Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced the launch of Zileuton Extended-Release Tablets, 600 mg, having received an approval from the United States Food and Drug Administration (U.S. FDA) earlier. The product would be manufactured at Lupin’s Nagpur facility, India.

Zileuton Extended-Release Tablets, 600 mg, is the generic equivalent of Zyflo CR^® Extended-Release Tablets, 600 mg, of Chiesi USA, Inc. and is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

Zileuton Extended-Release Tablets (RLD: Zyflo CR®) had an annual sales of approximately USD 40 million in the U.S. (IQVIA MAT June 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

Zyflo CR® is a registered trademark of Chiesi USA Inc.