Lupin Limited, a global pharmaceutical company, has announced the launch of Risperidone extended-release injectable suspension in the United States. The product is available in three single-dose vial strengths: 25 mg, 37.5 mg, and 50 mg. It has received approval from the US Food and Drug Administration and will be protected by 180 days of CGT exclusivity. This launch holds special importance for Lupin as it is the first commercial product made using PrecisionSphere, a long-acting injectable platform developed by its subsidiary, Nanomi B.V.
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Nanomi’s long-acting technology creates uniform microspheres that deliver medication steadily over weeks or even months. This system ensures consistent dosing, easier administration with smaller needles, and steady drug levels in the body for patients. With this launch, Lupin aims to expand the use of the PrecisionSphere platform by working with other companies who want to prolong the life of their therapies.
Spiro Gavaris, President of US Generics at Lupin, said that launching Risperidone represents a major milestone for the company. He highlighted that this achievement shows Lupin’s increasing capability to develop complex injectable products and demonstrates the effectiveness of PrecisionSphere technology. Gavaris also pointed out that this move supports Lupin’s plan to grow its range of advanced long-acting treatments in various areas of healthcare.
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Dr. Fabrice Egros, President of Corporate Development at Lupin, added that the proven success of the PrecisionSphere platform, combined with Lupin’s history of successful partnerships, positions the company well to improve access to next-generation long-acting treatments.
He stated that Lupin is ready to use its internal knowledge and network of partners to make these therapies available to more patients through its own development programs and new global collaborations.
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