Mumbai, Baltimore: Lupin Limited (NSE: Lupin), global pharmaceutical company, announced today that it has received tentative approval for its Efinaconazole Topical Solution, 10%, from the United States Food and Drug Administration, to market a generic equivalent of Jublia® Topical Solution, 10%, of Bausch Health Americas, Inc.

Efinaconazole Topical Solution, 10%, is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Efinaconazole Topical Solution, 10%, (RLD: Jublia®) had estimated annual sales of USD 222.9 million in the U.S. (IQVIA MAT September 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 3^rd largest pharmaceutical company in the U.S. by prescriptions and 5^th 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

Jublia® is a registered trademark of Bausch Health Ireland Limited.