Public View of Electronically Registered Products

Certificates issued on 22-Jan-2020

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
1COSMOS LIMITED15275ES-OMECOS 40MG ENTERIC COATED TABLETSHumanLocalESOMEPRAZOLE USP40MGH2020/CTD7890/15275TabletORAL24 monthsSALMON RED, ROUND SHAPED ENTERIC COATED TABLETS…A02BC05esomeprazoleCOSMOS LIMITEDRANGWE ROAD; OFF LUNGA LUNGA ROAD, INDUSTRIAL…-8096046COSMOS LIMITEDP.O. BOX 41433 GPO 00100-NAIROBI KENYARegisteredValid
2MEDISEL KENYA LTD17358OLAPIN-5 TABLETSHumanForeignOlanzapine USPOlanzapine USP 5 mgH2020/CTD5503/1188ERTabletORAL36 monthsN05AH03olanzapineMEDISEL KENYA LIMITEDP.O BOX 540-01000 THIKA, KENYAregulatory@mediselkenya.comAurochem Pharmaceuticals (I) Private Limited58, Palghar Taluka Industrial Co-operative Estate…RegisteredValid
3OPERA PHARMA (K) LTD19528SPAMCIL ORAL SUSPENSIONHumanForeignAMPICILLIN ORAL SUSPENSION B.P.125MGH2020/CTD5882/1593ERPowder And Solvent For Oral SuspensionORAL24 monthsJ01CA04amoxicillinSPARSH BIO-TECH (PVT) LTDPLOT NO. 1 SURVEY NO. 242/243/244 VILLAGE…RegisteredValid
4HARLEYS LTD-NAIROBI17345Xtrazid Injection 1gmHumanForeignCeftazidime (as pentahydrate)Each vial contains: Ceftazidime (as…H2020/CTD5666/1553ERInjectionINTRAVENOUS24 monthsJ01DD02ceftazidimeSURGE LABORATORIES LTDPLOT NO. 10 KM FAISALABAD ROAD, BIKHI DIST.…RegisteredValid
5MEDISEL KENYA LTD17359OLAPIN-10 TABLETSHumanForeignOlanzapine USPOlanzapine USP 10 mgH2020/CTD5504/1189ERTabletORAL36 monthsN05AH03olanzapineMEDISEL KENYA LIMITEDP.O BOX 540-01000 THIKA, KENYAregulatory@mediselkenya.comAurochem Pharmaceuticals (I) Private Limited58, Palghar Taluka Industrial Co-operative Estate…RegisteredValid
6SAI PHARMACEUTICALS LTD17510Bunase 200mcgHumanForeignBudesonide 200mcg ......suspended in Propellant…200mcgH2020/CTD5199/1262ERInhalation VapourORAL24 monthsR01AD05budesonideOXALIS LABSVILLAGE THEDA, P.O LODHI MAJRA TEHSIL BADDI,…RegisteredValid
7SUNPAR PHARMACEUTICALS LTD17513ARCHIFAR 1G POWDER FOR SOLUTION FOR INJECTIONHumanForeignMeropenemEach vial contains Meropenem 1gH2020/CTD5555/1254ERPowder For Solution For InjectionINTRAVENOUS24 monthsJ01DH02meropenemMEDOCHEMIE LTD., FACTORY AZ2, MICHEAL ERAKLEOUS STREET, AGIOS ATHANASSIOS…RegisteredValid
8ABACUS PHARMA (A) LTD19413PRAZIKANT TABLETSHumanForeignPraziquantel USP600 mgH2020/CTD5018/924ERTabletORAL36 monthsP02BA01praziquantelSKANT HEALTHCARE LTDPlot no. 1802 - 1805, GIDC, phase III, Vapi…RegisteredValid
9MEDISEL KENYA LTD19458ENMED SOLUTION FOR INJECTIONVetForeignENROFLOXACINENROFLOXACIN 100MGV2020/6261/1169ERSolution For InjectionPARENTERAL36 monthsQJ01MAFluoroquinolonesMEDISEL KENYA LTDGENERAL KAGO RD, P.O. BOX 540-01000, THIKARegisteredValid
10PHILLIPS THERAPEUTICS LIMITED12280Brintellix 10 mgHumanForeignVortioxetine (as hydrobromide)10 mg per tabletH2019/CTD6340/12280Film-Coated TabletORAL36 monthsYellow, almond-shaped film-coated tablet engraved…N06AXOther AntidepressantsH. Lundbeck A/SOttiliavej 9, DK-2500, Valby-Copenhagen, Denmarkinformation@ lundbeck.comH.LUNDBECK A/SOTTILIAVEJ 9,DK-2500 VALBY-COPENHAGEN, DENMARKRegisteredValid
Search