Zydus receives final approval from the USFDA for Empagliflozin and Metformin Hydrochloride Tablets

Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), 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.

Synjardy® (Empagliflozin and Metformin Hydrochloride) tablets had annual sales of 281 million in the United States according to IQVIA data (IQVIA MAT May 2022).

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.

Shares of Cadila Healthcare Limited was last trading in BSE at Rs. 365.80 as compared to the previous close of Rs. 367.65. The total number of shares traded during the day was 26125 in over 1289 trades.

The stock hit an intraday high of Rs. 369.50 and intraday low of 364.60. The net turnover during the day was Rs. 9595099.00.

Source : Equity Bulls

Keywords

ZydusLifesciences CadilaHealthcare INE010B01027 USFDA FinalApproval Empagliflozin MetforminHydrochloride Tablets