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Lupin's First Nanomi Long-Acting Injectable Product, Risperidone, Receives U.S. FDA Approval for Schizophrenia and Bipolar I Disorder
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Global pharmaceutical company Lupin announced that it has received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Risperidone, an extended-release injectable suspension. This marks a significant milestone as it is the first product to be developed using the proprietary technology of Nanomi B.V., a Lupin subsidiary specializing in long-acting injectable (LAI) medicines. The approval includes a 180-day competitive generic therapy (CGT) exclusivity period.

According to Vinita Gupta, CEO of Lupin, this approval validates the company's capabilities in developing complex injectables and reinforces its commitment to expanding patient access to such medicines. Dr. Shahin Fesharaki, Chief Scientific Officer of Lupin, highlighted that the approval provides crucial validation for Nanomi's LAI technology platform, which uses a proprietary particle control technology to create uniform microspheres. This technology allows for extended-release profiles from weeks to months, superior injectability, and consistent drug concentrations. The approved Risperidone product is bioequivalent to the reference listed drug, Risperdal Consta® Long-Acting Injection, and is indicated for the treatment of schizophrenia and bipolar I disorder. The reference product had estimated annual sales of USD 190 million in the U.S. as of July 2025. Lupin, a global pharmaceutical leader headquartered in Mumbai, India, distributes its products in over 100 markets and has a strong presence in the U.S. across various therapeutic areas.

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