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.

active US DMFs

valid CEPs

registered plants

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
Darmstadt, Germany	Not on file
Hamburg, 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
NPRA (MY)	1	None
ZLG (DE)	None	8
EMA	None	1

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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