India Pharma Outlook Team | Friday, 05 September 2025
Pharmaceutical company Lupin Ltd today announced that the US Food and Drug Administration (USFDA), granted approval on its generic risperidone LAI extended-release injectable suspension (25 mg, 37.5 mg, and 50 mg single-dose vials) for the treatment and maintenance of schizophrenia and bipolar disorder in adults.
This marks Lupin’s first product to be approved, developed with the proprietary technology for new injectable medicines from Nanomi BV, Lupin’s Netherland-based sub, which is focused primarily on innovative long-acting injectable (LAI) medicines. Additionally, approval also provides Lupin with a 180-day Competitive Generic Therapies (CGT) exclusivity as a first competitor entering the US market.
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Lupin CEO Vinita Gupta said this is the approval of the first product from the Nanomi LAI platform. "This first-cycle approval is a testament to the capabilities we have established for complex injectables across our teams in R&D, operations and related functions. It validates our platform capabilities at Nanomi and underscores our commitment to expanding access to complex injectables for patients globally," she added.
This Nanomi’s LAI prof has been effective in providing better drug delivery with safety and efficacy, and offers lifecycle of existing products through longer-acting formulations. The approved product is bioequivalent to the reference listed drug, Risperdal Consta, for the treatment of schizophrenia and continued treatment of bipolar disorder with acute mania (as monotherapy, lithium/valproate) for maintenance treatment based on appropriate criteria. Based upon IQVIA MAT July 2025, there is approximately USD 190 million annual US sales for this indication, and potential for further growth in the market.
