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Zydus Lifesciences Limited’s shares rose 0.62 per cent after the company, along with its subsidiaries/affiliates, received final approval from the United States Food and Drug Administration (USFDA) for Darunavir Tablets in 600 mg and 800 mg strengths.
Additionally, the company has obtained tentative approval for tablets in 75 mg and 150 mg strengths. The medication, a protease inhibitor antiviral, is used for the treatment of HIV-1 infection in both adult and pediatric patients. The approved products will be manufactured at the company’s formulation facility in SEZ, Ahmedabad, India.
Darunavir Tablets reported annual sales of $275 million in the United States (IQVIA MAT Oct. 2023). With this approval, Zydus gained a pharmaceutical portfolio with a total of 383 approvals and over 440 filed ANDAs since the initiation of the filing process in FY 2003-04.
The shares rose 0.62 per cent to ₹647.50 at 10.05 am on the BSE.
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