Gilteritinib 40 mg Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 40 mg
Reference Brands: Xospata (USA/India), LuciGil (Asia)
Category: Oncology Cancer Care
Gilteritinib is a Oncology Cancer Care product available as Tablets in strengths 40 mg. It corresponds to the reference brands Xospata (USA/India), LuciGil (Asia). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.
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.
Gilteritinib — third party manufacturing & bulk supply
Gilteritinib 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:
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 Gilteritinib 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.
Request a quote for Gilteritinib →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
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