Paliperidone Once-Monthly Im Injection Suppliers & Bulk Manufacturers
Available Forms: Once-Monthly IM Injection
Available Strengths: 39 mg, 78 mg, 117 mg, 156 mg, 234 mg
Reference Brands: Xeplion®(EU); Invega Sustenna®(US)
Category:
Antipsychotropic Drugs
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 IM Injection is available in Once-Monthly IM Injection
and strengths such as 39 mg, 78 mg, 117 mg, 156 mg, 234 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Paliperidone Once-Monthly IM Injection is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Paliperidone Once-Monthly IM Injection can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
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.
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