Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its 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. This is Lupin’s first product using proprietary Nanomi B.V.’s (Nanomi) technology and has a 180-day CGT exclusivity. Nanomi, a Lupin subsidiary, is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients.
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.”
Nanomi’s LAI platform has demonstrated efficacy and safety in drug delivery. Its proprietary particle control technology creates uniform microspheres that deliver extended-release profiles from weeks to months, superior injectability through smaller needles, and consistent drug concentrations. The technology can provide lifecycle extension opportunities for products in development or on the market that would benefit from longer-acting formulations.
“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,” said Dr. Shahin Fesharaki, Chief Scientific Officer of Lupin. “This is a critical milestone that validates the capabilities of our cross- functional teams and constitutes a significant step forward in our journey to develop novel long-acting injectables across various therapeutic areas.”
Risperidone for extended-release injectable suspension 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. Risperidone for extended-release injectable suspension (RLD Risperdal Consta®) had estimated annual sales of USD 190 million in the U.S. (IQVIA MAT July 2025)
