Suppliers / Merck Healthcare Kgaa

Merck Healthcare Kgaa

Germany Updated 9 July 2026

Merck Healthcare Kgaa is an API and finished-dose manufacturer based in Germany. It holds one active US drug master file. Its filings concentrate with EMA, AEMPS (ES) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and MFDS (Korea), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 13 May 2022 as VAI.

1
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
116
filings across 13 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 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

  • 13 May 2022 VAI US FDA

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

Registered plants

Site FDA FEI
Darmstadt, United Arab Emirates Not on file
DARMSTADT, Germany Not on file
Germany, Germany 3016570199
Frankfurter Strasse Darmstadt Germany, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Cetrorelix US FDA 1

Also appears on these molecule pages

Bisoprolol finished dose Cetrorelix API Levothyroxine finished dose Methimazole finished dose Olmesartan finished dose Oxymetazoline finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 22 1
AEMPS (ES) 20 None
INVIMA (CO) 16 None
NAFDAC (NG) 11 2
SFDA (Saudi Arabia) 9 None
UZPHARM (UZ) 9 None
ZLG (DE) None 4
ANVISA (Brazil) None 2
MFDS (Korea) None 2

Questions about Merck Healthcare Kgaa

Does Merck Healthcare Kgaa hold a US DMF or a CEP?
Merck Healthcare Kgaa holds 1 active US drug master file. 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 Merck Healthcare Kgaa FDA-registered?
One site operated by Merck Healthcare Kgaa carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Merck Healthcare Kgaa's last inspection go?
The most recent inspection on record closed on 13 May 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Merck Healthcare Kgaa manufacture?
4 registered sites are on record, in United Arab Emirates, Germany and Nigeria (Darmstadt, Darmstadt and Germany among others). Every site is listed on this page with the register it came from.
What does Merck Healthcare Kgaa make?
1 molecule is on record against Merck Healthcare Kgaa, including Cetrorelix. Each links through to that molecule's full manufacturer list.
Which regulators recognise Merck Healthcare Kgaa's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), MFDS (Korea), NAFDAC (NG) 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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Open risk flags

  • The most recent inspection outcome was VAI, on 13 May 2022.

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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