANDA-FDA25/HM/0185/0048 Tecnovula Clomiphene Citrate (Micronized) ORAL TABLET 36 Technopharma Egypt Egypt TechnoPharma Egypt HELIOS PHARMA Ltd 2026-03-18 2031-03-17
16 Rwanda FDA-HMP-MA-0131 TEGRETOL CR 200 Carbamazepine 200 mg 200 mg Film coated tablets 50’s Tablets PVC/PE/PVDC/Al foil 24 Months NOVARTIS FARMA S.p.A. Via Provinciale Schito 131, 80058 Torre Annunziata (NA), Italy ITALY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18
17 Rwanda FDA-HMP-MA-0158 TEGRETOL CR 400 MG Carbamazepine 400 mg 400mg Film coated tablets 50’s tablets PVC/PE/PVdC/ Al foil 24 Months NOVARTIS FARMA S.p.A. Via Provinciale Schito 131, 80058 Torre Annunziata (NA), Italy ITALY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20
18 Rwanda FDA-HMP-MA-0897 TEGRETOL ORAL SUSPENSION Carbamazepine 100mg/5ml Oral Suspension 100mg/5ml Oral suspension 100 ml Bottle Brown glass bottles with a child-resistant closure with tamper-proof ring packed in carton 36 Months DELPHARM HUNINGUE S.A.S, 26, rue de la Chapelle 68330 Huningue, France FRANCE NVS KENYA LIMITED, KENYA SURGIPHARM (RWANDA) LTD 2024-02-22 2029-02-21
19 Rwanda FDA-HMP-MA-2228 TELMI-40 TELMISARTAN 40MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03
20 Rwanda FDA-HMP-MA-2226 TELMI-40 AMH TELMISARTAN + AMLODIPINE + HYDROCHLOTHIAZIDE 40MG+ 5MG+ 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03
21 Rwanda FDA-HMP-MA-2230 TELMI-40 CT TELMISARTAN + CHLORTHALIDONE 40MG+ 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03
22 Rwanda FDA-HMP-MA-2231 TELMI-40 H TELMISARTAN + HYDROCHLOROTHIAZIDE 40MG + 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03
23 Rwanda FDA-HMP-MA-2227 TELMI-80 TELMISARTAN 80MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03
24 Rwanda FDA-HMP-MA-2225 TELMI-80 AMH TELMISARTAN + AMLODIPINE + HYDROCHLOTHIAZIDE 80MG + 5MG + 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03
25 Rwanda FDA-HMP-MA-2224 TELMI-80 CT TELMISARTAN + HYDROCHLOROTHIAZIDE 80MG +12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03
26 Rwanda FDA-HMP-MA-2229 TELMI-80 H TELMISARTAN + HYDROCHLOROTHIAZIDE 80MG + 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03
27 Rwanda FDA-HMP-MA-1108 TELMICLAR 40 Telmisartan USP 40mg 40 mg Uncoated tablet 3x 10 tablets Alu-PVC/Alu blisters packed in a carton box along with pack insert 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), 1085Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19
28 Rwanda FDA-HMP-MA-0953 TELMICLAR 80 Telmisartan Tablets USP 80 mg 80 mg Uncoated Tablets 3x10 Tablets Alu-Alu 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
29 Rwanda FDA-HMP-MA-1996 TELMILO 80 Telmisartan Tablets 80 mg Tablets 3×10’s Alu-Alu blister pack, 3×10’s Alu-Peel-Push blister pack Alu-Peel-Push blister pack 36 months M/S. Hetero Labs Limited (Unit-V) M/S. Hetero Labs Limited (Unit-V) \\ INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16
30 Rwanda FDA-HMP-MA-2287 TELSWIFT 40 Telmisartan 40mg 40 mg Tablets 3x10 Tablets Alu- Alu blister pack 36 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11
31 Rwanda FDA-HMP-MA-2286 TELSWIFT 80 Telmisartan 80mg 80 mg Tablets 3x10 Tablets Alu- Alu blister pack 36 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11
32 Rwanda FDA-HMP-MA-2285 TELSWIFT H 40 Telmisartan 40mg and Hydrochlorothiazide 12.5mg 40 mg / 12.5 mg Tablets 3x10 Tablets Alu- Alu blister pack 24 months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11
33 Rwanda FDA-HMP-MA-1313 TEMOL 10MG/ML SOLUTION FOR INTRAVENOUS INFUSION Paracetamol 10mg/ml 10mg/ml Solution for intravenous infusion 100 ml vial Colourless type II glass vial, closed with a bromobutyl rubber stopper and sealed with an aluminum flip-off cap, and inserted in the carton 24 Months S.M. FARMACEUTICI SRL, Zona Industrial – 85050 Tito – Potenza Italy ITALY SANDOZ GMBH, KUNDL, AUSTRIA SUN ENTERPRISES LTD 2024-05-16 2029-05-15
34 Rwanda FDA-HMP-MA-2256 TEMOTERO 20 TEMOZOLAMIDE 20 mg Capsules 4x5 Capsules Amber glass container 24 Months HETERO LABS LIMITED Unit VI APIIC Formulation SEZ, Survey No. 410 & 411, Polepally Village, Jadcherla, Mahaboob Nagar – 509 301, Andhra Pradesh, INDIA. & UNIT-V, Sy.No.439, 440, 441 & 458, TSIIC Formulation SEZ, Polepalle (V), Jadcherla (M),MAHABUBNAGAR (D), Telangana State, INDIA. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2025-02-04 2030-02-03
35 Rwanda FDA-HMP-MA-2351 TENECTASE TENECTEPLASE INJECTION 20MG LYOPHILIZED POWDER FOR INJECTION 1 VIAL GLASS VIAL TYPE I, WITH A GREY BROMOBUTYL RUBBER STOPPER AND A FLIP-OFF CAP FILLED 24 MONTHS GENNOVA BIOPHARMACEUTICALS LTD BLOCK 1, PLOT NO: P-1 & P-2, I.T. B.T. PARK, PHASE-II, M.I.D.C., HINJAWADI, PUNE- 411057, INDIA INDIA GENNOVA BIOPHARMACEUTICALS LTD SUN ENTERPRISES LTD 2025-10-09 2030-10-08

