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-0267 G-OUT 0.5 Colchicine 0.5 mg 0.5 mg Uncoated tablets 3X10 tablets, 30/100 tablets Alu/PVC/PVdC Blister pack of 10 tablets, such 1/3/10 Blisters packed in a carton along with pack insert, & HDPE container pack of 30/100 tablets. 24 Months MACLOEDS PHARMACEUTICALS LTD, Block N-2, Village: Theda, PO: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

2 Rwanda FDA-HMP-MA-1551 G-OUT PLUS Colchicine Tablets 1mg Film coated Tablets 10 Tablets ALU / WHITE OPAQUE PVC/PVDC BLISTER 24 Months MACLEODS PHARMACEUTICALS LIMITED 304, Atlanta Arcade, Marol Church road, Andheri (East), India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICAL (RWANDA)LTD 2024-08-17 2029-08-16

3 Rwanda FDA-HMP-MA-0274 GABALIN 300 Gabapentin Capsules USP 300 mg 300 mg Hard gelatin capsule 10 Capsules Alu-PVDC blister packed in a 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 2023-05-12 2028-05-11

4 Rwanda FDA-HMP-MA-2015 GABAR 25MG PREGABALIN 25MG Capsules 56 Capsules Blisters of aluminium and Double plastic bag of LDPE 36 months LABORATORIOS LICONSA, S.A Avda. Miralcampo, No7, Polígono Industrial Miralcampo- 19200 Azuqueca Henares (Guadalajara).Spain SPAIN FAES FARMA, S.A., Maximo Aguire 14-48940 Leioa, SpainPhone : 0034944818300Telefax : 0034944818309Email : ihermo@faes.es , ieguidazu@faes.es UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

5 Rwanda FDA-HMP-MA-0709 GABAZIM 300 Gabapentin 300mg 300mg Hard gelatin capsules 1 × 10 hard gelatin capsules Alu-PVC blister pack 24 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

6 RwandaFDA-HMP-MA-1887 GACET -125 ACETAMINOPHEN UPS 125MG SUPPOSITORY 2x5’s ALU/PVC BLISTER 36 Months Bliss GVS Pharma Limited Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Taluka Palghar, Thane 401404 Maharashtra State,India INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

7 Rwanda FDA-HMP-MA-1522 GACET -250 ACETAMINOPHEN USP 250MG SUPPOSITORIES 2X5 Suppositories A polyvinylchloride foil coated with Polyethylene. (PVC-PE Foil) 2 strips each containing 5 Suppositories are packed in a carton along with pack insert 36 Months BLISS GVS PHARMA LIMITED Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Taluka Palghar, Thane 401404, India INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-07-27 2029-07-26

8 Rwanda FDA-HMP-MA-2115 GACET 500 Paracetmol Effervescent Granules 500 MG Effervescent Granules 10 sachets Laminate foil 24 Months BLISS GVS PHARMA LTD Survey No. 43- 44, Vevoor village , Palghar 401404 India BLISS GVS PHARMA LTD Surya Depot Pharmacy Ltd 2024-10-18 2029-10-17

9 Rwanda FDA-HMP-MA-1697 GACET-500 PARACETAMOL EFFERVESCENT 500MG 500MG EFFERVESCENTS TABLETS 4 strips aluminium foil 36 month Vovantis Laboratories Pvt. Ltd Survey No. 546/1/1, Opposite Ranoli Railway Station, Near GACL Plant, City: Ranoli-391 350, Dist.: Vadodara, Gujrat State India BLISS GVS PHARMA LTD Address: 102, Hyde Park, Saki-Vihar Road, Andheri (East). Mumbai-400072Country: IndiaTelephone: +91-22-42160000Telefax: +91-22-28563930E-Mail: info@blissgvs.com SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

10 Rwanda FDA-HMP-MA-0984 GALAXY NEUROCARE CAPSULES Methylcobalamin 1500mcg, Gamma Linoleic Acid (From Borage oil BP) 60 mg, Alpha Lipoic Acid USP 100 mg, Folic Acid BP 1.5 mg, Pyridoxine Hydrochloride BP 3 mg, Biotin USP 3mg, Elemental Chromium (as Chromium Picolinate USP) 100 mcg, Elemental Zinc (as Zinc Sulfate USP) 10 mg 1500mcg,60 mg, 100 mg, 1.5 mg,3 mg, 3mg, 100 mcg,10 mg Soft Gelatin Capsules 3 X 10 Capsules Blister aluminium foil/plain PVDC foil pack of capsules packed in a primary carton along with the pack insert 24 Months SOFTGEL HEALTHCARE PRIVATE LIMITED, Survey no. 20/1, Vandalur Kelambakkam road, Pudupakkam village, Kancheepuram district– 603 103, Tamilnadu. India. INDIA GALAXY PHARMACEUTICALS, INDIA STAR BIOTECH LIMITED 2024-02-26 2029-02-25

11 Rwanda FDA-HMP-MA-0983 GALAXYS NEUROCARE PLUS CAPSULES Methylcobalamin 750mcg, Pregabalin 75mg, Folic acid BP 1.5mg, Pyridoxine hydrochloride BP 3mg, Alpha Lipoic acid USP 100mg 750mcg, 75mg, 1.5mg, 3mg, 100mg Soft Gelatin Capsules 3 X 10 Capsules Blister aluminium foil/plain PVDC foil pack of capsules packed in a primary carton along with the pack insert. 24 Months SOFTGEL HEALTHCARE PRIVATE LIMITED, Survey no. 20/1, Vandalur Kelambakkam road, Pudupakkam village, Kancheepuram district– 603 103, Tamilnadu. Country: India. INDIA GALAXY PHARMACEUTICALS, INDIA STAR BIOTECH LIMITED 2024-02-26 2029-02-25

12 Rwanda FDA-HMP-MA-1242 GALAXY’S HEEL CREAM Vitamin A Palmitate BP 1000IU/g, Vitamin D3 BP 30IU/g, Urea BP 5.0% w/w, Aloe vera Extract 5.0% w/w, Magnesium Lactate Dihydrate BP 2.0% w/w and Zinc Oxide BP 2.0% w/w 1000IU/g, 30IU/g, 5.0% w/w, 5.0% w/w, 2.0% w/w and 2.0% w/w Cream 30 gm Tube Laminated Tube 36 Months CURETECH SKINCARE, Plot No. 33 & 34, Phase – IV, Bhatoli Kalan, Baddi, Distt. Solan (HP)-173205, India INDIA GALAXY PHARMACEUTICALS STAR BIOTECH LIMITED 2024-05-06 2029-05-05

13 Rwanda FDA-HMP-MA-1269 GALAXY’S NEUROCARE-25 Methylcobalamin 750mcg, Pregabalin 25mg, Folic acid 1.5mg, Pyridoxine hydrochloride 3mg, Alpha Lipoic acid 100mg 750mcg, 25mg, 1.5mg, 3mg, 100mg Soft gelatin capsules 3x10 Capsules Alu-Alu Blister pack 24 Months SOFTGEL HEALTHCARE PVT LTD, Survey No. 20/1, new survey No. 9/810, Vandalur –Kelambakkam Road, Pudupakkam Village, Kancheepuram District – 603 103, Tamilnadu, India INDIA GALAXY PHARMACEUTICALS, INDIA STAR BIOTECH RWANDA 2024-05-07 2029-05-06

14 Rwanda FDA-HMP-MA-0286 GALVUS MET 50/1000MG FILM-COATED TABLET Vildagliptin 50mg/Metformin Hydrochloride 1000mg 50mg/ 1000mg Film coated tablets 30’s, 60’s, 10’s, 120’s, 180’s, 360’s tablets PA/AL/PVC, Aluminium foil blisters 18 Months NOVARTIS PHARMA PRODUKTIONS GmbH, Address: Öflinger Strasse 44,79664 Wehr, Germany. GERMANY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

15 Rwanda FDA-HMP-MA-0284 GALVUS MET 50/500MG Vildagliptin 50mg/Metformin Hydrochloride 500mg 50mg/ 500mg Film coated tablets 30’s, 60’s, 10’s, 120’s, 180’s, 360’s tablets PA/AL/PVC, Aluminium foil blisters 18 Months NOVARTIS PHARMA PRODUKTIONS GmbH, Address: Öflinger Strasse 44,79664 Wehr, Germany. GERMANY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

16 Rwanda FDA-HMP-MA-0285 GALVUS MET 50/850MG FILM-COATED TABLET Vildagliptin 50mg/Metformin Hydrochloride 850mg 50mg/ 850mg Film coated tablets 30’s, 60’s, 10’s, 120’s, 180’s, 360’s tablets PA/AL/PVC, Aluminium foil blisters 18 Months NOVARTIS PHARMA PRODUKTIONS GmbH, Address: Öflinger Strasse 44,79664 Wehr, Germany. GERMANY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

17 Rwanda FDA-HMP-MA-1390 GALVUS® 50MG Vildagliptin 50mg 50mg Tablets 56 Tablets PA/AL/PVC blister foil 36 months NOVARTIS FARMACÉUTICA S.A., Barberá del Vallés, Spain SPAIN NVS KENYA LIMITED, KENYA SURGIPHARM (RWANDA) LIMITED 2024-05-18 2029-05-17

