Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Propranolol Hydrochloride Extended-Release Capsules USP, 60 mg, 80 mg, 120 mg, and 160 mg, to market a generic equivalent of Inderal LA Extended- Release Capsules, 60 mg, 80 mg, 120 mg, and 160 mg, of ANI Pharmaceuticals, Inc. The product will be manufactured at Lupin’s Pithampur facility in India.
Propranolol Hydrochloride Extended-Release Capsules USP (RLD Inderal LA) had estimated annual sales of $71 million in the U.S. (IQVIA MAT November 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.
