Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension

Core Insights - Amneal Pharmaceuticals has received FDA approval for risperidone extended-release injectable suspension in multiple dosages, which will launch in Q4 2025, enhancing its complex injectables portfolio [1][3] - The product is indicated for the treatment of schizophrenia and as an adjunctive therapy for Bipolar I disorder, reflecting the company's focus on mental health [2][3] - The annual sales for risperidone extended-release injectable suspension were approximately $194 million for the 12 months ending July 2025, indicating a significant market opportunity [4] Company Overview - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, primarily in the U.S. market [5] - The company is expanding its Affordable Medicines segment across complex product categories, including injectables and biosimilars, while also growing its Specialty segment focused on central nervous system and endocrine disorders [5] - Amneal also operates the AvKARE segment, distributing pharmaceuticals and other products for the U.S. federal government and various markets [5]