Chemi is an API and finished-dose manufacturer based in Italy. It holds 9 active US drug master files and 6 valid CEPs across a filed portfolio of 10 molecules. Its filings concentrate with AIFA (IT), INFARMED (PT) and FAMHP (BE). Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 26 January 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Cinisello Balsamo, Italy | Not on file |
| Patrica, Italy | Not on file |
| Italy, Italy | 3000326763 |
| Italy, Italy | 3002806667 |
| Molecule | Regulators | Docs |
|---|---|---|
| Mesalazine | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Bupropion | US FDA | 2 |
| Leuprolide | EDQM, US FDA | 2 |
| Aminoimidazole Carboxamide | US FDA | 1 |
| Benserazide | EDQM | 1 |
| Diflunisal | US FDA | 1 |
| Flunarizine Dihydrochloride | EDQM | 1 |
| Givinostat | US FDA | 1 |
| Octreotide | US FDA | 1 |
| Paroxetine | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 97 | None |
| INFARMED (PT) | 12 | None |
| FAMHP (BE) | 10 | None |
| MPA (SE) | 9 | None |
| EMA | 8 | None |
| US FDA | 7 | 1 |
| MFDS (Korea) | None | 2 |
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