Biocon Biologics New mAbs Facility Receives EU GMP Certification
On Friday, Biocon Biologics stated in an exchange filing that its integrated, multi-product, monoclonal antibodies (mAbs) Drug Substance manufacturing facility (B3) at Biocon Park, Bengaluru, has received a Certificate of GMP Compliance for an additional product, biosimilar Bevacizumab, from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.\
“This approval reflects Biocon Biologics’ compliance with the highest international regulatory standards and enables the Company to continue addressing the needs of patients in the EU through its high-quality products," the company's spokesperson stated in the filing.
The spokesperson further said that the (B3) facility prior to this had received the EU GMP Certification for manufacturing biosimilar Trastuzumab last year. "It was also awarded the ‘Facility of the Year Award’ (FOYA) with an ‘Honourable Mention’, by the International Society for Pharmaceutical Engineering (ISPE) in 2021,” the spokesperson added.
