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).;

Published On 2022-11-03 05:45 GMT | Update On 2022-11-03 05:47 GMT

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.

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.

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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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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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).;

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