Suppliers / Edmond Pharma

Edmond Pharma

Italy 2 duplicate records merged Updated 9 July 2026

Edmond Pharma is an API manufacturer based in Italy. It holds 10 active US drug master files across a filed portfolio of 12 molecules. Its filings concentrate with INFARMED (PT), AIFA (IT) and MINSA (CR). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 15 July 2022 as VAI.

10
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
13
filings across 5 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

  • 15 July 2022 VAI US FDA
  • 18 May 2018 VAI US FDA
  • 5 February 2016 VAI US FDA
  • 16 November 2012 NAI US FDA
  • 30 July 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Italy, Italy 3003659426
Paderno Dugnano, Italy Not on file

What they file, and where

Molecule Regulators Docs
Dexmedetomidine SFDA (Saudi Arabia), US FDA 3
Levobupivacaine SFDA (Saudi Arabia), US FDA 2
Chloroprocaine US FDA 1
Clenbuterol US FDA 1
Isoprenaline US FDA 1
Lornoxicam SFDA (Saudi Arabia) 1
Lurasidone US FDA 1
Midodrine US FDA 1
Norepinephrine US FDA 1
Ropivacaine US FDA 1
Show all 12 molecules on file
Tirofiban SFDA (Saudi Arabia) 1
Tulobuterol US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
INFARMED (PT) 5 None
AIFA (IT) 4 None
MINSA (CR) 2 None
EMA 1 1
UZPHARM (UZ) 1 None

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Open risk flags

  • The most recent inspection outcome was VAI, on 15 July 2022.

Sources on this page

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