Suppliers / Merck KGaA

Merck KGaA

Germany MRK.DE 2 duplicate records merged Updated 9 July 2026

Merck KGaA is an API manufacturer based in Germany. It holds 12 valid CEPs across a filed portfolio of 18 molecules. Its filings concentrate with DAV (Vietnam), US FDA and DIGEMAPS (DO). Its GMP standing is certified by ZLG (DE) and EMA.

0
active US DMFs
12
valid CEPs
3
registered plants
38
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Darmstadt, United Arab Emirates Not on file
Hamburg, Germany Not on file
Darmstadt, Germany Not on file

What they file, and where

Molecule Regulators Docs
Sodium Bicarbonate EDQM, SFDA (Saudi Arabia) 3
Magnesium SFDA (Saudi Arabia) 2
Meglumine EDQM, SFDA (Saudi Arabia) 2
Potassium SFDA (Saudi Arabia) 2
Bisoprolol EDQM 1
Boric Acid EDQM 1
Calcium SFDA (Saudi Arabia) 1
Calcium Chloride EDQM 1
Di-Sodium Hydrogen SFDA (Saudi Arabia) 1
Dipotassium Phosphate EDQM 1
Show all 18 molecules on file
Magnesium Chloride Hexahydrate EDQM 1
Potassium Iodide EDQM 1
Praziquantel EDQM 1
Sodium Dihydrogen SFDA (Saudi Arabia) 1
Sodium Fluoride EDQM 1
Urea EDQM 1
Zinc SFDA (Saudi Arabia) 1
Zinc Chloride EDQM 1

Also appears on these molecule pages

Bisoprolol API Praziquantel API

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 16 None
US FDA 11 None
DIGEMAPS (DO) 3 None
DPM (TN) 2 None
ARCSA (EC) 1 None
INFARMED (PT) 1 None
ZLG (DE) None 8
EMA None 1

Questions about Merck KGaA

Does Merck KGaA hold a US DMF or a CEP?
Merck KGaA holds 12 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 KGaA manufacture?
3 registered sites are on record, in United Arab Emirates and Germany (Darmstadt and Hamburg among others). Every site is listed on this page with the register it came from.
What does Merck KGaA make?
18 molecules are on record against Merck KGaA, including Sodium Bicarbonate, Magnesium, Meglumine and Potassium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Merck KGaA's GMP?
Current GMP certificates are on record from ZLG (DE) and EMA. 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