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Ivosidenib bulk supplier for pharma manufacturers

Ivosidenib Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 250 mg

Reference Brands: Tibsovo (USA/EU)

Category: Oncology Cancer Care

Ivosidenib is available in Tablets and strengths such as 250 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, Ivosidenib 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)

Ivosidenib 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:

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.

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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.

Yes, Ivosidenib 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, Ivosidenib 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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