Biocon Ltd announced today 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 stock is trading higher by 3.7% in trade today.
This additional approval of its new manufacturing facility for Pegfilgrastim in Bengaluru will enable Biocon Biologics, a subsidiary of Biocon Ltd, and Mylan to scale up capacity multi-fold and address the growing market opportunities in the US and other global market. The USFDA had conducted a Pre-Approval Inspection of this new Drug Substance manufacturing facility from September 9 to September 19, 2019.
Biocon Biologics is uniquely positioned as a fully integrated 'pure play' biosimilars organization in the world. It has been investing in expanding it manufacturing capacity in line with is expectations of higher biosimilars penetration in developed and emerging markets.
Stock view:
Biocon Ltd is currently trading at Rs274 up by Rs9.7 or 3.67% from its previous closing of Rs264.30 on the BSE.

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