EMA Approves Biocon Biologics' New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites
24 Jun 2024
Drug Approval
BENGALURU, India, June 24, 2024 /PRNewswire/ -- 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
For more information: www.bioconbiologics.com
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