Public View of Electronically Registered Products

Certificates issued on 17-Jul-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
1MEDOX PHARMACEUTICALS LIMITED19482Epimate 25HumanForeignTopiramate25 mg/TabletH2020/CTD1519/1337ERTabletORALRecommended24 monthsN03AX11topiramateTorrent Pharmaceuticals LimitedIndrad – 382721, Dist. Mehsana, IndiaRegisteredValid
2SIMBA PHARMACEUTICALS LTD19551OROZART AHumanForeignLosartan Potassium/ Amlodipine BesylateLosartan Potassium USP 50MG/ Amlodipine Besylate…H2020/CTD5664/1742ERFilm-Coated TabletORALRecommended24 monthsC09DB06losartan and amlodipineSWISS GARNIER LIFE SCIENCESNO. 21-23 INDUSTRIAL AREA, MEHATPUR, DIST. UNA,…RegisteredValid
3MEDOX PHARMACEUTICALS LIMITED14853Cledomox 312.5 DTHumanForeignAmoxicillin Trihydrate B.P. equivalent to 250mg…250+ 62.5mgH2020/CTD7670/14853Dispersible TabletORALRecommended24 monthsYellow to light yellow colour flat circular…J01CR02amoxicillin and enzyme inhibitorMEDOPHARM PVT LTD C/O MEDOX PHARMACEUTICALS LTDP.o. Box 52771 - 00200, Nairobimedoxpharmaceuticalsltd@gmail.comMEDOPHARM PVT LTDNO. 50, KAYARAMBEDU VILLAGE, GUDUVANCHERY-603203,…RegisteredValid
4KRISHNA CHEMISTS LTD14978RIZAPTAN TABLETSHumanForeignRIZATRIPTAN TABLETSRIZATRIPTAN TABLETS 10 MGH2020/CTD7825/14978TabletORALRecommended36 monthsA White colour, round shape, flat bevelled edged,…N02CC04rizatriptanKRISHNA CHEMISTS LTD3rd Floor Metrix Hardware, Lusaka Road,…regulatory@krishnachemists.comRELAX BIOTECH PVT LTD862/1, GIDC, MAKARPURA, VADODARA-390010, GUJARAT,…RegisteredValid
5ABACUS PHARMA (A) LTD19407LARTEM DS TABLETSHumanForeignArtemether ph & Lumefantrine phArtemether 40mg & Lumefantrine 240mgH2020/CTD5023/906ERTabletORALRecommended24 monthsP01BF01artemether and lumefantrineSKANT HEALTHCARE LTDPlot no. 1802 - 1805, GIDC, phase III, Vapi…RegisteredValid
6KRISHNA CHEMISTS LTD14989FUNGISILHumanForeignTERBINAFINE TABLETS USPTERBINAFINE TABLETS USP 250MGH2020/CTD7835/14989Film-Coated TabletORALRecommended36 monthsA white colour round shaped biconvex film coated…D01AE15terbinafineKRISHNA CHEMISTS LTD3rd Floor Metrix Hardware, Lusaka Road,…regulatory@krishnachemists.comRELAX BIOTECH PVT LTD862/1, GIDC, MAKARPURA, VADODARA-390010, GUJARAT,…RegisteredValid
7SURGILINKS LTD16651XENGLU TABLETS 25mgHumanForeignEMPAGLIFLOZINEach film coated tablet contains: Empagliflozin…H2020/CTD7973/16651Film-Coated TabletORALRecommended24 monthsWhite rectangular biconvex coated tablet, having…A10BX12empagliflozinHilton Pharma (Pvt.) Ltd.Plot No. 13-14, Sector 15, Korangi Industrial…hilton@hiltonpharma.comHilton Pharma Pvt LtdPlot No 13-14 Sector 15, Korangi Industrial Area,…RegisteredValid
8NEXTGEN PHARMACEUTICALS (K) LTD19660ROXETIL CAPSULEHumanForeignCefpodoxime ProxetilEach hard gelatin capsule contains: Cefpodoxime…H2020/CTD3853/1821ERCapsule, HardORALRecommended24 monthsJ01DD13cefpodoximeHEALTHCARE PHARMACEUTICALS LTDGAZARIAPARA, P.O. MIRZAPUR BAZAR, RAJENDRAPUR,…RegisteredValid
9OPERA PHARMA (K) LTD19472ROSUVAX 10HumanForeignROSUVASTATIN 10MG10MGH2020/5581/1277ERTabletORALRecommended24 monthsC01AA07deslanosideAstra Lifecare (India) Pvt LtdSurvey No. 57/P, Sarkhej Bavla Highway,…RegisteredValid
10SURGILINKS LTD16739XENGLU-MET 12.5/1000mg TabletsHumanForeignEmpagliflozin + Metformin HClEmpagliflozin 12.5mg + Metformin HCl 1000mg per…H2020/CTD7975/16739Film-Coated TabletORALRecommended24 monthsWhite oblong biconvex coated tablet engraved “T”…A10BD20metformin and empagliflozinHilton Pharma (Pvt.) Ltd.Plot# 13-14, Sector 15, Korangi Industrial Area,…hilton@hiltonpharma.comHilton Pharma Pvt LtdPlot No 13-14 Sector 15, Korangi Industrial Area,…RegisteredValid
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