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-HM-1852 K-FLAM DICLOFENAC POTASSIUM 50MG TABLETS 10 sachets x 1 g, HMHDPE Bag, Fiber board Drum / HDPE Drum 36 months Neopharma Address: Plot No. A-1, 89-95. Industrial city of Abu Dhabi (ICAD), P.O Box 72900, ABU Dhabi, UAE Country: United Arab Emirates Telephone: 00971 2 550 1000 Telefax: 00971 2 550 11 99 UAE NEOPHARM89A1 – 95A1, Industrial City of Abu Dhabi, Mussafah,PO Box 72900 Abu Dhabi, UAETel: 00971 2 5501000Fax: 00971 2 5501199Email: neopharma@neopharma.ae PHILIPS PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

2 Rwanda FDA-HMP-MA-1673 KABIVEN Purified soybean oil, glucose (anhydrous), Alanine, Arginine, Aspartic acid, Glutamic acid, Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine, Calcium chloride (as dihydrate), Sodium glycerophosphate (as hydrated), Magnesium sulphate (as heptahydrate), Potassium chloride, Sodium acetate (as trihydrate) 40g, 100g, 4.8g, 3.4g, 1.0g, 1.7g, 2.4g, 2.0g, 1.7g, 2.4g, 2.7g, 1.7g, 2.4g, 2.0g, 1.4g, 1.7g, 0.57g, 0.07g, 2.2g, 0.22g, 1.5g, 0.48g, 1.8g, 1.5g EMULSION FOR INFUSION 1 x 1026 ml, 4 x 1026 ml, 1 x 2053 ml, 4 x 2053 ml Three chamber bag in an overpouch. 24 Months FRESENIUS Kabi AB Rapsgatan 7 SE-751 74 Uppsala, Sweden and Fresenius Kabi Austria GmbH Hafnerstrasse 36 8055 Graz, Austria Austria FRESENIUS KABI MANUFACTURING SA (PTY) LIMITED SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

3 RWANDA-FDA25/HM/0087/0006 KAICET Paracetamol 1% W/V Solution for infusion. 100 ml 24 Months Anhui BBCA Likang Pharmaceutical Co.LTD China KAIRUKI PHARMACEUTICALS INDUSTRY LIMITED KIPHARMA Ltd 2026-02-05 2031-02-04

4 RWANDA-FDA24/HM/0806/0005 KAIMET METRONIDAZOLE B.P 0.5%w/v Solution for Infusion 1x100ml 24 Months HUANGGANG QIHENG Sanitary Product Co., LTD HUANGGANG QIHENG Sanitary Product Co., LTD China KAIRUKI PHARMACEUTICALS INDUSTRY LIMITED KIPHARMA Ltd 2026-02-05 2031-02-04

5 RWANDA-FDA24/HM/0793/0046 KAINAZ FLUCONAZOLE BP 0.2%w/v Solution for infusion. 1x 100ml 24 Months meheco PHARMACEUTICALS PVT LTD India KAIRUKI PHARMACEUTICALS INDUSTRY LIMITED KIPHARMA Ltd 2025-12-12 2030-12-11

6 Rwanda FDA-HMP-MA-1099 KAMAGRA 100 Sildenafil Citrate USP 100 mg 100 mg Film Coated Tablets 4 Tablets Alu- PVC blister pack. 1 such blister is packed in a carton along with Patient Information Leaflet 36 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

7 Rwanda FDA-HMP-MA-1100 KAMAGRA 50 Sildenafil Citrate USP equivalent to Sildenafil 50mg 50mg Film Coated Tablets 4 Tablets Alu- PVC/PVdC blister pack, 1 such blister is packed in a carton along with PIL 36 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

8 Rwanda FDA-HMP-MA-1096 KAMAGRA CT 100 Sildenafil Citrate USP 100 mg 100 mg Uncoated chewable Tablets 4 Tablets Alu- PVC/PVdC blister pack. 1 such blister is packed in a carton along with Patient Information Leaflet 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