18 Rwanda FDA-HMP-MA-0322 GAMALATE B6 ORAL SOLUTION 2.0 g Magnesium Glutamate Hydrobromide (MGH), 1.0 g Pyridoxine hydrochloride (Vitamin B6), 1.0 g ?-amino-?-hydroxy-butyric acid (GABOB), 2.0 g ? -Aminobutyric Acid (GABA) 2.0 g, 1.0 g, 1.0 g, 2.0 g ORAL SOLUTION 100ml Bottle A carton box containing a topaz colour moulded glass with an aluminum cap (closure type “Pilfer-Proof”) 36 Months FERRER INTERNACIONAL, S.A, c/Joan Buscalla 1-9-08173-Sant Cugat del Valles (Barcelona), Spain SPAIN FERRER INTENACIONAL, S.A, Spain GOMHS LTD 2023-05-12 2028-05-11

19 Rwanda FDA-HMP-MA-0323 GAMALATE COATED TABLET Magnesium Glutamate Hydrobromide (MGH) 75mg, Pyridoxine hydrochloride (Vitamin B6) 37mg, ?-amino-?-hydroxy-butyric acid (GABOB) 37mg, ? -Aminobutyric Acid (GABA) 75mg 75mg, 37mg, 37mg, 75mg TABLETS Box with 20 and 60 coated tablets AL/AL foil Blisters. The blisters strips are packed in a carton box 60 Months FERRER INTERNACIONAL, S.A. Joan Buscalla 1-9-08173-Sant Cugat del Valles (Barcelona), Spain SPAIN FERRER INTENACIONAL, S.A, Spain GOMHS LTD 2023-05-12 2028-05-11

20 Rwanda FDA-HMP-MA-0028 GAMMA IV- 5 Human Normal Immunoglobulin for Intravenous use BP (Bulk).5g / Vial 5g/Vial Solution for injection 100 ml Vial USP Type – I, moulded flint glass vial. 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 421506, Maharashtra State, India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-07-08 2028-07-07

21 RWANDA-FDA25/HM/0226/0042 Ganfort Bimatoprost 0,3 mg and Timolol maleate equivalent to 5 mg timolol Eye drops, solution 24 ALLERGAN PHARMACEUTICALS IRELAND Ireland AbbVie Pty Ltd PRAFIN RWANDA LTD 2026-03-14 2031-03-13

22 Rwanda FDA-HMP-MA-1284 GANVIR GEL OPHTHALMIC Ganciclovir 0.15% w/w 0.15% w/w Eye gel 10 gm bottle LDPE white plastic dropper bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES. Al Obour CityIndustrial zone, Area 14, 15 Block no. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL IND, EGYPT M/S ETS CONTINENTAL 2024-05-16 2029-05-15

23 Rwanda FDA-HBP-MA-0140 GARDASIL 9 Human Pappilomavirus L1 Virus Like Particle Type 6, 11, 16, 18, 31, 33, 45, 52, 58 Each 0.5 ml dose contains approximately: 30 ?g HPV Type 6 L1 protein, 40 ?g HPV Type 11 L1 protein, 60 ?g HPV Type 16 L1 protein, 40 ?g HPV Type 18 L1 protein, 20 ?g HPV Type 31 L1 protein, 20 ?g HPV Type 33 L1 protein, 20 ?g HPV Type 45 L1 protein, 20 ?g HPV Type 52 L1 protein, and 20 ?g HPV Type 58 L1 protein. Suspension for injection 10 vials GLASS Vials 36 Months Merck Sharp & Dohme LLC 770 Sumneytown Pike West Point, Pennsylvania, 19486 USA MSD Morocco UBIPHARM-RWANDA LTD 2024-10-18 2029-10-17

24 Rwanda FDA-HMP-MA-2028 Gastica Suspension Simethicone Emulsion, Calcium Carbonate, Magnesium Hydroxide & Magnesium Trisilicate Suspension 83mg, 400mg, 120mg & 50mg Oral Liquid 200ml Bottle AMBER COLOUR PET ROUND BOTTLES 24 Months ENICAR PHARMACEUTICAL Pvt. Ltd J-214,215,216 M.I.D.C TarapurBoisar, Dist-Palghar- 401506 INDIA ENICAR PHARMACEUTICAL Pvt. Ltd STAR BIOTECH LIMITED 2024-08-17 2029-08-16

