14 June 2019 | News
These facilities were inspected by the European agency in March 2019
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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 the company's existing DP and DS facilities and a pre-approval inspection of the additional DP manufacturing line.
This certification will enable Biocon to continue addressing the growing needs of patients in the EU markets and enhance access to its high quality biosimilars.