Registered
36 Rwanda FDA-HMP-MA-2302 TENGLYN TENELIGLIPTIN 20 mg TABLETS 3x10 Tablets ALU/PVC BLISTERS 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No. 203-213, Kundaim, Goa - 403 115, INDIA INDIA ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2025-05-12 2030-05-11
37 Rwanda FDA-HMP-MA-1245 TENOFOVIR ALAFENAMIDE 25MG Tenofovir alafenamide hemifumarate 25mg 25mg Film Coated Tablets 30 Tablets & 100 Tablets HDPE container 24 Months HETERO LABS LIMITED, (Unit-V), TSIIC Formulation sez, s.no 439, 440, 441 & 458 Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) –509301, Telangana, India INDIA HETERO LABS LIMITED VINE PHARMA LIMITED 2024-05-06 2029-05-05
38 Rwanda FDA-HMP-MA-2178 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETS 30 Tablets HDPE Container 36 Months MACLEODS PHARMACEUTICALS LIMITED Unit II, Phase II/Phase III Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN (R) LTD 2025-01-09 2030-01-08
39 Rwanda FDA-HMP-MA-0449 TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE TABLETS Tenofovir Disoproxil Fumarate 300 mg and Lamivudine 300 mg 300 mg and 300 mg film coated tablets 30 tablets HDPE bottle along with desiccant 24 Months MYLAN LABORATORIES LIMITED, F? 4 & F?12, MIDC, Malegaon, Sinnar, Nashik ? 422 113 Maharashtra, India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2023-08-24 2028-08-23
40 Rwanda FDA-HMP-MA0508 TENOFOVIR DISOPROXIL FUMARATE TABLETS 300 MG Tenofovir Disoproxil Fumarate 300mg equivalent to 245 mg of Tenofovir Disoproxil 300mg Film coated tablets 1x30 tablets white opaque HDPE container 24 Months STRIDES SHASUN LIMITED, Address: No 36/7, Suragajakkanahali, Indlavadi Cross, Anekal Taluk, Bangole-562106, India INDIA STRIDES SHASUN LIMITED SUN ENTERPRISES LTD 2023-09-06 2028-09-05
41 Rwanda FDA-HMP-MA-2160 TENOFOVIR DISOPROXIL FUMARATE/ LAMIVUDINE/ DOLUTEGRAVIR TABLETS TENOFOVIR DISOPROXIL FUMARATE/ LAMIVUDINE/ DOLUTEGRAVIR 300MG / 300 MG / 50MG TABLETS 28’s, 30’s, 56’s, 60’s, 84’s, 90’s, 168’s and 180’s HDPE bottles 36 Months STRIDES PHARMA SCIENCE LIMITED KRS Gardens, Tablet Block36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk, Bengaluru – 562 106 INDIA STRIDES PHARMA SCIENCE LIMITED SUN ENTEPRISES LTD 2024-10-18 2029-10-17
42 Rwanda FDA-HMP-MA-0473 TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/EFAVIRENZ TABLETS 300MG/300MG/600MG Tenofovir Disoproxil Fumarate/ Lamivudine/ Efavirenz Tablets 300mg/300mg/600mg 300mg/300mg/600mg Film coated tablets 30 and 90 Tablets 30’s in White opaque wide mouth HDPE bottle with a white opaque cap. and 90’s in Blue opaque wide opaque HDPE bottle with a blue opaque cap 36 Months MYLAN LABORATORIES LIMITED H-12 & H-13, MIDC, Waluj, Aurangabad - 431136, Maharashtra, India; F-4 & F-12, Malegaon MIDC, Sinnar, Nashik -422113, Maharashtra, India; Plot No. 11,12 & 13 Indore SEZ, Phase - II, Sector - III, Pithampur - 454775, Dist.- Dhar, M.P., India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LIMITED 2023-08-24 2028-08-23
43 Rwanda FDA-HMP-MA-1853 TENOFOVIR/LAMIVUDINE TENOFOVIR/LAMIVUDINE 300MG/300MG TABLET 30’s HDPE container. 30’s HDPE container. 24 months HETERO LABS LTD Unit-III) Address: 22-110, Industrial Development Area (IDA), Jeedimetla Hyderabad-500 055 Telangana. India HETERO LAB LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16
44 Rwanda FDA-HMP-MA-0548 TERBINAFORCE-250 Terbinafine Hydrochloride 250 mg 250 mg Uncoated tablets 10x10 Tablets Alu/Alu blister. Such blisters 10 are packed in a carton along with package insert 24 Months MANKIND PHARMA LIMITED; Unit-II, Village Kishanpura, P.O. Jamniwala, Tehsil-Paonta Sahib; Activities District Sirmour-173025, Himachal Pradesh, India. INDIA MANKIND PHARMA LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-10-13 2028-10-12
45 Rwanda FDA-HMP-MA-0069 TERBINOL Terbinafin Hydrochloride 250 mg Tablet 14tablets/Box PVC-PE-PVDC/ALU BLISTER 24 Months NOBEL ILAÇ SAN.VE TIC. A.? Sancaklar 81 100/ DÜZCE/ TURKEY TURKEY DAFRA PHARMA GMBH, SWITZERLAND MULTIPHAR UBIPHARM-RWANDA LTD 2021-06-01 2026-06-01
46 Rwanda FDA-HMP-MA-0678 TERBINOL® CREAM Terbinafine Hydrochloride 1% (10 mg/g) 1% (10 mg/g) Cream 15 g Tube Aluminium tube closed with a plastic screw cap in 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 2023-12-10 2028-12-09
47 Rwanda FDA-HBP-MA-0117 TETANUS ANTITOXIN Tetanus Antitoxin BP 1500 IU 1500 IU Liquid for injection 1 ml Ampoule 1 ml white USP type I One Point Cut (OPC) ampoule with liquid injection 24 Months SERUM INSTITUTE OF INDIA PVT. LTD. 212/2 Hadapsar, Pune- 411 0028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-23 2029-02-22
48 Rwanda FDA-HBP-MA- 009 TETGLOB 250 I.U. TETANUS IMMUNOGLOBULIN BULK POWDER 250 IU 250 IU Liquid Injection Clear or slightly opalescent, colorless or pale-yellow or light brown liquid 2 ML TUBULAR FLINT GLASS VIAL Tubular Flint Glass vial, Rubber Bung 13mm Chlorobutyl plain and Aluminum Flip off Seal 13mm yellow 36 Months BHARAT SERUMS & VACCINES LTD. Address: Plot No. K-27, K-27 part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421501 Maharashtra State, India INDIA BHARAT SERUMS AND VACCINES LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-01-25 2028-01-24
49 Rwanda FDA-HMP-MA-1645 TETRAREN CAPSULES Tetracycline HCl BP 250 mg Capsules 10 Capsules Aluminium/PVC blisters, such ten blisters are packed in a unit carton along with literature insert 24 Months RENE INDUSTRIES LTD PO Box 6034, Plot No.680, Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16
50 Rwanda FDA-HMP-MA-0121 TEXAVIR TABLETS Tenofovir Disoproxil Fumarate 300mg Film Coated Tablets 1x30 Tablets HDPE CONTAINER 36 Months CIPLA QUALITY CHEMICAL INDUSTRIES LTD Plot 1-7,1st Ring Road, Luzira Industrial Park, Kampala - Uganda UGANDA CIPLA QUALITY CHEMICAL INDUSTRIES LTD SURGIPHARM (RWANDA) LTD 2022-10-24 2027-10-23
51 Rwanda FDA-HMP-MA-0831 THEOMOX-250 Amoxicillin Trihydrate USP equivalent to Amoxicillin 250 mg 250 mg Hard gelatin capsules 10 x 10 Capsules Alu-PVC blisters packed in carton with pack insert 36 Months THEON PHARMACEUTICALS LIMITED, Address: Village Saini Majra, Tehsil Nalagarh, Distt. Solan Himachal Pradesh - 174 101, India INDIA THEON PHARMACEUTICALS LIMITED AIVEEN RWANDA LTD 2024-02-09 2029-02-08
52 Rwanda FDA-HMP-MA-2093 THERMODOL PARACETAMOL 1.0% W/V SOLUTION FOR INFUSION 100 ml LDPE bottle LPDE bottle and printed carton with insert 24 Months AKUMS DRUGS AND PHARMACEUTICALS LTD Plot no.2,3,4 & 5, Sector-6B, IIE., SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India. India UNOSOURCE PHARMA LTD AIVEEN (R) LTD 2024-10-18 2029-10-17
53 Rwanda FDA-HMP-MA-2100 THROMBAN 2.5 APIXABAN 2.5MG TABLETS Blister pack of 10’s (3x10 Tablets) Alu PVC/PVDC Blister pack 24 Months Zydus Lifesciences Limited Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17
54 Rwanda FDA-HMP-MA-2099 THROMBAN 5 APIXABAN 5mg TABLETS Blister pack of 10’s (3x10 Tablets) Alu-PVC/PVDC blister pack 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17
55 Rwanda FDA-HBP-MA- 0015 THYMOGAM Anti-thymocyte Globulin (Equine),250 mg / 5ml liquid injection 250 mg / 5ml Liquid for Injection 5 ml vial Vial made from USP Type I, neutral, colorless glass 24 Months BHARAT SERUMS & VACCINES LTD Plot No. K-27, K-27 part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421501 Maharashtra State, India INDIA BHARAT SERUMS AND VACCINES LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11
56 Rwanda FDA-HMP-MA-2202 TICANASE NASAL SPRAY Fluticasone Propionate 50 mcg Nasal Spray 12gm An amber glass (type III) bottle with white polypropylene nasal spray head, capped with transparent polypropylene cap and INOX pump 24 Months EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES Km 25 Alexandria-Cairo Desert Road, Amriya, Alexandria. Egypt. EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03
57 Rwanda FDA-HMP-MA-2207 TICANASE PLUS Azelastine Hydrochloride: 137 mcg / dose (0.137 ml) Fluticasone propionate 50 mcg / dose (0.137 ml) 137 mcg /50 mcg Nasal Spray 15 ml Bottle Type III glass bottle 24 Months EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES Cairo Desert Road KM 25, PO Box 111, El Manshia Alex., Amriya. Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03
58 Rwanda FDA-HMP-MA-0434 TIMOLOL® 0.5% SOLUTION One mL of the 0.5% eye drop solution contains 6.8 mg timolol maleate corresponding to 5 mg timolol 0.005 Eye drops 5ml Bottle LDPE bottle with a dispensing plug 36 Months S.A. ALCON-COUVREUR N.V. Rijksweg 14 B-2870 Puurs Belgium BELGIUM NOVARTIS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23
59 Rwanda FDA-HMP-MA-2312 TIMONIDIN Brimonidine Tartrate Ph. Eur. & Timolol Maleate USP 0.2 % W/V & 0.5 % W/V Ophthalmic Solution 1x5ml HDPE white dropper bottle with open nozzle single pilfer proof Gamma radiated cap 24 Months KILITCH DRUGS (INDIA) LTD Plot no C-301/2, MIDC T.T.C, Industrial Area, Pawane village, Navi Mumbai -400705, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LTD SUN ENTERPRISES LTD 2025-05-12 2030-05-11
