Glenmark Pharma gets USFDA nod for Qtern generic

Glenmark Pharmaceuticals announced on Wednesday that it had been granted tentative approval by United States Food & Drug Administration (USFDA) for Dapagliflozin and Saxagliptin tablets, 10 mg/5 mg, the generic version of Qtern 1 tablets, 10 mg/5 mg of AstraZeneca AB.

According to IMS Health and Quintiles (IQVIA), the sales data for the 12-month period ending February 2020, Qtern tablets, 10 mg/5 mg market, achieved annual sales of approximately US$ 10.4 million.

The company’s current portfolio consists of 162 products authorised for distribution in the US marketplace and 44 ANDA’s pending approval with the US health regulator. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Glenmark Pharmaceuticals Ltd (GPL) is a global research-led pharmaceutical company with a presence across generics, speciality and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It ranked among the top 80 pharma & biotech companies of the world in terms of revenue.

At 10.45 am on Wednesday, the stock was trading at Rs 331.25, up by 1.05 per cent or Rs 3.45 per share. The 52-week high is recorded at Rs 653.60 and the 52-week low is Rs 168 on BSE.