Dr. Willmar Schwabe GmbH is an API and finished-dose manufacturer based in Germany. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with EMA, AIFA (IT) and MPA (SE). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 5 authorities.
| Site | FDA FEI |
|---|---|
| KARLSRUHE, Germany | Not on file |
| Baden-Wuerttemberg, Germany | Not on file |
| Imt Rohtak, India | Not on file |
| Guadalajara, Mexico | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Colchicine | US FDA | 1 |
| Thiocolchicoside | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 89 | 2 |
| AIFA (IT) | 45 | None |
| MPA (SE) | 17 | None |
| FAMHP (BE) | 14 | None |
| AEMPS (ES) | 11 | None |
| INFARMED (PT) | 5 | None |
| ZLG (DE) | None | 6 |
| ANVISA (Brazil) | None | 3 |
| CDSCO (India) | None | 2 |
| COFEPRIS (MX) | None | 2 |
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