HUMAN MEDICINAL PRODUCTS REGISTER

HUMAN MEDICINE REGISTERED PRODUCTS

Search Box: A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z| All




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-1886 NAC MR 10 TABS DICLOFENAC POTASSIUM/PARACETAMOL/ CHLORZOXANE 50MG/325MG/250MG TABLET 1x10. Alu/Alu blister. 36 months. CORONA REMEDIES PVT LTD Village Jatoli, Post Office – Oachghat, Tehsil Solan, Dist. Solan, Himachal Pradesh – 173233, India. India CORONA REMEDIES PVT LTD AIVEEN RWANDA LTD 2024-08-17 2029-08-16

2 Rwanda FDA-HMP-MA-0172 NASOALDO Mometasone Furoate 50mcg 50mcg Nasal spray suspension 140 doses in an opaque white plastic bottle Opaque plastic bottle equipped with a manual metering spray pump, a nasal adapter and a dust cap 36 Months LABORATORIO ALDO-UNIÓN, Baronesa de Maldá, 73. 08950 Esplugues de Llobregat Barcelona, Spain SPAIN LABORATORIO ALDO-UNIÓN, S.L. GOMHS LTD 2022-12-14 2027-12-13

3 Rwanda FDA-HMP-MA-1090 NAT – B SOFT GELATIN CAPSULES Riboflavin (Vitamin B2) 50.00 Mg, Pyridoxine Hydrochloride (Vitamin B6) 50.00 Mg, Cyanocobalamin (Vitamin B12) 50.00 Mcg, Nicotinamide 50.00 Mg, Calcium Pantothenate 50.00 Mg, Folic Acid 100.00 Mcg, Choline Bitartrate 50.00 Mg, Biotin 50.00 Mcg, Inositol 50.00 Mg 50.00 Mg, 50.00 Mg, 50.00 Mcg, 50.00 Mg, 50.00 Mg, 100.00Mcg 50.00 Mg, 50.00 Mcg, 50.00 Mg Soft Gelatin Capsules 3 ×10 Soft gelatin capsules Alu-PVC/PVDC blister packed in a cardboard carton 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280 Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, THAILAND ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

4 Rwanda FDA-HMP-MA-1335 NAT-D Cholecalciferol (Vitamin D3 125µg…5,000I.U) 125µg…5,000I.U Soft Gelatin Capsules 30 & 60 Capsules Polypropylene bottles 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED. 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

5 Rwanda FDA-HMP-MA-2243 NATOA SUSPENSION Mebendazole BP 100 mg/5ml Oral suspension 30 ml Bottle Amber glass/PET bottle 36 Months LABORATORY & ALLIED LIMITED Plot no. 209/10349, Opposite Sameer business Park, next to Libra house, Mombasa Road. P. O. Box 42875, GPO 00100, Nairobi KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2025-02-04 2030-02-03

6 Rwanda FDA-HMP-MA-1095 NATOA TABLETS Mebendazole BP 100mg 100 mg Tablets 6 tablets, 100 tablets and 1000 Tablets Packed in blister packs in a unit box and in HDPE Containers for 1000 tablets 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 DEPOT PHARMACEUTIQUE LE MEDICAL 2024-04-20 2029-04-19

7 Rwanda FDA-HMP-MA-0818 NATRILIX SR Indapamide 1.5 mg 1.5 mg Film coated tablets 30 Sustained Release Tablets Aluminium/polyamide aluminium polyvinyl chloride blister packs 24 Months SERVIER EGYPT INDUSTRIES LTD (SEI), 61h October City, 151 Industrial zone, Giza A.R.E, EGYPT and LES LABORATOIRES SERVIER LNDUSTRIE (LSI), 905 route de Saran, 45520 Gidy, France EGYPT AND FRANCE LES LABORATOIRES SERVIER, FRANCE KIPHARMA LTD 2024-01-30 2029-01-29

8 Rwanda FDA-HMP-MA-0202 NATRIXAM 1.5MG/10MG Indapamide 1.5mg and amlodipine besilate 13.87 mg equivalent to amlodipine10 mg 1.5mg and 10 mg Modified- release tablets 30 tablets Blisters in Aluminium/Polyamide-Aluminium-polyvinyl choride complex 24 Months LES LABORATOIRES SERVIER INDUSTRIE, 905 route de Saran 45520 Gidy, France FRANCE LES LABORATOIRES SERVIER, FRANCE KIPHARMA LTD 2022-12-21 2027-12-20

