Lupin Secures USFDA Nod for Risperidone Long-Acting Injectable; Stock Gains Over 2%

Mumbai, September 3, 2025: Lupin Limited (NSE: LUPIN, BSE: 500257) shares surged 2.20% to ₹1,931.20 in the morning session today. The shift happened after the company announced that it had received a US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) related to Risperidone extended-release injectable suspension (in 25 mg, 37.5 mg and 50 mg) single-dose vials. The drug is used widely to treat schizophrenia and bipolar disorder, and the move strengthens Lupin’s specialty portfolio and signals strong growth potential.

By 2:30 PM IST, the stock was trading at ₹1,947.50, up ₹57.80 (3.06%) from its previous close of ₹1889.70. The day’s range was from ₹1,875.00 to ₹1,932.90 with a traded volume of 3.39 lakh shares and a traded value of ₹64.93 crore. The VWAP was ₹1,915.82. The last closing price was at ₹1,889.70, and it had a market cap of ₹88,199.30 crore and a 52-week range from ₹1,795.20 to ₹2,402.90, high and low, respectively.

USFDA Nod for Risperidone Injectables Boosts Lupin’s $190M Specialty Portfolio

Lupin has obtained approval for a risperidone long-acting injectable suspension, a bioequivalent of Risperdal Consta, from Johnson & Johnson. This represents Lupin’s first product from its long-acting injectable platform at Nanomi B.V. The company also obtained 180 days of Competitive Generic Therapy (CGT) exclusivity, offering a competitive advantage in the market. The reference product generated 190 million USD in annual sales in the US as of July 2025 (IQVIA MAT), indicating a strong commercial opportunity for Lupin’s launch.

Management Highlights Nanomi LAI Platform Validation and Global Specialty Growth Prospects

Vinita Gupta, CEO of Lupin, said: “We are very pleased with the approval of the first product from our Nanomi LAI platform. This first-cycle approval is a testament to the capabilities we have established for complex injectables. It validates our platform and underscores our commitment to expanding access to specialty products globally.”

Dr. Shahin Fesharaki, Chief Scientific Officer of Lupin, added: “Risperidone’s approval provides crucial validation of Nanomi’s LAI technology and marks a significant step in developing novel long-acting injectables across therapeutic areas.”

Risperidone Approval Strengthens Lupin’s Injectable Portfolio and US Presence

Lupin’s recent USFDA approval for risperidone long-acting injectable, along with 180-day CGT exclusivity, complements its growing complex injectable portfolio. The development is further supported by a $190 million market opportunity, which exemplifies Lupin’s prospects for growth and solidifies Lupin’s specialty pharmaceutical position globally.

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REF: https://nsearchives.nseindia.com/corporate/Lupin2_03092025125748_NSELetterwithPressRelease03092025.pdf

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