Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced today the launch of Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, after Lupin’s alliance partner Concord Biotech Limited (Concord) received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA).

Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, are the generic equivalent of Prograf® Capsules, 0.5 mg, 1 mg, and 5 mg, of Astellas Pharma US, Inc., and are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, and in pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants.

Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg (RLD: Prograf®) had an annual sales of approximately USD 303 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

Prograf^® is a registered trademark of Astellas Pharma Inc.