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Lupin Receives U.S. FDA Approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
Mumbai, Baltimore, June 07, 2021: Global pharma major Lupin Limited (Lupin) today announced that it has received approval for its Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Truvada® Tablets, 200 mg/300 mg, of Gilead Sciences, Inc. The product will be manufactured at Lupin’s facility in Nagpur, India.
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. It is also used for for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (RLD: Truvada®) had estimated annual sales of USD 2.1 billion in the U.S. (IQVIA MAT March 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 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 third largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue on research and development in FY21.
Lupin has 15 manufacturing sites, 7 research centres, 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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*Safe Harbor Statement
Truvada® is a registered trademark of Gilead Sciences Inc.