Suppliers / Polygen Pharmaceuticals

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.

0
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Questions about Polygen Pharmaceuticals

Does Polygen Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Polygen Pharmaceuticals. It does have 10 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Polygen Pharmaceuticals FDA-registered?
One site operated by Polygen Pharmaceuticals carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Polygen Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 18 December 2017 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Polygen Pharmaceuticals manufacture?
1 registered site is on record, in United States (Edgewood). Every site is listed on this page with the register it came from.
Where does Polygen Pharmaceuticals file?
Filings are on record with US FDA, 10 in total.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 18 December 2017.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability