Zydus Lifesciences gets USFDA nod for Colestipol Hydrochloride Tablets
Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet.
Ahemdabad: Zydus Lifesciences Ltd. (Formerly known as Cadila Healthcare Ltd.) has received final approval from the USFDA to market Colestipol Hydrochloride Tablets in the strength of 1mg (US RLD: Colestid). Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet.
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ColestipolHydrochloride is a highly complex macro molecule drug substance with little or no systemic absorption. Zydus' ANDA is only the second generic application approved by USFDA for this product. The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad. The group now has 330 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
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The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 23000 people worldwide and is driven by its mission to unlock new possibilities in life-sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through pathbreaking discoveries.
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