Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Obeticholic Acid Tablets, 5 mg and 10 mg, a generic equivalent of Ocaliva Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Nagpur facility in India. Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of $262 million in the U.S. (IQVIA MAT March 2023).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
