Zydus Lifesciences gets USFDA nod on Colestipol Hydrochloride tablets

Zydus Lifesciences received the 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).

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 (Gujarat). Currently, the group has 330 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

On a consolidated basis, Zydus Lifesciences' net profit fell 5.08% to Rs 500.40 crore on 0.61% increase in revenue from operations to Rs 3,655 crore in Q3 FY22 over Q3 FY21.

Shares of Zydus Lifesciences rose 1.44% to close at Rs 370.95 on BSE on Friday, 11 March 2022. Zydus Lifesciences (formerly known as Cadila Healthcare) is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

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