Suppliers / Patheon Pharmaceuticals

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.

0
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Questions about Patheon Pharmaceuticals

Does Patheon Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Patheon Pharmaceuticals. It does have 7 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Patheon Pharmaceuticals FDA-registered?
One site operated by Patheon Pharmaceuticals carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Patheon Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 26 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Patheon Pharmaceuticals manufacture?
3 registered sites are on record, in United States (Cincinnati and Cincinnati among others). Every site is listed on this page with the register it came from.
Which regulators recognise Patheon Pharmaceuticals's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MHRA (UK), NCELS (KZ) and US FDA. 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 26 September 2025.

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Sources on this page

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