Haupt Pharma Wuelfing
Germany Updated 9 July 2026
Haupt Pharma Wuelfing is a finished-dose manufacturer based in Germany. It appears in 38 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 6 June 2023 as VAI.
2
registered plants
1 with an FDA FEI number
38
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 6 June 2023 VAI US FDA
- 7 December 2018 NAI US FDA
- 17 March 2017 NAI US FDA
- 28 March 2014 VAI US FDA
- 20 April 2012 VAI US FDA
- 6 November 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 |
| Gronau/Leine, Germany | Not on file |
| Germany, Germany | 3003183252 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| NPRA (MY) | 38 | None |
| ZLG (DE) | None | 2 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 6 June 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates