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.254-255, Sarkhej-Bavla National Highway No. 8A Changodar, Tal-Sanand, Ahmedabad, Gujarat 382210, India (IND)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3006026405 · DUNS 650650802
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-02-14
- NAIDrug Quality Assurance2019-12-20
- NAIDrug Quality Assurance2018-03-28
- VAIDrug Quality Assurance2016-03-18
Drugs this plant is listed as making
27 distinct drugs across 58 products name this site in their FDA label.
- acyclovirViona Pharmaceuticals Inc
- Adapalene and benzoyl peroxideZydus Lifesciences Limited
- betamethasone dipropionateViona Pharmaceuticals Inc
- Clindamycin Phosphatein shortageViona Pharmaceuticals Inc
- Clindamycin Phosphate and Benzoyl PeroxideZydus Pharmaceuticals USA Inc.
- clobetasol propionateZydus Lifesciences Limited
- DapsoneZydus Lifesciences Limited
- DesonideZydus Lifesciences Limited
- desoximetasoneZydus Lifesciences Limited
- FluocinonideZydus Lifesciences Limited
- IndomethacinZydus Pharmaceuticals USA Inc.
- ivermectinViona Pharmaceuticals Inc
- KetoconazoleZydus Lifesciences Limited
- Lidocaine and prilocaineViona Pharmaceuticals Inc
- MesalamineNorthstar Rx LLC.
- Metronidazolein shortageViona Pharmaceuticals Inc
- NystatinZydus Lifesciences Limited
- Nystatin and Triamcinolone AcetonideZydus Lifesciences Limited
- TavaboroleViona Pharmaceuticals Inc
- TretinoinZydus 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.