Brexpiprazole Tablets

Form: Tablets

Strength: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

Reference Brands: Rexulti®(US & EU)

Category: Antipsychotropic Drugs

Brexpiprazole tablets are FDA-approved in the United States for the treatment of schizophrenia and as an adjunctive therapy for major depressive disorder (MDD) in adults. In the European Union, Brexpiprazole is approved under brand names like Rxulti, primarily for schizophrenia, following centralized EMA procedures. Regulatory compliance includes GMP standards, comprehensive clinical data, and documentation on metabolic side effects, akathisia, and suicidality risks. U.S. submissions must meet FDA requirements including boxed warnings for elderly dementia-related psychosis. EMA approval mandates a full Risk Management Plan (RMP) and pharmacovigilance commitments. For dossier-ready Brexpiprazole tablets and sourcing options, visit Pharmatradz.com — your trusted B2B pharma platform.