Glenmark Pharmaceuticals Receives ANDA Tentative Approval For Dapagliflozin Tablets, 5 mg And 10 mg

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dapagliflozin Tablets, 5 mg and 10 mg, the generic version of Farxiga®1 Tablets, 5 mg and 10 mg, of AstraZeneca AB.

According to IQVIATM sales data for the 12 month period ending January 2020, the Farxiga® Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately $1.8 billion*.

Glenmark’s current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 45 ANDA’s pending approval with the U.S. FDA. 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.

Shares of GLENMARK PHARMACEUTICALS LTD. was last trading in BSE at Rs.210.5 as compared to the previous close of Rs. 205.1. The total number of shares traded during the day was 214442 in over 5874 trades.

The stock hit an intraday high of Rs. 218.5 and intraday low of 203.9. The net turnover during the day was Rs. 45165155.

1All brand names and trademarks are the property of their respective owners.
2Market includes brand and all available therapeutic equivalents
*IQVIATM National Sales Perspectives: Retail & Non-Retail, January 2020.

-Equity Bulls