Suppliers / Minakem Dunkerque Production

Minakem Dunkerque Production

France Updated 9 July 2026

Minakem Dunkerque Production is an API manufacturer based in France. It holds 7 valid CEPs across a filed portfolio of 9 molecules. Its GMP standing is certified by ANSM (FR). Its most recent recorded inspection, by US FDA, closed on 21 May 2021 as VAI.

0
active US DMFs
7
valid CEPs
3
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 21 May 2021 VAI US FDA
  • 22 June 2018 VAI US FDA
  • 22 April 2016 VAI US FDA
  • 17 May 2013 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
DUNKERQUE, France Not on file
Dunkerque, France Not on file
France, France 3008093605

What they file, and where

Molecule Regulators Docs
Azaperone For Veterinary Use EDQM 1
Budesonide EDQM 1
Esomeprazole SFDA (Saudi Arabia) 1
Esomeprazole Magnesium Dihydrate EDQM 1
Esomeprazole Magnesium Trihydrate EDQM 1
Esomperazole SFDA (Saudi Arabia) 1
Fulvestrant EDQM 1
Remifentanil EDQM 1
Vindesine EDQM 1

Also appears on these molecule pages

Budesonide API Esomeprazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) None 18

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Open risk flags

  • The most recent inspection outcome was VAI, on 21 May 2021.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates