Teva API India Private Ltd.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- India
- Registered address
- Plot No. A-2, A-2/1, A-2/2 UPSIDC Industrial Area, Bijnor Road, Gajraula, Amroha (Uttar Prades 244235, India (IND)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3005343793 · DUNS 677604388
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-07-18
- VAIDrug Quality Assurance2018-02-09
- NAIDrug Quality Assurance2015-05-01
- VAIDrug Quality Assurance2012-06-06
- NAIDrug Quality Assurance2009-02-20
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- RisperidoneIndivior Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.