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.
Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Obeticholic Acid Tablets, 5 mg and 10 mg, to market a generic equivalent of Ocaliva® Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc.
Obeticholic Acid Tablets (RLD Ocaliva®) had estimated annual sales of USD 255 million in the U.S. (IQVIA MAT December 2022).
