Suppliers / Patheon

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.

0
active US DMFs
0
valid CEPs
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
Plants
2 of 2 confirmed
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 3003516812
Canada, Canada 3000264888

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 32 None
MINSA (CR) 9 None
INVIMA (CO) 2 None
NAFDAC (NG) 1 1
DAV (Vietnam) 1 None
ANVISA (Brazil) None 20

Questions about Patheon

Does Patheon hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Patheon. It does have 45 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Patheon FDA-registered?
2 sites operated by Patheon 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 Patheon's last inspection go?
The most recent inspection on record closed on 24 February 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Patheon manufacture?
3 registered sites are on record, in Canada (Ontario and Canada among others). Every site is listed on this page with the register it came from.
Which regulators recognise Patheon's GMP?
Current GMP certificates are on record from ANVISA (Brazil) and NAFDAC (NG). 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 24 February 2023.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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