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 5 mg and 10 mg sublingual tablets, a second-generation antipsychotic for bipolar I disorder and, in some markets, schizophrenia, for importers, distributors and hospital pharmacies.

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Product Description:

Asenapine maleate is a second-generation antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors, with affinity for many other serotonin, adrenergic and histamine receptors. Swallowed, it barely works, because the liver destroys almost all of it on first pass. The 5 mg and 10 mg tablets on this page are therefore sublingual, dissolving under the tongue within seconds and absorbed through the mouth lining. There is no swallowable version, and a transdermal patch in some markets is a separate product.

It is licensed for manic or mixed episodes of bipolar I disorder, alone or with lithium or valproate, and in the US also for schizophrenia. The tablet dissolves fully under the tongue, then the patient avoids food and drink for 10 minutes. Drowsiness, mouth numbness and altered taste are common. Serious allergic reactions, including angioedema, have been reported. Pharmacists expect the warning on elderly patients with dementia-related psychosis, metabolic monitoring, QT caution and care with fluvoxamine.

Sourcing notes. Asenapine is prescription-only. Reference tablets are fragile, moisture-sensitive fast-dissolving units in peelable blisters, so patients peel back the foil instead of pushing the tablet through. Ask for the CTD or ACTD dossier with sublingual bioequivalence, disintegration time and pack moisture-protection data, and for zone IVb stability where markets are hot and humid. Request batch CoAs, the GMP certificate and a CoPP. Give strength, pack size and labelling language, and confirm which indications your market registers.

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.