Glenmark Pharmaceuticals receives ANDA approval for Sodium Phenylbutyrate Tablets USP, 500 mg

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Sodium Phenylbutyrate Tablets USP, 500 mg, the generic version of Buphenyl® Tablets, 500 mg, of Horizon Therapeutics, LLC. Glenmark's Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA™ sales data for the 12-month period ending September 2022, the Buphenyl® market achieved annual sales of approximately $8.7 million*.

Glenmark's current portfolio consists of 177 products authorized for distribution in the U.S. marketplace and 46 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 Limited was last trading in BSE at Rs. 413.20 as compared to the previous close of Rs. 404.40. The total number of shares traded during the day was 103741 in over 4003 trades.

The stock hit an intraday high of Rs. 417.15 and intraday low of 406.30. The net turnover during the day was Rs. 42831678.00.

Source : Equity Bulls

Keywords

GlenmarkPharmaceuticals INE935A01035 USFDA FinalApproval SodiumPhenylbutyrateTablets