Glenmark Pharma gets 2nd ANDA tentative approval for Saxagliptin tablets

The drug maker said that it has received second tentative approval by US Food & Drug Administration for Saxagliptin tablets, 2.5 mg and 5 mg.

Saxagliptin is used to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Saxagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors.

The said drug is a generic version of Onglyza tablets of AstraZeneca AB. Saxagliptin tablets received first tentative approval on 12 June 2017.

According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $122.3 million.

Glenmark's current portfolio consists of 179 products authorized for distribution in the U.S. marketplace and 46 ANDA's pending approval with the U.S.FDA.

Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with presence across specialty, generics and OTC businesses.

The company's consolidated net profit jumps 22.8% to Rs 272.58 crore on 8% rise in net sales to Rs 3,392.24 crore in Q3 FY23 over Q3 FY22.

The scrip rose 0.61% to Rs 437.80 on the BSE.

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