Laboratoires Besins International is a finished-dose manufacturer based in France. It appears in 93 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, AIFA (IT) and INFARMED (PT). Its GMP standing is certified by ANSM (FR), EMA and NAFDAC (NG), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 20 April 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Montrouge, France | Not on file |
| France, France | 3002844244 |
| Paris, France | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 40 | 4 |
| AIFA (IT) | 22 | None |
| INFARMED (PT) | 10 | None |
| MPA (SE) | 7 | None |
| NPRA (MY) | 3 | None |
| SFDA (Saudi Arabia) | 3 | None |
| ANSM (FR) | None | 18 |
| NAFDAC (NG) | None | 1 |
| EAEU_EEC | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2024 | $31.5M | 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 We do not publish the identity of any buyer.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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