Zydus Lifesciences gets US FDA approval for cholesterol-lowering drug

14 Mar 2022 , 09:30 AM

The drug is a generic equivalent of the US reference listed drug Colestid of Pfizer Inc.

Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein cholesterol (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.

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.

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.

The scrip was currently trading 0.8% lower at Rs 368 on the BSE.

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