Guerbet is a finished-dose manufacturer based in France. It appears in 544 regulatory filings across 23 regulators, without an active US DMF or CEP on file. Its filings concentrate with FAMHP (BE), AIFA (IT) and EMA. Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 21 January 2021 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Aulnay-sous-bois, United Arab Emirates | Not on file |
| Aulnay-Sous-Bois, United Arab Emirates | Not on file |
| Zürich, Switzerland | Not on file |
| AULNAY-SOUS-BOIS, France | Not on file |
| France, France | 3002807063 |
| Aulnay Sous Bois, France | Not on file |
1 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Iobitridol | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| FAMHP (BE) | 113 | None |
| AIFA (IT) | 99 | None |
| EMA | 81 | 1 |
| SWISSMEDIC (CH) | 68 | None |
| ANSM (FR) | 21 | 17 |
| MPA (SE) | 21 | None |
| ANVISA (Brazil) | None | 3 |
| MFDS (Korea) | None | 2 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2024 | $910.3M | 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 We do not publish the identity of any buyer.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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