Suppliers / American Regent

American Regent

United States 94 employees Updated 9 July 2026

American Regent is a finished-dose manufacturer based in United States. It appears in 67 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, Health Canada and DMP (NO). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 29 January 2026 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 5 with an FDA FEI number
67
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
5 of 5 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 29 January 2026 VAI US FDA
  • 19 July 2024 VAI US FDA
  • 24 April 2024 VAI US FDA
  • 20 July 2023 VAI US FDA
  • 30 September 2022 VAI US FDA
  • 19 November 2021 NAI US FDA
  • 15 November 2019 NAI US FDA
  • 8 March 2019 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Columbus, United States 3003433784
Brea, United States 3011148804
Hilliard, United States 3005761472
Shirley, United States 2410375
New Albany, United States 3010209784

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 61 4
Health Canada 5 None
DMP (NO) 1 None

Questions about American Regent

Does American Regent hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for American Regent. It does have 67 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is American Regent FDA-registered?
5 sites operated by American Regent carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did American Regent's last inspection go?
The most recent inspection on record closed on 29 January 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does American Regent manufacture?
5 registered sites are on record, in United States (Columbus, Brea and Hilliard among others). Every site is listed on this page with the register it came from.
Which regulators recognise American Regent's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

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 29 January 2026.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates