Patheon
Canada Updated 9 July 2026
Patheon is a finished-dose manufacturer based in Canada. It appears in 45 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by ANVISA (Brazil) and NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 24 February 2023 as VAI.
3
registered plants
2 with an FDA FEI number
45
filings
across 5 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
- 24 February 2023 VAI US FDA
- 17 February 2023 VAI US FDA
- 12 April 2019 VAI US FDA
- 14 September 2018 VAI US FDA
- 9 December 2016 NAI US FDA
- 2 December 2016 NAI US FDA
- 26 February 2016 VAI US FDA
- 13 November 2015 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| ONTARIO, Canada | Not on file |
| Canada, Canada | 3000264888 |
| Canada, Canada | 3003516812 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| ARCSA (EC) | 32 | None |
| MINSA (CR) | 9 | None |
| INVIMA (CO) | 2 | None |
| DAV (Vietnam) | 1 | None |
| NAFDAC (NG) | 1 | 1 |
| ANVISA (Brazil) | None | 20 |
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Open risk flags
- The most recent inspection outcome was VAI, on 24 February 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates