Biocon has received the Certificate of GMP compliance from EMA for its Biologics Drug Product (DP) as well as Drug Substance (DS) facilities at Biocon Park, Bengaluru. These facilities, used for the manufacture of company’s portfolio of biosimilars, were inspected by the European agency in March 2019.
This was a surveillance inspection of company’s existing DP and OS facilities and a pre-approval inspection of its additional DP manufacturing line. This certification will enable company to continue addressing the growing needs of patients in the EU markets and enhance access to its high quality biosimilars.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.