25 Rwanda FDA-HMP-MA- 0438 GASTRICID® Famotidine BP 10 mg, Magnesium hydroxide BP 165 mg, Calcium carbonate BP 800 mg 10 mg, 165 mg, 800 mg Chewable tablet Pouch of 4 tablets, 20 or 50 tablets Pouch of 4 tablets packaged in Alu-Alu strips and 20 or 50 in a display box. 36 months MILAN LABORATORIES (INDIA) PVT. LTD, Jawhar Co-Op Industrial Estate Ltd., Kamothe, Panvel (Navi Mumbai), Maharashtra – 410209, India INDIA EXPHAR S.A H&H PHARMA LTD 2023-08-24 2028-08-23

26 Rwanda FDA-HMP-MA-1161 GATISTAR Gatifloxacin 3mg/ml 3 mg/ml Eye Drops 5 ml Bottle LDPE white plastic bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour city, Industrial zone, Area 15, Block no. 12011, Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES ETS CONTINENTAL 2024-04-20 2029-04-19

27 Rwanda FDA-HMP-MA-2253 GEFITINIB GEFITINIB Ph.Eur. 250 MG TABLETS 3x10 Tablets Clear PVC/Plain ALU blister pack in aluminium foil 24 Months CIPLA LIMITED GOA (UNIT-X) Address: Plot No. S-103 to S-105, S-107 to S-112, L-138, L-147, L-147/1 to L-147/3, L-147/A, Verna Industrial Estate, Verna, Salcette, Goa 403722, India INDIA CIPLA LIMITED KIPHARMA LTD 2025-02-04 2030-02-03

28 Rwanda FDA-HMP-MA-0804 GELOFUSINE 40MG/ML SOLUTION FOR INFUSION Succinylated Gelatin 40mg/ml and Sodium Chloride 7.01mg/ml 40mg/ml SOLUTION FOR INFUSION 10 x 500ml Bottle Ecoflac Plus LDPE bottle 24 Months B. BRAUN MEDICAL SA, Route de Sorge 9 CH-1023 Crissier, Switzerland SWITZERLAND B. BRAUN MELSUNGEN AG, GERMANY KIPHARMA LTD 2024-01-08 2029-01-07

29 Rwanda FDA-HMP-MA-2026 GEMCITABINE NEAPOLIS GEMCITABINE HYDROCHLORIDE 1G POWDER FOR SOLUTION FOR INFUSION 1 vial of 1g Type I glass vial 24 Months NEAPOLIS PHARMA Road of Tunis Km7 BP 206 Nabeul 8000, Tunisia. TUNISIA NEAPOLIS PHARMA KIPHARMA LTD 2024-08-17 2029-08-16

30 Rwanda FDA-HMP-MA-2000 GEMTERO 1G Gemcitabine for Injection USP 1 g Injection 1 x 1 pack USP type 1 glass vial 36 months Hetero Labs Limited Unit VI, Sy. No. 410-411TSIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Pin-509301 Telangana.India INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

31 Rwanda FDA-HMP-MA-1795 GEMTERO 200 Gemcitabine inj 200 mg Injection 1x1 pack glass vial 36 Months M/s. HETERO LABS LIMITED UNIT VI, Sy. No 410-411 TSIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR DISTRICT, PIN-509301 TELANGANA INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

32 Rwanda FDA-HMP-MA-1331 GEN-LEVO 500 Levofloxacin Hemihydrate USP 500mg 500mg Film Coated Tablets 1x10 tablets 1 blister of PVC with printed aluminium foil and insert 36 Months BROOKES PHARMA (PRIVATE) LIMITED, 58-59, Sector No. 15, Korangi Industrial, Area, Karachi-74900-Pakistan PAKISTAN BROOKES PHARMA (PRIVATE) LIMITED, PAKISTAN AFRI HEALTH CARE LTD 2024-05-18 2029-05-17

33 Rwanda FDA-HMP-MA-0405 GENTASOL® EYE DROPS SUSPENSION Gentamicin sulfate BP 0.3% 0.003 eye drops solution 5ml bottle LDPE bottle in carton box with leaflet 36 Months and 1 month after first opening the container AHLCON PARENTERALS (INDIA) LTD, SP 918, Phase III Bhiwadi 301019 Rajasthan, India INDIA EXPHAR S.A. H&H PHARMA LTD 2023-08-24 2028-08-23

34 Rwanda FDA-HMP-MA-1069 GIGAPYN TABLETS Paracetamol 500mg, Codeine Phosphate 8mg 500mg, 8mg Tablets 30’s and 100’s tablets or 3x10 tablets & or 1000 tablets 30’s and 100’s tablets in white round HDPE jar or induction sealing liner PVC/ Aluminium foil blister of 10 tablets in a carton of 30’s and or 1000’s 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willowvale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA 2024-04-20 2029-04-19

