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Ivosidenib bulk supplier for pharma manufacturers

Ivosidenib 250 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 250 mg

Reference Brands: Tibsovo (USA/EU)

Category: Oncology Cancer Care

Ivosidenib is a Oncology Cancer Care product available as Tablets in strengths 250 mg. It corresponds to the reference brand Tibsovo (USA/EU). 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:

Ivosidenib is a targeted anticancer therapy used alone or in combination with other treatments for adults with specific cancers that carry a mutation in the IDH1 gene. It is primarily indicated for the treatment of acute myeloid leukemia, cholangiocarcinoma (bile duct cancer), and certain types of myelodysplastic syndromes with confirmed IDH1 mutations. Genetic testing is required before treatment to ensure appropriate patient selection.

Ivosidenib works by selectively inhibiting the abnormal protein produced by the mutated IDH1 gene. By blocking this enzyme, the drug helps restore normal cellular differentiation and limits the uncontrolled growth of cancer cells. This targeted mechanism allows for a more precise treatment approach compared to conventional chemotherapy.

In addition to its approved indications, ivosidenib is being studied in clinical trials for the treatment of other IDH1-mutated cancers. It belongs to the class of enzyme inhibitors and is categorized as a targeted therapy. Ivosidenib is marketed under the brand name Tibsovo and is administered orally under specialist supervision, with regular monitoring required during treatment.

Ivosidenib — third party manufacturing & bulk supply

Ivosidenib 250 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 Ivosidenib 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

Ivosidenib is used for the treatment of adult patients with IDH1-mutated acute myeloid leukemia and other IDH1-mutated malignancies, as determined by an FDA-approved diagnostic test.

Ivosidenib is a small-molecule synthetic compound designed to selectively inhibit the mutant IDH1 enzyme involved in abnormal cancer cell metabolism.

The trade name of ivosidenib is Tibsovo.

Ivosidenib (Tibsovo) is manufactured by Servier Pharmaceuticals.

The generic name is ivosidenib.

The brand name is Tibsovo.

Ivosidenib is manufactured in regulated pharmaceutical facilities operated by Servier Pharmaceuticals for the USA, EU, and UK markets.

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