Minakem route gets EQDM approval

Minakem has revealed that the European Directorate for the Quality of Medicines & Health Care (EDQM has approved a Certificate of Suitability for the second-generation process it developed for the API Fulvestrant. Ecovamed has estimated that this has a carbon footprint reduction of 3.4 tonnes of CO2 eq./kg compared to the original process. 

This new process, Minakem said, “enables the production of significantly improved quality earlier in the process, eliminating the need for the final purification step”. This is highly solvent-intensive, with the solvents being burnt after use. The company has made the API, which is used to treat certain types of breast cancer, for more than ten years at its HPAPI facility in Louvain-la-Neuve, Belgium.