Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced that it has received tentative approval for its Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg, from the United States Food and Drug Administration (U.S. FDA) to market a generic version of Glyxambi^® Tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

Empagliflozin and Linagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg (RLD: Glyxambi^®) had an annual sales of approximately USD 242 million in the U.S. (IQVIA MAT Mar 2020).

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 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 and in India by global revenues. The Company invests 9.6 % of its revenues on research and development.

Lupin has fifteen manufacturing sites, seven 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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*Safe Harbor Statement

Glyxambi® is a registered trademark of Boehringer Ingelheim International GmbH