Mumbai, Baltimore, March 11, 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), Vigabatrin for Oral Solution USP, 500 mg to market a generic equivalent of Sabril® for Oral Solution, 500 mg of Lundbeck Pharmaceuticals, LLC. The product will be manufactured at Lupin’s facility in Goa, India.
Vigabatrin for Oral Solution USP, 500 mg (RLD Sabril®) had estimated annual sales of USD 275 million in the U.S. (IQVIA MAT December 2021).
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 9.6% of its revenue in research and development in FY21.
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.
For further information or queries please contact –
Vice President & Global Head – Corporate Communications
Sabril® is a registered trademark of Lundbeck LLC.