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-0375 ODIMONT L Montelukast and Levocetirizine Dihydrochloride 10mg/5mg 10mg/5mg Film coated tablets 3 x 10 tablets Alu-Alu blister packs 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, INDIA INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07
2 Rwanda FDA-HMP-MA-1809 OFLOX-OZ Ofloxacin BP, Ornidazole 200 mg/ 500mg Film Coated Tablets 3x10 Tablets Alu/Alu 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
3 Rwanda FDA-HMP-MA-1153 OFLOZOLE TABLETS Ofloxacin BP 200 mg and Ornidazole 500 mg 200 mg and 500 mg Film coated Tablets 10 Tablets Alu/ Alu Blister packed in a carton 36 Months AUROCHEM LABORATORIES (INDIA) PVT. LTD. Plot 8, Palghar Taluka, Industrial Co.-Op. Estate Ltd INDIA AUROCHEM LABORATORIES (INDIA) PVT. LTD UBIPHARM-RWANDA LTD 2024-04-27 2029-04-26
4 Rwanda FDA-HMP-MA-0955 OFUSIDIC Fusidic acid 10mg/g 10mg/g Eye Drops 5 ml Bottle LDPE white plastic dropper 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
5 RwandaFDA-HMP-MA-1871 OFZOLE 30 TABS OFLOXACIN + ORNIDAZOLE 200MG/500MG TABLET 1x10’s ALU/PVC BLISTER 24 Months CORONA REMEDIES PVT LTD Address: Village Jatoli, Post Office - Oachghat, Tehsil Solan, Dist. Solan Himachal Pradesh – 173223. Country: India INDIA CORONA REMEDIES PVT LTD AIVEEN RWANDA LTD 2024-08-17 2029-08-16
6 Rwanda FDA-HMP-MA-0917 OLEPTISS 180 MG FILM-COATED TABLETS Deferasirox 180mg 180mg Film coated tablets 90 Tablets PVC/PVDC/Aluminium blisters 36 Months NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 Stein AG, Switzerland SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-02-22 2029-02-21
7 Rwanda FDA-HMP-MA-0916 OLEPTISS 360 MG FILM-COATED TABLETS Deferasirox 360mg 360mg Film coated tablets 90 Tablets PVC/PVDC/Aluminium blisters 36 Months NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 Stein AG, Switzerland SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-02-22 2029-02-21
8 Rwanda FDA-HMP-MA-0888 OLEPTISS 90 MG FILM-COATED TABLETS Deferasirox 90mg 90mg Film-Coated Tablets 90 Tablets PVC/PVDC/Aluminium blisters 36 Months NOVARTIS PHARMA STEIN AG, Schaffhauserstrasse, 4332 Stein AG, Switzerland. SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LIMITED 2024-02-17 2029-02-16
9 Rwanda FDA-HMP-MA-0789 OLIGOCARE TABLETS L-Carnitine Tartrate 50mg, L-Arginine USP 10mg, L- Glutathione BP 2.5mg, Zinc Sulphate Monohydrate USP 7.5mg, Sodium Selenate Anhydrous 100 mcg, Ferrous Fumarate BP 5 mg, Copper Sulphate Pentahydrate USP 3.929 mg, Copper Sulphate (In House Dried) 2.795 mg, Manganese Sulphate Monohydrate USP 2 mg, Folic Acid BP 250 mcg, Thiamine Nitrate BP 5 mg, Pyridoxine Hydrochloride BP 5 mg, Siberian Ginseng Extract 10 mg, Vitamin E Acetate 12.5 mg, Vitamin C, 75 mg eq.78.125 mg, Vitamin A Acetate BP 1250 IU, Methylcobalamin 750 mcg, and Lycopene 6% Beadlets 2 mg 50mg, 10mg, 2.5mg, 7.5mg, 100 mcg, 5 mg, 3.929 mg, 2.795 mg, 2 mg, 250 mcg, 5 mg, 5 mg, 10 mg, 12.5 mg, 75 mg, 1250 IU, 750 mcg, 6% and 2 mg Film coated tablets 30 Tablets Printed Polylaminated, Aluminium foil for strip Packing 24 Months MEYER ORGANICS PVT. LTD., Plot 10 D, Phase II, Peenya Industrial Area, Bangalore 560058, India. INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2024-01-08 2029-01-07