9 Rwanda FDA-HMP-MA-1097 KAMAGRA CT 50 Sildenafil Citrate USP 50 mg 50 mg Uncoated Chewable Tablets 4 Tablets Alu- PVC/PVdC blister. 1 such blister is packed in a carton along with Patient Information Leaflet 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

10 Rwanda FDA-HMP-MA-0896 KARECIPRO 500 MG Ciprofloxacin Hydrochloride 500 mg 500 mg Film coated tablets 10x10 Tablets PVC/Aluminium Blisters packed in unit box along with leaflet insert 36 Months REYOUNG PHARMACEUTICAL CO., LTD, No.1 Ruiyang Road, Yiyuan County, Shandong Province, P.R. China. CHINA KAREMAX INDUSTRIAL LTD, CHINA SUN ENTERPRISES LTD 2024-02-17 2029-02-16

11 Rwanda FDA-HMP-MA-0885 KARECLOX 500MG Cloxacillin Sodium 500mg 500mg Crystalline Powder for solution for injection 50 Vials of 7ml Mould vials glass containers, Non flip off cap, butyl rubber stopper, with adhesive label in box alongside with leaflet 36 Months REYOUNG PHARMACEUTICAL CO., LTD, No.1 Ruiyang Road, Yiyuan County, Shandong Province, P. R. China. CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-17 2029-02-16

12 Rwanda FDA-HMP-MA-0910 KAREFENAC INJECTION Diclofenac Sodium BP injection 75mg/3mL 75mg/3mL Powder for solution for injection 10x10 Ampoules of 3ml in box Packed in 3ml USP type I glass ampoule, then 10 amps are packed in a tray, the 10 trays are in turn packed in a box. The boxes are then 200 boxes contained in a carton 36 Months REYOUNG PHARMACEUTICAL CO., LTD. No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R. China P. R. CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-22 2029-02-21

13 Rwanda FDA-HMP-MA-0919 KAREFOTAX Cefotaxime Sodium 1.0 g 1.0 g Powder for Solution for Injection 50 Vials of 10ml Mould Vials Glass containers 36 Months REYOUNG PHARMACEUTICAL CO., LTD, No.1 Ruiyang Road, Yiyuan County, Shandong Province, P. R. China CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-21 2029-02-20

14 Rwanda FDA-HMP-MA-0959 KAREMOL TABLETS Paracetamol 500mg 500mg Uncoated Tablets 1x10 Tablets Alu/Alu blister s packed in outer carton 36 Months HEBEI JIHENG (GROUP) PHARMACEUTICAL CO., LTD, No.368Jianshe Street, Hengshui City, Hebei Province 053000 P.R. China CHINA KAREMAX INDUSTRIAL LIMITED SUN ENTERPRISES LTD 2024-02-26 2029-02-25

15 Rwanda FDA-HMP-MA-2014 KAREMOX-250 AMOXICILLIN 250MG CAPSULE 11 x 10 Tablets and 500 Tablets PVC-Aluminium blister packs or in polythen bag contained in HDPE container 36 months Reyoung Pharmaceutical Co., Ltd No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R.China China KAREMAX INDUSTRIAL LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

16 Rwanda FDA-HMP-MA-2013 KAREMOX-500 AMOXICILLIN 500MG CAPSULE 10 x 10 Tablets and 500 Tablets PVC-Aluminium blister packs, and in polythen bag contained in HDPE container 36 months Reyoung Pharmaceutical Co., Ltd No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R.China China KAREMAX INDUSTRIAL LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

17 Rwanda FDA-HMP-MA-0911 KAREMYCIN Gentamicin Sulfate, 80mg/2ml 80mg/2ml Solution for injection 10x10 Ampoules of 2ml in box 2mL USP type I glass amber ampoules, 10 amps/tray, 10 trays/box, 200 boxes/ carton along with literature insert 36 Months REYOUNG PHARMACEUTICAL CO., LTD. No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R. China CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-22 2029-02-21

18 Rwanda FDA-HMP-MA-0871 KAREXONE 1G Ceftriaxone Sodium 1G 1G Powder for Solution for injection 10 x 10mL and 50 x 10mL Type II Glass Mould Vial 36 Months REYOUNG PHARMACEUTICAL CO., Ltd. No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R. China CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-17 2029-02-16

