Suppliers / Merck Santé S.A.S

Merck Santé S.A.S

France 2 duplicate records merged Updated 9 July 2026

Merck Santé S.A.S is an API and finished-dose manufacturer based in France. It holds 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with EMA, DPM (TN) and ANPP (DZ). Its GMP standing is certified by NAFDAC (NG) and ANVISA (Brazil).

0
active US DMFs
2
valid CEPs
4
registered plants
87
filings across 12 regulators

Registered plants

Site FDA FEI
SEMOY, United Arab Emirates Not on file
SEMOY, France Not on file
Lyon, France Not on file
Semoy, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Metformin EDQM, SFDA (Saudi Arabia) 2
Acamprosate EDQM 1

Also appears on these molecule pages

Acamprosate API Metformin API Methimazole finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 21 None
DPM (TN) 16 None
ANPP (DZ) 11 None
MPA (SE) 10 None
DAV (Vietnam) 10 None
NAFDAC (NG) 5 1
ANVISA (Brazil) None 1

Questions about Merck Santé S.A.S

Does Merck Santé S.A.S hold a US DMF or a CEP?
Merck Santé S.A.S holds 2 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.
Where does Merck Santé S.A.S manufacture?
4 registered sites are on record, in United Arab Emirates, France and Nigeria (Semoy, Lyon and Semoy among others). Every site is listed on this page with the register it came from.
What does Merck Santé S.A.S make?
2 molecules are on record against Merck Santé S.A.S, including Metformin and Acamprosate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Merck Santé S.A.S's GMP?
Current GMP certificates are on record from NAFDAC (NG) 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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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates