Evonik Operations is an API manufacturer based in Germany. It holds 3 active US drug master files and 5 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 24 October 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Essen, Germany | Not on file |
| Dossenheim, Germany | Not on file |
| Darmstadt, Germany | Not on file |
| Germany, Germany | 3002911044 |
| Germany, Germany | 3002806792 |
| Germany, Germany | 3002808332 |
4 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Azelastine | EDQM, US FDA | 2 |
| Lisinopril | EDQM, US FDA | 2 |
| Lorazepam | EDQM, US FDA | 2 |
| Dimercaprol | EDQM | 1 |
| Hydrogen Peroxide Solution (30 Per Cent) | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ZLG (DE) | None | 34 |
| US FDA | None | 3 |
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