9 Rwanda FDA-HMP-MA-0203 NATRIXAM 1.5MG/5MG Indapamide 1.5mg and amlodipine besilate 6.935 mg equivalent to amlodipine 5mg 1.5mg and 5mg Modified- release tablets 30 tablets Blisters in Aluminium/Polyamide-Aluminium-polyvinyl choride complex 24 Months LES LABORATOIRES SERVIER INDUSTRIE, 905 route de Saran 45520 Gidy, France FRANCE LES LABORATOIRES SERVIER, FRANCE KIPHARMA LTD 2022-12-21 2027-12-20

10 Rwanda FDA-HMP-MA-0540 NEBILET PLUS Nebivolol 5mg and Hydrochlorothiazide 25mg 5mg and 25mg Film-coated tablets 28’s tablets and 4’s tablets Blisters (PP/COC/PP/Aluminium) 36 Months BERLIN CHEMIE AG, Menarini Group, Tempelhofer Weg 83, D-12347 Berlin, Germany GERMANY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A PRAFIN RWANDA LTD 2023-10-13 2028-10-12

11 Rwanda FDA-HMP-MA-0635 NEBILET PLUS Nebivolol 5mg (as Nebivolol hydrochloride) & hydrochlorothiazide 12.5 mg 5mg & 12.5 mg Film-coated tablets 28’s tablets and 4’s tablets PP/COC/PP/Aluminium Blisters 36 Months BERLIN CHEMIE AG, MENARINI GROUP, Leipziger Strasse 7-13, 01097 – Dresden, Germany GERMANY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. PRAFIN RWANDA LTD 2023-12-10 2028-12-09

12 Rwanda FDA-HMP-MA-0931 NEBILET-5 Nebivolol (as Nebivolol hydrochloride) 5 mg 5 mg Tablets 28 Tablets and 14 Tablets PVC/Alu blister pack 36 Months BERLIN CHEMIE AG, Glicnicker Weg 125, D-12489 Berlin, Germany GERMANY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A PRAFIN RWANDA LTD 2024-02-21 2029-02-20

13 Rwanda FDA-HMP-MA- 0552 NEBILONG 2.5 Nebivolol Tablets 2.5mg 2.5mg Tablets 3 x 10 Tablets. Alu/Alu blister pack of 3 x 10's. 36 Months MICRO LABS LIMITED, 92, SIPCOT, Industrial Complex, Hosur-635 126, Tamil Nadu India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-10 2028-12-09

14 Rwanda FDA-HMP-MA-0723 NEBILONG 5 Nebivolol Hydrochloride 5mg 5mg Uncoated tablets 3 x 10's Tablets Alu/Alu blister pack of 3 x 10's tablets Packed in outer carton 24 Months MICRO LABS LIMITED, 92 SIPCOT Industrial Complex Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-15 2029-01-14

15 Rwanda FDA-HMP-MA-0963 NEBILONG-10 Nebivolol Hydrochloride 10mg 10mg Uncoated Tablets 3x10 Tablets Alu/Alu Blister. 3 such blisters are placed in carton along with pack insert 36 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25

16 Rwanda FDA-HMP-MA-0500 NEBILONG-AM Nebivolol 5mg and Amlodipine 5 mg 5mg and 5 mg Uncoated, bi-layered 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

17 Rwanda FDA-HMP-MA-0575 NEBILONG-H Nebivolol 5mg and Hydrochlorothiazide 12.5mg 5mg and 12.5mg Tablets 3x10 Tablets Alu/Alu blister pack 24 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

18 Rwanda FDA-HMP-MA-0788 NEBIMAC 10 Nebivolol Hydrochloride 10 mg 10 mg Uncoated tablets 4x7’s tablets Alu/clear PVC/ PVDC blister pack. Such 4 blisters are packed in a carton along with a pack insert 36 month MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Village: Theda, PO: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-08 2029-01-07

19 Rwanda FDA-HMP-MA-0655 NEBIMAC-5 Nebivolol Hydrochloride 5mg 5mg Uncoated tablets 4X7 Tablets Alu/Clear PVC/ PVDC Blister pack of 7 Tablets. Such 4 blisters packed in a carton along with a pack insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Village: Theda, PO: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-02 2028-12-01

20 Rwanda FDA-HMP-MA-1082 NEBTAS 5 Nebivolol Hydrochloride 5mg 5 mg Uncoated Tablet 1x 10 tablets Alu/PVC blister 36 Months INTAS PHARMACEUTICALS LIMITED, Camp Road, Selaqui – 248 197, Dehradun, Uttarakhand, India INDIA INTAS PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

21 Rwanda FDA-HMP-MA-1894 NEBTAS-H NEBIVOLOL HYDROCHLORIDE+HYDROCHLORTHIAZIDE 5MG/12.5MG TABLET 3x10 tablets Alu/Alu Blister Pack 36 months. INTAS PHARMACEUTICALS LTD Camp Road, Selaqui – 248 197, Dehradun, Uttarakhand, India India INTAS PHARMACEUTICALS LTD/INDIACorporate House, Near Sola Bridge, S. G. Highway, Thaltej, Ahmedabad - 380054 - Gujarat – INDIA. ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

