Recordati Industria Chimica e Farmaceutica is an API and finished-dose manufacturer based in Italy. It holds 16 active US drug master files and 8 valid CEPs across a filed portfolio of 17 molecules. Its filings concentrate with AIFA (IT), URPL (PL) and EMA. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 30 September 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| APRILIA, Italy | Not on file |
| Milano, Italy | Not on file |
| Milan, Italy | Not on file |
| Italy, Italy | 3002807989 |
| Molecule | Regulators | Docs |
|---|---|---|
| Acyclovir | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Cysteamine | SFDA (Saudi Arabia), US FDA | 3 |
| Dimenhydrinate | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Diphenhydramine | EDQM, US FDA | 3 |
| Dobutamine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Phenytoin | US FDA | 3 |
| Dopamine | SFDA (Saudi Arabia), US FDA | 2 |
| Ketorolac | EDQM, US FDA | 2 |
| Carglumic Acid | US FDA | 1 |
| Cysteamine Bitartrate | SFDA (Saudi Arabia) | 1 |
| Fenticonazole | EDQM | 1 |
| Flavoxate | US FDA | 1 |
| Lercanidipine | SFDA (Saudi Arabia) | 1 |
| Mebeverine | EDQM | 1 |
| Papaverine | US FDA | 1 |
| Tribenoside | EDQM | 1 |
| Verapamil | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 208 | None |
| URPL (PL) | 161 | None |
| EMA | 62 | 2 |
| ANSM (FR) | 12 | None |
| FAMHP (BE) | 9 | None |
| MINSA (CR) | 4 | None |
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