Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for the manufacture and marketing of Estradiol Transdermal System USP, 0.014 mg/day (weekly), which is used in the prevention of postmenopausal osteoporosis.
The drug will be produced at the company's Moraiya, Ahmedabad facility in India.
Estradiol Transdermal System USP, 0.014 mg/day (weekly) had an annual sale of $1.9 million in the United States as of February 2023, according to IQVIA.
This approval brings the company's total approvals to 363, with over 440 ANDAs filed since the filing process began 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's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.
Shares of Zydus Lifesciences rose 2.78% to Rs 515.75 on Tuesday, 18 April 2023.
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