Zydus Lifesciences bags USFDA approval for Colestipol Hydrochloride Tablets; stock slips ~2%

14 Mar 2022 , 12:41 PM

USFDA has given the final approval to market Zydus Lifesciences’ (formerly Cadila Healthcare) Colestipol Hydrochloride Tablets in the strength of 1mg.

Colestipol hydrochloride tablets are helpful 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.

USFDA has so far approved only two generic applications for this product including Zydus’ ANDA. The company will manufacture the drug at the group’s formulation manufacturing facility at SEZ, Ahmedabad.

The group has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04 and has 330 approvals so far.

Zydus Lifesciences was trading 1.98% lower at Rs363.60 against its previous closing price of Rs370.95. It touched the intraday high and low of Rs373.95 and Rs362.95 respectively.