35 RWANDA-FDA25/HB/0202/0047 GINSOMIN EVE GINSENG EXTRACT (EQ. TO DRIED GINSENG ROOTS 200 MG) and multivitamins SOFTGEL CAPSULES 24 DALIANT TIANSHAN INDUSTRIAL CO., LTD China MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) Ltd 2026-03-18 2031-03-17

36 Rwanda FDA-HBP-MA-0113 GLARITUS 100 IU/ML Insulin glargine Injection USP, 100 IU/mL (r-DNA origin) 100 IU/mL Solution for Injection. 10 ml vial, 3ml Cartridge Type I Glass Vial, Cartridge and Dispopen 36 Months WOCKHARDT LIMITED, Biotech Park, H-14/2, MIDC, Waluj, Aurangabad-431136, India INDIA WOCKHARDT LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-02-26 2029-02-25

37 Rwanda FDA-HMP-MA-0734 GLIBENCLAMIDE TABLETS Glibenclamide BP 5 mg 5 mg Uncoated tablets 10 x 10 Tablets Blister Packs 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, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

38 Rwanda FDA-HMP-MA-2341 GLICOR MR GLICLAZIDE BP 60MG TABLETS 3X10 TABLETS ALU-ALU BLISTER PACK 36 MONTHS STALLION LABORATORIES PVT. LTD LTD 817, 8TH FLOOR, DEVPATH, OFF C. G. ROAD, B/H LAL BUNGLOW, AHMEDABAD GUJARAT, INDIA INDIA STALLION LABORATORIES PVT. LTD GLAXO PHARMA WHOLESALE LTD 2025-09-11 2030-09-10

Registered

39 Rwanda FDA-HMP-MA-0236 GLIMEPIRIDE DENK 2 Glimepiride 2mg 2mg Uncoated tablet 30 Tablets PVC/PVDC/aluminium blisters 48 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

40 Rwanda FDA-HMP-MA-0237 GLIMEPIRIDE DENK 3 Glimepiride 3mg 3mg Uncoated tablet 30 Tablets PVC/PVDC/aluminium blisters 48 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

41 Rwanda FDA-HMP-MA-1980 GLINSIP 100 Sitagliptin Tablets USP 100 mg Tablets 2x15 Tablets PVC/PE/PVDC-Blister Pack 24 Months M/s Annora Pharma Private Limited Survey No. 261, Annaram village, Gummadidala Mandal, Sangareddy, Telangana-502313. Country: India \" INDIA HETERO LABS LIMITED Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

42 Rwanda FDA-HMP-MA-1995 GLINSIP 25 Sitagliptin Phosphate anhydrous 25mg 25 mg Tablets 2×15 PVC/PE/PVDC-Blister Pack and Carton 24 months M/s Annora Pharma Private Limited M/s Annora Pharma Private Limited \\ INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

43 Rwanda FDA-HMP-MA-1991 GLINSIP 50 Sitagliptin Tablets USP 50 mg Tablets 2x15 Tablets PVC/PE/PVDC-Blister 24 Months M/s Annora Pharma Private Limited Survey No. 261, Annaram village, Gummadidala Mandal, Sangareddy, Telangana-502313, India INDIA Hetero Labs Limited, Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

44 Rwanda FDA-HMP-MA-2086 GLIPMEVIA 50/1000 SITAGLIPTIN + METFORMIN HCL 50/1000MG TABLETS 3x10 Tablets Alu-Alu Blister 24 Months FREDUM PHARMACEUTICALS LIMITED 14,15,16, Zorbian Industrial Complex, Veoor, Palghar(E) -401404 India FREDUM PHARMACEUTICALS LIMITED STAR BIOTECH LIMITED 2024-08-17 2029-08-16

45 Rwanda FDA-HMP-MA-1965 GLIPMEVIA 50/850 Sitagliptin phosphate monohydrate, Metformin hydrochloride 50/850MG TABLETS 3x10 Tablets ALU/PVC BLISTER 24 Months FREDUM PHARMACEUTICALS LIMITED 14,15,16, Zorbian Industrial Complex, Veoor, Palghar(E) -401404 INDIA FREDUN PHARMACEUTICALS LTD STAR BIOTECH LIMITED 2024-08-17 2029-08-16

46 Rwanda FDA-HMP-MA-2245 GLUCOMET 500 MG FILM COATED TABLETS Metformin Hydrochloride BP 500 mg TABLETS 2X14, 4X14, 10X10, 8X18 Tablets PVC Blisters 36 Months COSMOS LIMITED Rangwe Road; Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03

47 Rwanda FDA-HMP-MA-2244 GLUCOMET 850 MG FILM COATED TABLETS Metformin Hydrochloride BP 850 mg TABLETS 2X14, 4X14, 10X10, 8X14 Tablets PVC Blisters 36 Months COSMOS LIMITED Rangwe Road; Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03

