Merck Sante is an API and finished-dose manufacturer based in France. It holds 2 active US drug master files. Its filings concentrate with ANSM (FR), ANPP (DZ) and DAV (Vietnam). 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 25 October 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| SEMOY, United Arab Emirates | Not on file |
| CALAIS, France | Not on file |
| France, France | 3002807502 |
| Semoy, France | Not on file |
| France, France | 3002807504 |
| France, France | 3002807474 |
3 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Metformin | US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ANSM (FR) | 42 | 45 |
| ANPP (DZ) | 11 | None |
| DAV (Vietnam) | 10 | None |
| DIGEMAPS (DO) | 9 | None |
| SFDA (Saudi Arabia) | 6 | None |
| EDA (EG) | 6 | None |
| EMA | None | 3 |
| NAFDAC (NG) | None | 1 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2023 | $676.6M | 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 We do not publish the identity of any buyer.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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