The drug major announced that it has received a tentative approval from the United States Food and Drug Administration (USFDA) to market Azilsartan Medoxomil and Chlorthalidone tablets.
Azilsartan and Chlorthalidone is an angiotensin II receptor blocker (ARB) and a thiazide like diuretic combination product indicated for the treatment of high blood pressure (hypertension), to lower blood pressure. The said drug is equivalent to reference listed drug, Edarbyclor tablets.
The drug will be manufactured at the groups formulation manufacturing facility in Ahmedabad SEZ - II, India.
According to IQVIA MAT March 2024 data, Azilsartan Medoxomil and Chlorthalidone tablets had annual sales of $77.9 million in the United States
The group now has 397 approvals and has so far filed over 460 ANDAs since the commencement of the filing process in FY 2003-04.
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Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The pharma major reported consolidated net profit of Rs 1,182.3 crore in Q4 FY24 steeply higher than Rs 296.6 crore recorded in Q4 FY23. Revenue from operations jumped 10.44% to Rs 5,533.8 crore during the quarter as compared with Rs 5,010.6 crore posted in corresponding quarter last year.
Shares of Zydus Lifesciences rose 0.85% to trade at Rs 1,099.55 on the BSE.
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