22 Rwanda FDA-HMP-MA-1109 NEBUNTA 5 Nebivolol Hydrochloride IH 5mg 5 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), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

23 Rwanda FDA-HMP-MA-0263 NELGRA-100 Sildenafil (as Citrate) 100 mg 100 mg Film coated tablets 1 x 4’s tablets PVC/ALU Blister 36 Months UNIVERSAL CORPORATION LIMITED, Club Road, Past Kikuyu, P.O Box 1748-00902, Kikuyu Town, Kenya Kenya UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2023-05-12 2028-05-11

24 Rwanda FDA-HMP-MA-1212 NEOCLAV POWDER FOR ORAL SUSPENSION 228.5 MG/ 5 ML Amoxicillin 200 mg and Clavulanic Acid 28.5 mg 228.5 Mg/ 5 ml Powder for Oral Suspension 70ml Bottle Amber glass bottle 24 Months NEOPHARMA, Plot No. A1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O. Box 72900, Mussafah, Abu Dhabi UAE, United Arab Emirates UNITED ARAB EMIRATES NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

25 Rwanda FDA-HMP-MA-1735 NEOPRED Neomycin sulfate and Prednisolone sodium phosphate Neomycin sulfate 0.35g +Prednisolone sodium phosphate 0.55g Eye drops 1 vial of 5ml VIALS 24 Months LES LABORATOIRES MEDIS Km 7 Route de Tunis, B.P.206,800 Nabeul, TUNISIA. Country: Tunisia Telephone: (+216-72) 235006/235010/235011 Telephax: (+216-72) 235016/235115/235106 E-mail: contact@labomedis.com TUNISIA LES LABORATOIRES MEDIS KIPHARMA LTD 2024-08-17 2029-08-16

26 Rwanda FDA-HMP-MA-2120 NEOTAGMIN NEOSTIGMINE METHYLSULFATE 0.5MG/ML SOLUTION FOR INJECTION 1mL Ampoule USP Type – I clear glass Ampoules 24 Months THEMIS MEDICARE LIMITED Sector 6A, Plot No. 16, 17 & 18, IIE, SIDCUL, Haridwar, Uttarakhand – 249403 India THEMIS MEDICARE LIMITED Wessex Pharmaceuticals (Rwanda) Ltd 2024-10-18 2029-10-17

27 Rwanda FDA-HMP-MA-0191 NEOVAG Nystatin USP, 100000 IU 100000 IU Vaginal Tablets 10X10 tablets 10 tablets are strip packed. Such 10 strips are packed in a Printed 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 2022-12-21 2027-12-20

28 Rwanda FDA-HMP-MA-0232 NEPIN-SR-20 Nifedipine BP, 20 mg 20 mg Film coated sustained release tablets 10x10 tablets PVC blister pack. Such 10 PVC blisters are packed in a printed carton along with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khantraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

29 Rwanda FDA-HMP-MA-1892 NERVILIN 75MG CAPS PREGABALIN 75MG CAPSULES 3 packs X10 tablets Alu alu blister packs 24 months. DAWA LIMITED. Plot no. 7879/8, baba dogo road, ruaraka. P.o. box 16633 - 00620, Nairobi, Kenya. Email: admin@dawalimited.com Kenya DAWA LTD/KENYA, Plot No 7879/8, Baba Dogo Road -Ruaraka P.O Box 16633-00620, NAIROBI KENYA. Tel: 0724764747, 0735764747. Fax: +254-20-8561550. Emaiadmin@dawalimited.com SUN ENTERPRISES LTD 2024-08-17 2029-08-16

30 Rwanda FDA-HMP-MA-1885 NERVILIN NT PREGABALIN 75MG TABLET 3x10 capsules Alu-Alu blister pack 36 months. DAWA limited Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.o. Box 16633 - 00620, Nairobi, Kenya. E-mail: admin@dawalimited.com Kenya DAWA limited,plot no. 7879/8, baba dogo road, ruaraka.p.o. box 16633 - 00620,nairobi, kenya.email: admin@dawalimited.com SUN ENTEPRISES LTD 2024-08-17 2029-08-16

31 Rwanda FDA-HMP-MA-1436 NERVILIN-NT Pregabalin 75 mg and Nortriptyline 10 mg 75 mg and 10 mg Film Coated Tablets 3 X 10 Tablets Alu/ Alu blisters packed in a unit box 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 2024-07-20 2029-07-19

