Quagen Pharmaceuticals
United States 68 employees Updated 9 July 2026
Quagen Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 14 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 8 November 2023 as VAI.
2
registered plants
2 with an FDA FEI number
14
filings
across 1 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 2023 VAI US FDA
- 9 May 2023 NAI US FDA
- 19 December 2022 NAI US FDA
- 26 October 2020 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| West Caldwell, United States | 3012232287 |
| West Caldwell, United States | 3012403297 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 14 | 2 |
Comparing suppliers?
Choose your molecules and target markets. Quagen Pharmaceuticals comes back tiered against every other
supplier able to file there.
Start for free No sales call.
Open risk flags
- The most recent inspection outcome was VAI, on 8 November 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates