Polygen Pharmaceuticals
United States 8 employees Updated 9 July 2026
Polygen Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 10 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its most recent recorded inspection, by US FDA, closed on 18 December 2017 as VAI.
1
registered plants
1 with an FDA FEI number
10
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 18 December 2017 VAI US FDA
- 24 March 2015 VAI US FDA
- 29 August 2014 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Edgewood, United States | 3008383084 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 10 | None |
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Open risk flags
- The most recent inspection outcome was VAI, on 18 December 2017.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability