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.
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
Inspections
8 of 8 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 |
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Open risk flags
- The most recent inspection outcome was NAI, on 30 January 2026.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates