Merck Healthcare Kgaa is a finished-dose manufacturer based in Germany. It holds one active US drug master file. Its filings concentrate with EMA, AEMPS (ES) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and MFDS (Korea), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 13 May 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Darmstadt, United Arab Emirates | Not on file |
| DARMSTADT, Germany | Not on file |
| Germany, Germany | 3016570199 |
| Frankfurter Strasse Darmstadt Germany, Nigeria | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Cetrorelix | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 22 | 1 |
| AEMPS (ES) | 20 | None |
| INVIMA (CO) | 16 | None |
| NAFDAC (NG) | 11 | 2 |
| SFDA (Saudi Arabia) | 9 | None |
| UZPHARM (UZ) | 9 | None |
| ZLG (DE) | None | 4 |
| ANVISA (Brazil) | None | 2 |
| MFDS (Korea) | None | 2 |
Choose your molecules and target markets. Merck Healthcare Kgaa comes back tiered against every other supplier able to file there.
Start for free