Biocon’s biologics facilities in Bengaluru received GMP compliance certificate from EMA

The certification will enable the company to continue addressing the growing needs of patients in the EU markets

Biocon has received good manufacturing practice compliance certificate from the European Medicines Agency (EMA) for its biologics facilities in Bengaluru.

The biotechnology major has received the certificate for its biologics drug product and drug substance facilities at Biocon Park, Bengaluru, the company said in a filing to BSE.

These facilities, used for the manufacture of Biocon’s portfolio of biosimilars, were inspected by the European agency in March 2019, a company spokesperson said in a statement.
According to a company statement, “This was a surveillance inspection of our existing drug product and drug substance facilities and a pre-approval inspection of our additional drug product manufacturing line,” the statement added.
This certification will enable the company to continue addressing the growing needs of patients in the EU markets and enhance access to its high-quality biosimilars, it said. “We remain committed to global standards of quality and compliance,” it added.