Suppliers / EUROAPI Italy

EUROAPI Italy

Italy Updated 9 July 2026

The public registers hold a second record for EUROAPI Italy. The fuller profile, with 48 active US DMFs and 53 valid CEPs, is at EUROAPI. Figures on this page cover only this record.

EUROAPI Italy is an API manufacturer based in Italy. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its most recent recorded inspection, by US FDA, closed on 25 February 2022 as VAI.

2
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 25 February 2022 VAI US FDA
  • 9 March 2018 VAI US FDA
  • 29 May 2014 NAI US FDA
  • 17 March 2011 VAI 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 3003677892

What they file, and where

Molecule Regulators Docs
Rifampin US FDA 1
Rifaximin US FDA 1

Also appears on these molecule pages

Rifampicin API Rifampin API Rifaximin API

Questions about EUROAPI Italy

Does EUROAPI Italy hold a US DMF or a CEP?
EUROAPI Italy holds 2 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 EUROAPI Italy FDA-registered?
One site operated by EUROAPI 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 EUROAPI Italy's last inspection go?
The most recent inspection on record closed on 25 February 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does EUROAPI Italy manufacture?
1 registered site is on record, in Italy (Italy). Every site is listed on this page with the register it came from.
What does EUROAPI Italy make?
2 molecules are on record against EUROAPI Italy, including Rifampin and Rifaximin. Each links through to that molecule's full manufacturer list.

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.

Checking EUROAPI Italy?

Ask Fred what the record holds on EUROAPI Italy, including filings and inspection history.

Chat with Fred, your AI analyst
Opens WhatsApp. Free to start.

Open risk flags

  • The most recent inspection outcome was VAI, on 25 February 2022.

Comparable suppliers

Olon shares 3 molecules Lupin shares 3 molecules CKD Bio shares 2 molecules MSN Laboratories shares 1 molecule Apitoria Pharma shares 1 molecule

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