Glenmark gets ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg

Glenmark Pharma has received final approval by the United States Food & Drug Administration (US FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg, the generic version of Onglyza Tablets, 2.5 mg and 5 mg, of AstraZeneca AB. Glenmark’s Saxagliptin Tablets, 2.5 mg and 5 mg, will be distributed in the US by Glenmark Pharma, USA.

According to IQVIA sales data for the 12‐month period ending June 2023, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $100.7 million.

Glenmark’s current portfolio consists of 184 products authorised for distribution in the US marketplace and 49 ANDAs pending approval with the US FDA.