Amino Chemicals is an API manufacturer based in Malta. It holds 10 active US drug master files across a filed portfolio of 12 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 November 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Malta, Malta | 3003118161 |
| Molecule | Regulators | Docs |
|---|---|---|
| Pramipexole | US FDA | 2 |
| Benazepril | US FDA | 1 |
| Bosentan | US FDA | 1 |
| Miglustat | SFDA (Saudi Arabia) | 1 |
| Paliperidone | US FDA | 1 |
| Pantoprazole | SFDA (Saudi Arabia) | 1 |
| Pramipexole Base | SFDA (Saudi Arabia) | 1 |
| Rasagiline | US FDA | 1 |
| Telmisartan | US FDA | 1 |
| Terbinafine | US FDA | 1 |
| Tolterodine | US FDA | 1 |
| Ziprasidone | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 5 | None |
| US FDA | None | 1 |
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