Biocon Biologics gets EU GMP certification from Ireland's HPRA

Biologics, an arm of Biocon, on Tuesday said its Bengaluru-based manufacturing plant has received EU GMP certification from Ireland's Health Products Regulatory Authority (HPRA). The company's new monoclonal antibodies (mAbs) drug substance manufacturing facility (B3) at Biocon Park, Bengaluru has received the certification following a GMP inspection in April 2022, a Biocon Biologics spokesperson said in a statement.

The facility, spread across 340,000-square feet, will enhance the company's capabilities manifold to manufacture drug substance of mAbs portfolio, the spokesperson said.

This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing, the statement added.