Lupin gets USFDA nod for Sevelamer Hydrochloride Tablets
Sevelamer Hydrochloride Tablets, 800 mg is a generic equivalent of Renagel® Tablets, 800 mg of Genzyme Corporation.
Mumbai: Global pharma major Lupin Limited (Lupin) today announced the launch of Sevelamer Hydrochloride Tablets, 800 mg, having received an approval from the United States Food and Drug Administration (FDA). The product will be manufactured at Lupin's facility in Nagpur, India.
Sevelamer Hydrochloride Tablets, 800 mg is a generic equivalent of Renagel® Tablets, 800 mg of Genzyme Corporation.
Sevelamer Hydrochloride Tablets, 800 mg (RLD: Renagel®) had estimated annual sales of USD 75 million in the U.S. (IQVIA MAT December 2021).
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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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. Lupin's R&D effort is aligned with our enterprise goal — to bring affordable, quality medicines to market in order to address unmet patient needs.
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The Company has position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas.Lupin commenced operations as a manufacturer of vitamins, and soon started producing drugs to combat tuberculosis (TB). Over the years, Lupin has grown and expanded into new areas and regions, manufacturing drugs that extend the promise of good health to communities across the globe. Beginning with two employees — a peon-cum-packer and a part-time typist — Lupin's current global footprint spans 11 countries, across six continents. The Intellectual Property Management Group (IPMG) at Lupin is responsible for creating, securing and leveraging advanced research to build a high-value portfolio of patents, products and research pipeline products.
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