USFDA approves Biocon’s sBLA for Pegfilgrastim new manufacturing facility

27 Nov 2019 Evaluate

Biocon and Mylan's supplemental Biologics License Application (sBLA) for Pegfilgrastim Drug Substance to be manufactured at Biocon's new Biologics manufacturing facility has been approved by the US Food and Drug Administration (USFDA).

This additional approval of its new manufacturing facility for Pegfilgrastim in Bengaluru will enable Biocon Biologics, a subsidiary of Biocon, and Mylan to scale up capacity multi-fold and address the growing market opportunities in the US and other global markets. The USFDA had conducted a Pre-Approval Inspection of this new Drug Substance manufacturing facility from September 10 to September 19, 2019.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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