Carbogen Amcis is an API manufacturer based in Switzerland. It holds 5 active US drug master files across a filed portfolio of 8 molecules. Its GMP standing is certified by ANSM (FR), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 26 June 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Switzerland, Switzerland | 3005976586 |
| Switzerland, Switzerland | 3000998501 |
| Switzerland, Switzerland | 3006999285 |
| Bubendorf, Switzerland | Not on file |
| Hunzenschwil, Switzerland | Not on file |
| Aarau, Switzerland | Not on file |
2 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Cholesterol | US FDA | 2 |
| Azacitidine | SFDA (Saudi Arabia) | 1 |
| Bendamustine | SFDA (Saudi Arabia) | 1 |
| Calcifediol | US FDA | 1 |
| Calcitriol | US FDA | 1 |
| Nepafenac | US FDA | 1 |
| Ozanimod | SFDA (Saudi Arabia) | 1 |
| Pomalidomide | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 5 | None |
| ANSM (FR) | None | 10 |
| EMA | None | 6 |
| US FDA | None | 2 |
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