60 Rwanda FDA-HMP-MA-0538 TIMOSOL® Timolol maleate 0.5% 0.005 Eye drops solution 5 ml Bottle (flacon) LDPE transparent bottle with white cap 36 Months AHLCON PARENTERALS (INDIA) LTD, SP 918, Phase III Bhiwadi 301019 Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-09-11 2028-09-10
61 Rwanda FDA-HMP-MA-0979 TINI-500 Tinidazole Tablets 500 mg 500 mg Film Coated Tablets 10x10 Tablets Blister Pack, such a 10 Blisters Packed in Printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-02-26 2029-02-25
62 Rwanda FDA-HMP-MA-0848 TOB-DEX Tobramycin: 0.3%w/v USP and Dexemethasone Sodium phosphate: 0.1%w/v BP 0.3%w/v and 0.1%w/v Ophthalmic Eye Drops 5 ml Bottle 10 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08
63 Rwanda FDA-HMP-MA-0159 TOBRADEX Tobramycin 3mg/ml and Dexamethasone 1mg/ml 3mg/ml and 1mg/ml Eye Drops 5ml Bottle LDPE bottle 24 Months ALCON-COUVREUR NV Rijksweg 14 Puurs, 2870 Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20
64 Rwanda FDA-HMP-MA-1102 TOFACITINIB PFIZER 5 FILM COATED TABLETS Tofacitinib Citrate 5 mg 5 mg Film Coated Tablets 56 Tablets Aluminium foil/PVC Blisters 48 Months Pfizer Manufacturing Deutschland GmbH Betriebsstätte, Freiburg Mooswaldallee 1 79090 Freiburg Germany GERMANY PFIZER LIMITED, UNITED KINGDOM GILMED LIMITED 2024-04-20 2029-04-19
65 Rwanda FDA-HMP-MA-1147 TOFF PLUS Paracetamol BP 500 mg, Dextromethorphan Hydrobromide BP 15 mg, Chlorpheniramine Maleate BP 2 mg, Phenylephrine Hydrochloride BP 10 mg 500 mg, 15 mg, 2 mg, P 10 mg Hard Gelatin Capsules 2x 10 capsuless­ Blister alu foil/ clear PVdC coated PVC film packed in a carton along with package insert 36 Months PANACEA BIOTEC PHARMA LTD. Village-Malpur, Baddi District Solan- 173205, Himachal Pradesh, India INDIA PANACEA BIOTEC PHARMA LTD, INDIA AIVEEN RWANDA LTD 2024-04-27 2029-04-26
66 Rwanda FDA-HMP-MA-1774 TOPHEN-100 Phenytoin 100 mg Film Coated Tablets 10x10 Tablets 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 AGOG PHARMA LTD. SUN ENTERPRISES LTD 2024-08-17 2029-08-16
67 Rwanda FDA-HMP-MA-2316 TORAS-DENK 5 Toresemide 5 mg TABLETS 30 Tablets BLISTER STRIPS 36 MONTHS DENK PHARMA GMBH & CO. KG PRINZREGENTENSTR. 79 81675 MÃœNCHEN, GERMANY GERMANY DENK PHARMA GMBH & CO. KG HERILY - AGENCE DE MARKETING LTD 2025-06-19 2030-06-18

Registered
68 Rwanda FDA-HMP-MA-1693 TORICOX -120 ETORICOXIB 120MG TABLET 3 x 10’s Alu/ Clear PVDC Blister 24 month Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane India OCHOA LABORATORIESAddress 430, Mzz,F, Gundecha Indl.Complex Akurli Road, Kandivali €, Email: maheshshah@aurochemgroup.com, poonam@aurochemgroup.com, Pallavmshah@aurochemgroup.com; Telephone: +(91) -(22)-28858503/04/05 SUN ENTERPRISES LTD 2024-08-17 2029-08-16
69 Rwanda FDA-HMP-MA-1692 TORICOX-90 ETORICOXIB 90MG TABLET 3 x 10 Alu/ Clear PVDC Blister 24 month Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane India OCHOA LABORATORIESAddress 430, Mzz,F, Gundecha Indl.Complex Akurli Road, Kandivali €, Email: maheshshah@aurochemgroup.com, poonam@aurochemgroup.com, Pallavmshah@aurochemgroup.com; Telephone: +(91) -(22)-28858503/04/05 SUN ENTERPRISES LTD 2024-08-17 2029-08-16
70 Rwanda FDA-HMP-MA-0554 TORSINEX-10 Torsemide 10 mg 10 mg Uncoated tablets 3x10 Tablets Alu/Alu blister pack and carton 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-10-05 2028-10-04
71 Rwanda FDA-HMP-MA-1959 TORSINEX-20 TORSEMIDE 20 MG TABLETS 3x10 Tablets Alu-Alu Blister pack 36 Months MICRO LABS LIMITED 92, SIPCOT Industrial Complex HOSUR-635 126. (T.N) INDIA India MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16
72 Rwanda FDA-HMP-MA-0650 TOSSEQUE Bromhexine 0.8mg/ml 0.8mg/ml Syrup 200ml Bottle Type III amber glass bottles closed with white polyethylene caps 36 Months FARMALABOR- PRODUTOS FARMACEUTICOS, S.A. Zona Industrial de condeixa-a-Nova 3150-194 Condeixa-a-Nova, Portugal PORTUGAL MEDINFAR CONSUMER HEALTHCARE-PRODUTOS FARMACEUTICOS, LDA, PORTUGAL UBIPHARM-RWANDA LTD 2023-12-10 2028-12-09
73 Rwanda FDA-HMP-MA-1777 TOTACEF-1000 Cefepime hydrochloride (Sterile) USP 1000 mg Powder for Injection 20 ml Vials Clear transparent USP Type-I glass vial 24 Months MANKIND PHARMA LIMITED Village Kishanpura, P.O. Jamniwala Tehsil- Paonta Sahib, District Sirmour -173025 (Himachal Pradesh), INDIA MANKIND PHARMA LIMITED WESSEX PHARMACEUTICALS(RWANDA) LTD 2024-08-17 2029-08-16
74 Rwanda FDA-HMP-MA-1743 TOTOMOL SUSPENSION Paracetamol BP 120mg/5ml Suspension 60mL/100mL Bottles AMMBER PET/GLASS BOTTLES 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. Postal Address: P.O Box 42875 GPO 00100 Nairobi, Country: Kenya. Telephone: +254 20 8040306 Telefax: +254 20 8040309 E-Mail: info@laballied.com KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16
