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
France, France 3008093605
Dunkerque, France Not on file

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 Esomperazole API Fulvestrant API Remifentanil API Esomeprazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) None 18

Questions about Minakem Dunkerque Production

Does Minakem Dunkerque Production hold a US DMF or a CEP?
Minakem Dunkerque Production holds 7 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Minakem Dunkerque Production FDA-registered?
One site operated by Minakem Dunkerque Production carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Minakem Dunkerque Production's last inspection go?
The most recent inspection on record closed on 21 May 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Minakem Dunkerque Production manufacture?
3 registered sites are on record, in France (Dunkerque, France and Dunkerque). Every site is listed on this page with the register it came from.
What does Minakem Dunkerque Production make?
9 molecules are on record against Minakem Dunkerque Production, including Azaperone For Veterinary Use, Budesonide, Esomeprazole and Esomeprazole Magnesium Dihydrate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Minakem Dunkerque Production's GMP?
Current GMP certificates are on record from ANSM (FR). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

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

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Sources on this page

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