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-1849 SABULIN SYRUP Salbutamol (as sulphate) 2mg/5ml Syrup 60ml and 100ml Bottles AMBER COLOURED PET BOTTLE 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16
2 Rwanda FDA-HMP-MA-1817 SACUVAN 24/26 Sacubitril Valsartan Sodium on Colloidal Silicon, Dioxide 24 mg/ 26 mg Tablets 3x10 Tablets ALU-ALU BLISTERS 24 Months HETERO LABS LIMITED Unit-III Address: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
3 Rwanda FDA-HMP-MA-1816 SACUVAN 49/51 Sacubitril and Valsartan 49 mg/ 51 mg Tablets 3x10 Tablets ALU-ALU BLISTERS 24 Months HETERO LABS LIMITED Unit-III Address: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
4 Rwanda FDA-HMP-MA-1819 SACUVAN 97/103 Sacubitril and Valsartan 97 mg/ 103 mg Tablets 3x10 Tablets ALU-ALU BLISTERS 24 Months HETERO LABS LIMITED Unit-III Address: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
5 Rwanda FDA-HMP-MA-1568 SALBUCORT Salbutamol Pressurized Inhalation BP 100 mcg/dose Pressurised metered dose inhaler formulation 19 ml Aluminium Cans, 200 Metered doses ALUMINIUM CANISTER 24 Months HETERO LABS LIMITED Unit-VII, Sy.No.50, Plot No. l4, Phase-III, IDA, Jeedimetla, Hyderabad-500 0:55, Telangana State, India INDIA HETERO LABS LIMITED VINE PHARMA LTD 2024-08-17 2029-08-16
6 Rwanda FDA-HMP-MA-2215 SALBUT 4 SALBUTAMOL SULPHATE 4 mg TABLETS 10x10 Tablets ALUMINIUM/PVC BLISTER 36 Months COSMOS LIMITED Rangwe Road; Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03
7 Rwanda FDA-HMP-MA-0517 SALCOF SYRUP Salbutamol 1.0mg, Bromhexine HCl 2.0mg, Guaifenesin 50mg 1.0mg, 2.0mg, 50mg Syrup 100ml Bottles PET Amber colored bottles 36 Months UNIVERSAL CORPORATION LIMITED, P.O. Box 1748-00902, Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED, KENYA SUN ENTERPRISES LTD 2023-10-13 2028-10-12
8 Rwanda FDA-HMP-MA-1034 SAMVEC-4 Vecuronium Bromide 4mg 4mg Lyophilised Powder for Injection 5 Vials Glass vials with five 2 ml ampoules of sterile water for injection packed in PVC tray such one tray along with packing insert is packed in a carton 24 Months SAMARTH LIFE SCIENCES PVT. LTD, Unit – II, Plot No: 2, Industrial Area, Lodhimajra, Baddi, Himachal Pradesh - 173 205, India INDIA SAMARTH LIFE SCIENCES PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27
9 Rwanda FDA-HMP-MA-1745 SANAXONE Ceftriaxone Sodium USP 1000mg Powder for injection 10ml Vials TYPE III GLASS VIALS-BUTYL RUBBER STOPPER 36 Months M/S SANSE LABORATORIES PVT LTD VI/51B,P.B.NO 2 Kozhuvanal,pala Kottayam-686573 Kerala, Country: India Phone: +914822268877/267799 Fax: +914822269406 Email: info@sancepharma.com Website: www.sancepharma.com INDIA M/S SANSE LABORATORIES PVT LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16
10 Rwanda FDA-HMP-MA-1529 SANDIMMUM NEORAL 100MG CICLOSPORIN 100MG SOFT GELATIN CAPSULES 30’s, 50’s and 60 Capsules PA/AL/PVC (aluminium) blister packs, blister packs are packed in a cardboard based pack 24 Months CATALENT GERMANY EBERBACH GmbH, Gammelsbacher Str. 269412 Eberbach Germany Germany NVS Kenya Limited SURGIPHARM (RWANDA) LTD 2024-07-27 2029-07-26
11 Rwanda FDA-HMP-MA-1473 SANDIMMUM NEORAL 25MG CICLOSPORIN 25MG SOFT GELATIN CAPSULES 30 Capsules PA/AL/PVC (aluminium) blister packs, blister packs are packed in a cardboard based pack 24 Months CATALENT GERMANY EBERBACH GmbH, Gammelsbacher Str. 269412 Eberbach Germany Germany NVS Kenya Limited SURGIPHARM (RWANDA) LTD 2024-07-27 2029-07-26
12 Rwanda FDA-HMP-MA-2247 SANMOL PARACETAMOL 1000MG/100ML SOLUTION FOR INFUSION 100 ml Bottle Bottle 100 mL clear type II 24 Months PT. SANBE FARMA PT. SANBE FARMA Jl. Industri Cimareme No. 8, Desa Cimareme, Kecamatan Ngamprah, Kabupaten Bandung Barat Indonesia Telephone: +62 22 6867966 INDONESIA PT SANBE FARMA AFRIHEALTH CARE LIMITED 2025-02-04 2030-02-03
13 Rwanda FDA-HMP-MA-0055 SANTOCYN OXYTOCIN 10 IU/ML SOLUTION FOR INJECTION 10 X 1ML AMPOULE CLEAR TYPE I GLASS 18 Months PT SANBE FARMA STERILE PREPARATION PLANT Unit 3, Jl. Industri Cimarene No. 8, Desa Cimareme, Kecamatan Ngamprah, Kabupaten Bandung Barat – Indonesia INDONESIA PT. SANBE FARMA AFRI HEALTH CARE LTD 2021-04-27 2026-04-27
14 Rwanda FDA-HMP-MA-0889 SANTRIAX 1000 Ceftriaxone Sodium USP 1000 mg 1000 mg Powder for Injection 10ml Vial Flint glass vial USP type III with 20mm grey bromo butyl rubber stopper and sealed with 20 mm blue coloured flip-off aluminium seal 24 Months INJECT CARE PARENTERAL PVT LTD, Plot No. 130, Silvassa Road, GIDC, Vapi – 396 195, Dist – Valsad, India. INDIA BLISS GVS PHARMA LTD, INDIA SURYA DEPOT PHARMACY LTD 2024-02-17 2029-02-16
15 Rwanda FDA-HMP-MA-2263 SARTILOS LOSARTAN POTASSIUM 50MG TABLETS 3x10 Tablets PVC/Alu blisters 36 Months BIODEAL LABORATORIES LTD 123, LUNGA LUNGA P.O BOX 32040-00600, NAIROBI, KENYA KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2025-02-04 2030-02-03
16 Rwanda FDA-HMP-MA-0198 SAYANA PRESS 104 MG/0.65 ML Medroxyprogesterone Acetate, 104mg/0.65ml 104mg/0.65ml Suspension of injection Box of 1 or box of 200 Multilayered thermoformed plastic film reservoir whose product contact layer is LDPE 36 Months PFIZER MANUFACTURING BELGIUM NV, Rijksweg 12, 2870 PUURS, Belgium BELGIUM PFIZER LABORATORIES LTD, KENYA GILMED LIMITED 2022-12-21 2027-12-20
17 Rwanda FDA-HMP-MA-1328 SCOFIX Cefixime 200mg 200mg Film coated tablets 10x1x10 Tablets Alu/Alu Blister packed in mono carton 36 Months SCOTT-EDIL ADVANCE RESEARCH LABORATORY EDUCATION LTD, Hill top industrial area, bhatoli Kalan, baddi-173205, (HP), India INDIA SCOTT-EDIL ADVANCE RESEARCH LABORATORY EDUCATION LTD. SUN ENTERPRISE LTD 2024-05-18 2029-05-17
18 Rwanda FDA-HMP-MA-1254 SCOFIX SUSPENSION Cefixime USP as trihydrate 50 mg/5ml 50 mg/5ml Powder for oral suspension 60 ml Bottle HDPE bottle 36 Months SCOTT-EDIL ADVANCE RESEARCH LABORATORY EDUCATION LTD, hill top industrial area, bhatoli Kalan, baddi-173205, (HP), India. INDIA SCOTT-EDIL ADVANCE RESEARCH LABORATORY EDUCATION LTD. ESCORTS PHARMACEUTICALS (RWANDA) LTD. 2024-05-06 2029-05-05
19 Rwanda FDA-HMP-MA-1303 SEKALGIC SUSPENSION Paracetamol 125mg & Ibuprofen 100mg/5ml 125 mg,100 mg/5 ml Suspension Bottle of 100 ml Amber, PET bottle 36 Months BAROQUE PHARMACEUTICALS PVT, LTD, 192/2 & 3, Sokhada-388 620Tal: khambhat, Dist. Anand (Gujarat), India INDIA BEKRA PHARMA UK LTD UBIPHARM-RWANDA LTD 2024-05-07 2029-05-06
20 Rwanda FDA-HMP-MA-1490 SEKALGIC TABLET Ibuprofen 400 mg, Paracetamol 500 mg and Caffeine (Anhydrous) 30 mg 400 mg, 500 mg and 30 mg Uncoated Tablets 1x12 tablets Alu–PVC blister pack, placed in a printed carton along with a pack insert 36 Months BAROQUE PHARMACEUTICALS PVT, LTD, 192/2 & 3, Sokhada-388 620Tal: khambhat, Dist. Anand (Gujarat), India INDIA BEKRA PHARMA UK LTD UBIPHARM-RWANDA LTD 2024-07-20 2029-07-19
21 Rwanda FDA-HMP-MA-0509 SEKISAN SYRUP Cloperastine fendizoate 3.54 mg /ml 3.54 mg /ml Syrup 120ml Bottles Amber PVC bottles with "pilfer proof" cap 60 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. Ctra. Nacional Il, km 593 E-08740 Sant Andreu de la Barca Barcelona Spain SPAIN ALMIRALL, S.A MULTIPHAR-UBIPHARM-RWANDA LTD 2023-09-06 2028-09-05
22 Rwanda FDA-HMP-MA-0095 SEKROL SYRUP ADULT Ambroxol Hydrochloride 30mg/5 ml Syrup 150 Ml AMBER COLOURED GLASS BOTTLE, TYPE III GLASS WITH A WHITE POLYETHYLENE SCREW CAP. 36 Months BILIM ILAÇ SANAYI VE TICARET A.S. (BILIM PHARMACEUTICALS), GOSB, 1900 Sokak N°1904, 41480 Gebze – Kocaeli, Turkey TURKEY DAFRA PHARMA GMBH/ SWITZERLAND MULTIPHAR UBIPHARM-RWANDA LTD 2021-08-05 2026-08-05
23 Rwanda FDA-HMP-MA-0096 SEKROL SYRUP PAEDIATRIC Ambroxol Hydrochloride 15 mg/5 ml Syrup 100 Ml AMBER COLOURED GLASS BOTTLE, TYPE III GLASS WITH A WHITE POLYETHYLENE SCREW CAP. 36 Months BILIM ILAÇ SANAYI VE TICARET A.?. (BILIM PHARMACEUTICALS) GOSB, 1900 Sokak N°1904, 41480 Gebze – Kocaeli, Turkey TURKEY DAFRA PHARMA GMBH, SWITZERLAND MULTIPHAR UBIPHARM-RWANDA LTD 2021-08-05 2026-08-05
24 Rwanda FDA-HMP-MA-0949 SENSOCAIN SPINAL 0.5% INJECTION Bupivacaine Hydrochloride 5mg, Dextrose Anhydrous 80mg 5mg /80mg Solution for Injection 5 Ampoules of 4ml 5ml Amber Glass Usp Type-I Ampoule 24 Months BROOKES PHARMA (PRIVATE) LIMITED, 58-59, Sector No. 15, Korangi Industrial Area, Karachi-74900, Pakistan PAKISTAN BROOKES PHARMA (PRIVATE) LIMITED AFRI HEALTH CARE LTD 2024-02-26 2029-02-25
25 Rwanda FDA-HMP-MA-1921 SERETIDE 100/50MCG DISKUS FLUTICASONE PROPRIONATE MICRONIZED/SALMETEROL XINAFOATE MICRONIZED 100/50MCG Powder for inhalation 28s or 60 Doses Two tone purple MDPI device moulded in plastic containing a blister strip 24 Months Glaxo wellcome Production Zone Industrielle No. 223 Rue Lavoisier27000 Evreux France France GlaxoSmithKline Pharmaceutical Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16
26 Rwanda FDA-HMP-MA-2083 SERETIDE 50/250MCG DISKUS SALMETEROL XINAFOATE MICRONIZED /FLUTICASONE PROPRIONATE MICRONIZED 50µG/250µG Powder for oral inhalation 28 s or 60s Aluminium foil laminate strip 24 Months Glaxo Wellcome Production Zone Industrielle No. 2 23 Rue Lavoisier 27000 Evreux France GlaxoSmithKline Pharmaceutical Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16
27 Rwanda FDA-HMP-MA-1920 SERETIDE 500mcg/50mcg Diskus Fluticasone propionate and salmeterol 500mcg and 50mcg Powder for inhalation 20s or 60 doses Hermetically sealed blister pockets that are performed in the aluminium foil laminate strip 24 Months Glaxo wellcome Production Zone Industrielle No. 2 23 Rue Lavoisier 27000 Evreux France France GlaxoSmithKline Pharmaceutical Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16
28 Rwanda FDA-HMP-MA-2275 SERTOFEN 1.25% GEL DEXKETOPROFEN 1.25% GEL 60g/tube Lacquered aluminium tube 36 Months WORLD MEDICINE ILAC SAN. VE TIC.A.S 15 Temmuz Mah. Cami Yolu Cad. No:50, Günesli, Bagcilar, Istanbul, TURKEY TURKEY WORLD MEDICINE ILAC SAN. VE TIC.A.S GOODMAN INTERNATIONAL ® LTD 2025-05-12 2030-05-11
29 Rwanda FDA-HMP-MA-2350 SEVCAR 400 SEVELAMER CARBONATE 400MG TABLETS 5X10 TABLETS 10 TABLETS ARE PACKED IN ALU-ALU BLISTER; SUCH 5 BLISTER ALONG WITH THE PACK INSERT IS PACKED IN A CARTON 24 MONTHS EMCURE PHARMACETICALS LTD PLOT NO. P-2. I.T.B.T PARK, PHASE II, M.I.D.C, HINJWADI, PUNE – 411 057, INDIA INDIA EMCURE PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2025-10-09 2030-10-08

Registered
30 RWANDA-FDA24/HM/0954/0032 SEZUMA 150 TRASTUZUMAB Lyophilized powder for injection 36 HETERO BIOPHARMA LIMITED India HETERO BIOPHARMA LIMITED BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13
31 RWANDA-FDA24/HM/0950/0033 SEZUMA 440 TRASTUZUMAB Lyophilized powder for injection 36 HETERO BIOPHARMA LIMITED India HETERO BIOPHARMA LIMITED BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13
32 Rwanda FDA-HMP-MA- 0895 SILDENAFIL TABLETS BP 50MG Sildenafil Citrate 50mg 50mg Film coated tablets 4 Tablets ALU/PVC blister. Such 1 blister are packed in a carton along with 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 SUN ENTERPRISES LTD 2024-02-17 2029-02-16
33 Rwanda FDA-HMP-MA-1049 SILDENAFIL-100 TABLETS Sildenafil Citrate BP 100mg 100mg Film coated tablet 4 Tablets ALU-PVC blister is packed in a carton along with 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 SUN ENTERPRISES LTD 2024-02-28 2029-02-27
34 Rwanda FDA-HMP-MA-2057 SILVERKANT SILVER SULPHADIAZINE 1% w/w Cream 30g Tube Aluminium collapsible 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 INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29
35 Rwanda FDA-HMP-MA-1478 SIMBRINZA EYE DROPS, SUSPENSION 1 mL of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate equivalent to 1.3 mg of brimonidine 10mg and 2mg/ml Eye drops 1 or 3 bottles of 5 mL LDPE bottles with a LDPE dropper tip and white polypropylene screw cap containing 5 mL suspension 24 Months ALCON-COUVREUR NV, Rijksweg 14, A 2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LIMITED 2024-07-20 2029-07-19
36 RWANDA-FDA25/HM/0261/0039 Simulect 20 mg powder and solvent for solution for infusion or injection BASILIXIMAB 20mg Powder for Solution for Injection/Infusion 36 Months NOVARTIS PHARMA S.A.S. France Novartis Pharma AG Surgipharm Rwanda Ltd. 2025-10-16 2030-10-15
37 Rwanda FDA-HMP-MA-0367 SIMVA-DENK 40 Simvastatin 40mg 40mg Film-Coated Tablets 30 Tablets Blister strips of clear transparent PVC film coated uniformly with PVdC on inner side with a backing of aluminium foil coated with heat seal lacquer 36 Months DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Production site: Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH&Co. KG/ Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-07-08 2028-07-07
38 Rwanda FDA-HMP-MA-0811 SIMVASTATIN 20 MG FILM COATED TABLETS Simvastatin 20 mg 20 mg Film coated tablets 7,10,14,20,21,28,30,35,40,42,49,50,56,63,70,77,84,91 and 100 tablets Aluminum/PVC blister 36 Months SANDOZ GRUP, Saglik unreli ilaclari sanayive ticaret A.S GOSB ihsan dede cad.900.sok TR-41480 Gebze-Kocaeli, Turkey TURKEY SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29
39 Rwanda FDA-HMP-MA-0812 SIMVASTATIN 40 MG FILM COATED TABLETS Simvastatin 40 mg 40 mg Film coated tablets 7,10,14,20,21,28,30,35,40,42,49,50,56,63,70,77,84,91 and 100 tablets Aluminum/PVC blister 36 Months SANDOZ GRUP, Saglik unreli ilaclari sanayive ticaret A.S GOSB ihsan dede cad.900.sok TR-41480 Gebze-Kocaeli, Turkey TURKEY SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29
40 Rwanda FDA-HMP-MA-1008 SINAREST NASAL DROPS Oxymetazoline Hydrochloride USP 0.5 mg 0.5 mg Nasal Solution 10 ml solution Botttle White LDPE Flat Bottle 36 Months CENTAUR PHARMACEUTICAL PVT. LTD., Plant-I, Plot No.3, 5B, 2C, Tivim Industrial Estate, Karaswada, Mapusa, Goa-403 526, India. INDIA CENTAUR PHARMACEUTICALS PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-23 2029-02-22
41 Rwanda FDA-HMP-MA-1945 SINAREST PAEDIATRIC NASAL DROPS OXYMETHAZOLINE HYDROCHLORIDE USP 0.25MG NASAL DROPS 10ml Bottle LDPE FLAT BOTTLE 36 Months CENTAUR PHARMACEUTICALS PVT LTD Plant :1, plot No:3,5B,2C. Tivin industrial Estate, Karaswada, Mapusa Goa-403526, India INDIA CENTAUR PHARMACEUTICALS PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-15 2029-08-15
42 RWANDA-FDA23/HM/0587/0021 Siropil Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets 50 mg/ 300 mg/ 300 mg Film-Coated Tablet 24 Months EMCURE PHARMACETICALS LTD/INDIA Emcure Pharmaceuticals Limited ABACUS(Ltd) DOWNTOWN BRANCH 2026-02-05 2031-02-04
43 Rwanda FDA-HMP-MA-0053 SIRTURO Bedaquiline Fumarate 100 mg Tablet 188 Tablets HDPE BOTTLE 36 Months RECIPHARM PHARMASERVICES PRIVATE LIMITED INDIA INDIA JANSSEN CILAG INTERNATIONAL NV, BELGIUM GILMED LIMITED 2021-03-17 2026-03-17

Grace Period
44 Rwanda FDA-HMP-MA-0918 SIRTURO™ 20MG Bedaquiline fumarate 20mg 20mg Film coated tablets 60 Tablets Opaque white high-density polyethylene (HDPE) bottle with child-resistant polypropylene (PP) closure with induction seal liner. 36 Months RECIPHARM PHARMASERVICES PRIVATE LIMITED, 34th KM, Tumkur Road Teppada Begur Nelamangala Taluk Bangalore – 562 123 India INDIA JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-02-22 2029-02-21
45 Rwanda FDA-HMP-MA-1798 SITA TABLET 100 Sitagliptin phosphate monohydrate 100 mg Tablets 4x7 Tablets ALU-ALU BLISTER 24 Months CCL PHARMACEUTICALS (Pvt) Ltd 62-INDUSTRIAL ESTATE,KOT LAKHAPAT,LAHORE-54770 PAKISTAN CCL PHARMACEUTICALS (Pvt) LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16
46 Rwanda FDA-HMP-MA-1797 SITA TABLET 50 Sitagliptin phosphate monohydrate 50 mg Tablets 4x7 Tablets ALU-ALU BLISTER 24 Months CCL PHARMACEUTICALS (Pvt) Ltd 62-INDUSTRIAL ESTATE,KOT LAKHAPAT,LAHORE-54770 PAKISTAN CCL PHARMACEUTICALS (Pvt) LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16
47 Rwanda FDA-HMP-MA-2106 Sita-Met Tablet 50/1000mg Sitagliptin Phosphate Monohydrate 50 mg and Metformin Hydrochloride USP 1000 mg 50/1000mg Film Coated Tablets 4x7 Tablets Alu-PVC blisters 24 Months CCL Pharmaceuticals (Pvt.) Ltd 62-Industrial Estate, Kot Lakhpat, Lahore-54770 Pakistan CCL Pharmaceuticals (Pvt.) Ltd Depot Pharmaceutique Le Medical 2024-10-18 2029-10-17
48 RWANDA-FDA25/HM/0105/0049 Sitamac 100 SITAGLIPTIN USP 100 mg Film Coated Tablet 24 Months Macleods Pharmaceuticals limited India MACLEODS PHARMACEUTICALS LTD AIVEEN (R) LTD 2025-12-12 2030-12-11
