Paliperidone Once-Monthly IM Injection bulk supplier for pharma manufacturers

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 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.

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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.

Frequently Asked Questions

Yes, Paliperidone Once-Monthly IM Injection is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Paliperidone Once-Monthly IM Injection is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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