GMP-compliant chemical synthesis of active pharmaceutical ingredients (APIs), specializing in Reduced Folates for oncology and Women's Health.
GMT Fine Chemicals SA
Couvet (canton of Neuchâtel), SwitzerlandNew on Amplifa
About GMT Fine Chemicals SA
GMT Fine Chemicals SA is a Swiss pharmaceutical company founded in 1998 in the industrial area of Couvet in the canton of Neuchâtel, in French-speaking Switzerland. The company specializes in the GMP-compliant chemical synthesis of Active Pharmaceutical Ingredients (APIs), with a focus on Reduced Folates. The production site was designed from the ground up to ensure product quality (GMP), personnel safety, and environmental protection. The portfolio includes Calcium Levofolinate and Calcium Folinate; the therapeutically active substances are primarily used in the manufacture of pharmaceutical medicinal products in the fields of oncology and Women's Health. Swissmedic has granted the company a GMP certificate for the manufacture and distribution of APIs. Since September 2011, Cerbios-Pharma SA has been the majority shareholder of GMT Fine Chemicals SA.
- Site
- Couvet
- Processes
- Chemical synthesis of Active Pharmaceutical Ingredients (APIs) under GMP conditions, GMP-compliant chemical synthesis of active ingredients (APIs)
- Materials
- Calcium Levofolinate, Calcium Folinate
- Certificates
- GMP certificate (manufacture and distribution of APIs), Accreditation of Foreign Manufacturer, GMP certificate Swissmedic (API manufacture and distribution), PMDA Accreditation of Foreign Manufacturer (Japan), FDA inspection (passed in 2016)
- Founded
- 1998
- Industries
- Pharmaceutical industry, Oncology, Women's Health
- 01
Chemical synthesis of APIs under GMP conditions
- 02
Quality assurance in accordance with GMP (Swissmedic)
- 03
Distribution of active ingredients
Products & Processes
Calcium Levofolinate
Reduced Folate as therapeutically active ingredient (API), manufactured under GMP conditions.
Calcium Folinate
Reduced Folate as therapeutically active ingredient (API), manufactured under GMP conditions.
Sites
Couvet
CHProduction site (chemical synthesis of APIs)
- Materials
- Calcium Levofolinate, Calcium Folinate
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Chemical synthesis of Active Pharmaceutical Ingredients (APIs) under GMP conditionsChemicals/Pharmaceuticals | – | – | – | – | – |
Additional services
Quality & Approvals
Swissmedic has granted GMT Fine Chemicals SA a GMP certificate for the manufacture and distribution of Active Pharmaceutical Ingredients (APIs). The company was successfully inspected by the FDA in 2016 and has been accredited as a Foreign Manufacturer by the Japanese PMDA since 2005.
| Evidence | Couvet |
|---|---|
| GMP certificate Swissmedic (API manufacture and distribution) | |
| PMDA Accreditation of Foreign Manufacturer (Japan) | |
| FDA inspection (passed in 2016) |
History
- 1998
Foundation of GMT Fine Chemicals SA in the industrial area of Couvet, canton of Neuchâtel
- 2005
- 2011
Cerbios-Pharma SA becomes majority shareholder (September 2011)
- 2005
Accreditation of Foreign Manufacturer from the Japanese PMDA since 2005
- 2016
Successful FDA inspection