49 Rwanda FDA-HMP-MA-2107 Sitamet tablets 50/500 mg Sitagliptin Phosphate Monohydrate 50 mg and Metformin Hydrochloride USP 500 mg 50/500 mg FILM COATED TABLETS 4x7 Tablets Alu-PVC blister 36 Months CCL Pharmaceuticals (Pvt.) Ltd 62-Industrial Estate, Kot Lakhpat, Lahore-54770 Pakistan CCL Pharmaceuticals (Pvt.) Ltd DEPOT PHARMACEUTIQUE LE MEDICAL 2024-10-18 2029-10-17
50 Rwanda FDA-HMP-MA-0238 SITAPRIL 100 Sitagliptin 100mg 100mg Film coated tablets 3X10 tablets Blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, B B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
51 Rwanda FDA-HMP-MA-0240 SITAPRIL 25 Sitagliptin 25mg 25mg Film coated tablets 3X10 tablets Blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, B B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
52 Rwanda FDA-HMP-MA-0239 SITAPRIL 50 Sitagliptin 50mg 50mg Film coated tablets 3X10 tablets Blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, B B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
53 Rwanda FDA-HMP-MA-0262 SITAPRIL M 50/1000 Sitagliptin Phosphate Monohydrate 50 mg and Metformin Hydrochloride USP 1000 mg 50 mg and 1000 mg Film coated tablets 3*10 tablets Packed in blisters and 3 such blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, B B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
54 Rwanda FDA-HMP-MA-0275 SITAPRIL M 50/500 Sitagliptin Phosphate Monohydrate 50 mg and Metformin Hydrochloride USP 500 mg 50 mg and 500 mg Film coated tablets 3x10’s tablets Alu/Alu blister pack, 3 such blisters in a printed carton along with pack insert 24 Months AJANTA PHARMA LIMITED, B-4/5/6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra state, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
55 Rwanda FDA-HBP-MA-0002 SITCOM CREAM Euphorbia Prostrata Dry Extract Ethanolic 80%V/V 1% w/w Cream 30g Laminated collapsible tubes 24 Months Panacea Biotec Limited B-1 Ext. / A-27, MCIE,Mathura Road, New Delhi-110044,Country: India INDIA Panacea Biotec Limited AIVEEN (R) LTD 2025-05-12 2030-05-11
56 Rwanda FDA-HBP-MA-0003 SITCOM TABLET Euphorbia Prostrata Dry Extract 100mg Film coated Tablets 7X2 Tablets White opaque PVdC coated PVC blister strip 36 Months Panacea Biotec Limited Panacea Biotec LimitedB-1 Ext. / A-27, MCIE,Mathura Road, New Delhi-110044,Country: India India Panacea Biotec Limited AIVEEN (R) LTD 2025-05-12 2030-05-11
57 Rwanda FDA-HMP-MA-1744 SKAZI 200 Azithromycin USP 200 mg/5ml Suspension 15 ml Bottles DOUBLE LDPE-HDPE Bottles 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India Country:India Telephone:+91-260-6539518 Telefax:+91-260-2430527 E-Mail: regulatory@skant.com INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16
58 Rwanda FDA-HMP-MA-1439 SKDERM CREAM Betamethasone Dipropionate USP 0.05% w/w Clotrimazole BP 1.0% w/w and Gentamicin Sulfate BP 0.1% w/w 0.05% w/w 1.0% w/w and 0.1% w/w Cream 15 g Tubes Aluminium Collapsible tubes internally lacquered with epoxy phenol such tube is packed in a carton with a pack insert 36 Months S.KANT HEALTHCARE LIMITED. 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 2024-07-20 2029-07-19
59 Rwanda FDA-HMP-MA-1845 SLEEPGABA 3 Eszopiclone 3mg Film Coated Tablets 10 Tablets ALU- ALU BLISTER PACK 36 Months HETERO LABS LIMITED Unit V. Address: TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
60 Rwanda FDA-HMP-MA-2072 SMOFKABIVEN GLUCOSE 42%/AA/, LIPID EMULSION 20%. Amino acid solution with electrolytes (Alanine 7.1 g, Arginine 6.1 g, Glycine 5.6 g, Histidine1.5 g, Isoleucine2.5 g, Leucine3.8 g, Lysine3.4 g, Methionine2.2 g, Phenylalanine2.6 g, Proline5.7 g, Serine3.3 g, Taurine0.5 g, Threonine2.2 g, Tryptophan1.0 g, Tyrosine0.20 g, Calcium chloride0.28 g, Sodium glycerophosphate 2.1 g, Magnesium sulphate0.61 g, Potassium chloride 2.3 g, Sodium acetate1.7 g, Zinc sulphate0.0066 g, Glucose127 g, Soya-bean oil, refined11.4 g, Medium-chain triglycerides11.4 g, Olive oil, refined9.5 g, Fish oil, rich in omega-3-acids5.7 g.) 7.1 g, 6.1 g, 5.6 g, 1.5 g, 2.5 g, 3.8 g, 3.4 g, 2.2 g, 2.6 g, 5.7 g, 3.3 g, 0.5 g, 2.2 g, 1.0 g, 0.20 g, 0.28 g, 2.1 g, 0.61 g, 2.3 g, 1.7 g, 0.0066 g, 127 g, 11.4 g, 11.4 g, 9.5 g, 5.7 g. EMULSION FOR INFUSION 493 ml, 986 ml, 1477 ml, 1970 ml, 2463 ml Three chamber bag system 24 Months FRESENIUS Kabi AB Rapsgatan 7, SE-751 74, Uppsala, Sweden Sweden FRESENIUS KABI SOUTH AFRICA PTY) LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16
61 Rwanda FDA-HMP-MA-2073 SMOFKABIVEN PERIPHERAL AMINO ACID SOLUTION WITH ELECTROLYTES, GLUCOSE 13%& LIPID EMULSION (1000 ml contains: Glucose71g, Alanine4.4g, Arginine3.8g, Glycine3.5g, Histidine0.93g, Isoleucine1.6g, Leucine2.3g, Lysine2.1g, Methionine1.3g, Phenylalanine1.6g, Proline3.5g, Serine2.1g, Taurine0.32g, Threonine1.4 g, Tryptophan0.63 g, Tyrosine 0.12 g, Valine2.0 g, Calcium chloride0.18 g, Sodium glycerophosphate1.3 g, Magnesium sulphate0.38 g, Potassium chloride1.4 g, Sodium acetate1.1 g, Zinc sulphate0.004 g, Soya-bean oil, refined8.5 g, Medium-chain triglycerides 8.5 g, Olive oil, refined7.0 g, Fish oil, rich in omega-3-acids4.2 g per 1000ml) 71g, 4.4g, 3.8g, 3.5g, 0.93g, 1.6g, 2.3g, 2.1g, 1.3g, 1.6g, 3.5g, 2.1g, 0.32g, 1.4 g, 0.63 g, 0.12 g, 2.0 g, 0.18 g, 1.3 g, 0.38 g, 1.4 g, 1.1 g, 0.004 g, 8.5 g, 8.5 g, 7.0 g, 4.2 g EMULSION FOR INFUSION 1206 ml, 1448 ml, 1904 ml , 4x1206 ml three chamber inner bag is made of transparent Excel® film and equipped with a port system 24 Months FRESENIUS Kabi AB Rapsgatan 7, SE-751 74, Uppsala, Sweden Sweden FRESENIUS KABI SOUTH AFRICA PTY) LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16
