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.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| 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 |
| 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 |
| 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 We do not publish the identity of any buyer.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.
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