Mipharm
Italy 217 employees 2 duplicate records merged Updated 9 July 2026
Mipharm is a finished-dose manufacturer based in Italy. It appears in 18 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), EDE (AE) and NAFDAC (NG). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 22 September 2023 as VAI.
5
registered plants
1 with an FDA FEI number
18
filings
across 3 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
- 22 September 2023 VAI US FDA
- 17 October 2019 VAI US FDA
- 3 February 2017 VAI US FDA
- 14 February 2014 VAI US FDA
- 27 September 2013 VAI US FDA
- 10 June 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 |
| Milan, United Arab Emirates | Not on file |
| MILANO (MILAO), Italy | Not on file |
| MILANO, Italy | Not on file |
| Italy, Italy | 3002807647 |
| Milan, Italy | Not on file |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| NPRA (MY) | 15 | None |
| EDE (AE) | 2 | None |
| NAFDAC (NG) | 1 | None |
| EMA | None | 2 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 22 September 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates