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)

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.

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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.

Paliperidone Once-Monthly Im Injection — third party manufacturing & bulk supply

Paliperidone Once-Monthly Im Injection is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Paliperidone Once-Monthly Im Injection is supplied as Once-Monthly IM Injection — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Paliperidone Once-Monthly Im Injection listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Paliperidone Once-Monthly IM Injection is listed as Once-Monthly IM Injection in 39 mg, 78 mg, 117 mg, 156 mg, 234 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Paliperidone Once-Monthly IM Injection is referenced against Xeplion®(EU); Invega Sustenna®(US). Reference brands are shown for identification only and remain the property of their respective trademark owners.