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Zydus gets USFDA approval to market Colestipol Hydrochloride Tablets
Zydus Lifesciences Ltd. today said that it has received final approval from the US-based drug regulator, the USFDA to market Colestipol Hydrochloride Tablets in the strength of 1mg
Zydus Lifesciences Ltd. today said that it has received final approval from the US-based drug regulator, the United States Food & Drug Administration (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. Colestipol Hydrochloride is a highly complex macromolecule 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.
Currently, 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.
Earlier on February 24, 2022, the Zydus group announced its new brand identity with the listed entity of the group Cadila Healthcare Ltd. to be known as Zydus Lifesciences Ltd. The company's new brand identity brought together two hearts in purple and teal colours symbolising its commitment to science and innovation along with care and nurturance.