48 Rwanda FDA-HMP-MA-0844 GLUCOSE 5% INJECTION Anhydrous Glucose, 25g/500ml 25g/500ml Solution for Injection 25 bottles of 500ml per carton PP (polypropylene) bottle, each carton contains 25 bottles 36 Months SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD. No. 288, Zhujiang Road, High-Tech Industrial Development Zone, Shijiazhuang City, Hebei Province, China CHINA SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD, CHINA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

49 Rwanda FDA-HMP-MA-1822 GLUNDOWN 500 TABLETS Metformin Hydrochloride 500mg Tablets 2x10’s, 2x14’s, 3x10’s,4x14’s, 6x10’s, 6x14’s, 9x10’s, 10x10s and 8x14’s Tablets ALU/PVC BLISTERS 24 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. Postal Address: 42875 GPO 00100, Kenya. KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

50 Rwanda FDA-HMP-MA-1626 GLYCOREN TABLETS Glibenclamide 5 mg 5 mg Tablets 10 tablets ALUMINIUM /PVC BLISTERS 36 Months RENE INDUSTRIES LTD Rene Industries Limited, PO Box 6034, Plot No 680, Kamuli, Kireka, Kampala, Uganda UGANDA Rene Industries Limited, RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

51 Rwanda FDA-HMP-MA-2032 GLYDA 10 Dapagliflozin Tablets 10mg 10 mg Tablets 10’s Alu/Alu Blister Pack 24 Months HETERO LABS LIMITED M/s Hetero Labs Limited, Unit III Plot no 22 – 110, I.D.A Jeedimetla, Hyderabad, Telangana, India. Pin Code – 500 055 INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

52 Rwanda FDA-HMP-MA-0358 GLYFERON 1000 Metformin Hydrochloride 1000 mg 1000 mg Film Coated Tablets 30 film-coated tablets Transparent PVC coated with PE- PVDC and aluminium foil 24 Months Bilim Ilaç San.ve Tic. A.?, Turkey Turkey DAFRA PHARMA GmbH, Germany MULTIPHAR UBIPHARM-RWANDA LTD 2023-07-08 2028-07-07

53 Rwanda FDA-HMP-MA- 0357 GLYFERON 850 Metformin Hydrochloride 850 mg 850 mg Film Coated Tablets 30 film-coated tablets Transparent PVC coated with PE-PVDC and aluminium foil. 24 Months BILIM ILAÇ SAN.VE TIC. A.?, Turkey Turkey DAFRA PHARMA GMBH, GERMANY SUN ENTERPRISES LTD 2023-08-24 2028-08-23

54 Rwanda FDA-HMP-MA-1270 GLYKA MR TABLETS 60 MG Gliclazide 60 mg 60 mg Modified Release Tablets 3×10 tablets Alu/Alu blister placed in a printed carton along with a pack insert 36 Months NEOPHARMA, Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAE UAE NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06

55 Rwanda FDA-HMP-MA-2040 GMYCIN-80 Gentamicin Injection 80mg/2ml Injection 10 Ampoules Glass ampoules packed on trays. 10 trays/box 36 Months Reyoung Pharmaceutical Co., Ltd No.1 Ruiyang Road, Yiyuan County, Shandong Province , P.R. China CHINA Farmasino Co., Ltd ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29

56 Rwanda FDA-HMP-MA-1739 GOAB 10 Solifenacin Succinate 10 mg Tablets 3x10 Tablets Alu-PVC Blister pack 24 Months MS. ANNORA PHARMA PRIVATE LIMITED M/S. Annora Pharma Private Limited, Sy.N0.261, Annaram Village Gummadidal Mandal, Sangareddy District. INDIA ANNORA PHARMA PRIVATE LIMITED BION-PHARMA GROUP Limited 2024-08-17 2029-08-16

57 Rwanda FDA-HMP-MA-0436 GOFEN 200 Each Soft Gelatin Capsule Contains: Ibuprofen Equivalent to Ibuprofen 200mg (Present as Free Acid and Potassium Salt) 200mg Soft Gelatin Shell Capsule 6 x 10 capsules Aluminium foil/PVC/PVDC blister 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED. Address: 384 moo 4, soi 6, bang poo industrial estate, pattana 3 road, phraeksa, mueang, samutprakarn 10280. Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

58 Rwanda FDA-HMP-MA-0333 GOFEN 400MG SOFT GEL CAPSULES Ibuprofen 400mg (Present as Free Acid and Potassium Salt) 400mg Soft gelatin shell capsules 6x10 capsules Aluminium foil/PVC/PVDC in printed 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 ABACUS PHARMA (A) LTD 2023-06-26 2028-06-25

