Suppliers / Astrazeneca Dunkerque Production

Astrazeneca Dunkerque Production

France Updated 9 July 2026

Astrazeneca Dunkerque Production is a finished-dose manufacturer based in France. It appears in 16 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), NCELS (KZ) and EDE (AE). Its GMP standing is certified by ANSM (FR), NCELS (KZ) and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 3 February 2022 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
16
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 3 February 2022 VAI US FDA
  • 21 December 2018 VAI US FDA
  • 20 November 2015 VAI US FDA
  • 17 May 2013 NAI US FDA
  • 30 January 2009 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, United Arab Emirates Not on file
DUNKERQUE, France Not on file
DUNKERQUE, France Not on file
France, France 3003063819

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 5 None
NCELS (KZ) 4 2
EDE (AE) 3 None
ARCSA (EC) 2 None
NPRA (MY) 2 None
ANSM (FR) None 13
EMA None 1
ANVISA (Brazil) None 1

Scale

Year Revenue Exports Destinations
2024 $2.2B Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Astrazeneca Dunkerque Production

Does Astrazeneca Dunkerque Production hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Astrazeneca Dunkerque Production. It does have 16 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Astrazeneca Dunkerque Production FDA-registered?
One site operated by Astrazeneca 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 Astrazeneca Dunkerque Production's last inspection go?
The most recent inspection on record closed on 3 February 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Astrazeneca Dunkerque Production manufacture?
4 registered sites are on record, in United Arab Emirates and France (Dunkerque, Dunkerque and France among others). Every site is listed on this page with the register it came from.
Which regulators recognise Astrazeneca Dunkerque Production's GMP?
Current GMP certificates are on record from ANSM (FR), NCELS (KZ), EMA and ANVISA (Brazil). 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 3 February 2022.

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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
Company filings
Revenue as reported