Mumbai, Baltimore, December 24, 2021: Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Azilsartan Medoxomil Tablets, 40 mg, and 80 mg to market a generic equivalent of Edarbi® Tablets, 40 mg, and 80 mg, of Arbor Pharmaceuticals, LLC. This product will be manufactured at Lupin’s Nagpur facility in India.
Azilsartan Medoxomil Tablets (RLD: Edarbi® Tablets) had estimated annual sales of USD 103.4 million in the U.S. (IQVIA MAT September 2021).
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.
The Company enjoys a leadership 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 is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue in research and development in FY21.
Lupin has 15 manufacturing sites, 7 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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Vice President & Global Head – Corporate Communications