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Lupin Shares End 3% Higher on USFDA Nod for Schizophrenia, Bipolar Disorder Drug

Lupin
Lupin will receive an upfront licence fee along with royalties on net sales.

Shares of Lupin Ltd ended 3% higher after hitting a day’s high of Rs 1,953.80 on 3rd September, following the company’s announcement that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Injectable.

Lupin received USFDA approval for Risperidone extended-release injectable suspension in single-dose vials of 25 mg, 37.5 mg, and 50 mg. The drug is the bioequivalent of Risperdal Consta and is used to treat schizophrenia and bipolar disorder.

This is Lupin’s first product developed using Nanomi B.V.’s technology and comes with 180 days of CGT exclusivity. Nanomi, a Lupin subsidiary, focuses on creating innovative long-acting injectable medicines.

CEO Vinita Gupta said the company will continue to leverage the Nanomi platform to build novel long-acting injectables that address unmet patient needs.

Risperidone extended-release injectable suspension had estimated annual US sales of $190 million as of July 2025, according to IQVIA.

At 3:30 PM, shares of Lupin ended 3.30% higher at Rs 1,952 on NSE.

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