Biocon Biologics receives EU GMP certification for biologics manufacturing facility in Bengaluru

The facility, spread across 340,000-square feet, will enhance its capabilities manifold to manufacture drug substances of the mAbs portfolio

Biocon Biologics, a subsidiary of Biocon has received an EU GMP certificate from the Health Products Regulatory Authority (HPRA), Ireland, for its new monoclonal antibodies (mAbs) drug substance manufacturing facility (B3) at Biocon Park, Bengaluru, following a GMP inspection in April 2022.

The facility, spread across 340,000-square feet, will enhance its capabilities manifold to manufacture drug substances of the mAbs portfolio and will enable us to serve patients across the globe. This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing. Upon successful completion and qualification in 2021, it was awarded the Facility of the Year Award (FOYA) with an Honorable Mention, by the International Society for Pharmaceutical Engineering (ISPE).”