Suppliers / Patheon Italia

Patheon Italia

Italy 2 duplicate records merged Updated 9 July 2026

Patheon Italia is a finished-dose manufacturer based in Italy. It appears in 15 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and NAFDAC (NG). Its GMP standing is certified by ANVISA (Brazil), EMA and US FDA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 30 January 2026 as NAI.

0
active US DMFs
0
valid CEPs
5
registered plants 2 with an FDA FEI number
15
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 30 January 2026 NAI US FDA
  • 29 September 2023 VAI US FDA
  • 26 May 2023 VAI US FDA
  • 26 January 2023 VAI US FDA
  • 14 June 2022 NAI US FDA
  • 8 April 2022 VAI US FDA
  • 25 February 2022 VAI US FDA
  • 5 July 2019 VAI US FDA

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

Registered plants

Site FDA FEI
MONZA, Italy Not on file
Italy, Italy 3004110157
Italy, Italy 3003065803
Monza, Italy Not on file
Ferentino, Italy Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 12 None
MINSA (CR) 2 None
NAFDAC (NG) 1 None
ANVISA (Brazil) None 39
EMA None 2
US FDA None 2
NCELS (KZ) None 1
EAEU_EEC None 1

Questions about Patheon Italia

Does Patheon Italia hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Patheon Italia. It does have 15 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Patheon Italia FDA-registered?
2 sites operated by Patheon Italia 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 Italia's last inspection go?
The most recent inspection on record closed on 30 January 2026 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Patheon Italia manufacture?
5 registered sites are on record, in Italy (Monza, Italy and Monza among others). Every site is listed on this page with the register it came from.
Which regulators recognise Patheon Italia's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, US FDA, NCELS (KZ) and EEC (Eurasian Economic Union). 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 30 January 2026.

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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