Mumbai, Baltimore: Global pharma major Lupin Limited (Lupin) today announced the launch of Posaconazole Delayed-Release Tablets, 100 mg, after its alliance partner AET Pharma US Inc. (part of Tiefenbacher Group) received an approval for its ANDA from the United States Food and Drug Administration.

Posaconazole Delayed-Release Tablets, 100 mg, are the generic equivalent of Noxafil® Delayed-Release Tablets, 100 mg, of Merck Sharp & Dohme Corp, and are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Posaconazole Delayed-Release Tablets, 100 mg (RLD: Noxafil®) had estimated annual sales of USD 186 million in the U.S. (IQVIA MAT December 2020).

About Lupin Limited

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 15 manufacturing sites, 7 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

Noxafil® is a registered trademark of Merck Sharp & Dohme Corp.