Mumbai, Baltimore: Lupin Limited (Lupin), global pharmaceutical company, announced today that it has received approval for its Sevelamer Carbonate Tablets, 800 mg, from the United States Food and Drug Administration, to market a generic equivalent of Renvela® Tablets, 800 mg, of Genzyme Corporation.
Sevelamer Carbonate Tablets, 800 mg, are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis.
Sevelamer Carbonate Tablets (RLD: Renvela®) had estimated annual sales of USD 348 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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Renvela® is a registered trademark of Genzyme Corporation.