Biocon Ltd. can commence commercial supplies for its greenfield active-pharmaceutical-ingredient facility at Visakhapatnam to the US market after it received an establishment inspection report from the Food and Drug Administration.
The EIR follows a pre-approval inspection conducted by the FDA from June 10–14, the biopharmaceutical firm said in an exchange filing on Friday.
In another filing, it said Biocon Pharma Ltd., a wholly owned subsidiary of Biocon, received approval from the FDA for its abbreviated new drug application for daptomycin for injection (500 mg vial).
This product is meant for the treatment of complicated skin and skin structure infections and is also used to treat staphylococcus aureus infections in the bloodstream, including right-sided infective endocarditis in adult patients.
The company, which announced its June-quarter earnings on Aug. 8, reported a fivefold growth in its net profit to Rs 861.8 crore and surpassed analysts' estimates.
Shares of Biocon closed 1.14% higher at Rs 359.30 apiece on the BSE, compared to a 0.28% advance in the benchmark Sensex.
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