Suppliers / EUROAPI

EUROAPI

France reconciled across 8 public records · 5 entities Updated 9 July 2026

EUROAPI is an API manufacturer based in France. It holds 48 active US drug master files and 53 valid CEPs. Its filings concentrate with MINSA (CR) and NCELS (KZ). Its GMP standing is certified by ANSM (FR), EDQM and ZLG (DE), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 4 March 2022 as VAI.

48
active US DMFs
53
valid CEPs
14
registered plants 5 with an FDA FEI number
25
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 4 March 2022 VAI US FDA
  • 25 February 2022 VAI US FDA
  • 5 February 2021 VAI US FDA
  • 21 June 2019 NAI US FDA
  • 20 April 2018 VAI US FDA
  • 9 March 2018 VAI US FDA
  • 22 April 2016 NAI US FDA
  • 30 May 2014 NAI US FDA
  • 29 May 2014 NAI US FDA
  • 27 June 2013 NAI US FDA
  • 17 March 2011 VAI US FDA
  • 6 May 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Frankfurt am Main, Germany Not on file
Frankfurt, Germany Not on file
Germany, Germany 3020754015
Paris, France Not on file
France, France 0000001463
Saint-Aubin-lès-Elbeuf, France Not on file

8 further sites are on record.

What they file, and where

Molecule Regulators Docs
Hydrocortisone EDQM, SFDA (Saudi Arabia), US FDA 9
Dexamethasone EDQM, SFDA (Saudi Arabia), US FDA 8
Prednisolone EDQM, US FDA 7
Methylprednisolone EDQM, SFDA (Saudi Arabia), US FDA 6
Alprostadil EDQM, SFDA (Saudi Arabia), US FDA 4
Clobazam EDQM, SFDA (Saudi Arabia), US FDA 4
Hydroxocobalamin EDQM, US FDA 4
Cyanocobalamin EDQM, US FDA 3
Glimepiride EDQM, US FDA 3
Norepinephrine EDQM, SFDA (Saudi Arabia) 3
Show all 40 molecules on file
Bimatoprost SFDA (Saudi Arabia), US FDA 2
Furosemide EDQM, US FDA 2
Irbesartan EDQM, US FDA 2
Ketoprofen EDQM, US FDA 2
Latanoprost EDQM, US FDA 2
Prednisone EDQM, US FDA 2
Ramipril EDQM, US FDA 2
Selegiline EDQM, US FDA 2
Spironolactone EDQM, US FDA 2
Apomorphine US FDA 1
Buserelin EDQM 1
Carboprost US FDA 1
Ciclopirox EDQM 1
Ciclopirox Olamine EDQM 1
Deflazacort EDQM 1
Desoximetasone US FDA 1
Dinoprost EDQM 1
Dinoprostone US FDA 1
Fexofenadine EDQM 1
Fluorometholone US FDA 1
Fluticasone Propionate EDQM 1
Gonadorelin EDQM 1
Hydroxychloroquine US FDA 1
Iloprost US FDA 1
Leflunomide US FDA 1
Levomepromazine Maleate EDQM 1
Levomethadone EDQM 1
Metamizole EDQM 1
Nadolol EDQM 1
Nalbuphine US FDA 1

Also appears on these molecule pages

Show 10 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 24 None
NCELS (KZ) 1 None
ANSM (FR) None 88
EDQM None 26
ZLG (DE) None 4
ANVISA (Brazil) None 2

Scale

Year Revenue Exports Destinations
2024 $475.8M Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about EUROAPI

Does EUROAPI hold a US DMF or a CEP?
EUROAPI holds 48 active US drug master files and 53 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 FDA-registered?
5 sites operated by EUROAPI carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did EUROAPI's last inspection go?
The most recent inspection on record closed on 4 March 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 13 inspections are on file.
Where does EUROAPI manufacture?
14 registered sites are on record, in Germany, France, United Kingdom and Hungary (Frankfurt Am Main, Frankfurt and Germany among others). Every site is listed on this page with the register it came from.
What does EUROAPI make?
40 molecules are on record against EUROAPI, including Hydrocortisone, Dexamethasone, Prednisolone and Methylprednisolone. Each links through to that molecule's full manufacturer list.
Which regulators recognise EUROAPI's GMP?
Current GMP certificates are on record from ANSM (FR), EDQM, ZLG (DE) and ANVISA (Brazil). 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 4 March 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Company filings
Revenue as reported