Risperidone will be available in single –dose vials, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial and is bioequivalent to the reference listed drug (RLD), 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 I disorder.
This is Lupin’s first product using proprietary Nanomi B.V.’s (Nanomi) technology and has a 180-day CGT exclusivity. Nanomi, a subsidiary of the company, focuses on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients.
As per IQVIA MAT July 2025, Risperidone extended-release injectable suspension had estimated annual sales of $190 million in the U.S.
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 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. As we execute on our strategy to evolve specialty/novel products, we plan to leverage the Nanomi platform for novel long-acting injectables that meet unmet patient needs.”
Dr. Shahin Fesharaki, chief scientific officer of Lupin, said, “Risperidone’s U.S. FDA approval provides crucial validation of Nanomi’s LAI technology platform and testifies to Lupin’s ability to bring complex injectables to market. This is a critical milestone that validates the capabilities of our crossfunctional teams and constitutes a significant step forward in our journey to develop novel long-acting injectables across various therapeutic areas.”
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
Lupin’s consolidated net profit jumped 52.13% to Rs 1,219.03 crore on 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.