Lupin shares gain on tentative USFDA approval for Valbenazine capsules

Lupin also announced that USFDA has completed a post-marketing adverse drug experience (PADE) inspection of the company’s operations, which closed with no observations.

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Lupin’s share price rose 2 percent intraday on March 27 after the pharma company received tentative approval from United States Food and Drug Administration (USFDA) for Valbenazine Capsules.

Lupin received the tentative approval for its abbreviated new drug application (ANDA), Valbenazine Capsules (40 mg, 60 mg, and 80 mg) to market a generic equivalent of Ingrezza Capsules (40 mg, 60 mg, and 80 mg) of Neurocrine Biosciences Inc, as per the press release.

Valbenazine Capsules had estimated annual sales of $1,235 million in the US.

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On March 25, the company announced the successful completion of the inspection carried out by the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA) at its Pithampur facilities in India. The inspection was conducted from March 20 to March 24, 2023.

“With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility and maintaining the highest standards of quality and compliance is a must,” said Nilesh Gupta, managing director at Lupin.

Lupin also announced that USFDA has completed a post-marketing adverse drug experience (PADE) inspection of the company’s operations. The inspection closed with no observations.

At 10:12 am, Lupin was quoting at Rs 659.10, up nearly 3 percent on the NSE.