62 RwandaFDA-HMP-MA-1869 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 9%W/V IV INFUSION 500 ml PE Bottle PE Bottle 36 Months REALCADE LIFESCIENCE PVT. LTD Survey No. 891-892, Y - Junction, At Narmada Canal, Karannagar, Ta.: Kadi, Kadi, Gujarat - 382715, India Email Address : field.realcade@gmail.com INDIA LUMIERE LIFE SCIENCEAddress: SHEETAL, NO-16/17 LALBAUG SHOPPING CENTER, MANJALPUR VADODARA, -390011, GUJARAT. Country: INDIATelephone: +91-9825038695Telefax: +91-9825038695E-Mail: ketan@lumierelife.com PHARMACEUTICAL &MEDICAL SUPPLIES SOCIETY LTD (PMSS) 2024-08-17 2029-08-16
63 Rwanda FDA-HMP-MA-2077 SODIUM CHLORIDE 0.9% W/V AND GLUCOSE 5% W/V INTRAVENOUS INFUSION BP Sodium Chloride 0.9% w/v and Glucose 5% w/v Intravenous Infusion BP 0.9% w/v & 5% w/v INTRAVENOUS INFUSION 500 ml LDPE bottle 36 Months B. BRAUN PHARMACEUTICALS EPZ LIMITED No. 18474/84, Athi River, P.O. Box 51200-00100, Nairobi, Kenya. KENYA B. Braun Pharmaceuticals EPZ Limited LE MEDICAL LTD 2024-09-30 2029-09-30
64 Rwanda FDA-HMP-MA-2139 SODIUM CHLORIDE GRIFOLS 0.9% SOLUTION FOR INFUSION BP SODIUM CHLORIDE 0.9% (900mg/100ml) / 250ml SOLUTION FOR INFUSION 250ML The polypropylene bags (Fleboflex) 24 Months LABORATORIOS GRIFOLS, S.A Polígono Industrial Los Llanos. C/ Marte nº 4. 30565 Las Torres de Cotillas, Murcia SPAIN LABORATORIOS GRIFOLS, S.A Bion Pharma Group (BPG) Limited 2024-10-18 2029-10-17
65 Rwanda FDA-HMP-MA-2149 Sodium Chloride Grifols 0.9% Solution for infusion BP Sodium Chloride Grifols 0.9% Solution for infusion BP 0.9% (900 mg/100 mL) /1000ML Injection 1000ml The polypropylene bags (Fleboflex) 24 Months LABORATORIOS GRIFOLS, S.A Polígono Industrial Los Llanos. C/ Marte nº 4. 30565 Las Torres de Cotillas, Murcia Spain LABORATORIOS GRIFOLS, S.A BION PHARMA GROUP LTD 2024-10-18 2029-10-17
66 Rwanda FDA-HMP-MA-2148 Sodium Chloride Grifols 0.9% Solution for infusion BP Sodium Chloride Grifols 0.9% Solution for infusion BP 0.9% (900 mg/100 mL) /500ML Infusion 500 mL The polypropylene bags (Fleboflex) 24 months LABORATORIOS GRIFOLS, S.A Polígono Industrial Los Llanos. C/ Marte nº 4. 30565 Las Torres de Cotillas, Murcia Spain LABORATORIOS GRIFOLS, S.A Bion Pharma Group (BPG) Limited 2024-10-25 2029-10-24
67 Rwanda FDA-HMP-MA-2147 Sodium Chloride Grifols 0.9% Solution for infusion BP Sodium Chloride Grifols 0.9% Solution for infusion BP 0.9% (900 mg/100 mL) 100ML Injection 100ml polypropylene bags (Fleboflex) 24 Months LABORATORIOS GRIFOLS, S.A Polígono Industrial Los Llanos. C/ Marte nº 4. 30565 Las Torres de Cotillas, Murcia Spain LABORATORIOS GRIFOLS, S.A BION PHARMA GROUP LTD 2024-10-18 2029-10-17
68 Rwanda FDA-HMP-MA-2267 SODIUM CHLORIDE GRIFOLS 0.9% SOLUTION FOR INFUSION BP Sodium Chloride Grifols 0.9% Solution for infusion BP 0.9% (900 mg/100)/ 50mL Solution for Infusion 50 mL of solution x 115 bags The polypropylene bags (Fleboflex) 18 Months LABORATORIOS GRIFOLS, S.A. Polígono Industrial Zeta. C/ Logística, 2. 08150 Parets del Vallès, Barcelona, spain SPAIN LABORATORIOS GRIFOLS, S.A. BION PHARMA GROUP LTD 2024-10-18 2029-10-17
69 Rwanda FDA-HMP-MA-0933 SODIUM CHLORIDE INJECTION Sodium chloride 0.9%, 500mL: 4.5g 0.9%, (500mL: 4.5g) Solution for infusion 500 ml Bottle Polypropylene Infusion Bottle 36 Months SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD. Yangzi Road, Economic & Technological Development Zone, Shijiazhuang City, Hebei Province, China CHINA SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-21 2029-02-20
70 Rwanda FDA-HMP-MA-0531 SODIUM CHLORIDE INTRAVENOUS INFUSION (NS) Sodium Chloride 0.9% w/v 0.9% w/v Solution for infusion 500 ml & 250 ml Bottles LDPE bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04
71 Rwanda FDA-HMP-MA-1116 SODIUM CHLORIDE INTRAVENOUS INFUSION BP (0.9% W/V) Sodium Chloride Intravenous Infusion BP (0.9% w/v) (0.9% w/v) Intravenous Infusion 500ml & 1000 ml Bottles LDPE Plastic Bottles 36 Months ACULIFE HEALTHCARE PVT. LTD. Sachana. Taluka: Viramgam, District: Ahmedabad - 382 I50, Gujarat, India INDIA ACULIFE HEALTHCARE PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-04-20 2029-04-19
72 Rwanda FDA-HMP-MA-0902 SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9% W/V Sodium Chloride 0.9 gms/100ml 0.9 gms/100ml Solution for infusion 500 ml bottle Closed System Container (CSC) which is a plastic collapsible container fabricated from LDPE. The container is formed with euro head where a twin-port cap is welded. The Twin Cap has injected thermoplastic elastomers (TPE) closure 24 Months B. BRAUN PHARMACEUTICALS EPZ LTD, L.R. No 18474/84 Athi River, P.O. Box 51200 – 00100, Nairobi, Kenya KENYA B. BRAUN PHARMACEUTICALS EPZ LTD, KENYA KIPHARMA LTD 2024-02-22 2029-02-21
73 Rwanda FDA-HMP-MA-0964 SODIUM LACTATE RINGER'S INJECTION Sodium Lactate 0.320g, Sodium chloride 0.600g, Potassium chloride 0.040g and Calcium chloride (CaCl2·dihydrate) 0.027g. 0.320g+0.600g+0.040g +0.027g Solution for intravenous infusion 30 bottles of 500ml Polypropylene Bottles in a carton 36 Months SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD, Yangzi Road, Economic & Technological Development Zone, Shijiazhuang City, Hebei Province, China. CHINA SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25
