Research & Development
Lupin launches Risperidone long-acting injectable with 180-day CGT exclusivity in US market
17 November 2025 -

India-based global pharma company Lupin Limited (BSE: 500257) (NSE: LUPIN) announced on Friday the US launch of Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials, with 180-day CGT exclusivity.

This follows the recent approval from the US Food and Drug Administration (FDA).

The product is Lupin's first using proprietary technology from PrecisionSphere, the long-acting injectable (LAI) platform developed by its subsidiary Nanomi B.V.

PrecisionSphere technology creates uniform microspheres that deliver extended-release profiles from weeks to months, superior injectability through smaller needles, and consistent drug concentrations. Lupin is expanding the reach of its PrecisionSphere technology through collaborations with companies looking to extend their product lifecycles.

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