Lupin Limited, a prominent international pharmaceutical company, declared that its Abbreviated New Drug Application (ANDA) for risperidone extended-release injectable suspension in 25 mg, 37.5 mg, and 50 mg per vial, intended for single-dose use, has been approved by the U.S. Food and Drug Administration (FDA). This marks Lupin’s first product developed using the proprietary technology of Nanomi BV, a Lupin subsidiary, and it carries 180-day CGT exclusivity. Nanomi specializes in advancing long-acting injectable (LAI) medicines aimed at improving patient outcomes and addressing critical treatment needs.
Vinita Gupta, Chief Executive Officer of Lupin, expressed her satisfaction with this regulatory milestone, emphasizing that the approval of the first product from the Nanomi LAI platform underscores the strength of the company’s research, operations, and development teams. She highlighted that the successful clearance not only validates the innovation behind the Nanomi platform but also reinforces Lupin’s commitment to making specialized injectable therapies more accessible for patients globally. Gupta further shared that Lupin’s strategy involves leveraging this platform to deliver new long-acting treatments that address significant unmet medical needs.
Nanomi’s LAI technology has been engineered to provide safe and effective drug delivery. Its patented particle control system creates highly uniform microspheres that allow for a prolonged and controlled release of medication, lasting from several weeks to months. This design makes administration easier through the use of finer needles while maintaining steady concentrations of the active drug in the patient’s system. Beyond improved administration, this technology holds the potential to extend the stability and shelf life of both new and existing products that can benefit from long-acting formulations.
Dr. Shahin Fesharaki, Chief Scientific Officer at Lupin, added that FDA’s approval of risperidone is a significant validation of Nanomi’s advanced technology and confirms Lupin’s capability to bring complex injectable medicines to market. He noted that this achievement reflects the expertise of Lupin’s multidisciplinary teams and marks an important step forward in the company’s mission to develop innovative long-acting therapies across a wide range of therapeutic categories.
Risperidone extended-release injectable suspension is approved as a bioequivalent to Risperdal Consta® Long-Release Injection, indicated for schizophrenia treatment and as monotherapy or adjunctive therapy with lithium or valproate for bipolar I disorder maintenance. The reference product recorded U.S. sales of about $190 million (IQVIA MAT, July 2025).
