Medichem Manufacturing (Malta) is an API manufacturer based in Malta. It holds 11 active US drug master files and 3 valid CEPs across a filed portfolio of 14 molecules. Its most recent recorded inspection, by US FDA, closed on 23 May 2018 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hal Far, Malta | Not on file |
| Malta, Malta | 3005427637 |
| Molecule | Regulators | Docs |
|---|---|---|
| Apixaban | SFDA (Saudi Arabia), US FDA | 3 |
| Micafungin | SFDA (Saudi Arabia), US FDA | 3 |
| Rivaroxaban | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Voriconazole | EDQM, SFDA (Saudi Arabia) | 2 |
| Ambrisentan | US FDA | 1 |
| Cinacalcet | US FDA | 1 |
| Edaravone | US FDA | 1 |
| Lofexidine | US FDA | 1 |
| Prucalopride | US FDA | 1 |
| Revefenacin | US FDA | 1 |
| Solifenacin Succinate | EDQM | 1 |
| Sugammadex | US FDA | 1 |
| Sunitinib | US FDA | 1 |
| スガマデクスナトリウム | PMDA (Japan) | 1 |
Also appears on these molecule pages
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