Lupin Receives Tentative Approval from U.S. FDA for Drospirenone Tablets
Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg, to market a
Global pharma major Lupin Limited (Lupin) today announced
that it has received tentative approval from the United States Food and Drug Administration (FDA) for
its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg, to market a generic
equivalent of Slynd® Tablets, 4 mg, of Exeltis USA Inc.
Drospirenone Tablets (RLD Slynd®) had estimated annual sales of USD 141 million in the U.S. (IQVIA
MAT September 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.