Hot Pursuit     15-Dec-23
Zydus Life gets US FDA approval for antiretroviral medication Darunavir
Zydus Lifesciences said that it has received final approval from the United States Food and Drug Administration (US FDA) for Darunavir Tablets.

Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body. It is indicated for the treatment of HIV-1 infection in adult patients. It is also indicated for the treatment of HIV-1 infection in pediatric patients 3 years of age and older.

It must be–co-administered with Ritonavir and with other antiretroviral agents. The product will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad (India). Darunavir Tablets had annual sales of $275 million in the United States (IQVIA MAT Oct. 2023).

The group now has 383 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company consolidated net profit surged 53.2% to Rs 800.7 crore in Q2 FY24 as compared with Rs 522.5 crore posted in Q2 FY23. Revenue from operations rose 9.1% YoY to Rs 4,368.8 crore during the quarter ended 30 September 2023.

The scrip rose 0.78% to currently trade at Rs 648.55 on the BSE.

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