Mumbai, Baltimore: Lupin Limited (NSE: Lupin), global pharmaceutical company, announced today that it has received approval for its Rufinamide Oral Suspension, 40 mg/mL, from the United States Food and Drug Administration, to market a generic equivalent of Banzel® Oral Suspension, 40 mg/mL, of Eisai Inc.
Rufinamide Oral Suspension, 40 mg/mL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in pediatric patients 1 year of age and older, and in adults.
Rufinamide Oral Suspension, 40 mg/ mL (RLD: Banzel®) had estimated annual sales of USD 124.5 million in the
U.S. (IQVIA MAT September 2020).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the 3rd largest pharmaceutical company in the U.S. by prescriptions and 5th in India by global revenues. The Company invests 9.6 % of its revenues on research and development.
Lupin has fifteen manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
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Head – Corporate Communications
Head – Investor Relations/Corporate M&A
General Manager – Corporate Communications
Banzel® is a registered trademark of Novartis AG Corporation.