Lurasidone Tablets

Form: Oral Tablets

Strength: 20 mg, 40 mg, 60 mg, 80 mg, 120 mg

Reference Brands: Latuda® (US)

Category: Antipsychotropic Drugs

Lurasidone tablets are FDA-approved in the United States for the treatment of schizophrenia and bipolar depression (bipolar I disorder) in adults and adolescents. In the European Union, Lurasidone is authorized under the brand name Latuda for schizophrenia in adults and adolescents aged 13 years and older, via centralized EMA procedures. Regulatory requirements include GMP-compliant manufacturing, clinical trial data demonstrating efficacy and safety, and documentation addressing metabolic effects, akathisia, and suicidality risks. U.S. submissions must comply with boxed warning requirements, while EMA approval requires Risk Management Plans (RMPs) and ongoing pharmacovigilance. To explore dossier-ready Lurasidone tablets and sourcing options, visit Pharmatradz.com — your trusted B2B pharma partner.