Suppliers / Merck And Cie Kmg

Merck And Cie Kmg

Switzerland Updated 9 July 2026

Merck And Cie Kmg is an API manufacturer based in Switzerland. It holds 3 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 29 March 2023 as VAI.

3
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
7 of 7 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

  • 29 March 2023 VAI US FDA
  • 10 May 2019 NAI US FDA
  • 2 November 2018 VAI US FDA
  • 12 June 2014 NAI US FDA
  • 14 February 2014 NAI US FDA
  • 27 July 2011 NAI US FDA
  • 25 March 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Schaffhausen, Switzerland Not on file
Switzerland, Switzerland 3002806918
Switzerland, Switzerland 3004369363

What they file, and where

Molecule Regulators Docs
Leucovorin Calcium US FDA 2
Levomefolic Acid US FDA 1

Also appears on these molecule pages

Leucovorin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Merck And Cie Kmg

Does Merck And Cie Kmg hold a US DMF or a CEP?
Merck And Cie Kmg holds 3 active US drug master files. 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 And Cie Kmg FDA-registered?
2 sites operated by Merck And Cie Kmg 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 Merck And Cie Kmg's last inspection go?
The most recent inspection on record closed on 29 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Merck And Cie Kmg manufacture?
3 registered sites are on record, in Switzerland (Schaffhausen and Switzerland among others). Every site is listed on this page with the register it came from.
What does Merck And Cie Kmg make?
2 molecules are on record against Merck And Cie Kmg, including Leucovorin Calcium and Levomefolic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Merck And Cie Kmg's GMP?
Current GMP certificates are on record from 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 29 March 2023.

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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