September 29, 2022 Lupin Receives Approval from U.S. FDA for Mirabegron Extended-Release Tablets

Mumbai, Baltimore, September 29, 2022: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Mirabegron Extended-Release Tablets, 25 mg and 50 mg, to market a generic equivalent of Myrbetriq® Extended-Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development, Inc. The product will be manufactured at Lupin's facility in Nagpur, India.

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, (RLD Myrbetriq®) had estimated annual sales of USD 2403 million in the U.S. (IQVIA MAT June 2022).

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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a 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. The company invested 8.7% of its revenue in research and development in FY22.

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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For further information or queries please contact -

Shweta Munjal
Vice President & Global Head - Corporate Communications
Email: [email protected]

*Safe Harbor Statement
Myrbetriq® is a registered trademark of Astellas Pharma, Inc.