Zydus Lifesciences 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.
Colestipol Hydrochloride 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.
