Lupin surges on USFDA nod for valbenazine capsules — What's aiding the pharma scrip

Lupin shares surged on Friday after the pharmaceutical major received nod from the US Food and Drug Administration (FDA) for valbenazine capsules, used in the treatment of adults with tardive dyskinesia, a medical condition that affects a person's movement and facial tics like lip-smacking and grimacing.

Valbenazine Capsules had an estimated sales of $1,235 million in the US, according to a filing. | Representational image: Reuters

Lupin shares surged more than five per cent on Friday as the pharmaceutical major received nod from the US Food and Drug Administration (FDA) for valbenazine capsules. The medicine is used for the treatment of adults with tardive dyskinesia, which is a medical condition that affects a person's movement and facial tics like lip-smacking and grimacing.

"...it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) 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," Lupin said in an exchange filing.

Valbenazine Capsules had an estimated sales of $1,235 million in the US, the filing added.

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Lupin share price today

Lupin shares finished the day with a gain of Rs 19.4 or three per cent at Rs 659.1 apiece on BSE, having risen as much as 5.3 per cent to Rs 673.6 apiece during the session. The Lupin stock has lost 11 per cent in the last one year, in line with a 12 per cent fall in the Nifty Pharma index.

Why was Lupin in news last week?

On March 25, Lupin 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 done from March 20 to March 24, 2023.

What did the management say on the UK regulator's inspection?

Lupin's Managing Director Nilesh Gupta said, "We are proud that our Pithampur site has been successfully inspected by the MHRA again, highlighting our unwavering commitment to quality and compliance. 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."

What does Lupin do?

The Mumbai-based pharma company manufactures and sells a wide range of branded and generic formulations, biotech products and active pharmaceutial ingredients (APIs) catering to over 100 markets in the US, India, South Africa and the APAC, Latin America, Europe and West Asia. It enjoys a leadership position in cardiovascular or heart diseases, anti-diabetic, and respiratory segments.

Lupin is the third-largest pharma company in the US by prescriptions and the company, having invested 8.7 percent of its revenue in research and development in the year ended March 2022.

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