Patheon France S.A.S
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
- 40 Boulevard de Champaret, Bourgoin Jallieu, - 38 300, France (FRA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3004468553 · DUNS 543127229
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-09-29
- VAIDrug Quality Assurance2019-09-27
- VAIDrug Quality Assurance2018-06-08
- VAIDrug Quality Assurance2016-03-11
- VAIDrug Quality Assurance2014-03-28
Drugs this plant is listed as making
9 distinct drugs across 14 products name this site in their FDA label.
- Abiraterone acetateJanssen Biotech, Inc.
- Ferric MaltolShield TX (UK) Ltd
- macitentanActelion Pharmaceuticals US, Inc.
- Metoclopramide HydrochlorideEvoke Pharma, Inc.
- NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATEJanssen Biotech, Inc.
- odevixibatAlbireo Pharma, Inc.
- PonesimodJanssen Pharmaceuticals, Inc
- sorafenibBayer HealthCare Pharmaceuticals 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.