Mitim
Italy Updated 9 July 2026
Mitim is a finished-dose manufacturer based in Italy. It appears in 10 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 18 May 2023 as VAI.
3
registered plants
1 with an FDA FEI number
10
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
6 of 6 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
- 18 May 2023 VAI US FDA
- 16 November 2018 VAI US FDA
- 24 July 2018 NAI US FDA
- 10 May 2016 VAI US FDA
- 1 April 2014 VAI US FDA
- 15 November 2011 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| BRESCIA (BS), Italy | Not on file |
| Brescia, Italy | Not on file |
| Italy, Italy | 3005746589 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| NCELS (KZ) | 10 | None |
| EMA | None | 6 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 18 May 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates