Suppliers / EUROAPI Hungary

EUROAPI Hungary

Hungary Updated 9 July 2026

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

EUROAPI Hungary is an API manufacturer based in Hungary. It holds 13 active US drug master files and 7 valid CEPs across a filed portfolio of 15 molecules. Its most recent recorded inspection, by US FDA, closed on 21 June 2019 as NAI.

13
active US DMFs
7
valid CEPs
2
registered plants 1 with an FDA FEI number
6
filings across 1 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

  • 21 June 2019 NAI US FDA
  • 20 April 2018 VAI US FDA
  • 30 May 2014 NAI US FDA
  • 4 February 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Budapest, Hungary Not on file
Hungary, Hungary 3002806675

What they file, and where

Molecule Regulators Docs
Alprostadil EDQM, SFDA (Saudi Arabia), US FDA 4
Bimatoprost SFDA (Saudi Arabia), US FDA 2
Irbesartan EDQM, US FDA 2
Latanoprost EDQM, US FDA 2
Selegiline EDQM, US FDA 2
Carboprost US FDA 1
Dinoprost EDQM 1
Dinoprostone US FDA 1
Hydroxychloroquine US FDA 1
Iloprost US FDA 1
Show all 15 molecules on file
Olmesartan US FDA 1
Olmesartan Medoxomil EDQM 1
Pentamidine Diisetionate EDQM 1
Travoprost US FDA 1
Treprostinil US FDA 1

Also appears on these molecule pages

Alprostadil API Bimatoprost API Carboprost API Hydroxychloroquine API Iloprost API Irbesartan API Latanoprost API Olmesartan API Olmesartan Medoxomil API Selegiline API Travoprost API Treprostinil API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 6 None

Questions about EUROAPI Hungary

Does EUROAPI Hungary hold a US DMF or a CEP?
EUROAPI Hungary holds 13 active US drug master files and 7 valid CEPs. 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 Hungary FDA-registered?
One site operated by EUROAPI Hungary 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 Hungary's last inspection go?
The most recent inspection on record closed on 21 June 2019 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does EUROAPI Hungary manufacture?
2 registered sites are on record, in Hungary (Budapest and Hungary). Every site is listed on this page with the register it came from.
What does EUROAPI Hungary make?
15 molecules are on record against EUROAPI Hungary, including Alprostadil, Bimatoprost, Irbesartan and Latanoprost. Each links through to that molecule's full manufacturer list.
Where does EUROAPI Hungary file?
Filings are on record with MINSA (CR), 6 in total.

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 NAI, on 21 June 2019.

Comparable suppliers

MSN Laboratories shares 8 molecules Chirogate International shares 6 molecules YS Life Science shares 5 molecules Dr Reddy's Laboratories shares 4 molecules Zydus Lifesciences shares 4 molecules

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