Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, to market a generic equivalent of Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, of Otsuka Pharmaceutical Co. This product will be manufactured at Lupin's Pithampur facility In India. Brexpiprazole Tablets (RLD: Rexulti Tablets) had estimated annual sales of $1258 million In the U.S. (IQVIA MAT July 2021).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.
