Maprimed is an API manufacturer based in Argentina. It holds 11 active US drug master files across a filed portfolio of 9 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 7 June 2019 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Argentina, Argentina | 1000242491 |
| Buenos Aires, Argentina | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Cariprazine | US FDA | 2 |
| Fingolimod | SFDA (Saudi Arabia), US FDA | 2 |
| Flecainide | US FDA | 2 |
| Teriflunomide | SFDA (Saudi Arabia), US FDA | 2 |
| Zoledronic Acid | SFDA (Saudi Arabia), US FDA | 2 |
| Leflunomide | US FDA | 1 |
| Nitazoxanide | US FDA | 1 |
| Ozanimod | US FDA | 1 |
| Rasagiline | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 2 | None |
| EMA | None | 1 |
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