14 June 2019 | News
This was a surveillance inspection of existing DP and OS facilities and a pre-approval inspection of additional DP manufacturing line
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 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.” said the company spokesperson.
The spokesperson stated further, “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. We remain committed to global standards of quality and compliance."