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

Comparing suppliers?

Choose your molecules and target markets. GMT Fine Chemicals comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 1 February 2024.

Sources on this page

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