Lupin’s Alliance Partner Concord Receives U.S. FDA Approval for Mycophenolate Mofetil Tablets USP

Mumbai, Baltimore, August 06, 2020: Pharma major Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Mycophenolate Mofetil Tablets USP, 500 mg, to market a generic version of CellCept^® Tablets of Roche Palo Alto LLC (Roche).

Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

Mycophenolate Mofetil Tablets USP, 500 mg (RLD: CellCept^®) had an annual sales of approximately USD 96 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

CellCept® is a registered trademark of Roche Holdings Inc.