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Neratinib maleate bulk supplier for pharma manufacturers

Neratinib Maleate 40 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 40 mg

Reference Brands: Nerlynx (USA/EU)

Category: Oncology Cancer Care

Neratinib Maleate is a Oncology Cancer Care product available as Tablets in strengths 40 mg. It corresponds to the reference brand Nerlynx (USA/EU). 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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📘 Sourcing Guide

Product Description:

Neratinib maleate is the maleate salt form of neratinib, an orally available, quinazoline-based small-molecule inhibitor with potent antineoplastic activity. It functions as an irreversible inhibitor of receptor tyrosine kinases, specifically human epidermal growth factor receptor 2 (HER2/ERBB2) and epidermal growth factor receptor (EGFR), both of which are commonly overexpressed or mutated in various types of cancer. These receptors play a crucial role in tumor cell proliferation, survival, and vascularization.

Following oral administration, neratinib maleate selectively targets and covalently binds to cysteine residues located within the ATP-binding pockets of HER2 and EGFR. This irreversible binding leads to sustained inhibition of receptor activity, effectively blocking downstream signal transduction pathways involved in cancer cell growth. As a result, neratinib induces cell cycle arrest and promotes programmed cell death (apoptosis) in tumor cells that express HER2 and EGFR.

Neratinib Maleate — third party manufacturing & bulk supply

Neratinib Maleate 40 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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Neratinib Maleate listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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Frequently Asked Questions


Neratinib is a small-molecule tyrosine kinase inhibitor. Its active pharmaceutical ingredient is neratinib maleate, which is chemically synthesized.


The trade name of neratinib is Nerlynx.


Neratinib (Nerlynx) is manufactured and marketed by Puma Biotechnology, Inc.


The generic name is neratinib maleate.


The brand name is Nerlynx.


Nerlynx is manufactured under GMP-compliant facilities approved for pharmaceutical production, primarily for the USA, EU, and UK markets.

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