Lupin receives USFDA approval for Risperidone for extended-release injectable suspension

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Lupin receives USFDA approval for Risperidone for extended-release injectable suspension	Share Back
(03 Sep 2025)
Lupin today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials. This is Lupin's first product using proprietary Nanomi B.V.'s (Nanomi) technology and has a 180-day CGT exclusivity. Nanomi, a Lupin subsidiary, is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients.
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