Suppliers / Patheon Manufacturing Services

Patheon Manufacturing Services

United States Updated 9 July 2026

Patheon Manufacturing Services is a finished-dose manufacturer based in United States. It appears in 25 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and NPRA (MY). Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 26 September 2025 as NAI.

0
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
25
filings across 4 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

  • 26 September 2025 NAI US FDA
  • 13 June 2024 VAI US FDA
  • 18 March 2024 VAI US FDA
  • 23 February 2024 VAI US FDA
  • 4 August 2022 VAI US FDA
  • 17 May 2019 NAI US FDA
  • 17 July 2018 VAI US FDA
  • 7 December 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
GREENVILLE, United States Not on file
Ridgefield, United States 2246315
Greenville, United States 1018495

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 16 None
ARCSA (EC) 7 None
NPRA (MY) 1 None
MINSA (CR) 1 None
ANVISA (Brazil) None 17
US FDA None 2

Questions about Patheon Manufacturing Services

Does Patheon Manufacturing Services hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Patheon Manufacturing Services. It does have 25 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Patheon Manufacturing Services FDA-registered?
2 sites operated by Patheon Manufacturing Services 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 Manufacturing Services's last inspection go?
The most recent inspection on record closed on 26 September 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Patheon Manufacturing Services manufacture?
3 registered sites are on record, in United States (Greenville, Ridgefield and Greenville). Every site is listed on this page with the register it came from.
Which regulators recognise Patheon Manufacturing Services's GMP?
Current GMP certificates are on record from ANVISA (Brazil) 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 NAI, 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