PROCOS is an API manufacturer based in Italy. It holds 20 active US drug master files and 2 valid CEPs across a filed portfolio of 22 molecules. Its most recent recorded inspection, by US FDA, closed on 16 September 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Italy, Italy | 3002807938 |
| Cameri, Italy | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Pyridostigmine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Memantine | SFDA (Saudi Arabia), US FDA | 2 |
| Orphenadrine | SFDA (Saudi Arabia), US FDA | 2 |
| Pirfenidone | EDQM, US FDA | 2 |
| Alverine | SFDA (Saudi Arabia) | 1 |
| Candesartan Cilexetil | SFDA (Saudi Arabia) | 1 |
| Carglumic Acid | US FDA | 1 |
| Clofedanol | US FDA | 1 |
| Dalfampridine | US FDA | 1 |
| Efinaconazole | US FDA | 1 |
| Embutramide | US FDA | 1 |
| Felbamate | US FDA | 1 |
| Guanfacine | US FDA | 1 |
| Iloperidone | US FDA | 1 |
| Istradefylline | US FDA | 1 |
| Labetalol | US FDA | 1 |
| Lofexidine | US FDA | 1 |
| Lurasidone | US FDA | 1 |
| Midostaurin | US FDA | 1 |
| Phenelzine | US FDA | 1 |
| Propafenone | US FDA | 1 |
| Trospium | US FDA | 1 |
Also appears on these molecule pages
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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