Biocon on 31 August announced that their wholly-owned subsidiary, Biocon Pharma Ltd received US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Daptomycin for injection (500mg vial).

In its regulatory filing, the company said, “This is to inform you that Biocon Pharma Limited, a wholly-owned subsidiary of the Company, has received approval of its ANDA for Daptomycin for injection (500mg vial), from the U.S Food and Drug Administration (US FDA).”

The Daptomycin is used to treat complicated skin and skin structure infractions along with Staphylococcus aureus infections in the bloodstream, and right-sided infective endocarditis in adult patients.

This approval will strengthen the company’s portfolio of complex drug products, which allows Biocon to expand its offerings in the US market. 

Earlier on 30 August, the company received an Establishment Inspection Report (EIR) from the USFDA for the company’s greenfield active pharmaceutical ingredient facility, Site 6, in Visakhapatnam, Andhra Pradesh.
 
The US regulator conducted a pre-approval inspection between 10 June and 14 June.

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