32 Rwanda FDA-HMP-MA-2291 NETAZOX 100MG/5ML NITAZOXANIDE 100mg/5ml ORAL SUSPENSION 30ml HDPE Bottle 30 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-2290 NETAZOX 500 NITAZOXANIDE 500 mg Tablets 1x6 Tablets ALU/PVC BLISTER 36 Months IND SWIFT LIMITED IND SWIFT LIMITED, Industrial Growth Center Phase I, Samba, 184121 J&K, India INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

34 Rwanda FDA-HMP-MA-0905 NEURO-FORTE TABLETS Vitamin B1 USP 200 mg, Vitamin B6 USP 50 mg, Vitamin B12 USP 1000 mcg, and Color Erythrosine 200 mg, 50 mg, 1000 mcg, Film coated tablets 2 x 10 Tablets Alu-PVDC white Opaque strip pack, packed in a carton 36 Months CENTAUR PHARMACEUTICALS PVT. LTD, Plant: I Plot No: 3. Tivim Industrial Estate. Karaswada, Mapusa Goa-403526, India INDIA CENTAUR PHARMACEUTICALS PVT. LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LIMITED 2024-02-22 2029-02-21

35 Rwanda FDA-HMP-MA-1430 NEURO-STONE Pregabalin BP 75 mg, MecobalaminJP 1500 mcg, Folic acid BP 5mg, Pyridoxine Hydrochloride BP 20mg 75 mg, 1500 mcg, 5mg, 20mg Film-coated tablets 3x10 Tablets Blister Pack 24 Months THE MADRAS PHARMACEUTICALS, No.137 B, Old Mahabalipuram road, Karapakkam, Chennai 600 096, India INDIA THE MADRAS PHARMACEUTICALS DOLIPHARM LTD 2024-07-18 2029-07-17

36 Rwanda FDA-HMP-MA-0110 NEUROBA 300MG Gabapentin 300mg Capsule 3x10 Capsule ALU-ALU BLISTER STRIPS 36 Months UNIVERSAL CORPORATION LIMITED Club road, Plot No. 13777, P.O.Box 1748-000902 Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2022-07-18 2027-07-17

37 Rwanda FDA-HMP-MA-1018 NEUROGIL®75 Pregabalin 75mg 75mg Hard gelatin Capsule 2 x 10 capsules ALU/ALU Pack 36 Months WEST-COAST PHARMACEUTICAL WORKS LTD, F.P. No. 17 & 16/5, Meldi Estate, B/S Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad- 382481 Gujarat State, India INDIA BEKRA PHARMA UK LTD UBIPHARM RWANDA LTD 2024-02-28 2029-02-27

38 Rwanda FDA-HMP-MA-2276 NEUTRAGEL SUSPENSION MAGNESIUM HYDROXIDE/ ALUMINIUM HYDROXIDE/ SIMETHICONE 400MG/ 318.4MG/ 50MG/10ML ORAL SOLUTION 100ml/200ml 100ml Natural round HDPE bottle with white polypropylene screw cap 200ml natural round HDPE bottle with white LDPE concap 200ml type II amber glass bottle with polypropylene screwcap 2Litres HDPE container with polypropylene screw cap 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD 194 Gleneagles Road, Willlowvale, Harare, Zimbwabwe Zimbwabwe VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA LTD 2025-05-12 2030-05-11

39 Rwanda FDA-HMP-MA-0479 NEVANAC EYE DROPS Nepafenac 1mg/ml 1mg/ml Ophthalmic suspension 10 Bottles LDPE Bottle in polyethylene bag with dispensing plug and PP closure 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

40 Rwanda FDA-HMP-MA-0247 NEVIRAPINE ORAL SUSPENSION Nevirapine hemihydrate, 50mg/5ml 50mg/5ml Oral Suspension 240ml and 100ml Bottles HDPE Bottle 36 Months AUROBINDO PHARMA LIMITED (UNIT III), Survey no: 313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri Dist, Telangana State, India INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

41 Rwanda FDA-HMP-MA-0969 NEVXAL Nepafenac, 1mg/ml 1mg/ml Ophthalmic Suspension 5 ml Bottle Low Density Polyethylene Bottle 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

42 Rwanda FDA-HMP-MA-1683 NEWCOX - P ETORIXOCIB&PARACETAMOL 60MG/325MG TABLETS 3x10\\\'s Alu-Alu blister 36 month M/S Skybiotech Lifesciences Pvt. Ltd Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India Star Biotech LimitedAddress: 1st floor, Prestige House, Rwandex, Kigali-Rwanda STAR BIOTECH RWANDA 2024-08-17 2029-08-16

