Zydus Lifesciences 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. 1A, PHARMEZ Special Economic Zone, Sarkhej - Bavla N. H. No. 8A, Matoda, Tal : Sanand, Ahmedabad, Gujarat 382213, India (IND)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3007621329 · DUNS 650348852
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-06-17
- OAIDrug Quality Assurance2024-03-27
- NAIDrug Quality Assurance2020-02-04
- NAIDrug Quality Assurance2019-03-26
- VAIBioresearch Monitoring2019-03-21
- NAIDrug Quality Assurance2018-06-05
- VAIDrug Quality Assurance2015-04-17
- VAIDrug Quality Assurance2014-01-31
- VAIDrug Quality Assurance2012-10-04
Drugs this plant is listed as making
7 distinct drugs across 27 products name this site in their FDA label.
- Arsenic trioxideZydus Pharmaceuticals USA Inc.
- clofarabineZydus Lifesciences Limited
- doxorubicin hydrochlorideBluePoint Laboratories
- Leuprolide AcetateZydus Pharmaceuticals USA Inc.
- NelarabineZydus Pharmaceuticals USA Inc.
- Pemetrexed disodiumAmneal Pharmaceuticals LLC
- plerixaforZydus Lifesciences Limited
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.