10 RWANDA-FDA24/HM/0782/0025 OLMAC Olanzapine 10mg Film Coated Tablet 24 Months MACLEODS PHARMACEUTICALS LIMITED 304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai- 400 059, India MACLEODS PHARMACEUTICALS LTD AIVEEN (R) LTD 2026-02-06 2031-02-05
11 Rwanda FDA-HMP-MA-1703 Olopat OD Olopatadine Hydrochloride USP Olopatadine Hydrochloride Ophthalmic Solution USP 0.2% w/v Ophthalmic 5 ml LDPE vial 36 month Ajanta Pharma Limited Mirza-Palashbhari road, vill.- Kokhjar, Kamrup (R), Guwahati, Assam- 781128 India Ajanta Pharma Limited Abacus Pharma (A) Ltd 2024-08-17 2029-08-16
12 Rwanda FDA-HMP-MA-0461 OM CAPSULES Omeprazole 20mg pellets 20mg Hard Gelatin Capsules 10x10’s capsules ALU-PVC blisters of hard gelatin capsules containing white pellets with a Patient Information Literature Insert 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 KENYA LABORATORY & ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23
13 Rwanda FDA-HMP-MA-1184 OMACILLIN 500 Amoxicillin trihydrate equivalent to Amoxicillin 500 mg 500 mg Capsules 2x10 Capsules PVC/PE/PVDC backed up with printed aluminium foil 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) SUN ENTERPRISES LTD 2024-05-06 2029-05-05
14 Rwanda FDA-HMP-MA-0577 OMEFLUX CAPSULES Omeprazole 20mg Capsules 20mg Capsules 3 x 10 Capsules Alu-Alu Blisters of 3 x 10’s inserted in unit boxes 36 Months BIODEAL LABORATORIES LTD, Plot No.123, Lunga Lunga Road, P.O BOX 32040-00600, Nairobi. Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LTD 2023-09-11 2028-09-10
15 Rwanda FDA-HMP-MA-1229 OMEP Omeprazole BP 20mg 20mg Capsules 10x10 Capsules Aluminium Strip 24 Months BAL PHARMA LIMITED, 21 & 22-Bommasandra Industrial Area Bangalore – 560099 Karnataka, India INDIA BAL PHARMA LIMITED SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05
16 Rwanda FDA-HMP-MA-1977 OMEPRAGLOBE OMEPRAZOLE 20MG CAPSULES 1x10 Capsules Alu-Alu Blister 36 Months GLOBELA PHARMA PVT. LIMITED Plot No. 357-358, G.I.D.C, Sachin, Road no. 3, Surat, Gujarat, India INDIA GLOBELA PHARMA PVT.LTD AFRIPHARM LTD 2024-08-17 2029-08-16
17 Rwanda FDA-HMP-MA-0672 OMESK Omeprazole delayed release Capsules USP 20mg 20mg Hard gelatin capsules 10x10 Capsules a Alu-Alu strip, such 10 strips in a printed carton with a printed insert 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, INDIA ABACUS PHARMA (A) LTD 2023-12-02 2028-12-01
18 Rwanda FDA-HMP-MA-1195 OMICAP-20 Omeprazole 20mg 20mg Capsules 3x10 capsules Alu/ Alu strips in 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 2024-05-06 2029-05-05
19 Rwanda FDA-HMP-MA-1033 OMILOK-20 CAPSULES Omeprazole BP 20 mg 20 mg Hard gelatin capsules 10x10 Capsules Alu-PVC blisters. Such 10 blisters are packed in an outer carton along with the pack insert 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, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27
20 Rwanda FDA-HMP-MA-1455 OMIREN CAPSULES OMEPRAZOLE BP 20MG Capsules 10x10 Capsules Alu-PVC foil blisters packed in a unit box 24 Months RENE INDUSTRIES LTD Plot No.680, P.O.Box 6034 Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-07-27 2029-07-26
