Cariprazine Capsules Generics - Manufacturers & Suppliers
Vraylar®(US); Reagila®(EU)
| Product/Composition:- | Cariprazine Capsules |
|---|---|
| Strength:- | 1.5 mg, 3 mg, 4.5 mg, 6 mg |
| Form:- | Oral Capsules |
| Reference Brands:- | Vraylar®(US); Reagila®(EU) |
| MOQ | As per the manufacturer batch size |
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Cariprazine is an atypical antipsychotic that works as a partial agonist at dopamine D2 and D3 receptors, with a higher affinity for D3, and serotonin 5-HT1A receptor partial agonism, along with 5-HT2A receptor antagonism. This receptor activity helps balance dopamine and serotonin levels in the brain. Cariprazine capsules are used to treat schizophrenia, bipolar I disorder (manic or mixed episodes), and as an adjunctive treatment for major depressive disorder (MDD). Its unique D3 activity may offer cognitive and mood-related benefits with a favorable side effect profile.
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.