74 Rwanda FDA-HMP-MA-1140 SOFTDROPS Carboxymethylcellulose Sodium 0.5 % w/v and Glycerin 0.5 % w/v 0.5 % w/v and 0.5 % w/v Eye drops 10 ml Vial LDPE vial packed in a carton along with the pack insert 36 Months AJANTA PHARMA LIMITED, Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam – 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-21 2029-04-20
75 Rwanda FDA-HMP-MA-1546 SOLIVO 10 LEFLUNOMIDE Ph.Eur 10 MG TABLETS 3x10 Tablets Alu-Alu Blister packed in a carton along with leaflet 24 Months EMCURE PHARMACEUTICALS LIMITED Plot No. P-1 & P- 2, I.T.B.T. Park, Phase II, MIDC, Hinjwadi, Pune-411 057, Maharashtra, India INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26
76 Rwanda FDA-HMP-MA-1547 SOLIVO-20 LEFLUNOMIDE 20 MG TABLETS 3x10 Tablets Alu-Alu Blister packed in a carton along with leaflet 24 Months EMCURE PHARMACEUTICALS LIMITED Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, MIDC, Hinjwadi, Pune-411 057, Maharashtra, India INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26
77 Rwanda FDA-HMP-MA-0814 SOLUDOL Diclofenac Sodium BP 50 mg 50 mg Dispersible tablets 10x10 Tablets Printed aluminum foil blister 36 Months WIN-MEDICARE PVT. LTD. Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29
78 Rwanda FDA-HMP-MA-0214 SOMAZINA 1000MG ORAL SOLUTION Citicoline sodium, 1000mg, oral solution 1000mg Oral solution 10 ml single sachets Aluminium single sachets 24 Months FERRER INTERNACIONAL, S.A. Joan Buscallà, 1-9 08173 Sant Cugat del Vallès (Barcelona), Spain SPAIN FERRER INTERNACIONAL, S.A., Spain GOMHS LTD 2022-12-21 2027-12-20
79 Rwanda FDA-HMP-MA-1125 SOMAZINA 1000MG SOLUTION FOR INJECTION Citicoline Sodium 1000mg 1000mg Solution for injection 5 ampoules Type 1 Eur. Ph. neutral glass colourless ampoules 36 Months FERRER INTERNACIONAL, S.A. Joan Buscallà, 1-9 08173 Sant Cugat del Vallès (Barcelona), Spain SPAIN FERRER INTERNATIONAL, S.A. GOMHS LTD 2024-04-21 2029-04-20
80 Rwanda FDA-HMP-MA-0854 SOMECID Omeprazole Sodium BP, 40mg 40mg Dry Powder for injection or infusion 10 ml vial Amber coloured glass vial. Such 1 vial is packed in printed carton along with pack insert 24 Months STALLION LABORATORIES PVT. LTD, C-1B, 305/2, 3, 4 & 5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad, Gujarat, India. INDIA STALLION LABORATORIES PVT. LTD. SUN ENTERPRISES LTD 2024-02-09 2029-02-08
81 Rwanda FDA-HMP-MA-1182 SONADERM CREAM Clobetasol Propionate BP 0.05% w/w, Miconazole Nitrate BP 2.0% w/w, & Gentamicin Sulphate BP equivalent to Gentamicin 0.1% w/w 0.05% w/w, 2.0% w/w, 0.1% w/w Cream 10g Tube Aluminium collapsible tube is packed in printed carton 24 Months BLUE CROSS LABORATORIES PVT. LTD, L-17, Verna Industrial Estate, Verna, GOA-403-722, India. INDIA BLUE CROSS LABORATORIES PVT. LTD. WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05
82 Rwanda FDA-HMP-MA-0133 SONATEC MOUTHWASH MENTHOL FRESH (ALCOHOL FREE) Cetylpyridinium Chloride BP 0.05% w/v 0.05% w/v Clear free flowing liquid 250ml mouthwash bottle Clear plastic bottle (33 Finke) inner plug with siphoning tube 36 Months REGAL PHARMACEUTICALS LIMITED, Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD, KENYA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18
83 Rwanda FDA-HMP-MA-1528 SPAMOX CAPSULES 500 Amoxicillin Capsules B.P 500MG Hard Gelatin Capsules 10x10 Capsules A blister of 10 capsules and such 10 blisters are placed in carton along with a product leaflet 24 Months SPARSH BIO-TECH PVT.LTD Plot No. 1; Survey No.242/243/244, Lakhabavad, Jamnagar 361 006 (India) INDIA SPARSH BIO-TECH PVT.LTD ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26
84 Rwanda FDA-HMP-MA-1308 SPAMOX ORAL SUSPENSION Amoxicillin Trihydrate 125 mg per 5ml 125 mg per 5ml Powder for reconstitution 100 ml Bottle Amber Colored Glass with measuring cup packed in a carton 24 Months SPARSH BIO-TECH PVT. LTD. Plot No. 1; Survey No.242/243/244,Lakhabavad, Jamnagar-361 006, India INDIA SPARSH BIO-TECH PVT. LTD. INDIA ABACUS PHARMA (A) LTD 2024-05-16 2029-05-15
85 Rwanda FDA-HMP-MA-2049 SPAMOX ORAL SUSPENSION 250 Amoxicillin trihydrate BP 250MG/5ML POWDER FOR ORAL SUSPENSION 100 ml Amber Colored Glass Bottle packed in a carton with leaflet and measuring cup 24 Months SPARSH BIO-TECH PVT. LTD Plot No. 1; Survey No. 242/243/244, Lakhabavad, Jamnagar-361 006 India SPARSH BIO-TECH PVT.LTD ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29
86 Rwanda FDA-HMP-MA-1040 SPASCOL® TABLETS Drotaverine Hydrochloride 80mg and Paracetamol 500mg 80mg, 500mg Film coated tablet 10 Tablets Alu-Alu Pack. Such 1 pack is packed in printed and laminated carton along with pack insert. 36 Months WEST-COSAT PHARMACEUTICAL WORK LTD, EP No.17&16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At& Post Gota, Ahmedabad-382481. Gujarat, India INDIA BEKRA PHARMA UK LTD UBIPHARMA-RWANDA LTD 2024-02-28 2029-02-27
87 Rwanda FDA-HMP-MA-1644 SPASMODEX - P PARACETAMOL & HYOSCINE BUTYLBROMIDE 500MG/10MG TABLETS 3×10 Tablets Alu-Alu Blisters pack 36 Months Skybiotech Life Sciences Pvt. Ltd Gut No.5, Gevrai Tanda Paithan Road, Aurangabad, 431 002, M.S., India India Star Biotech Limited Star Biotech Limited 2024-08-17 2029-08-16