21 RWANDA-FDA23/HM/0155/0034 OMITRON SOLUTION ONDANSETRON ORAL SOLUTION USP Oral solution 36 CADILA PHARMACEUTICAL LTD. India Aura Lifecare Pvt. Ltd. SUN ENTERPRISE Ltd 2026-03-14 2031-03-13
22 Rwanda FDA-HMP-MA-0204 OMLINK-20 Omeprazole USP 20mg & Omeprazole Pellets 7.15% 20mg & 7.15% Hard Gelatin Capsules 10 X 10’s Tablets Alu-strip pack 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
23 Rwanda FDA-HMP-MA-1073 OMOL TABLETS Paracetamol 500mg 500 mg Uncoated Tablet 2×10 tablets PVDC / PE coated PVC blisters, backed up with aluminium foil in a carton box 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) SUN ENTERPRISE LTD 2024-04-20 2029-04-19
24 Rwanda FDA-HMP-MA-0999 OPELAN ODT 5 Olanzapine Orodispersible 5mg 5mg Tablets 3 x 10 Tablets Alu/Alu Blisters. 3 such Blisters packed in a carton 36 Months MICRO LABS LIMITED, No 27, Race Course Road, Bangalore - 560 001, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25
25 Rwanda FDA-HMP-MA-1583 OPELAN ODT-10 Olanzapine oral dispersible 10 mg Tablets 10 Tablets ALU/ALU BLISTER 36 Months MICRO LABS LIMITED 92, Sipcot, hosur-635 126 INDIA MICRO LABS LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LIMITED 2024-08-17 2029-08-16
26 Rwanda FDA-HMP-MA-0424 OPELE LOTION Benzyl Benzoate emulsion, 25% w/v 25% w/v Emulsion 50ml bottle P40 50ml clear glass bottles which are sealed with 22mm aluminum ROPP cap and labelled and packed in chipboard unit carton 36 Months BETA HEALTHCARE INTERNATIONAL LTD, Plot No. L.R 209/6554 Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23
27 Rwanda FDA-HMP-MA-2156 ORAL REHYDRATION SALTS GLUCOSE ANHYDROUS BP, SODIUM CHLORIDE BP, SODIUM (TRISODIUM) CITRATE BP, POTASSIUM CHLORIDE BP 13.5GM / 2.6GM / 2.90GM / 1.50GM ORAL POWDER 20.6g / 10.3g Aluminium foil sachets 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road P.O Box 42875-00100 Nairobi. Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-10-18 2029-10-17
28 Rwanda FDA-HMP-MA-0394 ORASOL Dextrose anhydrous BP 75mmol/litre, Sodium chloride 75mmol/litre, Chlorides 65mmol/litre, Potassium 20mmol/litre, Citrate 10mmol/litre 75mmol/litre, 75mmol/litre, 65mmol/litre, 20mmol/litre, 10mmol/litre Powder for Oral Solution 25 Sachets and 50 Sachets 25 Sachets in 1 litre box, 50 Sachets in 500ml box 36 Months BIODEAL LABORATORIES LIMITED, Plot No. 123, Lunga Lunga Road, P.O. Box 32040- 00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LIMITED, KENYA CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2023-08-24 2028-08-23
29 Rwanda FDA-HMP-MA-1433 ORCHAZID OPHTHALMIC SOLUTION Ketotifen 0.25mg/ml 0.25mg/ml Ophthalmic Solution 5 ml Bottle LDPE white plastic bottles 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial Zone, Area 14, 15 Block No. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICALS ETS CONTINENTAL DEPOT 2024-07-20 2029-07-19
30 Rwanda FDA-HMP-MA-1015 ORCHAZID SDU Ketotifen fumarate 0.25mg/ml 0.25mg/ml Solution 30x0.4ml strips LDPE white plastic single dose unit 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour city, Industrial zone, Area15, Block no. 12011, Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES, EGYPT ETS CONTINENTAL LTD 2024-02-28 2029-02-27
