said in a filing that it 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 Biocon's portfolio of biosimilars, were inspected by the European agency in March 2019.
This was a surveillance inspection of our existing DP and OS facilities and a pre-approval inspection of our additional DP manufacturing line. This certification will enable us to continue addressing the growing needs of patients in the EU markets and enhance access to our high-quality biosimilars, the company added.
“We remain committed to global standards of quality and compliance," company spokesperson said.
Biocon Ltd is currently trading at Rs250.45, down by Rs5.95 or 2.32% from its previous closing of Rs256.40 on the BSE. The scrip opened at Rs259 and has touched a high and low of Rs259 and Rs248.40 respectively.