Glenmark Pharma receives USFDA approval for Sodium Phenylbutyrate Tablets

2 Nov 2022 , 11:11 AM

Glenmark Pharmaceuticals Limited has received United States Food & Drug Administration (U.S. FDA) final approval for Sodium Phenylbutyrate Tablets USP, 500 mg, the generic version of Buphenyl Tablets, 500 mg, of Horizon Therapeutics, LLC.

As per the filing, Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIATM 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.

At around 11:13 AM, Glenmark Pharmaceuticals Ltd is currently trading at Rs418.50 per share up by Rs5.3 or 1.28% from its previous closing of Rs413.20 per share on the BSE.

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