Biocons subsidiary receives approval for start of manufacturing in new plant in Bangalore
Pratik ShastriCategories: DSIJ News, Trending
Earlier this month, Biocon Biologics, had received the Establishment Inspection Report (EIR) from the USFDA, which stated that the inspection was done. A fresh start of manufacturing in the facility can be expected to give positive momentum to the company, going ahead.
On Wednesday, Biocon Ltd., the Bangalore headquartered biopharmaceutical company, has announced that its subsidiary, Biocon Biologics, received the approval for the commencement of production in its new facility from the US regulatory.
The supplemental Biologics License Application (sBLA) for Pegfilgrastim Drug substance of Biocon and its partner Mylan would be manufactured at Biocon's new Biologics manufacturing facility after the stated approval by the US Food and Drug Administration (USFDA).
The additional approval of its new manufacturing facility for Pegfilgrastim in Bengaluru will enable Biocon Biologics, a subsidiary of the company, and Mylan to scale up their 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 between September 10 to 19, 2019.
Earlier this month, Biocon Biologics, had received the Establishment Inspection Report (EIR) from the USFDA, which stated that the inspection was done. A fresh start of manufacturing in the facility can be expected to give positive momentum to the company, going ahead.
The stock reacted positively to the news and traded higher by more than 5 per cent intra-day on BSE. At 11.30, the stock traded at Rs. 276.10, up by 4.46 per cent.