Medac Gesellschaft für klinische Spezialpräparate mbH; is a finished-dose manufacturer based in Germany. It holds one active US drug master file. Its filings concentrate with AIFA (IT), MPA (SE) and INFARMED (PT). Its GMP standing is certified by ZLG (DE), US FDA and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 15 May 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Wedel, United Arab Emirates | Not on file |
| 22872 Wedel, United Arab Emirates | Not on file |
| Wedel, United Arab Emirates | Not on file |
| WEDEL, Germany | Not on file |
| Schleswig-Holstein, Germany | Not on file |
| Tornesch, Germany | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Treosulfan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 190 | None |
| MPA (SE) | 100 | None |
| INFARMED (PT) | 88 | None |
| FAMHP (BE) | 82 | None |
| URPL (PL) | 65 | None |
| ANSM (FR) | 42 | None |
| ZLG (DE) | None | 14 |
| US FDA | None | 2 |
| ANVISA (Brazil) | None | 1 |
| EMA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2025 | $53.6M | 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 We do not publish the identity of any buyer.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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