PCAS is an API manufacturer based in France. It holds 31 active US drug master files. Its filings concentrate with MINSA (CR), INVIMA (CO) and ARCSA (EC). Its GMP standing is certified by ANSM (FR), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 7 June 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Finland, Finland | 3003469991 |
| France, France | 3002808156 |
| France, France | 3014417426 |
| Aramon, France | Not on file |
| Porcheville, France | Not on file |
| France, France | 3003623331 |
4 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Oxybutynin | SFDA (Saudi Arabia), US FDA | 3 |
| Timolol | US FDA | 3 |
| Baclofen | SFDA (Saudi Arabia), US FDA | 2 |
| Clonidine | US FDA | 2 |
| Esomeprazole | US FDA | 2 |
| Alimemazine | US FDA | 1 |
| Apraclonidine | US FDA | 1 |
| Articaine | 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 |
| 酒石酸アリメマジン | PMDA (Japan) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 2 | None |
| INVIMA (CO) | 1 | None |
| ARCSA (EC) | 1 | None |
| Health Canada | 1 | None |
| ANSM (FR) | None | 52 |
| US FDA | None | 1 |
| EMA | 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.
Choose your molecules and target markets. PCAS comes back tiered against every other supplier able to file there.
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