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Neratinib maleate bulk supplier for pharma manufacturers

Neratinib Maleate Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 40 mg

Reference Brands: Nerlynx (USA/EU)

Category: Oncology Cancer Care

Neratinib maleate is available in Tablets and strengths such as 40 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, Neratinib maleate 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)

Neratinib maleate 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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📘 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.

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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.

Yes, Neratinib maleate 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, Neratinib maleate 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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