Pcas is an API manufacturer based in France. It holds 28 active US drug master files. Its filings concentrate with MINSA (CR) and Health Canada. Its GMP standing is certified by ANSM (FR). Its most recent recorded inspection, by US FDA, closed on 31 March 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| France, France | 3014417426 |
| Aramon, France | Not on file |
| France, France | 3002808156 |
| France, France | 3003623331 |
| Limay, France | Not on file |
| Rives d'Andaine, France | Not on file |
3 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Oxybutynin | SFDA (Saudi Arabia), US FDA | 3 |
| Timolol | US FDA | 3 |
| Clonidine | US FDA | 2 |
| Esomeprazole | US FDA | 2 |
| Alimemazine | US FDA | 1 |
| Apraclonidine | US FDA | 1 |
| Articaine | US FDA | 1 |
| Baclofen | US FDA | 1 |
| Ciclopirox | US FDA | 1 |
| Ciclopirox Olamine | SFDA (Saudi Arabia) | 1 |
| Cinacalcet | US FDA | 1 |
| Clomifene | US FDA | 1 |
| Desipramine | US FDA | 1 |
| Disopyramide | US FDA | 1 |
| Enclomiphene | US FDA | 1 |
| Estetrol | US FDA | 1 |
| Glycopyrronium | US FDA | 1 |
| Mepivacaine | US FDA | 1 |
| Mequitazine | PMDA (Japan) | 1 |
| Olopatadine | US FDA | 1 |
| Pindolol | US FDA | 1 |
| Praziquantel | US FDA | 1 |
| Roluperidone | US FDA | 1 |
| Sodium Divalproate | SFDA (Saudi Arabia) | 1 |
| Tazarotene | US FDA | 1 |
| Valproic Acid | US FDA | 1 |
| オキシブチニン塩酸塩 | PMDA (Japan) | 1 |
| ピペリドレート塩酸塩 | PMDA (Japan) | 1 |
| 塩酸オキシブチニン | PMDA (Japan) | 1 |
| 臭化メペンゾラート | PMDA (Japan) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 1 | None |
| Health Canada | 1 | None |
| ANSM (FR) | None | 52 |
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