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

Clenbuterol API Dexmedetomidine API Isoprenaline API Lornoxicam API Lurasidone API Midodrine API Norepinephrine API Ropivacaine API Tirofiban API

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

Questions about Edmond Pharma

Does Edmond Pharma hold a US DMF or a CEP?
Edmond Pharma holds 10 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Edmond Pharma FDA-registered?
One site operated by Edmond Pharma 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 Edmond Pharma's last inspection go?
The most recent inspection on record closed on 15 July 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Edmond Pharma manufacture?
2 registered sites are on record, in Italy (Italy and Paderno Dugnano). Every site is listed on this page with the register it came from.
What does Edmond Pharma make?
12 molecules are on record against Edmond Pharma, including Dexmedetomidine, Levobupivacaine, Chloroprocaine and Clenbuterol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Edmond Pharma's GMP?
Current GMP certificates are on record from EMA. 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 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