43 Rwanda FDA-HMP-MA-1234 NEWCOX-60 Etoricoxib Tablets 60 mg 60 mg Film coated tablets 3x10 Tablets Alu-Alu Blisters 36 Months M/S SKYBIOTECH LIFESCIENCES PVT. LTD, Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India INDIA PHARMA LIFE SCIENCE LTD STAR BIOTECH LIMITED 2024-05-06 2029-05-05

44 Rwanda FDA-HMP-MA-1235 NEWCOX-90 Etoricoxib Tablets 90 mg 90 mg film coated tablets 3x10 Tablets Alu-Alu Blisters 36 Months M/S SKYBIOTECH LIFESCIENCES PVT. LTD, Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India INDIA PHARMA LIFE SCIENCE LTD STAR BIOTECH LIMITED 2024-05-06 2029-05-05

45 Rwanda FDA-HMP-MA-1566 NEWCOX-TH Etoricoxib & Thiocolchicoside 60mg/8mg Film coated Tablets 3x10 Tablets ALU-ALU BLISTER PACK 36 Months SKYBIOTECH LIFESCIENCES PVT LTD Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India INDIA PHARMA LIFE SCIENCE LTD STAR BIOTECH LIMITED 2024-08-17 2029-08-16

46 Rwanda FDA-HMP-MA-0287 NEXIUM 10 MG SACHETS Esomeprazole magnesium trihydrate, 10mg 10mg Oral suspension 28 sachets Sachets made from aluminium laminate 36 Months AstraZeneca AB, Gärtunavägen SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

47 Rwanda FDA-HMP-MA-0288 NEXIUM 20MG TABLETS Esomeprazole magnesium trihydrate, 20 mg 20 mg Film coated tablets 14 tablets and 28 tablets Aluminium blister pack 30 Months AstraZeneca AB, Gärtunavägen SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

48 Rwanda FDA-HMP-MA-0289 NEXIUM 40MG TABLETS Esomeprazole magnesium trihydrate,40 mg 40 mg Film coated tablets 14 tablets Aluminium blister pack 30 Months AstraZeneca AB, Gärtunavägen SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

49 Rwanda FDA-HMP-MA-0307 NEXIUM IV INJECTION Esomeprazole magnesium trihydrate, 40 mg 40 mg Solution for injection/infusion 5ml in colourless glass vial Glass vial sealed with a bromobutyl rubber stopper and an aluminium cap with plastic flip-off seal 24 Months AstraZeneca AB, Gärtunavägen SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

50 RwandaFDA-HMP-MA-0569 NICARDIN- SR FILM-COATED TABLET Nifedipine BP 20 mg 20 mg Film-coated tablet 10x10 Tablets PVC Aluminum foil blister packs which are enclosed in a carton box 36 Months LABORATORY & ALLIED LIMITED, East gate road, off Mombasa, Opp, Sameer Africa, Plot N° 209/10349, Kenya KENYA LABORATORY & ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-10-13 2028-10-12

51 Rwanda FDA-HMP-MA-0278 NIFEDI-DENK RETARD Nifedipine 20 mg 20 mg Film coated tablets 3 x 10 or 10 x 10 tablets PVC/PVDC/aluminium blister, such 3 or 10 blisters are packed in carton with a pack insert 36 Months DENK PHARMA GmbH & Co. KG, Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & CO. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-05-12 2028-05-11

52 Rwanda FDA-HMP-MA-0976 NIFLURIL 400MG Morniflumate 400 mg 400 mg Suppository 8 Suppositories Polyvinylchloride film of 100 mm thickness, polyurethane adhesive, a low-density polyethylene film of 30 mm thickness 36 Months UPSA, 979, Avenue des Pyrenees, 47520 Le Passage –France FRANCE UPSA UBIPHARMA RWANDA LTD 2024-02-26 2029-02-25

53 Rwanda FDA-HMP-MA-0546 NIFLURIL CAPSULE Niflumic acid 250 mg 250 mg Capsules 30 capsules Aluminium foil packed in box 36 Months UPSA SAS. 979, Avenue des Pyrenees, 47520, Le Passage - France FRANCE UPSA, FRANCE KIPHARMA LTD 2023-10-05 2028-10-04

54 Rwanda FDA-HMP-MA-1726 NIFURAN TABLETS Nitrofurantoin BP 100mg Tablets 10x10 Tablets PVC/ALUMINIUM FOIL 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 2024-08-17 2029-08-16

55 Rwanda FDA-HMP-MA-1470 NIPINE-10 NIFEDIPINE BP 10MG TABLETS 10x10 Tablets Blister pack of 10x10 tablets placed in carton along with insert 36 Months AMBALAL SARABHAI ENTERPRISES LIMITED Division: Sarabhai Chemicals. Dr. Vikram Sarabhai Marg, Wadi, Vadodara – 390 023, India INDIA ASENCE PHARMA PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-07-27 2029-07-26

56 Rwanda FDA-HMP-MA-1416 NIPINE-SR 20 Nifedipine USP, 20 mg 20 mg Sustained Release Tablets 10×10 Tablets Blister pack along with one Insertpacked in a carton 36 Months CENTURION LABORATORIES PVT. LTD, Plot No: P-2, Savli Bio-Tech Park, At – Manjusar, Tal. – Savli, Dist. Vadodara – 391 775, India INDIA ASENCE PHARMA PVT. LTD SUN ENTERPRISES LTD 2024-07-18 2029-07-17

57 Rwanda FDA-HMP-MA-0890 NIRCIP Ciprofloxacin Intravenous Infusion BP 200mg/100ml (0.2% w/v) 200mg/100ml (0.2% w/v) Intravenous Infusion 100 ml Bottle Nipple Head FFS Plastic Bottle 36 Months ACULIFE HEALTHCARE PVT. LTD, Village: Sachana, Taluka: Viramgam, District: Ahmedabad - 382 150, Gujarat, India. INDIA ACULIFE HEALTHCARE PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-17 2029-02-16

58 Rwanda FDA-HMP-MA-0972 NIRFOL 1% Propofol BP 10mg/ml 10mg/ml Emulsion for Intravenous Injection Vial of 20 ml and 50 ml Type II glass vial closed with bromobutyl rubber stopper and flip off seal 24 Months ACULIFE HEALTHCARE PVT. LTD, Sachana, Taluka: Viramgam, District: Ahmedabad - 382 150. Gujarat, India INDIA ACULIFE HEALTHCARE PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-26 2029-02-25

59 Rwanda FDA-HMP-MA-2166 NIRMET METRONIDAZOLE 500MG/100ML Intravenous Infusion 100ml BFS bottle (using I-DPE plastic granule) 36 months ACULIFE HEALTHCARE PVT. LTD Village: Sachana, Taluka: Viramgam, District: Ahmedabad - 382 150. Gujarat, india India ACULIFE HEALTHCARE PVT. LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

60 Rwanda FDA-HMP-MA-0657 NITROCONTIN-2.6 Nitro-glycerine 2.6mg 2.6mg Uncoated tablets 25 Tablets Packed in polypropylene bottle 24 Months MODI-MUNDIPHARMA PVT. LT, Modipuram- 250110, U.P., India INDIA MODI-MUNDIPHARMA PVT. LTD, INDIA SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

61 Rwanda FDA-HMP-MA-2007 NIZACARD 1000 mg Ranolazine Extended-release 1000 mg Tablets 3x10 Tablets Alu PVC/PVdc Blister pack 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIA India Hetero Labs Limited, Address: 7-2-A2, Hetero Corporate, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, Pin Code - 500018 Country: INDIA Telephone : +91-40-23704923/24/25 Tele fax : +91-40-23704926/23714250 Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

62 Rwanda FDA-HMP-MA-2003 NIZACARD 500 Ranolazine 500 mg Extended-Release Tablets 3x10 Tablets Alu PVC/PVdc Blister pack 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIACountry: INDIA Telephone: +91-40-23096171/172/173/174 India Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

63 Rwanda FDA-HMP-MA-0208 NOKLOT Clopidogrel Bisulfate 75 mg 75mg Film-coated tablets 3x10 Tablets Alu-Alu Blister pack 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

64 Rwanda FDA-HMP-MA-0213 NOLVADEX TAMOXIFEN CITRATE, 20 mg 20mg Film-coated tablets, 30 film coated tablets Aluminium (Alu/PVC) blister pack 60 Months AstraZeneca UK LTD, Silk Road Business Park, Macclesfield, Cheshire, SK 10 2NA, United Kingdom UNITED KINGDOM AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20

65 Rwanda FDA-HMP-MA-0962 NOOTROPYL 800MG TABLETS Piracetam 800mg 800mg Film-coated tablets 45 Tablets PVC/Aluminium foil blister packs 48 Months UCB PHARMA SA, Chemin du foriest 1420 Braine-1’Alleud, Belgium BELGIUM GLAXOSMITHKLINE PHARMACEUTICAL LTD KIPHARMA LTD 2024-02-26 2029-02-25

66 Rwanda FDA-HMP-MA-2209 NORHINOSE Nasal Spray Mometasone Furoate Monohydrate 0.052 mg Nasal Spray 18gm suspension of 120 doses An amber glass (type III) glass bottle 24 Months EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES Cairo Desert Road KM 25, P.O Box 111, El Manshia Alex, Egypt EGYPT Amriya for Pharmaceutical Industries HELIOS PHARMA Ltd 2025-02-04 2030-02-03