19 RWANDA-FDA24/HM/0129/0026 KAVIDEZA DISTAB Abacavir, Dolutegravir and Lamivudine Dispersible Tablets 60 mg / 5 mg/ 30 mg Film-Coated Tablet 90's & 180's 24 Months MYLAN LABORATORIES LIMITED Plot No. 11,12 & 13, IndoreSpecial Economic Zone,Pharma Zone, Phase-II,Sector-III, Pithampur -454775, Dhar (MP) India India Mylan Laboratories Limited PYRAMID PHARMA LIMITED 2025-10-16 2030-10-15

20 Rwanda FDA-HMP-MA-1494 KEMOXYL 250 CAPSULES. Amoxicillin Trihydrate BP 250mg Hard Gelatin Capsules 10x10 Tablets and 1000 Tablets Blisters of 10 x 10’s in a unit box and 1000’s in HDPE container with 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 Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26

21 Rwanda FDA-HMP-MA-1590 KEMOXYL 500 CAPSULES Amoxicillin BP (Trihydrate) 500 mg Capsules 10x10 Capsules ALU/PVC BLISTER 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road. Postal Address:42875 GPO 00100 KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

22 Rwanda FDA-HMP-MA-0659 KEMOXYL FORTE DRY SUSPENSION Amoxicillin Trihydrate BP 250mg/5ml 250mg/5ml Dry Powder for Suspension 100 ml Bottle Amber glass /HDPE bottle and contained in a unit box with literature insert 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 AND ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2023-12-10 2028-12-09

23 Rwanda FDA-HMP-MA-1167 KENAZOLE CREAM Ketoconazole USP 2% w/w 2% w/w Topical cream 20 gm tube Collapsible Aluminium Tube in a unit carton 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LIMITED 2024-04-20 2029-04-19

24 RWANDA-FDA24/HM/0611/0018 KENIZA Ketoconazole BP 2% w/w Cream 36 Months AARTI DRUGS LIMITED,Mahendra Industrial Estate Plot No. – 109 –D Road No.29, Sion (East), Mumbai – 400 022. India UNIZA LIFECARE PVT. LTD. ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

25 Rwanda FDA-HMP-MA-0982 KETAM. Ketamine Hydrochloride Injection BP 50mg/ml 50mg/ml Solution for Injection 10 ml Bottle USP type I 10 ml amber glass vial plugged with grey butyl rubber plugs and sealed with yellow colour flip off aluminium seal. 24 Months KILITCH DRUGS (INDIA) LTD, C-301/2, M.I.D.C T.T.C, Industrial Area, Pawane Village, Navi Mumbai - 400 705, India. INDIA KILITCH DRUGS (INDIA) LTD, INDIA. SUN ENTERPRISES LTD 2024-02-26 2029-02-25

26 Rwanda FDA-HMP-MA-1510 KETAMAX 50 Ketamine Hydrochloride USP 50 mg/ml Solution for injection 10ml Vial Amber vial USP Type-I with 20 mm bromobutyl rubber stopper and 20 mm Ice blue flip off seal with “Troikaa embossed”. Further such 1 labelled vial packed in a 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

27 Rwanda FDA-HMP-MA-1271 KETAMINE HYDROCHLORIDE INJECTION USP 50 MG/ML, 10 ML Ketamine Hydrochloride Injection USP 50 mg/ml 50 mg/ml Solution for injection 10 ml vial Amber Glass vial (USP Type- I) in a carton with insert 36 Months SWISS PARENTERALS LTD, 808,809 & 810 Kerala Industrial Estate, G.I.D.C., Bavla, Dist. Ahmedabad – 382220, Gujarat, India INDIA SWISS PARENTERALS LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

28 Rwanda FDA-HMP-MA-2181 KETAPIL Ketamine Hydrochloride Injection 50mg/ml Injection 10ml Vial Amber colour USP Type-I glass vial 36 Months Psychotropics India Limited Plot No.12 & 12A, Industrial Park-II, Phase-I, Salempur Mehdood-2, Haridwar-249403, (Uttarakhand India Psychotropics India Limited Pharmaceutical and Medical Supplies Society Limited 2025-01-09 2030-01-08

