GEN has received European Union Good Manufacturing Practices (EU GMP) approval, which is one of the most valuable milestones in its goal of becoming a significant global actor in pharmaceuticals industry.
As publicly announced previously, GEN applied for marketing authorization in Germany and simultaneously in Denmark, Sweden, Norway and Austria coordinated by The German Federal Institute for Drugs and Medical Devices (BfArM) on 29 March 2021. As part of the drug registration process in the European Union countries, GEN manufacturing facility based in Ankara was inspected on-site between 27 September 2021 – 01 October 2021 by the German competent institution with the scope of its compliance to EU GMP. Gen Manufacturing Facility has been found as compliant with the EU GMP guidelines and qualified to receive EU GMP certification.
EU GMP certification, issued by the German competent institution, is a certificate that is accepted worldwide and can be recognized by the regulatory authorities in majority of the markets due to mutual recognition during drug registration processes. Sales and distribution of the products manufactured at the GEN Manufacturing Facility will be allowed following the successful completion of the registration processes.