Cariprazine Capsules

Form: Oral Capsules

Strength: 1.5 mg, 3 mg, 4.5 mg, 6 mg

Reference Brands: Vraylar®(US); Reagila®(EU)

Category: Antipsychotropic Drugs

Cariprazine capsules are FDA-approved in the U.S. for schizophrenia, bipolar I disorder (manic/mixed episodes), and as adjunctive therapy for major depressive disorder (MDD). In the EU, they are approved under the brand name Reagila for schizophrenia via centralized EMA procedures. Regulatory requirements include GMP-compliant manufacturing, robust clinical data, and safety documentation addressing extrapyramidal symptoms (EPS), akathisia, and metabolic effects. U.S. labeling must follow FDA guidance with boxed warnings for elderly dementia-related psychosis. EMA approval mandates detailed pharmacovigilance systems and Risk Management Plans (RMPs). To explore dossier-ready Cariprazine capsules, visit Pharmatradz.com — your global B2B pharma sourcing partner.