Bengaluru-based biotechnology subsidiary of Biocon Ltd., Biocon Biologics announced receiving the EU’s Good Manufacturing Practice (GMP) certification from the Health Products Regulatory Authority (HPRA), Ireland, for its new monoclonal antibodies (mAbs) drug substance manufacturing facility at Biocon Park, Bengaluru.
The European Union’s Good Manufacturing Practices (GMP) accreditation is offered to pharmaceutical manufacturers who adhere to a minimal standard in their production practices.
According to the company’s regulatory filing, the 340,000-square-foot facility will significantly improve its ability to produce the drug substances for its portfolio of mAbs, allowing it to serve patients all over the world. Furthermore, the facility is designed to accommodate manufacturing suites, analytical testing laboratories, and warehousing, according to the details shared by the company.
The facility was also given the Facility of the Year Award (FOYA) with an Honorable Mention by the International Society for Pharmaceutical Engineering (ISPE) following its completion and qualification in 2021, according to the statement shared by the spokesperson of Biocon Biologics.
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