Public View of Electronically Registered Products

Certificates issued on 17-Apr-2020

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
1REGAL PHARMACEUTICALS LTD12607UNITRIM DS TABLETSHumanLocalSulfamethoxazole B.P & Trimethoprim B.PEach tablet contains; Sulfamethoxazole B.P 800mg…H2020/CTD6398/12607TabletORALRecommended24 monthsWhite, Capsule shaped, biconvex tablet, scored on…J01EE01sulfamethoxazole and trimethoprimRegal Pharmaceuticals LimitedPlot No.: 7879/18, Off Baba Dogo Road, Ruaraka,info@regalpharmaceuticals.comREGAL PHARMACEUTICALS LTDBABA DOGO RD, RUARAKARegisteredValid
2ORIANA LIMITED19475SPIROVETVetForeignSpiramycinSpiramycin …… 60MIU/100ml or 600 000 IU per mlV2020/CTD5002/1282ERSolution For InjectionINTRAMUSCULARRecommended36 monthsQJ01FAMacrolidesCEVA SANTE ANIMALE - LIBOURNE10 AVENUE DE LA BALLASTIERE, 33500 LIBOURNE,…RegisteredValid
3MEDFO KENYA LIMITED19543DULOMIN-30HumanForeignMethylcobalamin USP and Duloxetine Hydrochloride…Methylcobalamin USP 500mcg and Duloxetine…H2020/CTD6100/1678ERTabletORALRecommended36 monthsN06AX21duloxetineCURIS LIFESCIENCES PVT LTDCURIS LIFESCIENCES PVT LTDRegisteredValid
4RADIANCE PHARMACEUTICALS LTD19552MOXQUIN XG EYE DROPSHumanForeignMoxifloxacin Hydrochloride5mg/mlH2020/CTD5875/1752EREye Drops, SolutionINTRAOCULARRecommended24 monthsJ01MA14moxifloxacinIncepta Pharmaceuticals Ltd Zirabo PlantSavar, Dhaka BangladeshRegisteredValid
5DAWA LTD14855DOLUTEGRAVIR TABLETS 50MGHumanForeignDolutegravir50 mgH2020/CTD7672/14855Film-Coated TabletORALRecommended24 monthsLight Orange colored, round shaped, biconvex film…J05AX12dolutegravirLAURUS LABS LIMITED2nd Floor, Serene Chambers, Road No.-7 Banjara…info@lauruslabs.comLAURUS LABS LIMITEDPLOT NO. 19, 20 & 21, WESTERN SECTOR, APSEZ,…RegisteredValid
6RADIANCE PHARMACEUTICALS LTD19655EXEPHIN 1GM IV INJECTIONHumanForeignCeftriaxone Sodium (Sterile Powder) USPCeftriaxone Sodium (Sterile Powder) USP 1.2579…H2020/CTD5825/1725ERInjectionINTRAVENOUSRecommended36 monthsJ01DD04ceftriaxoneINCEPTA PHARMACEUTICALS LTD ZIRABO PLANTSAVAR,DHAKA BANGLADESHRegisteredValid
7ORIANA LIMITED19489VECTORMUNE HVT NDV& RISPENS (Live, frozen vaccine)VetForeignMarek’s Disease, rHVT/ NDV Strain, Marek’s…Marek’s Disease, rHVT/ NDV Strain…………at least…V2020/CTD5452/1353ERInjectionSUBCUTANEOUSRecommended24 monthsQI01ADImmunologicals for Domestic Fowl: Live viral…CEVA BIOMUNE8901 Rosehill RoadRegisteredValid
8DOLOPHARMA HEALTHCARE LTD19496DOLOXIA 120 TABLETSHumanForeignETORICOXIB120 MGH2020/CTD4215/1455ERFilm-Coated TabletORALRecommended36 monthsM01AH05etoricoxibNUCLEUS FORMULATION PVT LTDPLOT NO. 3484/3485 PHASE IV GIDC INDUCTRIAL…RegisteredValid
9SIMBA PHARMACEUTICALS LTD19550DESLOVA 2.5HumanForeignDESLORATIDINE2.5MGH2020/CTD6053/1741ERSyrupORALRecommended24 monthsR06AX27desloratadineSWISS GARNIER LIFE SCIENCESNO. 21-23 INDUSTRIAL AREA, MEHATPUR, DIST. UNA,…RegisteredValid
10RADIANCE PHARMACEUTICALS LTD19656INTRAX CAPSULEHumanForeignTranexamic Acid500 mg/capsule.H2020/CTD5915/1729ERCapsuleORALRecommended24 monthsB02AA02tranexamic acidINCEPTA PHARMACEUTICALS LTD ZIRABO PLANTSAVAR,DHAKA BANGLADESHRegisteredValid
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