Lupin shares gain on approval from USFDA for chlorpromazine hydrochloride tablets

On July 12, company's Nagpur Oral Solid Dosage facility received two observations with Form-483 from USFDA after closing inspection between July 3 and July 11, 2023.

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Lupin share price gained in the early trade on July 17 after the company received USFDA approval for chlorpromazine hydrochloride tablets. On July 14, Lupin announced that its wholly-owned subsidiary, Lupin Inc., based in Somerset, New Jersey, had received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application for chlorpromazine hydrochloride tablets USP in 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, to market a generic equivalent to the reference listed drug (RLD), 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 US. The chlorpromazine hydrochloride tablets USP had an estimated annual sale of USD 45 million in the US (IQVIA MAT Mar 2023).

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On July 12, company's Nagpur Oral Solid Dosage facility received two observations with Form-483 from USFDA after closing inspection between July 3 and July 11, 2023.

Management speak

"We are confident of addressing the observations raised, and will work with the U.S. FDA to resolve them at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities," company said.

On July 11, the company received the establishment inspection report (EIR) from the USFDA for its Pithampur Unit-2 manufacturing facility that manufactures oral solids and ophthalmic dosage forms. The EIR was issued post the last inspection of the facility conducted from March 21 to March 29, 2023. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

At 09:27 hrs Lupin was quoting at Rs 934.00, up Rs 3.35, or 0.36 percent on the BSE.

The share touched a 52-week high of Rs 943.10 and a 52-week low of Rs 602.80 on 12 July, 2023 and 04 August, 2022, respectively.

Currently, the stock is trading 0.96 percent below its 52-week high and 54.94 percent above its 52-week low.