Asenapine Maleate bulk supplier for pharma manufacturers

Asenapine Maleate 5 mg, 10 mg Suppliers & Bulk Manufacturers

Q: What company makes Asenapine Maleate?

Asenapine maleate is developed and marketed by Novartis Pharmaceuticals globally.

Available Forms: Tablets

Available Strengths: 5 mg, 10 mg

Reference Brands: Saphris (USA)

Asenapine Maleate is a Antipsychotropic Drugs product available as Tablets in strengths 5 mg, 10 mg. It corresponds to the reference brand Saphris (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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Product Description:

Asenapine maleate is an atypical antipsychotic medication used for the treatment of schizophrenia and for the acute and long-term management of bipolar I disorder in adults. It is effective in controlling acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. Asenapine helps stabilize mood and reduce psychotic symptoms such as hallucinations, delusions, and severe mood swings by modulating dopamine and serotonin receptor activity in the brain.

Chemically, asenapine is derived from modifications of the tetracyclic antidepressant mianserin, resulting in a potent atypical antipsychotic profile with improved efficacy and tolerability. It is administered sublingually, allowing rapid absorption and onset of action. Approved by the FDA, asenapine is indicated for both acute treatment phases and maintenance therapy in adults with schizophrenia or bipolar I disorder. Its unique pharmacological properties make it a valuable option for managing complex psychiatric conditions while supporting adherence through convenient sublingual administration.

Asenapine Maleate — third party manufacturing & bulk supply

Asenapine Maleate 5 mg, 10 mg 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

Asenapine Maleate is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 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 Asenapine Maleate 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

Asenapine maleate is used for the treatment of schizophrenia in adults and for acute and maintenance treatment of manic or mixed episodes associated with bipolar I disorder. It helps control psychotic and mood symptoms by regulating dopamine and serotonin activity in the brain.

Asenapine maleate is a chemically synthesized atypical antipsychotic formulated as a sublingual tablet for rapid absorption.

The trade names include Saphris in the USA and Sycrest in Europe and the UK.

Asenapine maleate is developed and marketed by Novartis Pharmaceuticals globally.

The generic name is asenapine maleate.

The brand names are Saphris and Sycrest.

Asenapine maleate is manufactured in FDA-, EMA-, and MHRA-approved pharmaceutical facilities, adhering to international standards for sublingual antipsychotic medications.