Suppliers / Leo Pharma Manufacturing (Italy)

Leo Pharma Manufacturing (Italy)

Italy Updated 9 July 2026

The public registers hold a second record for Leo Pharma Manufacturing (Italy). The fuller profile, with 2 active US DMFs and 11 valid CEPs, is at Leo Pharma. Figures on this page cover only this record.

Leo Pharma Manufacturing (Italy) is a finished-dose manufacturer based in Italy. It appears in 9 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), ARCSA (EC) and UZPHARM (UZ). Its GMP standing is certified by ANVISA (Brazil), EMA and NCELS (KZ), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 30 November 2023 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
9
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 30 November 2023 VAI US FDA
  • 25 July 2019 VAI US FDA
  • 11 September 2014 NAI US FDA
  • 28 March 2012 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Segrate (Milan), United Arab Emirates Not on file
SEGRATE, Italy Not on file
Segrate, Italy Not on file
Italy, Italy 3002808260

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 5 None
ARCSA (EC) 2 None
UZPHARM (UZ) 1 None
NPRA (MY) 1 None
ANVISA (Brazil) None 3
EMA None 1
NCELS (KZ) None 1
US FDA None 1

Questions about Leo Pharma Manufacturing (Italy)

Does Leo Pharma Manufacturing (Italy) hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Leo Pharma Manufacturing (Italy). It does have 9 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Leo Pharma Manufacturing (Italy) FDA-registered?
One site operated by Leo Pharma Manufacturing (Italy) 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 Leo Pharma Manufacturing (Italy)'s last inspection go?
The most recent inspection on record closed on 30 November 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Leo Pharma Manufacturing (Italy) manufacture?
4 registered sites are on record, in United Arab Emirates and Italy (Segrate (milan), Segrate and Segrate among others). Every site is listed on this page with the register it came from.
Which regulators recognise Leo Pharma Manufacturing (Italy)'s GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, NCELS (KZ) 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 30 November 2023.

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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