75 Rwanda FDA-HMP-MA-0824 TOT’HEMA® Ferrous gluconate 50mg, Manganese gluconate 1.33mg and Copper gluconate 0.7mg 50mg, 1.33mg and 0.7mg Oral solution 20 ampoules of 10ml Ampoule (Brown Glass) 24 Months INNOTHERA CHOUZY, Rue René Chantereau Chouzy-sur-Cisse 41150 VALLOIRE-SUR-CISSE France FRANCE LABORATOIRE INNOTECH INTERNATIONAL MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-02-17 2029-02-16
76 Rwanda FDA-HMP-MA-2222 TRADMIN Tramadol 50mg/ml Injection 5x2 ml Glass Ampoules 24 Months AKUMS DRUGS & PHARMACEUTICALS LTD Plot No. 2, 3, 4 & 5, Sector-6B, IIE, Sidcul, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED AIVEEN (R) LTD 2025-02-04 2030-02-03
77 Rwanda FDA-HMP-MA-0947 TRADMIN Tramadol Hydrochloride 50 mg 50 mg Capsules 10x10 Capsules ALU-PVC Blister. 10 such blisters packed in a printed carton with pack insert 24 Months AKUMS DRUGS AND PHARMACEUTICALS LTD, Plot no. 19,20 & 21, Sector-6A, IIE., SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD ABACUS PHARMA (A) LTD. 2024-02-26 2029-02-25
78 Rwanda FDA-HMP-MA-1209 TRAJENTA 5 MG Linagliptin 5mg 5 mg Film coated Tablets 1x30’s aluminium unit /PVC/PVAC blister 36 Months WEST-WARD COLUMBUS INC. 1809 Wilson Road. Columbus, Ohio 43228, U.S.A. UNITED STATES OF AMERICA BOEHRINGER INGELHEIM INTERNATIONAL GMBH SURGIPHARM (RWANDA) LIMITED 2024-05-06 2029-05-05
79 Rwanda FDA-HMP-MA-0459 TRAMACEL TABLETS Acetaminophen and Tramadol 325mg+37.5mg 325mg+37.5mg Film coated tablets 10 tablets Alu PVC Blister and such 1 blister packed in a printed monocarton with pack insert 24 Months CACHET PHARMACEUTICALS PRIVATE LIMITED, Thana, Baddi, Himachal Pradesh-173 205, INDIA INDIA CACHET PHARMACEUTICALS PRIVATE LIMITED. SUN ENTERPRISES LTD 2023-08-24 2028-08-23
80 Rwanda FDA-HMP-MA-0771 TRAMADIS 100MG/2ML Tramadol hydrochloride 100mg/2ml 100mg/2ml Liquid Injectable Solution 5 Ampoules Type I white neutral drawn glass silk-screen ampoules with breaking point (OPC), capacity 2ml; are packed in a carton, with a package insert 48 Months LES LABORATOIRES MEDIS, Km 7 Route De Tunis, BP 206, 8000 Nabeul, Tunisia. TUNISIA LES LABORATOIRES MEDIS, TUNISIA KIPHARMA LTD 2024-01-05 2029-01-04
81 Rwanda FDA-HMP-MA-0719 TRAMADIS 50 MG Tramadol hydrochloride, 50mg 50mg Capsules 10 capsules PVC-Aluminium blisters 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
82 Rwanda FDA-HMP-MA-0281 TRAMAPA Tramadol Hydrochloride, Paracetamol 37.5mg/325mg 37.5mg/325mg Tablets 20 Tablets Aluminum/ Polyethylene strips or Aluminium/ PVC/PVDC blister packs 36 Months FERRER INTERNACIONAL, S.A. Joan Buscalla, 1-9 Sant cugat del Valles (Barcelona) Spain. SPAIN FERRER INTERNACIONAL S.A. GOMHS LTD 2023-05-12 2028-05-11
83 Rwanda FDA-HMP-MA-0803 TRAMAPA FORT 75MG/650MG Tramadol hydrochloride 75mg and Paracetamol 650mg 75mg and 650mg Tablets Box of 20 tablets Aluminium/polyethylene strips or aluminium/PVC-PVDC blister packs 36 months FERRER INTERNACIONAL, S.A. C/Joan Buscallà, 1-9. 08173 Sant Cugat del Vallès, Barcelona, Spain SPAIN FERRER INTERNATIONAL, S.A. GOMHS LTD 2024-01-08 2029-01-07
84 Rwanda FDA-HMP-MA-1215 TRAMAREN CAPSULES Tramadol Hydrochloride 50mg 50 mg Capsules 10x10 capsules Aluminium/PVC blister strip 36 Months RENE INDUSTRIES LIMITED. Plot No 680, P O Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05
85 Rwanda FDA-HMP-MA-0699 TRAMAZIM Tramadol BP 50 mg 50 mg Hard gelatin capsules 10 × 10 Capsules Alu- PVC Blister Pack 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra state, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29
86 Rwanda FDA-HMP-MA-1038 TRANGEL GEL Diclofenac Diethylammonium Gel Salt B.P. 1.16% w/w 1.16% w/w Gel for Topical administration 20mg Tube Aluminium Tubes 36 Months NEM LABORATORIES PVT. LTD, 133, Krishna Ind. Estate, Navghar Rd., Vasai (E), Dist. Thane- 401210, India. INDIA NEM LABORATORIES PVT. LTD, INDIA. RENE PHARMACY (R) LTD 2024-02-28 2029-02-27
87 RwandaFDA-HMP-MA-1889 TRANGEL ULTRA DICLOFENAC DIETYLAMINE +METHYL SALICYLATE+MENTHOL+CAPSICUM OLEORESIN 10/80/60/0.15MG GEL 20mg Aluminium collapsible Tubes 36 Months NEM LABORATORIES PVT. LTD 133, Krishna Ind. Estate, Navghar Rd., Vasai (E), Dist. Thane- 401210 Country: INDIA INDIA NEM LABORATORIES PVT LTD, Address: 133, Krishna Ind. Estate, Navghar Rd., Vasai (E), Dist. Thane- 401210 Country: India Telephone: 0250-239002/3Telefax: 0250-2392905 E-Mail: nemlabs@gmail.com RENE PHARMACY LTD RWANDA 2024-08-17 2029-08-16
88 RWANDA-FDA25/HM/0507/0039 Trastmab 150 TRASTUZUMAB LYOPHILISATE FOR CONCENTRATE FOR SOLUTION FOR INFUSION 36 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13
89 RWANDA-FDA25/HM/0493/0015 Trastmab 440 Trastuzumab lyophilized powder for concentrate for solution for infusion 21 mg/mL Lyophilized powder for reconstitution for injectio 20ml 36 Months INTAS PHARMACEUTICALS LIMITED, Plot No. 423/P/A Sarkhej - Bavla Highway. Moraiya, Taluka: Sanand Ahmedabad – 382 213 Gujarat, India India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-02-05 2031-02-04
90 Rwanda FDA-HMP-MA-1648 TRAUSAN CITICHOLONE 100MG/ML ORAL SOLUTION 50ML Bottles Type III amber glass bottle 36 Months Faes Farma, S.A, Máximo Aguirre, 14-48940 Leioa (Vizcaya) Spain SPAIN LABORATORIOS VITORIA S.A/ PORTUGAL UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16
91 Rwanda FDA-HMP-MA-0477 TRAVATAN EYE DROPS Travoprost, 40 micrograms/ml 40 micrograms/ml Eye Drops Solution 5 ml Plastic Droptainer Plastic Droptainer, LDPE. 36 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
92 Rwanda FDA-HMP-MA-1169 TRAVONORM OPHTALMIC SOLUTION Travoprost 0.04mg/ml 0.04mg/ml Ophtalmic solution 5 ml bottle LDPE white plastic dropper bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial zone, Area 14, 15 Block no. 12011, P.O Box 11341 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES ETS CONTINENTAL 2024-04-20 2029-04-19
93 Rwanda FDA-HMP-MA-0987 TRAVONORM PLUS Each mL of solution contains Travoprost 0.04 mg/ml, Timolol maleate 6.83 mg equivalent to Timolol 5 mg/ml 0.04 mg/ml, 5 mg/ml Eye drops 5ml Bottle LDPE plastic bottle with white plastic dropper covered with blue polypropylene plastic cap 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial zone, Area 14, 15 Block No. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES, EGYPT ETS CONTINENTAL LTD 2024-02-26 2029-02-25
94 Rwanda FDA-HMP-MA-1946 TRD-CONTIN 100 TRAMADOL HYDROCHLORIDE 100 mg TABLETS 5x10 Tablets PVDC/ Alu blisters 24 Months MODI-MUNDIPHARMA PVT.LTD Modipuram-25 110, U.P, INDIA India MODI-MUNDIPHARMA PVT.LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16
95 20-4368-DGC&PHS-2018-R1 TREMADOL-50 Tramadol 50 mg Tablets Box/20 ALU/PVC FILM BLISTER PACK/CARTON 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16
96 Rwanda FDA-HMP-MA-2210 TREXOZOLA Letrozole 2.5 mg TABLETS 10 Film coated tablets Al/Transparent colourless PVC strip 24 Months TECHNO PHARMA EGYPT 4th Industrial Zone, part No.1,2,21,22 Block 2, Egypt EGYPT TECHNO PHARMA EGYPT Le Medical Ltd 2025-02-04 2030-02-03
97 Rwanda FDA-HMP-MA-1680 TRIALGIC IBUPROFEN/PARACETAMOL/CAFFEINE 200MG/325MG/30MG Capsules 2 X 12 Capsules ALU/transparent PVC film blisters 36 Months Medreich Limited Medreich Limited. Plot/Building Number: No. 11, 12, 13, 14, and 15 Street/Area Name: Poojaramanahalli Village, Hoskote Taluk, City: Bangalore Rural District. Postal/Pin Code: 562114. State: Karnataka, India INDIA B&O Pharm KIPHARMA LTD 2024-08-17 2029-08-16
98 Rwanda FDA-HMP-MA-1646 TRIBEES FORTE Thiamine Nitrate (Vit B1), Pyridoxine (Vit B6), Cyanocobalamin (Vit B12) 200MG+50MG+ 1000MCG TABLETS 20 tablets PVDC/ Alu Blisters 24 Months COSMOS LIMITED Rangwe Road, Off Lunga Lunga, Industrial Area, P.O Box 41433, GPO 00100 Nairobi, Kenya KENYA COSMOS LIMITED/KENYA SUN ENTERPRISES LTD 2024-08-17 2029-08-16
99 Rwanda FDA-HMP-MA-0992 TRICOLAM. Tinidazole BP 500mg 500mg Film coated tablets 25 x 4 Tablets Printed Aluminium foil, clear PVC film, in cartons with leaflet 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 LIMITED, INDIA. SUN ENTERPRISES LTD 2024-02-26 2029-02-25
100 Rwanda FDA-HMP-MA-0463 TRICOZOLE SUSPENSION Metronidazole Benzoate 125mg/5ml 125mg/5ml Suspension 100ml /60ml amber glass/ bottles Amber glass/PET bottle and contained in a unit box 36 Months LABORATORY & ALLIED LTD, East gate road off, Mombasa Road, Opp Sameer Africa, Plot No. 209/10349, Kenya KENYA LABORATORY & ALLIED LTD, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23
101 Rwanda FDA-HMP-MA-0116 TRICOZOLE TABLETS Metronidazole Bp 250mg Ffbe Tablets 10x10’s ALU/PVC BLISTER 36 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 2022-10-24 2027-10-23
102 Rwanda FDA-HMP-MA-1304 TRIMAGO ORAL SUSPENSION Sulfamethoxazole 200 mg and Trimethoprim 40 mg/ 5ml 200 mg/40 mg/5ml Oral liquid Suspension Bottle pack of 60 ml & 100 ml Amber coloured pet bottles 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
103 Rwanda FDA-HMP-MA-1003 TRIMEX ADULT COUGH EXPECTORANT Chlorpheniramine Maleate PB 2.0 mg, Pseudoephedrine HCl 30.0 mg; Guafenesin BP 100.0 mg 2.0 mg, 30.0 mg, 100.0 mg Syrup 100 ml Bottle Glass Amber Bottle round with threaded head packed in unit carton 36 Months LABORATORY AND ALLIED LIMITED, Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY AND ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25
104 Rwanda FDA-HMP-MA-1031 TRIMEX DIABETIC COUGH SYRUP Chlorpheniramine Maleate 2mg, Pseudoephedrine HCl 30mg and Guaifenesin BP 100mg 2mg/30mg/100mg Syrup 100 ml Bottle 100 ml Amber glass bottle and in a unit carton pack 36 Months REGAL PHARMACEUTICALS LTD, P.O Box 44421-00100 GPO, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-02-28 2029-02-27
105 Rwanda FDA-HMP-MA-0334 TRIMEX MUCOLYTIC SYRUP Salbutamol sulphate BP 2.4mg/ Bromhexine HCL BP 4mg/ Guaifenesin BP 100mg 2.4mg, 4mg and 100mg Syrup 100ml bottle Glass amber colored bottle packed in unit carton together with a leaflet titled 36 Months REGAL PHARMACEUTICALS LTD, P.O box 44421-00100 GPO, Nairobi-Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-06-26 2028-06-25
106 Rwanda FDA-HMP-MA-0838 TRIMEX PAEDIATRIC COUGH EXPECTORANT Chlorpheniramine Maleate BP 1mg, Pseudoephedrine Hcl 15mg, Guaifenesin BP 50mg 1mg, 15mg, 50mg Oral syrup 100 ml Bottle Amber colored glass bottle, with a 25mm neck, ROPP cap and 10ml measuring cap 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) LIMITED 2024-02-17 2029-02-16
107 Rwanda FDA-HMP-MA-1613 TRIMOXOL SUSPENSION Each 5 ml of oral suspension contains Sulfamethoxazole BP 200mg and Trimethoprim BP 40mg 200mg/40mg/5ml Oral suspension 100ml Botlle PET BOTTLES 36 Months Dawa Limited 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
108 Rwanda FDA-HMP-MA-0318 TRIPLIXAM 10MG/ 2.5 MG/ 5 MG Perindopril arginine 10 mg / Indapamide 2.5 mg / Amlodipine besilate 5 mg 10mg/ 2.5 mg/ 5 mg Film coated tablets 30 tablets Polypropylene tablet container equipped with a LDPE flow reducer and a LDPE stopper containing a desiccant 24 Months SERVIER (IRELAND) INDUSTRIES LTD, Les Laboratoires Servier (LSI), Moneylands, Gorey Road, Arklow, Co. Wicklow, Ireland and 905 Route de saran, 45520 Gidy, France IRELAND, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2023-05-12 2028-05-11
109 Rwanda FDA-HMP-MA-0360 TRIPLIXAM 10mg/ 2.5mg/ 10mg Perindopril arginine 10mg / Indapamide 2.5mg / Amlodipine besilate 10 mg 10mg / 2.5mg / 10 mg Film-Coated Tablets 30 tablets Polypropylene tablet container equipped with LDPE floe reducer and stopper containing a desiccant. 24 Months Servier (Ireland) Industries Ltd, & Laboratoires Servier (LSI), Moneylands, Gorey Road, Arklow, Co. Wicklow, Ireland and Les & 905 Route de saran, 45520 Gidy, FRANCE IRELAND, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2023-07-08 2028-07-07
110 Rwanda FDA-HMP-MA-0242 TRIPLIXAM 5 MG/ 1.25 MG/ 10 MG Perindopril arginine 5 mg / Indapamide 1.25 mg / Amlodipine besilate 10 mg 5 mg/ 1.25 mg/ 10 mg Film-coated tablets 30 film-coated tablets Polypropylene tablet container equipped with low density polyethylene floe reducer and low density polyethylene stopper 24 Months SERVIER (IRELAND) INDUSTRIES LTD, LES LABORATOIRES SERVIER (LSI), Moneylands, Gorey Road, Arklow, Co. Wicklow, Ireland and 905 Route de saran, 45520 Gidy, FRANCE IRELAND, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2023-05-12 2028-05-11
111 Rwanda FDA-HMP-MA-0376 TRIPLIXAM 5 MG/ 1.25 MG/ 5 MG Perindopril arginine 5 mg / Indapamide 1.25 mg / Amlodipine besilate 5 mg 5 mg/ 1.25 mg/ 5 mg Film coated tablets 30 tablets Polypropylene tablet container equipped with LDPE flow reducer and stopper containing a desiccant 36 Months Servier (Ireland) Industries Ltd, and Les Laboratoires Servier (LSI), Moneylands, Gorey Road, Arklow, Co. Wicklow, Y14E284, Ireland and 905 Route de saran, 45520 Gidy, FRANCE IRELAND, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2023-07-08 2028-07-07
112 Rwanda FDA-HMP-MA-1943 TRISPORIN SP CEFDINIR 125MG/5ML SUSPENSION 100ml Bottle Amber coloured Type III glass bottles 36 Months Pharma Vision Sanayi ve Ticaret A. S/Bilim Ilaç San.ve Tic. A.S Davutpa?a Cad. No. 145, 34010 Topkapi, Istanbul/Turkey Turkey DEFRA PHARMA GmbH UBIPHARM RWANDA LTD 2024-08-17 2029-08-16
113 Rwanda FDA-HMP-MA-1367 TRISPORIN®, FILM COATED TABLETS Cefdinir 300mg Film Coated Tablets 300mg Film Coated Tablets 10 tablets (AL/PVC/PE/PVDC) Blister 36 Months PHARMAVISION SANAYI VE TICARET A. ?., Davutpa?a Cad. No: 145, 34010 Topkap?/Istanbul, Turkey TURKEY DAFRA PHARMA GMBH, SWITZERLAND SUN ENTERPRISES LTD 2024-05-18 2029-05-17
114 Rwanda FDA-HMP-MA-0420 TRIXON-1 GM Ceftriaxone Sodium USP, 1 gm/vial 1 gm/vial Powder for injection Powder filled in a 10 ml vial USP type-III vial. The vial is packed in Printed Carton with Packing Insert & Clear, colorless sterile water for injection is filled in 10 ml plastic ampoule pack 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
