Public View of Electronically Registered Products

Certificates issued on 20-Sep-2021

Electronically Registered Product Details

#Local Technical RepresentativeApplication NumberProduct Trade NameHuman VetLocal ForeignInn Of ApiApi Strength Per DosageProduct Registration NoDosage Form NameRoutes NameEvaluatedShelf Life NameProduct Visual DescAtc Code NamePharmacotherapeutic GroupMah Company NameMah Company AddressMah Company EmailSite NameSite AddressStatus NameStatus Description
1PHILLIPS THERAPEUTICS LIMITED13170NINLARO 2.3 mg hard capsulesHumanForeignIxazomib citrateEach capsule contains 2.3 mg of ixazomib (as 3.3…H2021/CTD6854/13170Capsule, HardORALRecommended36 monthsLight pink, size 4 hard gelatin capsule, marked…L01XX50ixazomibTakeda Pharma A/S,Dybendal Alle 10, Taastrup, 2630 DenmarkGhita.Astrup@takeda.comHaupt Pharma Amereg GmbH100000000000100 RegisteredValid
2PHILLIPS THERAPEUTICS LIMITED13171NINLARO 3 mg hard capsulesHumanForeignIxazomib citrateEach capsule contains 3 mg of ixazomib (as 4.3 mg…H2021/CTD6855/13171Capsule, HardORALRecommended36 monthsLight grey, size 4 hard gelatin capsule, marked…L01XX50ixazomibTakeda Pharma A/S,Dybendal Alle 10, Taastrup, 2630 DenmarkGhita.Astrup@takeda.comHaupt Pharma Amereg GmbHDonaustaufer Strasse 378, 93055 Regensburg GermanyRegisteredValid
3PHILLIPS THERAPEUTICS LIMITED13172NINLARO 4 mg hard capsulesHumanForeignIxazomib citrateEach capsule contains 4 mg of ixazomib (as 5.7 mg…H2021/CTD6856/13172Capsule, HardORALRecommended36 monthsLight orange, size 3 hard gelatin capsule, marked…L01XX50ixazomibTakeda Pharma A/S,Dybendal Alle 10, Taastrup, 2630 DenmarkGhita.Astrup@takeda.comHaupt Pharma Amereg GmbHDonaustaufer Strasse 378, 93055 Regensburg GermanyRegisteredValid
4METRO PHARMACEUTICALS LTD14034Digomet-250HumanForeignDigoxin250mcgH2021/CTD7168/14034TabletORALRecommended36 monthsC01AA05digoxinVapi Care Pharma (Pvt.) LtdPlot No. 225/3, Near Morarji Circle G.I.D.C.,…RegisteredValid
5NAIROBI ENTERPRISES LTD14138I-DOX 50mg/25mlHumanForeignDoxorubicin Hydrochloride2mgH2021/CTD7519/14138InjectionINTRAVENOUSRecommended24 monthsL01DB01doxorubicinGetwell Pharmaceuticals474 Udyog Vihar, Phase-V, Gurgaon Haryana, IndiaRegisteredValid
6REGAL PHARMACEUTICALS LTD14870CHLORODIN GELHumanLocalChlorhexidine Gluconate BPEach Gram contains: Chlorhexidine BP 7.1% w/wH2021/CTD7679/14870GelTOPICALRecommended36 monthsD08AC02chlorhexidineREGAL PHARMACEUTICALS LTDBABA DOGO RD, RUARAKARegisteredValid
7KRISHNA CHEMISTS LTD14973TAMDURAHumanForeignTAMSULOSIN HYDROCHLORIDE AND DUTASTERIDE TABLETSTamsulosin hydrochloride BP 0.4 MG Dutasteride BP…H2021/CTD7820/14973Film-Coated TabletORALRecommended36 monthsA white coloured round shaped, biconvex, Film…G04CA02tamsulosinKRISHNA CHEMISTS LTD3rd Floor Metrix Hardware, Lusaka Road,…regulatory@krishnachemists.comRELAX BIOTECH PVT. LIMITED862/1, GIDC, MAKARPURA, VADODARA - 390010,…RegisteredValid
8NAIROBI ENTERPRISES LTD15792TAXEWELL-RTU 20mg/mlHumanForeignDOCETAXEL ANHYDROUS USP20mgH2021/CTD8262/15792Concentrate For Solution For InfusionINTRAVENOUSRecommended24 monthsL01CD02docetaxelGetwell Pharmaceuticals474 Udyog Vihar, Phase-V, Gurgaon Haryana, IndiaRegisteredValid
9NAIROBI ENTERPRISES LTD15798TAXEWELL-RTU 80mg/4mlHumanForeignDocetaxel Anhydrous USP20mgH2021/CTD8264/15798Concentrate For Solution For InfusionINTRAVENOUSRecommended24 monthsL01CD02docetaxelGetwell Pharmaceuticals474 Udyog Vihar, Phase-V, Gurgaon Haryana, IndiaRegisteredValid
10GALAXY PHARMACEUTICAL LIMITED-DOCTORS PARK15977NEWCOX-90HumanForeignEtoricoxib90 mgH2021/CTD8347/15977TabletORALRecommended36 monthsM01AH05etoricoxibGALAXY PHARMACEUTICAL LTDP.O. BOX 39107-00623, NAIROBIinfo@galaxypharma.co.keSkybiotech Life Sciences (P) LtdGUT No.5, Georai Tanda, 10k.m stone, Paithan…RegisteredValid
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