29 Rwanda FDA-HMP-MA-0043 KETESSE Dexketoprofen Trometamol 50mg/2ml Solution For Injection 5 Ampoules Of 2ml Each AMBER AMPOULE PACKED IN BOX 60 Months MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., VIA SETTE SANTI, 3, 50131 FIRENZE-ITALY ITALY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. PRAFIN RWANDA LTD 2021-01-18 2026-01-18

Grace Period

30 Rwanda FDA-HMP-MA-0497 KETESSE 25MG Dexketoprofen Trametamol, 25mg 25mg Film coated tablets 4 Tablets and 20 Tablets PVC-Aluminium foil 24 Months LABORATORIOS MENARINI S.A, Dompé farmaceutici S.p.A., Menarini Group Via Campo di Pile, Alfonso XII, 587, E-08918 Badalona, Barcelona, Spain and Menarini Group Via Campo di Pile, L’Aquila, Italy; Dompé farmaceutici S.p.A., Via Campo di Pile, L’Aquila, Italy SPAIN AND ITALY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURGS S.A PRAFIN RWANDA LTD 2023-12-30 2028-12-29

31 Rwanda FDA-HMP-MA-0746 KETO PLUS SHAMPOO Ketoconazole BP 2% w/v and Zinc Pyrithione (ZPTO 1% w/v) 2% w/v and 1% w/v Viscous shampoo 60ml Bottle Printed sleeved HDPE bottle with white PP flip off cap 24 Months GLENMARK PHARMACEUTICALS LTD, Plot No. E-37, 39, DRoad, MIDC, Satpur, Nashik – 422007, Maharashtra, INDIA INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-01-15 2029-01-14

32 Rwanda FDA-HMP-MA-2056 KETOZ Ketoconazole 2% w/w Cream 15mg tube Aluminium tube 36 Months S KANT HEALTHCARE LTD S KANT HEALTHCARE LIMITED. PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT, INDIA Tel : 91-260-6538518 Email: skhcl@skant.com INDIA S KANT HEALTHCARE LTD SUN ENTERPRISES LTD 2024-09-30 2029-09-29

33 Rwanda FDA-HMP-MA-1629 KETRODOL INJECTION Phytometadione BP inj. 10mg/ml 10mg/ml Solution for Injection 100x 1ml Ampouls AMBER USP TYPE I AMPOULE 24 Months Ciron drugs & Pharmaceuticals Pvt Ltd Ciron drugs & Pharmaceuticals Pvt Ltd, N-118,119,113,119/1,119/2 & 118/1, M.I.D.C., Tarapur, Boisar, Dist. Palghar - 401 506, India INDIA Ciron drugs & Pharmaceuticals Pvt Ltd RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

34 Rwanda FDA-HMP-MA-0265 KIPEL 10 Montelukast Sodium 10 mg 10 mg Film coated tablets 3x10's tablets Pack sealed with printed cold forming made up of Aluminium foil (Lid foil). 24 Months MSN LABORATORIES PRIVATE LTD Plot No.: 42, ANRICH Industrial Estate, Bollaram, Sangareddy District, Pin Code – 502325, Telangana., India . INDIA MEGA LIFESCIENCES (AUSTRALIA) PTY LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

35 Rwanda FDA-HMP-MA-0264 KIPEL 4 Montelukast Sodium 4 mg 4 mg Chewable tablets 3x10's tablets Pack sealed with printed cold forming made up of Aluminium foil (Lid foil) 24 Months MSN LABORATORIES PRIVATE LTD, Plot No. 42, Anrich Industrial Estate, Bollaram, Sangareddy District – 502 325, Telangana, India. INDIA MEGA LIFESCIENCES (AUSTRALIA) PTY LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

