Minakem High Potent is an API manufacturer based in Belgium. It holds 3 active US drug master files and 4 valid CEPs across a filed portfolio of 3 molecules. Its most recent recorded inspection, by US FDA, closed on 19 April 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Mont-Saint-Guibert, Belgium | Not on file |
| Corbais, Belgium | Not on file |
| Mont-St-Guibert, Belgium | Not on file |
| Belgium, Belgium | 3002807801 |
| Molecule | Regulators | Docs |
|---|---|---|
| Vinblastine | EDQM, US FDA | 3 |
| Vincristine | EDQM, US FDA | 2 |
| Vinorelbine | EDQM, US FDA | 2 |
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