Public View of Electronically Registered Products

Certificates issued on 10-Sep-2021

Electronically Registered Product Details

#Local Technical RepresentativeApplication NumberProduct Trade NameHuman VetLocal ForeignInn Of ApiApi Strength Per DosageProduct Registration NoDosage Form NameRoutes NameShelf Life NameProduct Visual DescAtc Code NamePharmacotherapeutic GroupMah Company NameMah Company AddressMah Company EmailSite NameSite AddressStatus NameStatus Description
1MEDFO KENYA LIMITED14638CARDIPIN-40/2.5HHumanForeignTELMISARTAN, (s)-AMLODIPINE BESYLATE &…Telmisartan USP 40 mg, Amlodipine Besylate USP…H2021/CTD7491/14638TabletORAL36 monthsC09DXAgents acting on the renin-angiotensin system:…RELAX BIOTECH PVT. LIMITED862/1, GIDC, MAKARPURA, VADODARA - 390010,…RegisteredValid
2GALAXY PHARMACEUTICAL LIMITED-DOCTORS PARK18672GLIFEMPA M 10/500 TABLETSHumanForeignEMPAGLIFLOZIN AND METFORMIN HCL TABLETS- Empagliflozin 10 mg - Metformin Hydrochloride…H2021/CTD8466/18672Film-Coated TabletORAL36 monthsA10BD20metformin and empagliflozinGALAXY PHARMACEUTICAL LTD1st floor, doctors' park, 3rd Parklands Avenue,…info@galaxypharma.co.keFREDUN PHARMACEUTICAL LIMITED14, 15, 16, Zorabian industrial complex , Vevoor,…RegisteredValid
3SAI PHARMACEUTICALS LTD18621Rotavirus Vaccine, Live Attenuated (Oral)…HumanForeignLive Attenuated Rotavirus Vaccine (Oral)Each dose of 2.5 mL contains: Live Attenuated…H2021/CTD8690/18621Oral Drops, LiquidORAL24 monthsJ07BH02rota virus pentavalent live reassortedSerum Institute of India Pvt LimitedRegisteredValid
4PROLINE HEALTHCARE LIMITED14046Sevoprane Inhalation SolutionHumanForeignSevofluraneEach 100ml contains Sevoflurane USP 100mlH2021/CTD7142/14046Inhalation Vapour, LiquidRESPIRATORY (INHALATION)36 monthsN01AB08sevofluraneILSUNG PHARMACEUTICAL CO.LTD349,Sandan-ro,Danwon-gu,Ansan-Si,Gyeonggi-Do,repul…RegisteredValid
5TIBA HEALTHCARE LIMITED18403DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL…HumanForeignDOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL…Each tablet cotains DOLUTEGRAVIR 50MG, LAMIVUDINE…H2021/CTD8566/18403TabletORAL24 monthsJ05ARAntivirals for systemic use: Combinations of…CELLTRION PHARM, INC. CHEONGJU PLANTRegisteredValid
6GLAD HEALTHCARE KENYA LIMITED16456GLAMOXYHumanForeignAmoxicillin trihydrate500mgH2021/CTD8012/16456Capsule, HardORAL36 monthsWhile granules filled in 0# red & black capsulesJ01CA04amoxicillinReyoung Pharmaceutical Co., Ltd.No.1 Ruiyang Road Yiyuan county, Shandong…xie.manyi@reyoungh.comREYOUNG PHARMACEUTICAL Co LTDat No. 6, Erlangshan Road, Yiyuan county,…RegisteredValid
7UNISEL LTD18497Fastil GelHumanForeignKetoprofen BpEacg gram contains Ketoprofen Bp 25mgH2021/CTD8444/18497GelTOPICAL36 monthsM01AE03ketoprofenUnisel Pharma (K) LtdApricot Suites, 1st Floor, 4th Parkland Avenue,…regulatory@uniselpharma.comCoral Laboratories Ltd 2Plot No. 27-28, Pharmacity, Selaqui, Dehradun…RegisteredValid
8DAWA LTD18475Dapaflo 10mg TabletHumanLocalDapagliflozin propanediol monohydrateEach film coated tablet contains: Dapagliflozin…H2021/CTD8528/18475Film-Coated TabletORAL36 monthsYellow ,biconvex film coated tablet plain on both…A10BK01DapagliflozinDAWA LIMITEDPLOT NO 7879/8,BABA DOGO ROAD,RUARAKA-P.O BOX…admin@dawalimited.comDawa Limited16633RegisteredValid
9MEDCURE HEALTHCARE LTD14696PRODOM CAPSULESHumanForeignEnteric Coated Rabeprazole Sodium and Sustained…Rabeprazole Sodium AND Domperidone BPH2021/CTD7782/14696CapsuleORAL24 monthsGreen/ Green colored size “2” capsuleA03FA03domperidoneMEDCURE HEALTHCARE LTDAddress: P.O. Box 14609-00400 – Nairobi-Kenya…medcurepharmaceuticalskenya@gmail.comSaga Laboratories LtdSurvey no. 198/2 & 198/3, Chachrawadi, NR Claris,…RegisteredValid
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