31 RwandaFDA-HMP-MA-0486 ORILAM ODT-100 Lamotrigine USP 100 mg 100 mg Tablets 3×10’s Tablets Alu/Alu blister pack 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-0487 ORILAM ODT-25 Lamotrigine USP 25 mg 25 mg Tablets 3×10’s Tablets Alu/Alu blister pack 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
33 Rwanda FDA-HMP-MA-0633 ORILAM ODT-50 Lamotrigine USP 50 mg 50 mg Uncoated tablets 3x10’s 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 2023-12-10 2028-12-09
34 Rwanda FDA-HMP-MA-0834 ORNILOX Ornidazole 500mg/ Ofloxacine 200mg 500mg and 200mg Film coated tablets 1x10 Tablets Alu/Alu blister pack 36 Months MICRO LABS LIMITED, No. 31, Race Course Road, Bengaluru 560 001, Karnataka, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-09 2029-02-08
35 Rwanda FDA-HMP-MA-1485 OSMOWIN Each 15 ml contains Lactulose concentrate USP equivalent to lactulose 10 g 10 g/15ml Syrup 100ml and 200ml Bottles Amber coloured PET bottle of 100ml and 200ml with ROPP caps with coextruded polyethylene wads 24 Months G.S. PHARMBUTOR PVT. LTD., B-172, Industrial Area, Behror- 301 701, Rajasthan, India INDIA WIN-MEDICARE PVT. LTD, INDIA SURGIPHARM (RWANDA) LIMITED 2024-07-20 2029-07-19
36 Rwanda FDA-HMP-MA-2171 OSTEOMIN TABLETS Glucosamine Sulphate 2kcl 667mg Equivalent to Glucosamine Sulphate 500mg and Chondroitin Sulphate 400mg 500 mg & 400 mg TABLETS 3x10 Tablets PVC/PVDC film 36 Months MEGA LIFESCIENCES (Australia) Pty. Ltd 60 National Avenue, SouthEast Business Park, Pakenham, Victoria, Australia 3089 Australia MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2025-01-09 2030-01-08
37 Rwanda FDA-HMP-MA-1263 OTIPAX® 15ML SOLUTION, EAR DROPS Phenazone 4g Lidocaine Hydrochloride 1g for 100g of solution 4g & 1g for 100g of solution Solution for ear drops 15 ml Bottle containing 16 g of solution Yellow glass type III, closed by a stopper (LDPE) with a seal (LDPE) and a dropper (PE/vinyl acetate) and a stopper (LDPE). Box of 1 bottle 36 Months BIOCODEX, 1 avenue Blaise Pascal, 60000 Beauvais, France FRANCE BIOCODEX FORTILAB RWANDA 2024-05-07 2029-05-06
38 Rwanda FDA-HMP-MA-1383 OTRIVIN NASAL DROPS SOLUTION 0.05% Xylometazoline Hydrochloride 0.05% 0.0005 Nasal drops 10ml Bottle High density polyethylene bottle 36 months GSK CONSUMER HEALTHCARE S.A., Route de l’Etraz 2, 1260 Nyon, Switzerland. Fondation Polyval, Site de Nyon, Route de Divonne 48, 1260 Nyon, Switzerland. SWITZERLAND GLAXO SMITH KLINE LIMITED KIPHARMA LIMITED 2024-05-18 2029-05-17
39 Rwanda FDA-HMP-MA-1384 OTRIVIN NASAL DROPS SOLUTION 0.1% Xylometazoline Hydrochloride 0.1% 0.001 Nasal drops 10ml Bottle High density polyethylene bottle 36 months GSK CONSUMER HEALTHCARE S.A., Route de l’Etraz 2, 1260 Nyon, Switzerland. Fondation Polyval, Site de Nyon, Route de Divonne 48, 1260 Nyon, Switzerland SWITZERLAND GLAXO SMITH KLINE LIMITED KIPHARMA LIMITED 2024-05-18 2029-05-17
40 Rwanda FDA-HMP-MA-0495 OVOID Misoprostol Dispersion USP 200 mcg 200 mcg Uncoated tablets 3 x 10 Tablets Alu/Alu Blisters which are packed in a printed outer carton 24 Months AKUMS DRUGS & PHARMACEUTICALS LTD. 19, 20 & 21 Sector 6A, IIE, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12
