Lupin’s arm gets USFDA’s nod for Chlorpromazine Hydrochloride Tablets

Date: 14-07-2023

Lupin’s wholly-owned subsidiary -- Lupin Inc. has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, to market a generic equivalent to the reference listed drug, Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg of Upsher-Smith Laboratories, LLC. This product will be manufactured at Lupin’s Somerset facility in the U.S. Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of $45 million in the U.S. (IQVIA MAT Mar 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.