Zydus Lifesciences announced that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Fludrocortisone Acetate tablets USP, 0.1 mg.
Fludrocortisone Acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.The drug will be produced at the Groups manufacturing site at Moraiya, Ahmedabad.
According to IQVIA MAT July 2024, Fludrocortisone acetate tablets generated annual sales of $19.9 million in the United States.
The group now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
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The pharma companys consolidated net profit surged 30.64% to Rs 1,419.9 crore on 20.77% increase in revenue from operations to Rs 6,207.5 crore in Q1 FY25 over Q1 FY24.
Shares of Zydus Lifesciences fell 0.19% to Rs 1,019 on the BSE.
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