Wednesday, 21 August 2019

Biocon biologics facilities in Bengaluru receive EU GMP certification

14 June 2019 | News

These facilities were inspected by the European agency in March 2019

image credit- shuttershock.com

image credit- shuttershock.com

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. 

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