88 Rwanda FDA-HMP-MA-1230 SPASMODEX-10 Hyoscine Butylbromide 10 mg 10 mg Film Coated Tablets 3×10’s Alu-Alu Blisters 36 Months SKYBIOTECH LIFE SCIENCES PVT. LTD, Factory: Gut No.5, Gevrai Tanda Paithan Road, Aurangabad, 431 002, M.S. India INDIA PHARMA LIFE SCIENCE LTD STAR BIOTECH LIMITED 2024-05-06 2029-05-05
89 Rwanda FDA-HMP-MA-1045 SPASMOMEN TABLETS Otilonium Bromide 40mg 40mg Film-coated tablet 10 tablets or 30 tablets PVC/PVDC/AL blister, in a box 36 Months BERLIN CHEMIE AG, Glienicker Weg 125, D-12489 Berlin, Germany GERMANY GERMANY A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L. FLORENCE-ITALY PRAFFIN RWANDA LTD 2024-02-28 2029-02-27
90 Rwanda FDA-HMP-MA-1029 SPECTROMAX 500 Clarithromycin 500mg 500mg Tablets 2x7 Tablets Blister of PVC/PE/PVDC film with printed laminated aluminum backing foil. Two such blisters are packed in a carton 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 2024-02-28 2029-02-27
91 Rwanda FDA-HMP-MA-0989 SPECTROMAX-250 Clarithromycin 250mg 250 mg Film coated tablets 7 Tablets Blister of PVC film with printed laminated aluminum backing foil 36 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOG), P.O. Box 120, Rusal, Postal Code 124, Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOG) SUN ENTERPRISES LTD 2024-02-26 2029-02-25
92 20-4365-DGC&PHS-2018-R1 SPECTRUM-250 Ciprofloxacin 250 mg Tablets Box/10 ALU/PVC FILM BLISTER PACK/CARTON 24 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16
93 20-4366-DGC&PHS-2018-R1 SPECTRUM-500 Ciprofloxacin 500 mg Tablets Box/10 ALU/PVC FILM BLISTER PACK/CARTON 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16
94 20-4367-DGC&PHS-2018-R1 SPECTRUM-750 Ciprofloxacin 750 mg Tablets Box/10 ALU/PVC FILM BLISTER PACK/CARTON 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16
95 Rwanda FDA-HMP-MA- 0476 SPEGRA Dolutegravir 50mg, Emtricitabine 200mg and Tenofovir Alafenamide 25mg 50mg, 200mg and 25mg Film coated tablets 30 tablets and 90 tablets 30 tablets in 60 cc HDPE Container and 90 tablets in 150 cc HDPE Container 36 months EMCURE PHARMACEUTICALS LTD, Plot No. P-1. & P-2, I.T.B.T Park, Phase II, M.I.D.C, Hinjwadi, Pune – 411 057, India INDIA Emcure Pharmaceuticals Ltd, India ABACUS PHARMA (A) LTD 2023-12-10 2028-12-09
96 Rwanda FDA-HMP-MA-0956 SPIRIVA RESPIMAT Tiotropium bromide monohydrate 2.5 microgram 2.5 microgram Solution for Inhalation Cartridge/ 60 puffs and 1 Respimat inhaler 1 cartridge (60 puffs) & 1 Respimat inhaler (starter pack) 36 Months BOEHERINGER INGELHEIM PHARMA GmBH & Co.KG. Binger Strasse 173,55216 Ingelheim am Rhein, Germany GERMANY BOEHERINGER INGELHEIM INTERNATIONAL GMBH SURGIPHARM (RWANDA) LTD 2024-02-26 2029-02-25
97 Rwanda FDA-HMP-MA-1566 SPIROMIDE TABLETS Spironolactone and Furosemide 50mg/20mg Tablets 2x10 Tablets ALU/PVC BLISTERS 24 Months THE SEARLE COMPANY LIMITED F-319, S.I.T.E. Karachi Pakistan PAKISTAN THE SEARLE COMPANY LIMITED SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16
98 Rwanda FDA-HMP-MA-1424 SPIROMIDE-40 MG TABLETS Spironolactone (BP) 50 mg and furosemide (Ph.Eur.) 40 mg 50 mg and 40 mg Film Coated Tablets 3x10 Tablets PVC/ALU Blisters 24 Months THE SEARLE COMPANY LIMITED, F-319, S.I.T.E. Karachi, Pakistan PAKISTAN THE SEARLE COMPANY LIMITED SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17
99 Rwanda FDA-HMP-MA-1309 SPOTCLAV 625 Amoxycillin Trihydrate USP 500mg and Clavulanate Potassium USP 125mg 500mg 125mg Film Coated Tablet 2 ×10 Tablets Alu-Alu blisters packed in aluminium pouch with silica gel, which is further packed in a carton 24 Months SPARSH BIO-TECH PRIVATE LIMITED, Plot no. 1; Survey no. 242/243/244, Lakhabavad, Jamnagar-361 006, India INDIA SPARSH BIO-TECH PRIVATE LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-05-16 2029-05-15
100 Rwanda FDA-HMP-MA-2251 STATINOR 10 Rosuvastatin 10 mg Tablets 1x10 Tablets Alu- Alu blister pack 36 Months HETERO LABS LIMITED Unit V, TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2025-02-04 2030-02-03
101 Rwanda FDA-HMP-MA-2252 STATINOR 20 Rosuvastatin 20 mg Tablets 1x10 Tablets Alu- Alu blister pack 24 Months HETERO LABS LIMITED Unit-V Sy. No. 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2025-02-04 2030-02-03
102 Rwanda FDA-HMP-MA-0097 STERILISED WATER FOR INJECTIONS B.P Water For Injection 10ml Solution For Injection 50 Ampoules CARTON ALONG WITH PACKAGE INSERT. 48 Months AMANTA HEALTHCARE LIMITED Plot no: 876, N.H. No: 8, Hariala, Kheda-387411, Gujarat, India INDIA AMANTA HEALTHCARE LIMITED, INDIA SUN ENTERPRISES LTD 2021-08-05 2026-08-05
103 Rwanda FDA-HMP-MA-2330 STOPACID SUSPENSION ALUMINIUM HYDROXIDE BP 120MG AND MAGNESIUM TRISILICATE BP 250MG 120mg and 250mg/5ml Oral Suspension 100ML BOTTLE AMBER-COLOURED PET IN THE UNIT BOX, WITH LITERATURE INSERT 36 MONTHS DAWA LIMITED PLOT NO. 7879/8, BABA DOGO RD, RUARAKA. P.O. BOX 16633-00620. NAIROBI, KENYA. KENYA. DAWA LIMITED SUN ENTERPRISES LTD 2025-07-11 2030-07-10

Registered
104 Rwanda FDA-HMP-MA-0908 STOPKOF SYRUP Diphenhydramine HCL 13.5mg/5ml, Ammonium Chloride 131.5mg/5ml 13.5mg/5ml,131.5mg/5ml Syrup 60 ml & 100 ml Bottles Amber glass bottles 24 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), SULTANATE OF OMAN SUN ENTERPRISES LTD 2024-02-22 2029-02-21
105 Rwanda FDA-HMP-MA-1469 STOPKOF- P DIPHENHYDRAMINE HCL 7.0mg SYRUP 100ml Bottle Amber glass bottle sealed with plastic caps having PE wads 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 2024-07-27 2029-07-26