59 Rwanda FDA-HMP-MA-0052 GRAMOCEF-CV Cefixime, Clavulanic Acid 200mg, 125mg Film Coated Tablets 10 Tablets ALU/ALU BLISTER PACK 24 Months MICRO LABS LIMITED Plot No.121 to 124, KIADB, Bommasandra Industrial Area, 4 th Phase, Bangalore-560 099. Anekal Taluk, India. INDIA MICRO LABS LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-03-17 2026-03-17

Grace Period

60 Rwanda FDA-HMP-MA-1667 GRAMOCEF-O-100 DRY SYRUP CEFIXIME USP 100MG/5ML SUSPENSION 100ml Bottle Amber coloured bottles 24 Months MICRO LABS LIMITED No. 121-124, 4th Phase, K.I.A.D.B., Bommasandra Industrial Area, Anekal Taluk, Bangalore-560 099, India India MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

61 Rwanda FDA-HMP-MA-0093 GRAMOCEF-O-200 Cefixime 200mg Capsules 10 Capsules ALU/ALU BLISTERS 36 Months MICRO LABS LIMITED Plot No.121 to 124, KIADB, Bommasandra Industrial Area, 4 th Phase, Bangalore-560 099. Anekal Taluk, India. INDIA MICRO LABS LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-08-05 2026-08-05

62 Rwanda FDA-HMP-MA-1181 GRAMOCEF-O-400 Cefixime 400mg 400mg Capsules 1×10 Capsules Alu/Alu blister packed in a printed outer carton along with a pack insert 36 Months MICRO LABS LTD, Plot No.121 to 124, KIADB, Bommasandra Industrial Area, 4th Phase, Bangalore-560 099. Anekal Taluk INDIA MICRO LABS LTD WESSEX PHARMACEUTICALS RWANDA LTD 2024-05-06 2029-05-05

63 Rwanda FDA-HMP-MA-1914 GRAMOCEF-O-50 DRY SYRUP CEFIXIME 50MG/5ML 50MG/5ML DRY SYRUP 1x100 ml Amber Coloured glass bottle 24 months Micro Labs Limited Micro Labs Limited No. 121-124, 4th Phase, K.I.A.D.B., Bommasandra Industrial Area, Anekal Taluk, Bangalore-560 099, INDIA INDIA MICRO LABS LTD/INDIA Phillips Pharmaceuticals (Rwanda) Ltd. 2024-08-17 2029-08-16

64 RWANDA-FDA25/HM/0024/0053 Grateziano SOFOSBUVIR 400 mg Film-coated tablets, 28's 36 Months European Egyptian Pharmaceutical Industries Km 25 Alexandria-Cairo Desert Road, Amriya, Alexandria. Egypt Egypt European Egyptian Pharmaceutical Industries HELIOS PHARMA Ltd 2025-12-12 2030-12-11

65 Rwanda FDA-HMP-MA-2090 GRISORAL-250 Griseofulvin 250 MG Tablets 10x10 Tablets Alu foil - plain PVC blister 36 Months BAL PHARMA LIMITED Unit-I, 21,22,Bommasandra industrial area, Bangalore-560099, India.Email: delregulatory@balpharma.com India BAL PHARMA LIMITED SUN ENTERPRISES LTD 2024-10-18 2029-10-17

66 Rwanda FDA-HMP-MA-2234 GVIA-M TABLET 50MG/1000MG Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride USP 50mg and 1000mg TABLETS 60 Tablets ALU/ALU Blisters 24 Months GENIX PHARMA (PVT.) LTD 44, 45-B, Korangi Creek Road, Karachi, Pakistan PAKISTAN GENIX PHARMA (PVT.) LTD ETS CONTINENTAL LTD 2025-02-04 2030-02-03

67 Rwanda FDA-HMP-MA-1813 GVSOFT 1.2 Glycerine USP 1.2 G Suppositories 2X5 Suppositories ALU/PVC FOILS BOXES. 36 Months BLISS GVS PHARMA LIMITED PLOT No 11, SURVEY No 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR 401404, MAHARASHTRA INDIA BLISS GVS PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

68 Rwanda FDA-HMP-MA-1814 GVSOFT 2 Glycerine USP 2.0 g Suppositories 2X5 Suppositories ALU/PVC FOILS BOXES. 36 Months BLISS GVS PHARMA LIMITED PLOT No 11, SURVEY No 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR 401404, MAHARASHTRA INDIA BLISS GVS PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

