Lupin Limited has announced the U.S. launch of Risperidone for extended-release injectable suspension—available in 25 mg, 37.5 mg, and 50 mg single-dose vials—after receiving approval from the U.S. FDA. The product comes with 180-day Competitive Generic Therapy (CGT) exclusivity and marks the first commercial release from Lupin’s proprietary long-acting injectable platform, PrecisionSphere™, developed by its subsidiary Nanomi B.V.

Nanomi’s LAI platform uses PrecisionSphere™ technology to create uniform microspheres that enable controlled drug release from weeks to months, improved injectability with smaller needles, and consistent therapeutic concentrations. Lupin aims to expand the platform’s reach through collaborations with partners seeking longer-acting formulations for lifecycle extension.

Spiro Gavaris, President of U.S. Generics at Lupin, said the launch underscores the company’s strength in bringing complex injectables to market and highlights the capability of the PrecisionSphere™ platform. Dr. Fabrice Egros, President – Corporate Development, added that Lupin is positioned to broaden global access to advanced long-acting injectables through internal development and strategic partnerships.