Suppliers / Ethypharm

Ethypharm

France Updated 9 July 2026

Ethypharm is a finished-dose manufacturer based in France. It appears in 497 regulatory filings across 20 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), MPA (SE) and EMA. Its GMP standing is certified by ANSM (FR), EMA and ZLG (DE), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 25 March 2023 as VAI.

0
active US DMFs
0
valid CEPs
8
registered plants 2 with an FDA FEI number
497
filings across 20 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 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

  • 25 March 2023 VAI US FDA
  • 7 October 2022 VAI US FDA
  • 5 November 2020 VAI US FDA
  • 22 February 2018 VAI US FDA
  • 12 December 2014 NAI US FDA
  • 5 December 2014 NAI US FDA
  • 19 October 2012 VAI US FDA
  • 13 September 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Schönefeld, Germany Not on file
Chateauneuf-En-Thymerais, France Not on file
CHÂTEAUNEUF-EN-THYMERAIS, France Not on file
Le Grand Quevilly, France Not on file
France, France 3002807933
France, France 3004715600

2 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 173 None
MPA (SE) 71 None
EMA 69 2
INFARMED (PT) 46 None
AIFA (IT) 43 None
ANSM (FR) 36 10
ZLG (DE) None 2
TMDA (TZ) None 2
NAFDAC (NG) None 1

Scale

Year Revenue Exports Destinations
2024 $145.8M 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 We do not publish the identity of any buyer.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 Ethypharm

Does Ethypharm hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Ethypharm. It does have 497 filings with 20 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Ethypharm FDA-registered?
2 sites operated by Ethypharm 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 Ethypharm's last inspection go?
The most recent inspection on record closed on 25 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Ethypharm manufacture?
8 registered sites are on record, in Germany, France and Nigeria (Schönefeld, Chateauneuf-en-thymerais and Châteauneuf-en-thymerais among others). Every site is listed on this page with the register it came from.
Which regulators recognise Ethypharm's GMP?
Current GMP certificates are on record from ANSM (FR), EMA, ZLG (DE), TMDA (TZ) and NAFDAC (NG). 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.

Comparing suppliers?

Choose your molecules and target markets. Ethypharm comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 25 March 2023.

Comparable suppliers

AdhexPharma also in France Advanced Accelerator Applications also in France Aspen Notre Dame De Bondeville also in France Astrazeneca Dunkerque Production also in France Astrea Fontaine also in France

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
EudraGMDP and national regulators
GMP certificates
Company filings
Revenue as reported