Biocon Biologics has received the 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.
The certification followed a good manufacturing practice (GMP) inspection in April 2022, Biocon said.The Biocon Biologics spokesperson said, "The facility, spread across 340,000-square feet, will enhance our capabilities manifold to manufacture drug substance of 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 a Honorable Mention, by the International Society for Pharmaceutical Engineering's (ISPE).
Biocon is a global biopharmaceutical company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer, and autoimmune.
The company reported 6% fall in consolidated net profit to Rs 239 crore on a 31% rise in revenue from operations to Rs 2,409 crore in Q4 FY22 over Q4 FY21.
Shares of Biocon were up 0.80% to Rs 316.20 on the BSE.
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