Glenmark Pharma advances on USFDA nod for Qtern generic

Glenmark Pharmaceuticals rose 1.43% to Rs 332.50 after the drug maker said it received tentative abbreviated new drug application (ANDA) approval for Dapagliflozin and Saxagliptin tablets in 10 mg/5 mg strengths.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Dapagliflozin and Saxagliptin tablets, 10 mg/5 mg. The drug is the generic version of Qtern tablets of AstraZeneca AB.

According to IQVIA sales data for the 12 month period ending February 2020, the Qtern tablets, 10 mg/5 mg market achieved annual sales of approximately $10.4 million. The drug is indicated to improve glycemic control in adults with type 2 diabetes mellitus.

Glenmark's current portfolio consists of 162 products authorized for distribution in the US marketplace and 44 ANDA's pending approval with the USFDA. 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.

On a consolidated basis, the drug maker reported 64% rise in net profit to Rs 190.74 crore on a 5.1% increase in net sales to Rs 2638.62 crore in Q3 December 2019 over Q3 December 2018.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.

The stock has added 61.52% in the past one month while the Nifty Pharma has risen 30.76% during the same period.

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