Lupin Limited announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone for extended-release injectable suspension, available in 25 mg, 37.5 mg, and 50 mg single-dose vials. This marks Lupin's first product utilizing Nanomi B.V.'s technology and includes a 180-day CGT exclusivity.
Vinita Gupta, CEO of Lupin, expressed satisfaction with the approval of the first product from their Nanomi LAI platform. She emphasized that this first-cycle approval demonstrates the capabilities established for complex injectables across their R&D, Operations, and related functions. Gupta added that it validates their platform capabilities at Nanomi and reinforces their commitment to expanding access to complex injectables for patients globally, as they execute their strategy to evolve specialty/novel products.
Nanomi's LAI platform has shown efficacy and safety in drug delivery, employing proprietary particle control technology to create uniform microspheres. These microspheres provide extended-release profiles lasting from weeks to months, enhanced injectability through smaller needles, and consistent drug concentrations. The technology offers lifecycle extension opportunities for products in development or already on the market that could benefit from longer-acting formulations.
Dr. Shahin Fesharaki, Chief Scientific Officer of Lupin, stated that the U.S. FDA approval of Risperidone provides crucial validation of Nanomi's LAI technology platform and demonstrates Lupin's ability to bring complex injectables to market. He noted that this milestone validates the capabilities of their cross-functional teams and represents a significant step forward in their journey to develop novel long-acting injectables across various therapeutic areas.
Risperidone for extended-release injectable suspension is bioequivalent to Risperdal Consta® Long-Acting Injection and is indicated for the treatment of schizophrenia and as monotherapy or 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).
Lupin Limited, headquartered in Mumbai, India, distributes its products in over 100 markets. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has a strong presence in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. With 15 manufacturing sites and 7 research centers globally, Lupin employs over 24,000 professionals and is dedicated to improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
Risperdal Consta® is a registered trademark of Johnson & Johnson.
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