Suppliers / GMT Fine Chemicals

GMT Fine Chemicals

Switzerland Updated 9 July 2026

GMT Fine Chemicals is an API manufacturer based in Switzerland. It holds 2 active US drug master files and 2 valid CEPs across a filed portfolio of 3 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 1 February 2024 as VAI.

2
active US DMFs
2
valid CEPs
3
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 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

  • 1 February 2024 VAI US FDA
  • 5 February 2016 VAI US FDA

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

Registered plants

Site FDA FEI
S.A. Couvet, Switzerland Not on file
Couvet, Switzerland Not on file
Switzerland, Switzerland 3004051004

What they file, and where

Molecule Regulators Docs
Leucovorin Calcium US FDA 2
Calcium Folinate EDQM 1
Calcium Levofolinate Hydrate EDQM 1

Also appears on these molecule pages

Calcium Folinate API Leucovorin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

Questions about GMT Fine Chemicals

Does GMT Fine Chemicals hold a US DMF or a CEP?
GMT Fine Chemicals holds 2 active US drug master files and 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.
Is GMT Fine Chemicals FDA-registered?
One site operated by GMT Fine Chemicals 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 GMT Fine Chemicals's last inspection go?
The most recent inspection on record closed on 1 February 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does GMT Fine Chemicals manufacture?
3 registered sites are on record, in Switzerland (S.a. Couvet, Couvet and Switzerland). Every site is listed on this page with the register it came from.
What does GMT Fine Chemicals make?
3 molecules are on record against GMT Fine Chemicals, including Leucovorin Calcium, Calcium Folinate and Calcium Levofolinate Hydrate. Each links through to that molecule's full manufacturer list.
Which regulators recognise GMT Fine Chemicals's GMP?
Current GMP certificates are on record from US FDA 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 1 February 2024.

Comparable suppliers

Cerbios-Pharma shares 2 molecules Global Calcium shares 1 molecule Sichuan Huiyu Pharmaceutical shares 1 molecule Seacross Pharma (Europe) shares 1 molecule Merck And Cie Kmg shares 1 molecule

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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