Biocon announced that 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 USFDA.
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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