Roquette Frères is an API manufacturer based in France. It holds 4 active US drug master files and 7 valid CEPs across a filed portfolio of 9 molecules. Its GMP standing is certified by ANSM (FR) and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 4 December 2020 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Lestrem, France | Not on file |
| France, France | 1000114558 |
| Molecule | Regulators | Docs |
|---|---|---|
| Dextrose | SFDA (Saudi Arabia), US FDA | 4 |
| Mannitol | EDQM, US FDA | 3 |
| Sorbitol | EDQM, US FDA | 3 |
| 2-Hydroxylpropyl-Beta-Cyclodextrin | US FDA | 1 |
| Betadex | EDQM | 1 |
| Glucose Monohydrate | EDQM | 1 |
| Hydroxypropylbetadex | EDQM | 1 |
| Lidocaine | SFDA (Saudi Arabia) | 1 |
| Sodium Bicarbonate | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EEC_EAEU | 1 | None |
| ANSM (FR) | None | 26 |
| MFDS (Korea) | None | 2 |
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