Zentiva Private Limited
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 3501 to 3515, 6301 to 6313 & 16 Meter Road/c, GIDC Estate, ANKLESHWAR, Gujarat 393002, India (IND)
- Operations here
- api manufacture
- FDA identifiers
- FEI 3004086396 · DUNS 918593737
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-02-13
- NAIDrug Quality Assurance2019-02-07
- VAIDrug Quality Assurance2016-07-01
- NAIDrug Quality Assurance2012-05-19
- VAIDrug Quality Assurance2009-09-04
Drugs this plant is listed as making
1 distinct drugs across 3 products name this site in their FDA label.
- glyburideTEVA Pharmaceuticals USA 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.