Opella Healthcare International Sas
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
- France
- Registered address
- 56 Route de Choisy, Compiegne, 60200, France (FRA)
- Operations here
- analysislabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3003492806 · DUNS 275857012
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-01-10
- VAIDrug Quality Assurance2019-10-31
- VAIDrug Quality Assurance2017-06-23
- VAIDrug Quality Assurance2015-09-18
- VAIDrug Quality Assurance2013-09-19
- NAIDrug Quality Assurance2011-10-21
Drugs this plant is listed as making
3 distinct drugs across 8 products name this site in their FDA label.
- glyburideTEVA Pharmaceuticals USA Inc
- leflunomidesanofi-aventis U.S. LLC
- teriflunomideGenzyme Corporation
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.