Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor Tablets, 150 mg, to market a generic equivalent of Kalydeco Tablets, 150 mg of Vertex Pharmaceuticals Incorporated. This product will be manufactured at Lupin’s Nagpur facility in India. Ivacaftor Tablets (RLD: Kalydeco Tablets) had estimated annual sales of $109 million in the U.S.
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.