106 Rwanda FDA-HMP-MA-0160 STROM-50 Tramadol Hydrochloride BP 50mg 50mg Capsules 10 x 10 capsules PVC blister foil packed in printed carton 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
107 Rwanda FDA-HMP-MA-0654 SULPHATRIM Trimethoprim BP 40 mg & Sulfamethoxazole BP 200mg 40 mg & 200mg Oral suspension 100 ml bottle Amber PET bottle packed in printed carton with a packaging insert 36 Months LINCOLN PHARMACEUTICALS LTD, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat-India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-12-02 2028-12-01
108 Rwanda FDA-HMP-MA-0474 SULPHATRIM 480 Trimethoprim BP 80 mg & Sulfamethoxazole BP 400 mg 80 mg & 400 mg Tablets 10 x 10 tablets ALU-PVC blister pack. Such 10 blisters packed in printed unit carton with package insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
109 Rwanda FDA-HMP-MA-0098 SULPHATRIM-960 MG Sulphamethoxazole, Trimethoprim, 800mg, 160 mg Tablets 10 X 10 Tablets ALU-PVC BLISTER PACK 36 Months LINCOLN PHARMACEUTICALS LIMITED Trimul Estate, Khatraj, Taluka, Kalol, Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2021-08-05 2026-08-05
110 Rwanda FDA-HMP-MA-0426 SULPHUR OINTMENT Precipitated Sulphur BP 10.0 % w/w 10.0 % w/w Ointment 25g tube Aluminium tube with a white cap and packed in unit carton 36 Months REGAL PHARMACEUTICALS LIMITED, Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
111 Rwanda FDA-HMP-MA-0729 SUPER WELGRA Sildenafil citrate USP 100 mg and Dapoxetine Hydrochloride 60 mg 100 mg and 60 mg Film coated tablets 4 Tablets Printed Aluminium foil blister pack of 4 tablets, packed in a carton along with a leaflet. 36 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 2024-01-08 2029-01-07
112 Rwanda FDA-HMP-MA-0561 SUPIROCIN OINTMENT Mupirocin Ointment USP 2% w/w 2% w/w Ointment 15 g tube Printed carton containing a leaflet and a printed Aluminium collapsible tube 18 Months GLENMARK PHARMACEUTICALS LTD, Plot No. E-37, 39, DRoad, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-15 2029-01-14
113 Rwanda FDA-HMP-MA-1389 SUPIXA-2.5 Apixaban 2.5mg 2.5mg Film Coated Tablets 1x10 Tablets Alu/Alu blisters packed in a carton along with package insert 24 months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17
114 Rwanda FDA-HMP-MA-1385 SUPIXA-5 Apixaban 5mg 5 mg Film Coated Tablet 3x10 tablets Alu/Alu blisters packed in a carton along with package insert 24 months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17
115 Rwanda FDA-HMP-MA-1554 SUPRIDOL Tramadol Hydrochloride 50mg Solution for injection 1ml Ampoules FLINT AMPOULE WITH DOUBLE BLACK BAND S/O 12 Months M/s. NEON LABORATORIES LIMITED Plot no. 29 to 32 & 57, 60, The Palghar Taluka Industrial Estate Co-Op Estate Ltd., Boisar Road, Taluka – Palghar 401404 Maharashtra State, India INDIA M/s. NEON LABORATORIES LIMITED SUN ENTERPRISE LTD 2024-08-17 2029-08-16
116 Rwanda FDA-HMP-MA-1315 SURDEX SYRUP Phenylephrine Hydrochloride BP 2.5 mg, Paracetamol BP 125 mg and Chlorphenamine Maleate BP 1 mg 2.5 mg, 125 mg and 1 mg Syrup 60 ml bottle Amber coloured PET bottle packed in a carton 36 Months BLISS GVS PHARMA LTD, Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District-Thane – 401404, India INDIA IMEX PHARMA, MAURITIUS MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-05-16 2029-05-15
117 Rwanda FDA-HMP-MA-1221 SUVITRA-500 Levetiracetam USP 500mg 500mg Film Coated Tablets 3x10 Tablets Alu/Alu Blister Pack 36 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05
118 Rwanda FDA-HMP-MA-0584 SUXAMETHONIUM CHLORIDE 50MG/ML SOLUTION FOR INJECTION/INFUSION Each ml of solution for injection or infusion contains 50 mg of suxamethonium chloride dihydrate (equivalent to 36.55 mg of suxamethonium) 50mg/ml Solution for Injection/Infusion 10 Ampoules of 2ml Type I clear glass 2 ml ampoule. 10 ampoules are packed in one carton 18 months MACARTHYS LABORATORIES T/A MARTINDALE PHARMA, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom UNITED KINGDOM MACARTHYS LABORATORIES T/A MARTINDALE PHARM KIPHARMA LTD 2023-10-05 2028-10-04
119 Rwanda FDA-HMP-MA-2288 SWAMLO 10 Amlodipine Besilate BP 10 mg Tablets 10x10 Tablets PVC/PVDC aluminium blister strips 36 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11
120 Rwanda FDA-HMP-MA-2289 SWAMLO 5 Amlodipine Besilate BP 5 mg Tablets 10x10 Tablets PVC/PVDC Aluminium Blister Strips 36 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11
121 Rwanda FDA-HMP-MA-0408 SWFI Sterilized water for injections BP, 100.0%w/v 100.0%w/v Solvent for parenteral use 10 ml and 5ml bottles LDPE Bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda. UGANDA ABACUS PARENTERAL DRUGS LTD (APDL), UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
122 Rwanda FDA-HMP-MA-0270 SYMBICORT TURBUHALER Budesonide micronised, 160 ?g and Formoterol fumarate dihydrate, 4.5 ?g 160 ?g and 4.5 ?g Inhalation powder 60 doses and 120 doses Turbuhaler 24 Months AstraZeneca AB, Forskargatan 18, SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca AB SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11
123 Rwanda FDA-HMP-MA-2159 SYXTEN 2% CARBOCISTEINE 2% Syrup 125 mL Amber Pet Bottles 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 2024-10-18 2029-10-17
124 Rwanda FDA-HMP-MA-2157 SYXTEN 5% CARBOCISTEINE 5% Syrup 100 mL Amber Pet Bottles 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 2024-10-18 2029-10-17