Ipsen Pharma Biotech is a finished-dose manufacturer based in France. It appears in 30 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), EDE (AE) and MINSA (CR). Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 29 March 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| SIGNES, United Arab Emirates | Not on file |
| SIGNES, France | Not on file |
| France, France | 3003749112 |
| Marseille Cedex 14, France | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| NPRA (MY) | 12 | None |
| EDE (AE) | 8 | None |
| MINSA (CR) | 3 | None |
| ARCSA (EC) | 2 | None |
| INVIMA (CO) | 2 | None |
| DIGEMAPS (DO) | 2 | None |
| ANSM (FR) | None | 10 |
| ANVISA (Brazil) | None | 3 |
| EMA | None | 2 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2024 | $504.5M | 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 We do not publish the identity of any buyer.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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