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Zydus gets final approval from USFDA for Empagliflozin and Metformin Hydrochloride Tablets

11 Jul 2022 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Empagliflozin and Metformin Hydrochloride Tablets in the strengths of 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg (US RLD: Synjardy).

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. They are also used to lower the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease. The drug will be manufactured at the group’s formulation facility at SEZ, Ahmedabad, India.

The group now has 316 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.

Zydus Lifesciences Share Price

927.00 -1.85 (-0.20%)
22-Apr-2026 09:15 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1669.30
Dr. Reddys Lab 1216.20
Cipla 1230.10
Zydus Lifesciences 927.00
Lupin 2306.55
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