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Dabrafenib bulk supplier for pharma manufacturers

Dabrafenib 50 mg ,75 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 50 mg ,75 mg

Reference Brands: Tafinlar (USA/EU)

Category: Oncology Cancer Care

Dabrafenib is a Oncology Cancer Care product available as Capsules in strengths 50 mg ,75 mg. It corresponds to the reference brand Tafinlar (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:

Dabrafenib is a targeted anticancer medication used for the treatment of cancers that carry specific BRAF gene mutations, particularly the BRAF V600E mutation. It works as a BRAF kinase inhibitor, blocking the abnormal B-Raf protein that drives uncontrolled cell growth and tumor development in mutation-positive cancers. By inhibiting this signaling pathway, dabrafenib helps slow or stop the growth of cancer cells.

It is used as a single agent for the treatment of unresectable or metastatic melanoma with BRAF V600E mutation and is also widely used in combination with the MEK inhibitor trametinib for broader mutation-positive cancers. Combination therapy is approved for indications including metastatic melanoma, metastatic non-small cell lung cancer, anaplastic thyroid cancer, and certain other unresectable or metastatic solid tumors with BRAF V600E mutation. Treatment selection is based on confirmed molecular testing. Dabrafenib is marketed under the brand name Tafinlar and is prescribed under oncology specialist supervision, with regular monitoring to manage safety and treatment response. It represents an important precision therapy option in mutation-driven cancer care.

Dabrafenib — third party manufacturing & bulk supply

Dabrafenib 50 mg ,75 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 Dabrafenib 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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Frequently Asked Questions

Dabrafenib is used for the treatment of BRAF V600 mutation-positive melanoma, non-small cell lung cancer, and certain other mutation-driven tumors, either alone or in combination with other targeted therapies.

It is a synthetic small-molecule BRAF kinase inhibitor formulated as dabrafenib mesylate for oral administration.

The trade name is Tafinlar.

It is developed and marketed by Novartis.

The generic name is dabrafenib mesylate.

The brand name is Tafinlar.

It is manufactured in GMP-approved pharmaceutical facilities by Novartis and its authorized manufacturing partners across multiple regions.

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