Benuvia Operations
United States Updated 9 July 2026
Benuvia Operations is an API manufacturer based in United States. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 20 September 2021 as NAI.
2
registered plants
1 with an FDA FEI number
1
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 20 September 2021 NAI US FDA
- 12 September 2017 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| ROUND ROCK, United States | Not on file |
| Round Rock, United States | 3011419064 |
What they file, and where
| Molecule | Regulators | Docs |
| Cannabidiol | US FDA | 1 |
| Dronabinol | US FDA | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 1 | None |
| ANVISA (Brazil) | None | 2 |
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Open risk flags
- The most recent inspection outcome was NAI, on 20 September 2021.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates