Elysium Pharmaceuticals 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
- 253 to 256 and 258, Post: Dabhasa Taluka: Padra, Vadodara, Gujarat 391440, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3005183272 · DUNS 863182240
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-01-16
- NAIDrug Quality Assurance2017-09-08
- VAIDrug Quality Assurance2014-12-26
Drugs this plant is listed as making
2 distinct drugs across 3 products name this site in their FDA label.
- AzathioprineRising Pharma Holdings, Inc.
- Donepezil HydrochlorideACI Healthcare 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.