Public View of Electronically Registered Products

Certificates issued on 21-Feb-2019

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
1GOODMAN AGENCIES LTD12459Otocol Ear DropsHumanForeignChloramphenicol and Benzocaine5 %, 5%H2019/CTD6381/12459Ear DropsOTHERRecommended36 monthsS02AAOtological Anti-infectivesAmman Pharmaceutical IndustriesKing Abdullah II Estate-Sahab, Amman 11512api@orange.joAMMAN PHARMACEUTICALS LTDKING ABDUALLAH II INDUSTRIAL ESTATE, SEHAB P.O…RegisteredValid
2NAIROBI ENTERPRISES LTD17275ENDOPROST 125 MCG INJECTIONHumanForeignEach 1 ml Contains: Carboprost Tromethamine USP…Each 1 ml Contains: Carboprost Tromethamine USP…H2019/CTD4213/632ERInjectionORALRecommended36 monthsJ01ANTIBACTERIALS FOR SYSTEMIC USEBharat Serums and Vaccines LtdPlot No. K-47, Anand Nagar, M.I.D.C, Ambernath…ambernath@serums.comBHARAT SERUMS AND VACCINES LIMITED (AMBERNETH)PLOT NO. K-27, ANAND, NAGAR, ADDITIONAL MIDC,…RegisteredValid
3WESSEX PHARMACEUTICALS LTD17290OPTILIP 40HumanForeignATORVASTATIN CALCIUM TRIHYDRATE40MG/TABLETH2019/CTD6674/1008ERTabletORALRecommended24 monthsA yellow color oval shape biconvexed film coated…C10AA05atorvastatinInnocia Lifesciences Private Ltd12, Balaji Nagar, Ambattur, Chennai - 53,…ah@innocialife.comATOZ PHARMACEUTICALS PVT LTD18, NEW NO. 12, BALAJI NAGAR, AMBATTUR, CHENNAI…RegisteredValid
4PHILLIPS THERAPEUTICS LIMITED17317FEROPLUS CapsulesHumanForeignFerrous Fumarate BP Equivalent to Elemental Iron…Ferrous Fumarate (Equivalent to Elemental Iron 49…H2019/CTD2133/683ERCapsuleORALRecommended24 monthsHard Gelatin Capsule. Orange cap/Clear…B03AE10various combinationsWockhardt LimitedWockhardt Towers, Bandra - Kurla Complex, Bandra…KBerde@wockhardt.comOsaka Pharmaceuticals LimitedOld National Highway No. 8, Sankarda - 391 350,…RegisteredValid
5ORIANA LIMITED17399SEVLAREN 800HumanForeignSevelamer CarbonateEach Tablet contains Sevelamer Carbonate 800 mgH2019/CTD6179/921ERTabletORALRecommended24 monthsV03AE02sevelamerSTANFORD LABORATORIES PVT LTD100000000000071 RegisteredValid
6PSM PHARMACEUTICALS LTD17434TemozolHumanForeignTemozolomide100 mg/capsuleH2019/CTD7503/868ERCapsuleORALRecommended24 monthsL01AX03temozolomideKhandelwal Laboratories Pvt. Ltd - ThaneKhandelwal Laboratories Pvt. Ltd - ThaneRegisteredValid
7PSM PHARMACEUTICALS LTD17437PSM’S EPRAZHumanForeignEsomeprazole magnesium trihydrate40 mgH2019/CTD7507/872ERTabletORALRecommended36 monthsA02BC05esomeprazoleGLOBELA PHARMA PVT100000000000032 RegisteredValid
8PHILLIPS THERAPEUTICS LIMITED17592INVEGA® 9 mg prolonged-release tabletsHumanForeignPaliperidoneEach prolonged-release tablet contains 9 mg of…H2018/4832/173ERProlonged-Release TabletORALRecommended24 monthsN05AX13paliperidoneJanssen Ortho LLC & Janssen Cilag Manufacturing…State Road 933 Km 0.1 Mamey Ward, Gurabo, Puerto…RegisteredValid
9DAWA LTD17655OLAM TABLETHumanLocalOLMESARTAN MEDOXOMIL AND AMLODIPINE BESYLATEOLMESARTAN MEDOXOMIL 20MG AND AMLODIPINE (AS…H2019/CTD6956/892ERFilm-Coated TabletORALRecommended24 monthsC01DXOther vasodilators used in cardiac diseasesDAWA LTDPLOT NO. 7879/8, BABA DOGO RD, RUARAKA, NAIROBIRegisteredValid
10UMOJA PHARMACEUTICALS LTD17679KILMAX 500HumanForeignAmorphous Cefuroxime Axetil USP Eq. to Cefuroxime500 MGH2019/4642/1054ERFilm-Coated TabletORALRecommended36 monthsJ01DCBeta-lactamantibacterials: Second-generation…Eskayef Bangladesh Limited-Tongi SiteGazipur, BD-1711RegisteredValid
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