Biocon arm bags EU GMP certification for new Bengaluru facility

Bengaluru: Biocon Biologics Ltd., a subsidiary of Biocon Ltd. has announced that the company 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 our capabilities manifold to manufacture drug substance of our mAbs portfolio and will enable us to serve patients across the globe," the company's spokesperson stated.

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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 a Honorable Mention, by the International Society for Pharmaceutical Engineering's (ISPE).

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