Farmhispania is an API manufacturer based in Spain. It holds 17 active US drug master files across a filed portfolio of 15 molecules. Its GMP standing is certified by US FDA, AEMPS (ES) and EMA. Its most recent recorded inspection, by US FDA, closed on 12 May 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Barcelona, Spain | Not on file |
| Spain, Spain | 3002806964 |
| Molecule | Regulators | Docs |
|---|---|---|
| Rocuronium | SFDA (Saudi Arabia), US FDA | 5 |
| Metformin | SFDA (Saudi Arabia), US FDA | 3 |
| Atracurium Besylate | SFDA (Saudi Arabia), US FDA | 2 |
| Everolimus | US FDA | 2 |
| Milrinone | SFDA (Saudi Arabia), US FDA | 2 |
| Benazepril | US FDA | 1 |
| Cisatracurium | US FDA | 1 |
| Decitabine | US FDA | 1 |
| Deutetrabenazine | US FDA | 1 |
| Enalapril | US FDA | 1 |
| Gemcitabine | US FDA | 1 |
| Pemetrexed | SFDA (Saudi Arabia) | 1 |
| Quinapril | US FDA | 1 |
| Sugammadex | US FDA | 1 |
| Tacrolimus | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 3 | None |
| US FDA | None | 1 |
| AEMPS (ES) | None | 1 |
| EMA | None | 1 |
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