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Gilteritinib bulk supplier for pharma manufacturers

Gilteritinib Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 40 mg

Reference Brands: Xospata (USA/India), LuciGil (Asia)

Category: Oncology Cancer Care

Gilteritinib 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, Gilteritinib 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)

Gilteritinib 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:

Gilteritinib is a targeted anticancer medication used in the treatment of acute myeloid leukemia (AML), one of the most common types of leukemia in adults. AML is often associated with a poor prognosis, especially in patients whose disease has relapsed or does not respond to initial treatment. A significant proportion of AML patients carry a mutation in the FMS-like tyrosine kinase 3 (FLT3) gene, which leads to increased cancer cell growth and reduced cellular differentiation, contributing to the aggressive nature of the disease.

Gilteritinib is a second-generation FLT3 inhibitor designed to specifically target and block the activity of the FLT3 receptor. By inhibiting this signaling pathway, the drug helps slow the proliferation of leukemia cells and supports better disease control. It is primarily indicated for adult patients with relapsed or refractory AML who test positive for an FLT3 mutation using an approved diagnostic test.

Approved by the U.S. Food and Drug Administration (FDA), Gilteritinib represents an important advancement in targeted therapy for AML. It is marketed under the brand name Xospata and is administered orally in tablet form. The drug has shown improved clinical outcomes compared to conventional therapies in patients with FLT3-mutated AML.

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Frequently Asked Questions

Gilteritinib is used for the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults whose cancer cells have a mutation in the FLT3 gene. It helps control the progression of the disease in patients whose leukemia has returned or has not responded to previous treatments.

Gilteritinib is a small-molecule targeted therapy that works by inhibiting the FLT3 (FMS-like tyrosine kinase 3) receptor and other related kinases involved in the growth and survival of leukemia cells. By blocking these signals, Gilteritinib helps slow the growth and proliferation of cancerous cells.

The main trade name of Gilteritinib is Xospata.

Gilteritinib is developed and marketed by Astellas Pharma Inc..

The generic name of the medicine sold under the brand Xospata is Gilteritinib.

The primary brand name of Gilteritinib is Xospata.

Gilteritinib is manufactured at GMP-certified pharmaceutical facilities operated or authorized by Astellas Pharma Inc. and its global manufacturing partners, complying with regulatory standards such as the US FDA and EMA.

Yes, Gilteritinib 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, Gilteritinib 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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