36 Rwanda FDA-HMP-MA-0319 KIPEL 5 Montelukast Sodium, 5 mg 5 mg Chewable tablets 3x10's tablets Packed in sealed with printed cold forming made up of Aluminium foil (Lid foil) 24 Months MSN LABORATORIES PRIVATE LTD, Formulation Division, Plot No. 42, Anrich Industrial Estate, Bollaram, Sangareddy District-502325, Telangana, India INDIA MEGA LIFESCIENCES (AUSTRALIA) PTY LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

37 RWANDA-FDA24/HM/1067/0016 KIRACLAV® 112.5 powder for oral suspension AMOXICILLIN+CLAVULANATE POTASSIUM 100mg/12.5mg Graules for Oral suspension 60 ml 24 Months DSM Sinochem Pharmaceuticals India Private Limited (Now known as Centrient Pharmaceuticals). India BEKRA PHARMA LTD UBIPHARM-RWANDA LTD 2025-09-23 2030-09-22

38 Rwanda FDA-HMP-MA-1210 KIRACLAV® 562.5 Amoxicillin Trihydrate USP Eq. to Anhydrous Amoxicillin 500mg and diluted potassium clavulanate BP Eq. to Clavulanic acid 62.5mg 500mg/62.5 mg Film coated tablets 2x8 tablets Alu-Alu blisters of 8 tablets each packed in a carton along with leaflet 24 Months. BAROQUE PHARMACEUTICALS PVT.LTD., 192/2& 3, 190/1 and 202/9, Sokhada-388 620, Tal: Khambhat, Dist. Anand Gujarat State, India INDIA BEKRA PHARMA UK LTD UBIPHARMA-RWANDA LTD 2024-05-06 2029-05-05

39 Rwanda FDA-HMP-MA-0877 KLAMADOL Tramadol Hydrochloride Injection 50mg/ml 50mg/ml Liquid Injection 10 Ampoules of 2ml Flint USP Type 1 glass ampoule. 10 such labeled ampoules are to be placed in a transparent tray; inserted along with a leaflet in printed carton 30 Months KILITCH DRUGS LTD, C- 301/2, T.T.C. Industrial area, M.I.D.C, Pawane, Navi Mumbai- 400 705, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LTD SUN ENTERPRISES LTD 2024-02-17 2029-02-16

40 Rwanda FDA-HMP-MA-0354 KLARO-500 Clarithromycin Tablets USP 500mg 500mg Film Coated Tablets 1X10 tablets Blister, such a 1 blister packed in printed baby 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 2023-07-08 2028-07-07

41 Rwanda FDA-HMP-MA-1002 KLAVMOX LB 1000 Amoxicillin Trihydrate USP 875mg, Clavulanate Potassium USP 125mg, With Lactic Acid Bacillus 60millions Spores 875mg/125mg Film coated tablets 10 tablets Alu-Alu printed foil blister and one blister parked in box along with leaflet and silica gel bag 24months KILITCH DRUGS (INDIA) LTD, 37/39, Ujagar Industrial estate, W.T.Patil marg, Deonar, Mumbai-400 088, Maharashtra, India INDIA KILITCH DRUGS (INDIA) SUN ENTERPRISE LTD 2024-02-26 2029-02-25

42 Rwanda FDA-HMP-MA-0997 KLAVMOX LB 625 Amoxicillin Trihydrate USP 500MG, Clavulanate potassium USP 125mg and Lactic acid bacillus 500mg/125mg Tablets 1×10 tablets ALU-ALU FOIL 24 Months KILITCH DRUGS (INDIA) LTD, T.T.C Industrial Area, M.I.D.C Turbh, Navi Mumbai, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LTD, INDIA SUN ENTERPRISE LTD 2024-02-26 2029-02-25

43 Rwanda FDA-HMP-MA-1415 KLOVINAL Metronidazole, Clotrimazole and Lactobacillus spores 500 mg/100 mg/150 million spores 500 mg/100 mg/150 million spores Pessaries 6 Pessaries Polyvinyl chloride/polyethylene foil. 1 strip of 6 pessaries is packed in a carton with pack insert 24 Months BLISS GVS PHARMA LIMITED, Plot No. 10, 11a & 12, Survey No.38/1, Dewan Udyog Nagar, Aliyali, Palghar (W), Dist – Thane, Maharashtra-India. INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-07-18 2029-07-17

