Mercachem is delighted to announce that the GMP certificate for our API production site in Prague, Czech Republic, has recently been renewed.
The site was acquired in October 2014 from Synthon, a pharmaceutical company based in the Netherlands, and because of this transition the previous certificate had expired. An elaborate program began to adjust the Quality System of the site to meet Mercachem policies and standards.
Inspection by SUKL, the Czech State Institute for Drug Control, led to the accreditation of a new GMP certificate for the production of drug substances to be used in clinical trials. The new certificate is valid for three years, until August 2018.