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.
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
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 |
| Shirley, United States | 2410375 |
| Hilliard, United States | 3005761472 |
| Brea, United States | 3011148804 |
| Columbus, United States | 3003433784 |
| 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 |
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Open risk flags
- The most recent inspection outcome was VAI, on 29 January 2026.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates