Lupin Receives USFDA Approval for Chlorpromazine Hydrochloride Tablets, Shares Surge

17 Jul 2023 , 10:22 AM

In early trade on July 17, Lupin, a leading pharmaceutical company, witnessed a gain in its share price following the news of receiving approval from the United States Food and Drug Administration (USFDA) for chlorpromazine hydrochloride tablets. 

USFDA Approval: Lupin Inc., Lupin’s wholly-owned subsidiary based in Somerset, New Jersey, received approval from the USFDA for its abbreviated new drug application for chlorpromazine hydrochloride tablets USP in various strengths.

The approved strengths include 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, which will serve as a generic equivalent to the reference listed drug (RLD) chlorpromazine hydrochloride tablets USP, manufactured by Upsher-Smith Laboratories, LLC. These tablets will be manufactured at Lupin’s Somerset facility in the United States.

The chlorpromazine hydrochloride tablets USP had an estimated annual sale of USD 45 million in the US, based on IQVIA data for the Moving Annual Total (MAT) until March 2023.

Lupin’s achievement of USFDA approval for chlorpromazine hydrochloride tablets reflects its dedication to providing affordable generic alternatives in the US market. The company’s commitment to quality and compliance remains steadfast as it strives to address the observations raised during inspections and uphold CGMP standards across its operations.

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