Paliperidone Once-monthly Im Injection Generics - Manufacturers & Suppliers
Xeplion®(EU); Invega Sustenna®(US)
| Product/Composition:- | Paliperidone Once-Monthly IM Injection |
|---|---|
| Strength:- | 39 mg, 78 mg, 117 mg, 156 mg, 234 mg |
| Form:- | Once-Monthly IM Injection |
| Reference Brands:- | Xeplion®(EU); Invega Sustenna®(US) |
| MOQ | As per the manufacturer batch size |
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Paliperidone is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors, helping manage symptoms like delusions, hallucinations, and disorganized thinking. The once-monthly intramuscular injection (Invega Sustenna) is used for the acute and maintenance treatment of schizophrenia and schizoaffective disorder in adults. It delivers steady plasma levels, supports medication adherence, and reduces relapse risk by eliminating the need for daily oral dosing.
Paliperidone once-monthly intramuscular injection (brand name: Invega Sustenna) is FDA-approved in the U.S. for the treatment of schizophrenia and schizoaffective disorder in adults. In the European Union, it is approved by the EMA via the centralized procedure for schizophrenia. Regulatory approval requires GMP-compliant long-acting injectable manufacturing, validated pharmacokinetic bridging studies, and robust clinical trial data supporting safety and relapse prevention. U.S. labeling includes a boxed warning for increased mortality in elderly patients with dementia-related psychosis. EU approvals mandate Risk Management Plans (RMPs) and ongoing pharmacovigilance. For sourcing and dossier-ready options, visit Pharmatradz.com.