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 ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 3 February 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Dunkerque, United Arab Emirates | Not on file |
| DUNKERQUE, France | Not on file |
| DUNKERQUE, France | Not on file |
| France, France | 3003063819 |
| 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 |
| ANVISA (Brazil) | None | 1 |
| EMA | None | 1 |
| 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 We do not publish the identity of any buyer.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.
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