Biocon stock gains after arm receives several USFDA approval

2 Sep 2024 , 03:31 PM

Biocon’s share price climbed in early trading after the company’s arm gained various approvals from the US Food and Drug Administration (USFDA).

Biocon Pharma, the company’s wholly-owned subsidiary, has gained FDA approval for its ANDA for Sacubitril/Valsartan Tablets in strengths of 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.

This combination drug is used to treat chronic heart failure in adults, as well as to lower the risk of death and hospitalisation in children over the age of one year.

The USFDA has also approved the subsidiary’s ANDA for Daptomycin for Injection (500mg Vial).

This medication is used to treat complicated skin and skin structure infections (cSSSI) as well as Staphylococcus aureus bloodstream infections (bacteremia), especially right-sided infective endocarditis in adults.

Biocon also got an Establishment Inspection Report (EIR) from the US FDA for their greenfield API facility (Site 6) in Visakhapatnam, Andhra Pradesh. This EIR follows a pre-approval examination from June 10 to 14, 2024, and allows the corporation to begin commercial shipments to the US market from this facility.

At around 12.20 PM, Biocon was trading 0.58% higher at ₹361.20, against the previous close of ₹359.10 on NSE. The counter touched an intraday high and low of ₹368, and ₹359, respectively.

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