Suppliers / Italfarmaco

Italfarmaco

Italy 627 employees Updated 9 July 2026

Italfarmaco is a finished-dose manufacturer based in Italy. It appears in 744 regulatory filings across 24 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), AEMPS (ES) and EMA. Its GMP standing is certified by EMA, ANVISA (Brazil) and AEMPS (ES). Its most recent recorded inspection, by US FDA, closed on 15 July 2021 as VAI.

0
active US DMFs
0
valid CEPs
11
registered plants 2 with an FDA FEI number
744
filings across 24 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
1 of 1 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

  • 15 July 2021 VAI 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
Madrid, United Arab Emirates Not on file
Madrid, Spain Not on file
Spain, Spain 3007048260
Alcobendas, Spain Not on file
MILANO (MILAO), Italy Not on file

5 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 350 None
AEMPS (ES) 174 1
EMA 87 2
INFARMED (PT) 46 None
US FDA 14 None
MPA (SE) 13 None
ANVISA (Brazil) None 1

Questions about Italfarmaco

Does Italfarmaco hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Italfarmaco. It does have 744 filings with 24 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Italfarmaco FDA-registered?
2 sites operated by Italfarmaco carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Italfarmaco's last inspection go?
The most recent inspection on record closed on 15 July 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Italfarmaco manufacture?
11 registered sites are on record, in United Arab Emirates, Spain, Italy and Portugal (Milan, Madrid and Spain among others). Every site is listed on this page with the register it came from.
Which regulators recognise Italfarmaco's GMP?
Current GMP certificates are on record from EMA, ANVISA (Brazil) and AEMPS (ES). 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 15 July 2021.

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