Suppliers / Astrea Fontaine

Astrea Fontaine

France Updated 9 July 2026

Astrea Fontaine is a finished-dose manufacturer based in France. It appears in 5 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), ARCSA (EC) and UZPHARM (UZ). Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and MFDS (Korea), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 13 September 2024 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
5
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 13 September 2024 VAI US FDA
  • 11 December 2020 VAI US FDA
  • 10 November 2017 VAI US FDA
  • 22 January 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Fontaine Les Dijon, United Arab Emirates Not on file
Fontaine-Les-Dijon, France Not on file
FONTAINE LES DIJON, France Not on file
France, France 3002807473

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 3 None
ARCSA (EC) 1 None
UZPHARM (UZ) 1 None
ANSM (FR) None 9
ANVISA (Brazil) None 4
MFDS (Korea) None 2
EMA None 1
US FDA None 1

Scale

Year Revenue Exports Destinations
2024 $42.3M 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 We do not publish the identity of any buyer.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 Astrea Fontaine

Does Astrea Fontaine hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Astrea Fontaine. It does have 5 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Astrea Fontaine FDA-registered?
One site operated by Astrea Fontaine 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 Astrea Fontaine's last inspection go?
The most recent inspection on record closed on 13 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Astrea Fontaine manufacture?
4 registered sites are on record, in United Arab Emirates and France (Fontaine Les Dijon, Fontaine-les-dijon and Fontaine LES Dijon among others). Every site is listed on this page with the register it came from.
Which regulators recognise Astrea Fontaine's GMP?
Current GMP certificates are on record from ANSM (FR), ANVISA (Brazil), MFDS (Korea), EMA and US FDA. 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 13 September 2024.

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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