Glenmark Pharma gets USFDA nod for generic version of Buphenyl tablets
BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).
Mumbai: Glenmark Pharmaceuticals Limited has announced that the company has received final approval from the United States Food & Drug Administration (U.S. FDA) for Sodium Phenylbutyrate Tablets USP, 500 mg.
The product is a 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.
BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with the late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy.
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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.
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Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with a presence across generics, specialty and OTC businesses and with operations in over 50 countries. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 10 manufacturing facilities spread across 4 continents and operations in over 80 countries.
The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year.
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