Fermion Oy is an API manufacturer based in Finland. It holds 32 active US drug master files and 23 valid CEPs. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 24 November 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Espoo, Finland | Not on file |
| Oulu, Finland | Not on file |
| Finland, Finland | 3002807817 |
| Finland, Finland | 3003340711 |
| Finland, Finland | 3003491490 |
| Molecule | Regulators | Docs |
|---|---|---|
| Budesonide | EDQM | 4 |
| Carbidopa | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Azathioprine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Methotrexate | EDQM, US FDA | 3 |
| Quetiapine | EDQM, US FDA | 3 |
| Alprazolam | EDQM, US FDA | 2 |
| Buspirone | EDQM, US FDA | 2 |
| Entacapone | EDQM, US FDA | 2 |
| Fluoxetine | EDQM, US FDA | 2 |
| Flutamide | EDQM, US FDA | 2 |
| Formoterol | EDQM, US FDA | 2 |
| Hydroxychloroquine | EDQM, US FDA | 2 |
| Irinotecan | EDQM, US FDA | 2 |
| Mercaptopurine | EDQM, US FDA | 2 |
| Nintedanib | US FDA | 2 |
| Nitrofurantoin | US FDA | 2 |
| Propafenone | EDQM, US FDA | 2 |
| Trazodone | SFDA (Saudi Arabia), US FDA | 2 |
| B Irone | SFDA (Saudi Arabia) | 1 |
| Benserazide | EDQM | 1 |
| Cabozantinib | US FDA | 1 |
| Cromoglicic Acid | US FDA | 1 |
| Dexmedetomidine | US FDA | 1 |
| Diltiazem | US FDA | 1 |
| Fluticasone Propionate | EDQM | 1 |
| Glipizide | US FDA | 1 |
| Levosimendan | US FDA | 1 |
| Nadolol | US FDA | 1 |
| Ospemifene | US FDA | 1 |
| Salmeterol | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 6 | None |
| EMA | None | 1 |
| US FDA | None | 1 |
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