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USFDA Nod to Lupin Injection Used in Treating Schizophrenia
Financial Express Delhi
|September 04, 2025
PHARMA MAJOR LUPIN on Wednesday said it had received approval from the US health regulator for its generic version of risperidone for extended-release injectable suspension, used in the treatment and maintenance of schizophrenia and bipolar disorder in adults.
The approval by the US Food and Drug Administration (USFDA) is for the 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, Lupin said in a regulatory filing. "This is Lupin's first product using proprietary Nanomi BV's (Nanomi) technology and has a 180-day CGT (competitive generic therapies) exclusivity," it added. Nanomi, a Lupin subsidiary, is focused on the development of innovative long-acting injectable (LAI) medicines to improve health
This story is from the September 04, 2025 edition of Financial Express Delhi.
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