Suppliers / Delpharm Milano

Delpharm Milano

Italy 2 duplicate records merged Updated 9 July 2026

Delpharm Milano is a finished-dose manufacturer based in Italy. It appears in 89 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by ANVISA (Brazil), EMA and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 18 February 2022 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
89
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 18 February 2022 VAI US FDA
  • 12 May 2017 VAI US FDA
  • 25 September 2015 VAI US FDA
  • 19 September 2013 VAI US FDA
  • 24 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
(MI), United Arab Emirates Not on file
MILANO (MILAO), Italy Not on file
Segrate, Italy Not on file
Italy, Italy 3003716872

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 43 None
MINSA (CR) 19 None
INVIMA (CO) 12 None
ARCSA (EC) 8 None
EDE (AE) 5 None
FDA (GH) 1 None
ANVISA (Brazil) None 6
EMA None 3
MFDS (Korea) None 2
EAEU_EEC None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 18 February 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates