Mumbai, Baltimore: Global pharma major Lupin Limited (Lupin) today announced that it has received approval for its Tavaborole Topical Solution, 5%, from the United States Food and Drug Administration, to market a generic equivalent of Kerydin® Topical Solution, 5%, of Anacor Pharmaceuticals, Inc. The product will be manufactured at Lupin’s facility in Pithampur, India.

Tavaborole Topical Solution, 5%, is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Tavaborole Topical Solution (RLD: Kerydin®) had estimated annual sales of USD 76 million in the U.S. (IQVIA MAT December 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. For the nine months ended December 31, 2020, the Company invested 9.8% 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

Kerydin® is a registered trademark of Anacor Pharmaceuticals, Inc.