Fougera Pharmaceuticals
United States 132 employees Updated 9 July 2026
Fougera Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 5 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and MPA (SE). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 8 December 2023 as NAI.
2
registered plants
2 with an FDA FEI number
5
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 8 December 2023 NAI US FDA
- 10 August 2022 VAI US FDA
- 10 August 2022 VAI US FDA
- 8 August 2019 VAI US FDA
- 29 May 2018 VAI US FDA
- 29 May 2018 VAI US FDA
- 10 November 2016 VAI US FDA
- 10 November 2016 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Hicksville, United States | 2410271 |
| Melville, United States | 2432435 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 4 | 1 |
| MPA (SE) | 1 | None |
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Open risk flags
- The most recent inspection outcome was NAI, on 8 December 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates