Zydus Lifesciences receives USFDA approval for Colestipol Hydrochloride Tablets

20 Mar 2022 , 01:33 AM

Zydus Lifesciences 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 groups 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