EMA Approves Biocon Biologics' New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites

Biocon Biologics Ltd (BBL), a global, fully integrated biosimilars company and a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru. This approval will provide significant additional capacity to address patients' needs across markets in Europe. The facility has previously been approved to manufacture biosimilar Trastuzumab in September 2022.

The Company also announced that EMA has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilars manufacturing facility at Bengaluru and its insulin facility in Malaysia following routine GMP inspections. These certificates were issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA.

"These GMP certifications across our manufacturing sites in India and Malaysia reflect Biocon Biologics' continued compliance with the highest standards of quality and our unwavering commitment to addressing patient needs globally." - Company Spokesperson.

Shares of Biocon Limited was last trading in BSE at Rs. 345.60 as compared to the previous close of Rs. 343.20. The total number of shares traded during the day was 453345 in over 6570 trades.

The stock hit an intraday high of Rs. 350.95 and intraday low of 340.05. The net turnover during the day was Rs. 157092841.00.

Source : Equity Bulls

Keywords

Biocon INE376G01013 BioconBiologics EMA Approval Biosimilar Bevacizumab mABS Bengaluru