Register entry

Teva API India Private Ltd.

Data as of · How to read this entry

Registered sites
2
Active NDC listings
36
Labeller names
4
Live patents
0
Countries
1
Base
India
Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture2
Sites

Registered establishments

2
EstablishmentAddressRegistered forFEI / DUNS
Teva API India Private Ltd.Plot No. A-2, A-2/1, A-2/2 UPSIDC Industrial Area, Bijnor Road, Gajraula, Amroha (Uttar Prades 244235, India (IND)Analytical testing, Active ingredient (API) manufacture3005343793677604388
Teva API India Private Ltd.Plot No. Q1 to Q4 Industrial Area Ghirongi, Malanpur, Distt. Bhind (M.P.) 477117, India (IND)Analytical testing, Active ingredient (API) manufacture3008256596677604426
Catalogue

Drug listings by form and route

36

36 active NDC listings: 36 bulk ingredient. By marketing category: BULK INGREDIENT 35, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.

Dosage formNDCs
powder35
poultice1
RouteNDCs
Labeller name on the listingNDCs
teva api india private ltd19
teva api india limited12
teva api india ltd3
teva api india private limited2
Catalogue

Marketed products

36
BrandGeneric nameForm / routeNDC
-Amitriptyline Hydrochloridepowder15894-0033BULK INGREDIENT
-Atorvastatin Calciumpowder15894-0023BULK INGREDIENT
-Carbidopapowder15894-0040BULK INGREDIENT
-Caspofungin Acetate IHpowder15894-0014BULK INGREDIENT
-Clarithromycinpowder15894-0026BULK INGREDIENT
-Dabigatran Etexilate Mesylatepowder15894-0025BULK INGREDIENT
-Diltiazem Hydrochloridepowder15894-0022BULK INGREDIENT
-Docosanolpowder15894-0036BULK INGREDIENT
-Doxepin HClpowder15894-0035BULK INGREDIENT
-Eletriptan Hydrobromide IHpowder15894-0031BULK INGREDIENT
-Ezetimibepowder15894-0011BULK INGREDIENT
-FERRIC CARBOXY MALTOSEpowder15894-0048BULK INGREDIENT
-FLUOXETINE hclpowder15894-0039BULK INGREDIENT
-Ferric Derisomaltosepowder15894-0047BULK INGREDIENT
-Glycerol Phenyl Butyratepowder15894-0037BULK INGREDIENT
-Imipramine Hydrochloridepowder15894-0034BULK INGREDIENT
-Irbesartanpowder15894-0008BULK INGREDIENT
-Losartan Potassiumpowder15894-0028BULK INGREDIENT
-Methyldopapowder15894-0038BULK INGREDIENT
-Montelukast Sodiumpowder15894-0004BULK INGREDIENT
-Olanzapinepowder15894-0006BULK INGREDIENT
-Olmesartan Medoxomilpowder15894-0019BULK INGREDIENT
-Pioglitazone Hydrochloridepowder15894-0017BULK INGREDIENT
-Pregabalinpowder15894-0016BULK INGREDIENT
-Quetiapine Fumaratepowder15894-0005BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-RESMETIROMpowder15894-0045BULK INGREDIENT
-Rilpivirine HClpowder15894-0032BULK INGREDIENT
-SODIUM CAPRATEpowder15894-0042BULK INGREDIENT
-Sitagliptin Malatepoultice15894-0029BULK INGREDIENT
-Sitagliptin Phosphatepowder15894-0018BULK INGREDIENT
-Sofosbuverpowder15894-0027BULK INGREDIENT
-Teva API Indiapowder15894-0044BULK INGREDIENT
-Ticagrelorpowder15894-0030BULK INGREDIENT
-Triheptanoinpowder15894-0041BULK INGREDIENT
-Varenicline Tartratepowder15894-0024BULK INGREDIENT
-ZOLPIDEM TARTRATEpowder15894-0043BULK INGREDIENT
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Enquiry

Common questions

Is Teva API India Private Ltd. FDA approved?
Teva API India Private Ltd. holds 2 FDA-registered establishments in India. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Teva API India Private Ltd.'s drugs manufactured?
The FDA register lists Gajraula; Malanpur. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Teva API India Private Ltd. make?
36 products are listed under Teva API India Private Ltd. in the openFDA NDC Directory, most often as powder; poultice. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.