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- September 10, 2025

Lupin Receives U.S. FDA Approval for Risperidone Long-Acting Injectable, with 180-Day CGT Exclusivity

NAPLES, Fla., Sept. 10, 2025 /PRNewswire/ — Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) 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.

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