Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, a generic equivalent of Rexulti Tablets of Otsuka Pharmaceutical Company. This product would be manufactured at Lupin’s Pithampur facility in India.
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of $1,575 million in the U.S. (IQVIA MAT December 2022).
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.
