Minakem Dunkerque Production
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
- Zone D Entreprises Du Nord Gracht 224 Avenue De La Dordogne, Dunkerque, 59640, France (FRA)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3008093605 · DUNS 277412599
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2021-05-21
- VAIDrug Quality Assurance2018-06-22
- VAIDrug Quality Assurance2016-04-22
- NAIDrug Quality Assurance2013-05-17
Drugs this plant is listed as making
2 distinct drugs across 3 products name this site in their FDA label.
- budesonideCalliditas Therapeutics AB
- MetyraponeHRA Pharma Rare Diseases
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.