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Lupin Receives Approval from USFDA for Chlorpromazine Hydrochloride Tablets; Shares Gain on Approval

The EIR was issued following an inspection of the Dabhasa facility from 8 April to 12 April 2024.

On July 14, Lupin announced that its subsidiary, Lupin Inc, which is based in Somerset, New Jersey, had received a nod from United States Food and Drug Administration (USFDA) on its new drug application for chlorpromazine hydrochloride tablets USP in 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.

Upsher-Smith Laboratories LLC has a drug equivalent available in the market, chlorpromazine hydrochloride tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.

The drug will be produced at Lupin’s Somerset facility in the US.

The chlorpromazine hydrochloride tablets USP has an annual estimated sales of $45 million in the US.

The Company’s Nagpur Oral ODosage facility received two observations with Form-483 from the USFDA, closing inspection on July 3 and July 11.

On July 11, the company received the establishment inspection report from USFDA for its Pithampur Unit-2 manufacturing facility. The facility manufactures oral solids and ophthalmic dosage forms.

On July 12, the share touched a 52-week high of Rs 943.10.

At 9:27 am, Lupin quoted Rs 934 apiece, up by 0.36% or Rs 3.35 on BSE.

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