44 Rwanda FDA-HMP-MA-1168 KLOXY DRY SYRUP Cloxacillin sodium BP 125mg/5ml 125mg/5ml Powder for oral suspension 100 ml bottle Amber Glass/HDPE bottle in a unit box along with literature insert 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 2024-04-20 2029-04-19

45 Rwanda FDA-HMP-MA-0372 KNAC 75MG TABLETS Diclofenac Potassium 75mg 75mg Film Coated Tablets 30’s tablets ALU/ALU blisters which are then packed in unit boxes 36 Months M/s UNIVERSAL CORPORATION LIMITED Address: P.O. Box 1748-00902, Kikuyu - Kenya. KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2023-07-08 2028-07-07

46 Rwanda FDA-HMP-MA-1926 KODOXY DOXYCYCLINE Hyclate BP 100MG CAPSULES 10x10 Capsules ALU/PVC BLISTER 36 Months KOPRAN LIMITED Village Savroli Khalapur, Dist-Raigad, Maharashtra Country: India INDIA Kopran Limited PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

47 Rwanda FDA-HMP-MA-2319 KOF OFF SYRUP 100ML Chlorpheniramine Maleate 2mg + Pseudoephedrine HCl 30mg + Ammonium Chloride 100mg + Sodium Citrate 60mg + Menthol 0.5mg 2mg/30mg/100mg/60mg/0.5mg SYRUP 100ML Bottle AMBER COLOURED PET BOTTLE 24 MONTHS RENE INDUSTRIES LTD PO BOX 6034, PLOT NO 680, KAMULI, KIREKA, KAMPALA, UGANDA UGANDA RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2025-06-19 2030-06-18

Registered

48 Rwanda FDA-HMP-MA-1925 KOFLYN PINEAPPLE FLAVOUR COUGH EXPECTORANT CHLORAMPHENIRAMINE MALEATE, AMMONIUM CHLORIDE, SODIUM CITRATE 2.2MG, 110MG, 40MG /5ML SYRUP 100ml Bottle Amber Glass Bottle 36 Months BETA HEALTHCARE INTERNATIONAL LTD P.O. BOX 42569-00100 Physical Address: Plot No. L.R 209/6554 Mogadishu Road, industrial Area, Nairobi Country: Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

49 Rwanda FDA-HMP-MA-1071 KOFLYN RASPBERRY FLAVOUR COUGH EXPECTORANT Chlorpheniramine Maleate 2.2mg, Ammonium Chloride 110mg and Sodium Citrate 40mg per 5ml 2.2mg, 110mg, 40mg per 5ml Syrup 100 ml bottle Amber coloured glass bottles that are sealed with 25mm ROPP aluminium caps and labelled, then packed in unit cartons made of chipboard 36 Months BETA HEALTHCARE INTERNATIONAL LTD, Plot No. LR 209/6554, Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LIMITED 2024-04-20 2029-04-19

50 Rwanda FDA-HMP-MA-0320 KOMEFAN 140 Artemether/Lumefantrine 20mg/120mg 20mg/120mg Tablets 6’s, 18’s, 24’s, tablets Cold form (Desiccant embedded) blister pack, Cold form blister pack, PVC/Aclar blister pack and PVC/PE/PVdC blister pack 36 Months MYLAN LABORATORIES LIMITED, F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik-422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED, INDIA. PYRAMID PHARMA LIMITED 2023-05-12 2028-05-11

51 Rwanda FDA-HMP-MA-0161 KONAZOL Ketoconazole BP 2.0 % w/w 2.0 % w/w Cream 15 GM Tube Aluminium Tube & Cap 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

52 Rwanda FDA-HMP-MA-1625 KRYXANA 200MG FILM-COATED TABLETS Ribociclib 200mg 200mg Film-coated tablets 63 Tablets PCTFE/PVC BLISTER PA/AL/PVC BLISTER 36 Months Lek Pharmaceuticals d.d., Lek Pharmaceuticals d.d., Verovškova ulica 57, Ljubljana, 1526, Slovenia SLOVENIA NVS KENYA LIMITED SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16