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Mumbai, Naples, June 03, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received a tentative approval from the United States Food and Drug Administration (U.S. FDA)for its Abbreviated New Drug Application for Letermovir Tablets, 240 mg and 480 mg, to market a generic equivalent of Prevymis® Tablets, 240 mg and 480 mg, of Merck Sharp & Dohme LLC. This product will be manufactured at Lupin’s Nagpur facility in India.

Letermovir Tablets, 240 mg and 480 mg are indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.

Letermovir Tablets(RLD Prevymis®)had an estimated annual sale of USD314million in the U.S. (IQVIA MAT April 2024).

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 7.8% of its revenue in research and development in FY24.

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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