Nivagen Pharmaceuticals
United States 128 employees Updated 9 July 2026
Nivagen Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 25 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 23 October 2024 as NAI.
2
registered plants
2 with an FDA FEI number
25
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 23 October 2024 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Pittsburg, United States | 3026171274 |
| Davis, United States | 3013195770 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 25 | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 23 October 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates