Lupin receives USFDA approval for generic risperidone extended-release injectable suspension, stock ends over 3% higher

Lupin on Wednesday, September 3, said that it has received approval from the US Food and Drug Administration (USFDA) for its generic version of risperidone for extended-release injectable suspension, used in the treatment and maintenance of schizophrenia and bipolar disorder in adults.

Shares of Lupin Limited ended 3.3% up at ₹1,952 apiece on the NSE on Wednesday after touching an intraday high of ₹1,953.80 apiece.

The approval by the US health regulator is for the abbreviated new drug application (ANDA) for risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial and 50 mg per vial, single-dose vials, Lupin said in a regulatory filing.

"This is Lupin's first product using proprietary Nanomi BV's (Nanomi) technology and has a 180-day CGT (competitive generic therapies) exclusivity," it added.

Lupin’s subsidiary Nanomi is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients, the filing read. 

This is the approval of the first product from the Nanomi LAI platform, Lupin CEO Vinita Gupta said. 

"This first-cycle approval is a testament to the capabilities we have established for complex injectables across our teams in R&D, operations and related functions. It validates our platform capabilities at Nanomi and underscores our commitment to expanding access to complex injectables for patients globally," she said.

Gupta added, "As we execute on our strategy to evolve speciality/novel products, we plan to leverage the Nanomi platform for novel long-acting injectables that meet unmet patient needs".

Nanomi's LAI platform has shown efficacy and safety in drug delivery. The technology can offer lifecycle extension opportunities for products in development or on the market that would benefit from longer-acting formulations, the company said.

Risperidone for extended-release injectable suspension is bioequivalent to the reference listed drug Risperdal Consta long-acting injection, and is indicated for the treatment of schizophrenia, and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder.

The medicine had estimated annual sales of $190 million in the US, Lupin said, citing IQVIA MAT July 2025 data.

Lupin shares

Lupin shares touched their 52-week high of ₹2,402.90 per share on January 2, 2025, while they were at their 52-week low of ₹1,795.20 apiece.  The company’s market capitalisation stands at ₹89,158.48 crore.

Over the last five days, Lupin shares have jumped 2.5%, while they have rallied 3.7% in the past month. In the last six months, Lupin’s stock has declined by 0.05%. Year-to-date, the scrip dropped by as much as 17.46%.