Laboratorium Ofichem is a 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, NMPA (CN) and MINSA (CR). Its GMP standing is certified by ZLG (DE), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 12 October 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Dusseldorf, Germany | Not on file |
| Duesseldorf, Germany | Not on file |
| Netherlands, Netherlands | 1000286391 |
| Molecule | Regulators | Docs |
|---|---|---|
| Dimethyl Fumarate | US FDA | 1 |
| Histamine Phosphate | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 19 | 1 |
| NMPA (CN) | 1 | None |
| MINSA (CR) | 1 | None |
| ZLG (DE) | None | 4 |
| US FDA | None | 1 |
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