Suppliers / Mipharm

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.

0
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 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

Questions about Mipharm

Does Mipharm hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Mipharm. It does have 18 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Mipharm FDA-registered?
One site operated by Mipharm 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 Mipharm's last inspection go?
The most recent inspection on record closed on 22 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Mipharm manufacture?
5 registered sites are on record, in United Arab Emirates and Italy (Milan, Milano (milao) and Milano among others). Every site is listed on this page with the register it came from.
Which regulators recognise Mipharm's GMP?
Current GMP certificates are on record from EMA and US FDA. 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 22 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