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
Logo -
https://mma.prnewswire.com/media/2143906/Biocon_Biologics_Logo.jpg
View original
content:https://www.prnewswire.co.uk/news-releases/ema-approves-biocon-biologics-new-mabs-facility-in-india-and-renews-gmp-certifications-for-india-and-malaysia-sites-302180507.html