67 Rwanda FDA-HMP-MA-1561 NORIGYNON Estradiol valerate Norethisterone enantate 5mg/50mg Solution for Injection 100 x1ml Ampoules GLASS AMPOULES 60 Months BAYER DE MEXICO, S.A DE C.V Ixtaczoquitlán Ojo de Agua S/N 94450 Ixtaczoquitlán, Veracruz México MEXICO BAYER EAST AFRICA LIMITED SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

68 Rwanda FDA-HMP-MA-0679 NORISTERAT® Norethisterone enantate, 200 mg 200 mg Solution 100 x 1 ml ampoules Brown glass ampoule, type I OPC 60 Months Bayer Ag, Berlin, Müllerstraße 178, 13 353 Berlin, Germany GERMANY BAYER EAST AFRICA LTD SURGIPHARM (RWANDA) LTD 2023-12-10 2028-12-09

69 Rwanda FDA-HMP-MA-2133 NORMAGUT CAPSULES Saccharomyces boulardii 250MG CAPSULES 1x10\'s ALU-PVC/PVDC 24 Months ARDEYPHARM GmbH LOERFELDSTR, 20 58313 HERDECKE, GERMANY GERMANY MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

70 Rwanda FDA-HMP-MA-0958 NOTIUM Diazepam Injection BP 10mg/2mL 10mg/2mL Solution for Injection. 10 Ampoules of 2 ml Amber ampoule is filled, sealed and labelled. 10 such ampoules are to be placed in a transparent tray then placed in a carton 36 Months KILITCH DRUGS INDIA LTD, Plot no- C-301/2, M.I.D.C T.T.C, Industrial Area, Pawane Village, Navi Mumbai - 400 705, Maharashtra, India INDIA KILITCH DRUGS (I) LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25

71 Rwanda FDA-HMP-MA-1213 NOVAMENTIN-228.5 Amoxicillin 200mg and Clavulanic Acid 28.5 mg. 228.5 mg/5ml Powder for Oral Suspension 100 ml Amber glass bottle Amber glass bottle 24 Months SCOTT- EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD, Hill Top Industrial Area, Bhatoli Kalan, Baddi-173205, Himachal Pradesh, India INDIA SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & ESCORTS PHARMACEUTICALS LIMITED 2024-05-06 2029-05-05

72 Rwanda FDA-HMP-MA-1484 NOVAMENTIN-625 Amoxicillin Trihydrate USP 500 mg & Diluted Clavulanate Potassium BP 125mg 500 mg & 125mg Film Coated Tablets 2x10 Tablets Alu/Alu Blister 24 Months SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LIMITED, Hill Top Industrial Area, Bhatolikalan, Baddi- 173205, (HP) India INDIA SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LIMITED, INDIA SUN ENTERPRISES LTD 2024-07-20 2029-07-19

73 Rwanda FDA-HBP-MA- 0018 NOVOMIX 30 FLEXPEN Insulin Aspart 100 U/ml 100 U/ml Suspension for Injection 5x3 ml in cartridge Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene 24 Months NOVO NORDISK A/S, AND NOVO NORDISK PRODUCTION SAS NOVO NORDISK A/S, Novo Alle, DK-2880 Bagsvaerd, Denmark and NOVO NORDISK PRODUCTION SAS, 45 Avenue d'Orleans, F-2000 Chartres, France FRANCE AND DENMARK NOVO NORDISK A/S, DENMARK WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

Registered

74 Rwanda FDA-HBP-MA- 0022 NOVORAPID FLEXPEN 1 ml of the solution contains 100 U of insulin aspart (equivalent to 3.5 mg).1 pre-filled pen contains 3 ml equivalent to 300 U 100U/ML & 300U/ML Solution for injection 3 ml solution in cartridge Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/ polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene 30 Months NOVO NORDISK PRODUCTION SAS, and Novo Nordisk A/S Novo Allé 45 Avenue d’Orléans F-28000 Chartres, France and DK-2880 Bagsværd, Denmark FRANCE, DENMARK NOVO NORDISK S/A WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-06-26 2028-06-25

75 Rwanda FDA-HMP-MA-1498 NOZINAN 100 MG Levomepromazine maleate acid 100MG Film Coated Tablets 20 Tablets PVC-Aluminum blisters 24 Months SANOFI S.P.A. Strada Statale 17, Km 22 67019 Scoppito (AQ), Italy Italy Sanofi Aventis Kenya Limited KIPHARMA LTD 2024-07-27 2029-07-26

