Public View of Electronically Registered Products

Certificates issued on 11-Aug-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
1GAMMA ZENITH KENYA LIMITED19826Dolutegravir Sodium, Lamivudine and Tenofovir…HumanForeignDolutegravir Sodium, Lamivudine and Tenofovir…Dolutegravir Sodium 50mg, Lamivudine 300mg and…H2021/CTD8639/19826TabletORALRecommended24 monthsJ05ADIRECT ACTING ANTIVIRALSCipla Quality Chemical Industries LimitedPlot 1 - 7, 1st Ring Road, Luzira Industrial…info@ciplaqcil.co.ugCipla Quality Chemical Industries LimitedP. O. Box 34871RegisteredValid
2PHILLIPS THERAPEUTICS LIMITED13104Heparin Sodium Injection USP 25000IU/5mlHumanForeignHeparin Sodium Injection USP 25000IU/5mlHeparin Sodium USP 25000IUH2021/CTD6845/13104InjectionINTRAVENOUSRecommended24 monthsB01AB01heparinZen Pharma Private Limited.75/1, G.I.D.C, Vapi - 396195, Gujarat, IndiaRegisteredValid
3IMPERIAL MANAGED SOLUTIONS EAST AFRICA LTD-…13897ONCOGEM-1000HumanForeignGemcitabine HydrochlorideGemcitabine Hydrochloride ……….1000mgH2021/CTD7157/13897InjectionINTRAVENOUSRecommended24 monthsWhite to off white dried cake.sterile freeze…L01BC05gemcitabineCIPLA LIMITEDCipla House, Peninsula Business Park, Ganpatrao…globalra@cipla.comCipla Limited Goa (Unit V)RegisteredValid
4PHILLIPS THERAPEUTICS LIMITED13103Heparin Sodium Injection USP 5000IU/5mlHumanForeignHeparin Sodium Injection USP 5000IU/5mleach ml contains: Heparin Sodium USP 1000 IUH2021/CTD6844/13103InjectionINTRAVENOUSRecommended24 monthsB01AB01heparinZen Pharma Private Limited.75/1, G.I.D.C, Vapi - 396195, Gujarat, IndiaRegisteredValid
5HARLEYS LTD-NAIROBI14281Norvir Oral PowderHumanForeignRitonavir100 mg ritonavir per sachetH2021/CTD7295/14281Powder For Oral SuspensionORALRecommended36 monthsFree flowing powder- beige to slightly yellow to…J05AE03ritonavirAbbvie (Pty) LtdAbbott Place, 219 Golf Club Terrace, Constantia…Betty.kekana@abbvie.comCatalent Germany Schorndorf GmbH, GermanyCatalent Germany Schorndorf GmbH,Steinbeisstraße…RegisteredValid
6PROLINE HEALTHCARE LIMITED14035Calutami TabletsHumanForeignBicalutamideEach tablet contains Bicalutamide IH 50mgH2021/CTD7139/14035Coated TabletORALRecommended36 monthsL02BB03bicalutamideCHONG KUN DANG PHARMACEUTICAL CORP797-48 MANGHYANG -RO SEONGGEO-UP…RegisteredValid
7EUROPA HEALTHCARE LTD18209MovicolHumanForeignSodium Chloride BP 350.7mg, Polyethylene Glycol…Sodium Chloride BP 350.7mg, Polyethylene Glycol…H2021/CTD6510/18209Powder For Oral Solution In SachetORALRecommended24 monthsA06ADDrugs for constipation: Osmotically acting…Win-Medicare Pvt. Ltd.Modipuram - 250 110 Uttar Pradesh (U.P.)RegisteredValid
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