USFDA approves Biocon's sBLA for Pegfilgrastim manufactured at new biologics facility in Bengaluru
The 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 10 September to 19 September 2019.
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