115 Rwanda FDA-HMP-MA-2039 TRIXONE CEFTRIAXONE SODIUM INJECTION BP 1G Powder for Injection 10 Vials Vials 36 Months Reyoung Pharmaceutical Co., Ltd Ruiyang Road, Yiyuan County, Shandong Province, P.R. China CHINA Farmasino Co., Ltd ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29
116 Rwanda FDA-HMP-MA-1422 TROGYL PLUS SUSPENSION Metronidazole Benzoate 200mg and Diloxanide Furoate 250mg 200mg and 250mg Suspension 60ml, 100ml Bottles Amber colored (Glass/PET) bottles and card box 36 Months BIODEAL LABORATORIES LTD, 123, Lunga. P.O Box 32040-00600, Nairobi, Kenya. KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-18 2029-07-17
117 Rwanda FDA-HMP-MA-2262 TROGYL PLUS TABLET METRONIDAZOLE/ DILOXANIDE FUROATE 200MG/ 250MG TABLETS 10x10 Tablets Alu-PVC Blisters 36 Months BIODEAL LABORATORIES LTD 123, Lunga Lunga P.O BOX 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2025-02-04 2030-02-03
118 Rwanda FDA-HMP-MA-1866 TROGYL SUSPENSION METRONIDAZOLE BENZOATE 60ML & 100ML ORAL SUSPENSION 100mls/60mls in PET bottles PET bottles with a cap and unit carton, Amber coloured bottles 36 months. BIODEAL LABORATORIES LTD LTD, PLOT NO. 123, LUNGA LUNGA ROAD, P.O. BOX 32040-00600, NAIROBI, KENYA Kenya BIODEAL LABORATORIES LTD/KENYAAddress: PLOT NO. 123, LUNGA LUNGA ROAD, P.O. BOX 32040- 00600, NAIROBI.Country: KENYA.Telephone: +254 720 333 829.Telefax: N/AE-Mail: regulatoryaffairs@biodealkenya.com CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-08-17 2029-08-16
119 Rwanda FDA-HMP-MA-2306 TROPIN 1MG Atropine Sulfate Monohydrate 1MG/ML Solution for injection 10 X 1 Plain glass ampoule in a plastic tray 36 Months SWISS PARENTERALS LTD 808, 809 & 810, Kerala Industrial Estate, G.I.D.C., Nr. Bavla, Dist: Ahmedabad-382220, Gujarat, India INDIA SWISS PARENTERALS LTD Pharmaceutical and Medical Supplies Society Limited 2025-05-12 2030-05-11
120 Rwanda FDA-HMP-MA-1499 TROYPOFOL 20 ML Propofol Injection BP 1% w/v Emulsion for Injection or infusion 20ml Vial Flint vial USP Type I with Bromo butyl rubber closure and blue flip off aluminium seal with Troikaa logo. Such 1 vial packed in printed carton along with package insert 36 Months TROIKAA PHARMACEUTICALS LTD C-1, Sara Industrial Estate, Selaqui, Dehradun-248197, Uttarakhand, India INDIA TROIKAA PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26
121 Rwanda FDA-HMP-MA- 0646 TURBOVAS-10 Rosuvastatin Calcium 10mg 10mg film coated tablets 3x10 Tablets Alu/Alu blister pack. Such 3 blisters are packed in carton along with pack insert 24 Months MICRO LABS LIMITED, 92, SIPCOT, Industrial Complex, Hosur-635 126, Tamil Nadu India INDIA MICRO LABS LIMITED, INDIA. WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-12-10 2028-12-09
122 Rwanda FDA-HMP-MA- 0766 TURBOVAS-20 Rosuvastatin Calcium 20mg 20mg Film coated 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
123 Rwanda FDA-HMP-MA-1175 TUSQ – X LIQUID Terbutaline Sulphate 1.25mg, Bromhexine Hydrochloride 4mg, and Guaifenesin50mg/5ml syrup 1.25mg, 4mg, 50mg/5ml Syrup 100 ml bottle Pet bottle Amber, sealed with 25 mm ROPP cap with EP WAD and 10 ml measuring cup 24 Months BLUE CROSS LABORATORIES PVT. LTD. A-12, M.I.D.C., Ambad, Nashik-422010. Maharashtra. India INDIA BLUE CROSS LABORATORIES PVT. LTD. PHILIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05
124 Rwanda FDA-HMP-MA-1171 TUSQ–DX LIQUID Dextromethorphan Hydrobromide BP 15mg, 15mg, Liquid 100 ml Bottle PET bottle Amber packed in a carton with a leaflet 24 Months BLUE CROSS LABORATORIES PVT. LTD A-12, M.I.D.C., Ambad, Nashik- 422010, Maharashtra, India INDIA BLUE CROSS LABORATORIES PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-04-20 2029-04-19
125 Rwanda FDA-HMP-MA-1014 TWINZOL SDU Dorzolamide Hydrochloride 20mg/ml and Timolol Maleate 5mg/ml 20mg/ml-5mg/ml Solution 0.2 ml strips Carton box containing strips, each containing 5 LDPE plastic single dose units each of 0.2 ml + insert leaflet 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial zone, Area 14, 15 Block no. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES, EGYPT ETS CONTINENTAL LTD 2024-02-28 2029-02-27
126 Rwanda FDA-HMP-MA-1170 TWYNSTA 80MG/5MG Telmisartan 80mg/Amlodipine 5mg 80mg/5mg Tablets 28 Tablets Aluminium/Aluminium blister (PA/Al/PVC/Al) in printed outer carton 36 Months CIPLA LIMITED, Verna Industrial Estate, Goa - 403 722, India INDIA BOEHRINGER INGELHEIM INTERNATIONAL GmbH SURGIPHARM (RWANDA) LIMITED 2024-04-20 2029-04-19