Sanofi is an API and finished-dose manufacturer based in France. It holds 11 active US drug master files across a filed portfolio of 11 molecules. Its filings concentrate with AIFA (IT), Health Canada and US FDA. Its GMP standing is certified by ANSM (FR), MFDS (Korea) and EMA, among 11 authorities. Its most recent recorded inspection, by US FDA, closed on 13 June 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Ridgefield, United Arab Emirates | Not on file |
| Scoppito, United Arab Emirates | Not on file |
| Tours, United Arab Emirates | Not on file |
| Le Trait, United Arab Emirates | Not on file |
| Maison Alfort Cedex, United Arab Emirates | Not on file |
| Cedex, United Arab Emirates | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Alfuzosin | US FDA | 1 |
| Avanafil | US FDA | 1 |
| Cabazitaxel | US FDA | 1 |
| Chlorpromazine | US FDA | 1 |
| Clopidogrel | US FDA | 1 |
| Cromoglicic Acid | US FDA | 1 |
| Dronedarone | US FDA | 1 |
| Irbesartan | US FDA | 1 |
| Meglumine | US FDA | 1 |
| Promethazine | US FDA | 1 |
| Zolpidem | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 1,082 | None |
| Health Canada | 210 | None |
| US FDA | 173 | 3 |
| INFARMED (PT) | 171 | None |
| EMA | 158 | 6 |
| DIGEMAPS (DO) | 140 | None |
| ANSM (FR) | None | 212 |
| MFDS (Korea) | None | 8 |
| EAEU_EEC | None | 5 |
| CDSCO (India) | None | 4 |
| HSA (SG) | None | 4 |
| SAHPRA (ZA) | None | 3 |
| MHRA (UK) | None | 3 |
| ANVISA (Brazil) | None | 3 |
| MINPROMTORG (RU) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2022 | $1.4B | 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 We do not publish the identity of any buyer.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.
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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