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Olutasidenib bulk supplier for pharma manufacturers

Olutasidenib 150 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 150 mg

Reference Brands: Rezlidhia (USA)

Category: Oncology Cancer Care

Olutasidenib is a Oncology Cancer Care product available as Capsules in strengths 150 mg. It corresponds to the reference brand Rezlidhia (USA). 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:

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.

Olutasidenib — third party manufacturing & bulk supply

Olutasidenib 150 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 Olutasidenib 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

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.

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