Patheon Pharmaceuticals
United States 12 employees Updated 9 July 2026
Patheon Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 7 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC) and NCELS (KZ). Its GMP standing is certified by ANVISA (Brazil), MHRA (UK) and NCELS (KZ), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 26 September 2025 as VAI.
3
registered plants
1 with an FDA FEI number
7
filings
across 2 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
- 26 September 2025 VAI US FDA
- 21 April 2023 NAI US FDA
- 14 January 2020 NAI US FDA
- 14 February 2018 VAI US FDA
- 2 March 2017 VAI US FDA
- 11 March 2016 VAI US FDA
- 30 October 2014 VAI US FDA
- 18 June 2014 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| CINCINNATI, United States | Not on file |
| CINCINNATI, United States | Not on file |
| Cincinnati, United States | 1510437 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| ARCSA (EC) | 5 | None |
| NCELS (KZ) | 2 | 1 |
| ANVISA (Brazil) | None | 10 |
| MHRA (UK) | None | 1 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 26 September 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates