Glenmark Pharma receives USFDA approval for sodium phenylbutyrate tablets | Tech Reddy


Glenmark Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (US FDA) for Sodium Phenylbutyrate Tablets USP, 500 mg, Generic Version Buphenyl Tablets, 500 mg, Horizon Therapeutics, LLC.

According to the filings, Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, is distributed in the USA by Glenmark Pharmaceuticals Inc., USA.

According to IQVIATM sales data, for the 12-month period ending September 2022, the Buphenyl market reached approximately $8.7 million in annual sales.

Glenmark’s current portfolio consists of 177 products approved for distribution in the US market and 46 ANDAs pending US FDA approval. In addition to these internal applications, Glenmark continues to identify and explore external development partnerships to complement and accelerate the growth of its existing pipeline and portfolio.

At around 11:13 AM, Glenmark Pharmaceuticals Ltd is currently trading at Rs 418.50 per share, or up by Rs 5.3 or 1.28% from its previous close of Rs 413.20 per share on the BSE.

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