Mumbai, Baltimore, October 05, 2023: Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg to market a generic equivalent of Jynarque^® Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Co., Ltd. This product will be manufactured at Lupin’s Nagpur facility in India.

Tolvaptan Tablets (RLD Jynarque^®) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023).

About Lupin
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 7.9% of its revenue in research and development in FY23.

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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For further information or queries please contact –

Shweta Munjal
Vice President & Global Head – Corporate Communications & Sustainability
Email: shwetamunjal@lupin.com

*Safe Harbor Statement
Jynarque^® is the registered trademark of Otsuka Pharmaceutical Co., Ltd.