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
NAFDAC (NG) 1 None
ANVISA (Brazil) None 6
EMA None 3
MFDS (Korea) None 2
EAEU_EEC None 1

Questions about Delpharm Milano

Does Delpharm Milano hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Delpharm Milano. It does have 89 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Delpharm Milano FDA-registered?
One site operated by Delpharm Milano 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 Delpharm Milano's last inspection go?
The most recent inspection on record closed on 18 February 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Delpharm Milano manufacture?
4 registered sites are on record, in United Arab Emirates and Italy ((mi), Milano (milao) and Segrate among others). Every site is listed on this page with the register it came from.
Which regulators recognise Delpharm Milano's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, MFDS (Korea) and EEC (Eurasian Economic Union). 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 18 February 2022.

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Sources on this page

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