bene pharmaChem GmbH
Germany Updated 9 July 2026
bene pharmaChem GmbH is an API manufacturer based in Germany. It holds one active US drug master file. Its GMP standing is certified by ZLG (DE). Its most recent recorded inspection, by US FDA, closed on 8 November 2018 as VAI.
2
registered plants
1 with an FDA FEI number
0
filings
across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 8 November 2018 VAI US FDA
- 21 May 2014 NAI US FDA
- 8 July 2011 VAI US FDA
- 23 October 2008 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Geretsried, Germany | Not on file |
| Germany, Germany | 3006803926 |
What they file, and where
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| ZLG (DE) | None | 4 |
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Open risk flags
- The most recent inspection outcome was VAI, on 8 November 2018.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates