Cerbios-Pharma is an API manufacturer based in Switzerland. It holds 8 active US drug master files and 6 valid CEPs across a filed portfolio of 10 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 7 March 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Barbengo, Switzerland | Not on file |
| Barbengo, Switzerland | Not on file |
| Switzerland, Switzerland | 3002808250 |
| Lugano, Switzerland | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Calcipotriol | EDQM, US FDA | 4 |
| Leucovorin Calcium | SFDA (Saudi Arabia), US FDA | 3 |
| Tiotropium | SFDA (Saudi Arabia), US FDA | 3 |
| Calcitriol | EDQM, US FDA | 2 |
| Calcium Folinate | EDQM, SFDA (Saudi Arabia) | 2 |
| Calcium Folinate Hydrate | EDQM | 1 |
| Calcium Levofolinate Hydrate | EDQM | 1 |
| Doxercalciferol | US FDA | 1 |
| ホリナートカルシウム | PMDA (Japan) | 1 |
| レボホリナートカルシウム | PMDA (Japan) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 6 | None |
| EMA | None | 2 |
| US FDA | None | 1 |
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