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Olutasidenib bulk supplier for pharma manufacturers

Olutasidenib Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 150 mg

Reference Brands: Rezlidhia (USA)

Category: Oncology Cancer Care

Olutasidenib is available in Capsules and strengths such as 150 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, Olutasidenib 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)

Olutasidenib 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:

Olutasidenib, marketed under the brand name Rezlidhia, is an oral targeted anticancer therapy used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. It belongs to a class of precision oncology drugs designed to address the underlying genetic drivers of certain cancers.

Olutasidenib works by selectively inhibiting the mutant IDH1 enzyme, which is responsible for producing the oncometabolite 2-hydroxyglutarate (2-HG). Elevated levels of 2-HG disrupt normal cellular differentiation and contribute to the development and progression of leukemia. By reducing 2-HG production, olutasidenib helps restore normal cell maturation and suppress the growth of malignant leukemic cells.

Administered orally, Rezlidhia offers a convenient treatment option for patients who have limited therapeutic alternatives after disease relapse or resistance to prior therapies. The drug represents an important advancement in personalized cancer treatment, as it is specifically indicated for patients whose tumors harbor an IDH1 mutation. Through its targeted mechanism of action, olutasidenib provides a focused approach to managing AML while minimizing effects on non-mutated cells, supporting improved disease control and patient outcomes.

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Frequently Asked Questions

Olutasidenib is used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation.

Olutasidenib is a small-molecule, synthetic IDH1 inhibitor designed to selectively block mutant IDH1 enzyme activity.

The trade name of olutasidenib is Rezlidhia.

Olutasidenib (Rezlidhia) is developed and marketed by Rigel Pharmaceuticals, Inc.

The generic name of Olutasidenib is olutasidenib.

Where is Olutasidenib manufactured?

Olutasidenib (Rezlidhia) is manufactured for Rigel Pharmaceuticals in the United States through FDA-approved pharmaceutical manufacturing facilities.

Yes, Olutasidenib 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, Olutasidenib 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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