69 Rwanda FDA-HMP-MA-0138 GXACIN Gentamicin Sulfate Ophthalmic Solution USP, (0.3% w/v) 0.3% w/v Ophthalmic Solution 1×10 ml vial LDPE vial packed in a carton along with pack insert 36 Months AXA PARENTERALS LIMITED, Plot No 936, 937& 939, Vill. Kishanpur, Jamalpur, Roorkee-247667, Distt. Haridwar (Uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

70 RWANDA-FDA24/HM/1064/0021 GYNAGONE KIT. Each Kit contains: 2 Azithromycin (Zerocin) tablets 500mg each, 4 Secnidazole (Labgentil) tablets 500mg each & 1 Fluconazole (Ucozole) capsule 150mg in a unit box. Capsules, tablets, 1 x 7’s 36 Months Anuh Pharma Ltd. India Laboratory & Allied Ltd Depot Pharmaceutique Le Medical 2025-09-30 2030-09-29

71 Rwanda FDA-HMP-MA-1966 GYNASTATIN BP NYSTATIN BP 100000IU VAGINAL PESSARIES 2x7 Pessaries PVC/PE foil 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District-Thane – 401404, India India BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

72 Rwanda FDA-HMP-MA-1790 GYNO BALANCE Lactose monohydrate BP 1200 mg Suppositories 2X5 Suppositories PVC/PE FILM 24 Months BLISS GVS PHARMA LIMITED 10,11-A&12 Dewan Udyog Nagar, Aliyali, Palghar, Maharashtra 401 404 INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMA LTD 2024-08-17 2029-08-16

73 Rwanda FDA-HMP-MA-2280 GYNOFAST VAGINAL SUPPOSITORY CLINDAMYCIN/ CLOTRIMAZOLE 100MG/200MG VAGINAL SUPPOSITORIES 3 Suppositories PVC/PE Foil 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District- Thane – 401404. INDIA IMEX Pharma Mediasol Pharmaceutical Depot Ltd 2025-05-12 2030-05-11

74 Rwanda FDA-HMP-MA-1166 GYNOFER TABLETS Tinidazole BP 500mg, Miconazole Nitrate BP 100mg, Neomycin Sulphate BP 20mg 500mg, 100mg, and 20mg Uncoated Tablets 2x4 Tablets Strip pack 36 Months CENTAUR PHARMACEUTICALS PVT. LTD, Plant: I. Plot No: 3. Tivim Industrial Estate. Karaswada, Mapusa Goa-403526, India INDIA CENTAUR PHARMACEUTICALS PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-04-20 2029-04-19

75 Rwanda FDA-HMP-MA-1789 GYNOSPAN Phloroglucinol BP , Trimethyl phloroglucinol IH 40.00mg/0.04mg Injection 6 ampoules of 4 ml AMPOULES OF 4 ML INJECTION PLACED ON A TRAY 24 Months BLISS GVS PHARMA LIMITED ( INDASI LIFESCIENCE PVT. LTD) Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404, India INDIA IMEX PHARMA KIPHARMA LTD 2024-08-17 2029-08-16

76 Rwanda FDA-HMP-MA-1951 GYNOSPAN Phloroglucinol BP and Trimethylphloroglucinol IH 62.233MG/80MG TABLETS 3x10 Tablets ALU/PVC BLISTER 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 , India INDIA IMEX PHARMA, Maurice KIPHARMA LTD 2024-08-17 2029-08-16

77 Rwanda FDA-HMP-MA-1961 GYNOSPAN Phloroglucinol BP, Trimethylphloroglucinol IH 116.70MG/150MG SUPPOSITORIES 2X5 Suppositories Polyvinyl chloride/ Polyethyllene foil 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 INDIA IMEX PHARMA, Maurice KIPHARMA LTD 2024-08-17 2029-08-16

78 Rwanda FDA-HMP-MA-2167 GYNOZOL MICONAZOLE NITRATE 400 mg VAGINAL SOFT GELATIN CAPSULES 3 VAGINAL SOFT GELATIN CAPSULES PVC/Al Blisters 36 Months SAFE for Pharmaceuticals (Safe Pharma) 2nd Industrial Zone, Section No.3, Block 31, New Borg El Arab city, Alexandria, Egypt EGYPT PHARCO PHARMACEUTICALS HELIOS PHARMA Ltd 2025-01-09 2030-01-08

79 RWANDA-FDA25/HM/0186/0029 GYNOZOL Vaginal Cream MICONAZOLE NITRATE 0.8 G Vaginal Cream 40g Cream 36 Months Pharco Pharmaceuticals Industries Alexandria-Cairo Desert Road Km 31, Amriya, Alexandria, Egypt Egypt Pharco Pharmaceuticals HELIOS PHARMA Ltd 2025-10-16 2030-10-15