76 Rwanda FDA-HMP-MA-1576 NOZINAN 25 MG Levomepromazine maleate acid 25 mg Tablets 20 Tablets PVC CLEAR/ALU BLISTER 36 Months SANOFI S.P.S Strada Statale 17, Km 22 67019 Scoppito (AQ) ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-08-17 2029-08-16

77 Rwanda FDA-HMP-MA-0185 NS Sodium Chloride Intravenous Infusion BP 0.9% w/v 0.9% w/v Intravenous infusion 1X500ml Bottle LDPE Bottle 36 Months AXA PARENTERALS LIMITED, Plot No 936,937,938, Vill. Kishanpur, jamalpur, roorkee247667, Distt. Haridwar (uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

78 Rwanda FDA-HMP-MA-0374 NUCLEO-CMP FORTE CAPSULES CMP disodium salt/UTP trisodium salt, 5mg/3mg 5mg/3mg Hard gelatin capsules 3 x 10 Capsules 10 Capsules are packed in aluminium/PVC-Aclar-PVC blister. Such 3 blisters are packed in a printed carton with pack insert 24 Months FERER INTERNATIONAL, S.A, Joan Buscalla 1-9,08173 –Saint Cugat del Valles, Spain. SPAIN FERRER INTERNATIONAL, S.A. GOMHS LTD 2023-08-24 2028-08-23

79 Rwanda FDA-HMP-MA-0207 NUCOXIA-120 Etoricoxib 120mg 120mg Film-coated tablets 3x10 Tablets Alu-Alu Blister pack 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

80 Rwanda FDA-HMP-MA-0210 NUCOXIA-60 Etoricoxib 60mg 60mg Film-coated tablets 3x10 Tablets Alu-Alu Blister 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

81 Rwanda FDA-HMP-MA-0209 NUCOXIA-90 Etoricoxib 90 mg 90mg Film-coated tablets 3x10 Tablets Alu-Alu Blister 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

82 Rwanda FDA-HMP-MA-1357 NUGREL 75MG Clopidogrel Tablets USP 75 mg 75 mg Film-Coated Tablets 3 ×10 tablets Alu/Alu Blisters packed in a carton 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126. India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

83 Rwanda FDA-HMP-MA-1174 NUSAR 50 Losartan Potassium BP/USP 50 mg 50 mg Film-coated tablet 3×10 capsules Alu-Alu blister (Palin Alu-Alu foil/Printed Blister Aluminium foil) 36 Months EMCURE PHARMACEUTICALS LIMITED, Lane No.3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu – 181133, India INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA(A) LTD 2024-05-06 2029-05-05

84 Rwanda FDA-HMP-MA-0703 NUSAR-H Losartan potassium USP 50mg & Hydrochlorothiazide BP. 12.5mg 50mg & 12.5mg Film coated tablets 3X10 tablets Bister strip (VMCH coated printed Aluminium foil / PVC foil). 3 such strips are packed in a carton along with a package insert 36 Months EMCURE PHARMACEUTICALS LTD, Lane No. 3. Phase-II, SIDCO Industrial Complex Bari – Brahmana, Jammu (J&K) - 181133 INDIA INDIA EMCURE PHARMACEUTICALS LTD, INDIA ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29

85 Rwanda FDA-HMP-MA-0555 NYSKA Nystatin tablets USP 500,000IU 500,000IU Film coated tablets 10x10 tablets 10 tablets in a strip and 10 such strips along with the insert in the Carton 24 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 2023-10-05 2028-10-04

86 Rwanda FDA-HMP-MA-1757 NYSKA-P Nystatin BP 100,000 IU Suspension 30 ml Bottles GLASS BOTTLE 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 2024-08-17 2029-08-16

87 Rwanda FDA-HMP-MA-0557 NYSKA-V Nystatin, 100,000IU 100,000IU Tablets (vaginal inserts) 1x14 tablets 1x14’s strip pack along with the insert in the Carton 24 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 2023-10-05 2028-10-04

88 Rwanda FDA-HMP-MA-1821 NYSTATIN TABLETS Nystatin BP 500000 IU Tablets 10x10 Tablets ALU/PVC BLISTERS 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

89 Rwanda FDA-HMP-MA-0782 NYSTATIN VAGINAL TABLETS USP 1,00,000 IU Nystatin 100,000 IU 100,000 IU Vaginal Tablets 1 x 14 tablets Packed in aluminium strip, in a carton 36 Months AURA LIFECARE PVT. LTD, Survey No 254/ 14/1, Jarod, Savli Road, P.O. Karachiya, Tal-Savli, Dist: Vadodara-391520. Gujarat State, India INDIA AURA LIFECARE PVT. LTD SUN ENTERPRISES LTD 2024-01-08 2029-01-07