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Dabrafenib bulk supplier for pharma manufacturers

Dabrafenib Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 50 mg ,75 mg

Reference Brands: Tafinlar (USA/EU)

Category: Oncology Cancer Care

Dabrafenib is available in Capsules and strengths such as 50 mg ,75 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, Dabrafenib 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)

Dabrafenib 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:

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.

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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.

Yes, Dabrafenib 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, Dabrafenib 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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