Nordmark Pharma is a finished-dose manufacturer based in Germany. It holds 3 active US drug master files and 2 valid CEPs across a filed portfolio of 4 molecules. Its filings concentrate with EMA and FAMHP (BE). Its GMP standing is certified by ZLG (DE), MFDS (Korea) and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 13 February 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Schleswig-Holstein, Germany | Not on file |
| Uetersen, Germany | Not on file |
| Germany, Germany | 3003293533 |
| Molecule | Regulators | Docs |
|---|---|---|
| Collagenase Clostridium Histolyticum | US FDA | 2 |
| Collagenase N | EDQM | 1 |
| Pancreas Powder | EDQM | 1 |
| Pancrelipase | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 14 | 2 |
| FAMHP (BE) | 2 | None |
| ZLG (DE) | None | 8 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
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