Suppliers / Patheon France S.A.S

Patheon France S.A.S

France 2 duplicate records merged Updated 9 July 2026

Patheon France S.A.S is a finished-dose manufacturer based in France. It appears in 23 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with JFDA (JO), DIGEMAPS (DO) and NPRA (MY). Its GMP standing is certified by MFDS (Korea), US FDA and NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 29 September 2023 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
23
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 29 September 2023 VAI US FDA
  • 27 September 2019 VAI US FDA
  • 8 June 2018 VAI US FDA
  • 11 March 2016 VAI US FDA
  • 28 March 2014 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Bourgoin-Jallieu, United Arab Emirates Not on file
Ontario, United Arab Emirates Not on file
Ferentino, United Arab Emirates Not on file
France, France 3004468553
Bourgoin-Jallieu, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Neostigmine Metilsulfate SFDA (Saudi Arabia) 1
Ponesimod SFDA (Saudi Arabia) 1
Pyridostigmine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Abiraterone finished dose Bupropion finished dose Indocyanine Green finished dose Macitentan finished dose Mavacamten finished dose Naltrexone finished dose Pyridostigmine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
JFDA (JO) 9 None
DIGEMAPS (DO) 4 None
NPRA (MY) 2 None
EDE (AE) 2 None
ARCSA (EC) 2 None
UZPHARM (UZ) 2 None
MFDS (Korea) None 12
US FDA None 1
NAFDAC (NG) None 1

Questions about Patheon France S.A.S

Does Patheon France S.A.S hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Patheon France S.A.S. It does have 23 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Patheon France S.A.S FDA-registered?
One site operated by Patheon France S.A.S 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 France S.A.S's last inspection go?
The most recent inspection on record closed on 29 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Patheon France S.A.S manufacture?
5 registered sites are on record, in United Arab Emirates, France and Nigeria (Bourgoin-jallieu, Ontario and Ferentino among others). Every site is listed on this page with the register it came from.
What does Patheon France S.A.S make?
3 molecules are on record against Patheon France S.A.S, including Neostigmine Metilsulfate, Ponesimod and Pyridostigmine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Patheon France S.A.S's GMP?
Current GMP certificates are on record from MFDS (Korea), US FDA 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 29 September 2023.

Comparable suppliers

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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