F.I.S. Fabbrica Italiana Sintetici is an API manufacturer based in Italy. It holds 43 active US drug master files. Its GMP standing is certified by EMA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 28 October 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| VICENZA, Italy | Not on file |
| TERMOLI, Italy | Not on file |
| Italy, Italy | 3002806961 |
| Italy, Italy | 3008347496 |
| Italy, Italy | 3002808541 |
| LONIGO, Italy | Not on file |
1 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Nitrofurantoin | US FDA | 3 |
| Acetylcysteine | SFDA (Saudi Arabia), US FDA | 2 |
| Diazepam | SFDA (Saudi Arabia), US FDA | 2 |
| Dorzolamide | SFDA (Saudi Arabia), US FDA | 2 |
| Imatinib | US FDA | 2 |
| Indomethacin | US FDA | 2 |
| Pentazocine | US FDA | 2 |
| Ataluren | SFDA (Saudi Arabia) | 1 |
| Carbamazepine | US FDA | 1 |
| Chlordiazepoxide | US FDA | 1 |
| Clobazam | US FDA | 1 |
| Clomifene | US FDA | 1 |
| Clonazepam | US FDA | 1 |
| Clotrimazole | US FDA | 1 |
| Dexlansoprazole | SFDA (Saudi Arabia) | 1 |
| Diltiazem | US FDA | 1 |
| Eletriptan | US FDA | 1 |
| Enclomiphene | US FDA | 1 |
| Entacapone | SFDA (Saudi Arabia) | 1 |
| Estazolam | US FDA | 1 |
| Flurazepam | US FDA | 1 |
| Fluvastatin | US FDA | 1 |
| Fosfomycin | US FDA | 1 |
| Furosemide | US FDA | 1 |
| Gabapentin | US FDA | 1 |
| Lorazepam | US FDA | 1 |
| Midazolam | US FDA | 1 |
| Nebivolol | US FDA | 1 |
| Nifedipine | US FDA | 1 |
| Nitrofurantoin Macrocrystals | SFDA (Saudi Arabia) | 1 |
| Olopatadine | US FDA | 1 |
| Oxazepam | US FDA | 1 |
| Oxcarbazepine | US FDA | 1 |
| Phloroglucinol | SFDA (Saudi Arabia) | 1 |
| Prasterone | US FDA | 1 |
| Progesterone | US FDA | 1 |
| Quetiapine | US FDA | 1 |
| Ranolazine | SFDA (Saudi Arabia) | 1 |
| Rifaximin | US FDA | 1 |
| Safinamide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 9 | None |
| EMA | None | 1 |
| ANVISA (Brazil) | None | 1 |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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