PMC Isochem is an API manufacturer based in France. It holds 33 active US drug master files across a filed portfolio of 11 molecules. Its GMP standing is certified by ANSM (FR) and US FDA. Its most recent recorded inspection, by US FDA, closed on 17 November 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| VERT LE PETIT, France | Not on file |
| France, France | 3002807312 |
| France, France | 3003955453 |
| Pithiviers, France | Not on file |
| Vert Le Petit, France | Not on file |
| Gennevilliers, France | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Acetohydroxamic Acid | US FDA | 3 |
| Amiodarone | US FDA | 3 |
| Diosmin | US FDA | 3 |
| Domiphen | US FDA | 3 |
| Econazole | US FDA | 3 |
| Indoramin | US FDA | 3 |
| Loperamide | US FDA | 3 |
| Nefopam | US FDA | 3 |
| Pantoprazole | US FDA | 3 |
| Tocofersolan | US FDA | 3 |
| Trimebutine | US FDA | 3 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 1 | None |
| ANSM (FR) | None | 42 |
| US FDA | None | 1 |
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