Zydus Lifesciences Ltd.

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Mid Cap | Pharmaceuticals & Drugs
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Zydus Lifesciences gets final approval from USFDA for Empagliflozin Tablets

Date: 05-08-2022

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Empagliflozin Tablets USP 10 mg and 25 mg. USRLD: Jardiance.

Empagliflozin is used to lower blood sugar levels in people with type 2 diabetes. It is also used to reduce the risk of stroke, heart attack, or death in people with type 2 diabetes along with heart and blood vessel disease. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Empagliflozin Tablets had annual sales of $9,810 million in the United States according to IQVIA data (IQVIA MAT June 2022). The group now has 319 approvals and has so far filed over 420 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.