41 RWANDA-FDA25/HM/0419/0019 OXALIPLATIN 5MG/ML solution for infusion OXALIPLATIN 5 mg/ml (filling size: 100 mg/20 ml) Concentrate for solution for infusion 1's 48 Months HERAEUS MEDICAL GMBH Germany ONCOPHARM WHOLESALE ONCOPHARM RWANDA LTD 2026-02-05 2031-02-04
42 Rwanda FDA-HMP-MA-1502 OXCIN OPHTHALMIC SOLUTION MOXIFLOXACIN HYDROCHLORIDE BP 5MG EYE DROPS 5ml Bottle LDPE bottle packed in a printed carton 24 Months ATCO Laboratories Limited, B?18, S.I.T.E., Karachi ?75700, Karachi. Sindh, Pakistan Pakistan ATCO Laboratories Limited AFRI HEALTH CARE LIMITED 2024-07-27 2029-07-26
43 Rwanda FDA-HMP-MA-1503 OXCIN-D OPHTHALMIC SOLUTION MOXIFLOXACIN HYDROCHLORIDE BP /DEXAMETHASONE PHOSPHATE 0.5%W/V+0.1%W/V EYE DROPS 5ml Bottle LDPE bottle packed in a printed carton 24 Months ATCO Laboratories Limited, B?18, S.I.T.E., Karachi ?75700, Karachi. Sindh, Pakistan Pakistan ATCO Laboratories Limited AFRI HEALTH CARE LIMITED 2024-07-27 2029-07-26
44 Rwanda FDA-HMP-MA-1900 OXYNIR INJ OXYTOCIN 10IU/ML Intravenous injection 5x10x1ml glass Ampoule USP Type I 24 months Aculife Healthcare Pvt. Ltd Aculife Healthcare Pvt. Ltd. Sachana, Taluka; Viramgam, Ahmedabad - 382 150. Gujarat, India. INDIA Aculife Healthcare Pvt. Ltd.Address: Village: Sachana, Tal: Viramgam, Dist: AhmedabadCountry: India SUN ENTERPRISES LTD 2024-08-17 2029-08-16
45 Rwanda FDA-HMP-MA-1567 OXYTOCIN 10 I.U Oxytocin 10 IU/ 1ml Solution for injection 10 ampoules of 1 ml solution GLASS AMPOULES 36 Months EVER PHARMA GMBH JENA Otto-Schott-Stra?e 15 07745 Jena, Germany GERMANY SANDOZ GMBH KUNDL SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16
46 Rwanda FDA-HMP-MA- 1426 OXYTOCIN 5 I.U HEXAL Oxytocin, 5IU/1ml 5 IU/1ml Solution for Injection 10 ampoules of 1 ml solution Ampoules of 1 ml solution for injection in clear glass bott 36 Months SALUTAS PHARMA GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben Germany GERMANY SANDOZ GmbH, Kundl, Germany SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17
47 Rwanda FDA-HMP-MA-1558 OXYTOCIN INJECTION Oxytocin injection BP 10IU/ml Solution for injection 10 Ampoules for 1ml AMBER GLASS AMPOULE 24 Months CIRON DRUGS &PHARMACEUTICALS PVT LTD N-118, N-119, N-113, MIDC, Tarapur, Boisar, Dist: Thane-401 506. Maharashtra, India INDIA CIRON DRUGS &PHARMACEUTICALS PVT LTD RENE PHARMACEUTICALS LTD 2024-08-17 2029-08-16
48 Rwanda FDA-HMP-MA-1394 OZITAS-10 Olanzapine 10 mg tablets 10 mg Film Coated Tablets 3 X 10 Tablets Alu/Alu blister pack which is in a printed carton 24 Months INTAS PHARMACEUTICALS LIMITED, Camp Road, Selaqui-248197 Dehradun Uttarakhand, India INDIA INTAS PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-07-18 2029-07-17
49 Rwanda FDA-HMP-MA-1395 OZITAS-5 Olanzapine 5 mg tablets 5 mg Film Coated Tablets 3 X 10 Tablets Alu/Alu blister pack where each one is inserted a printed carton 24 Months INTAS PHARMACEUTICALS LIMITED, Camp Road, Selaqui-248197 Dehradun Uttarakhand, India INDIA INTAS PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-07-18 2029-07-17