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Enasidenib Mesylate bulk supplier for pharma manufacturers

Enasidenib Mesylate Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 100 mg

Reference Brands: Idhifa (USA)

Category: Oncology Cancer Care

Enasidenib Mesylate is available in Tablets and strengths such as 100 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, Enasidenib Mesylate 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)

Enasidenib Mesylate 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:

Enasidenib mesylate is a targeted anticancer therapy used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who carry a specific mutation in the isocitrate dehydrogenase-2 (IDH2) gene. It is prescribed when the disease has returned or has not responded adequately to prior treatment and is administered under specialist oncology care. In addition to its approved indication in AML, enasidenib mesylate is also being studied for potential use in other cancer types.

Mechanistically, enasidenib mesylate works by selectively inhibiting the abnormal IDH2 enzyme produced by the mutated gene. This inhibition helps reduce the production of oncometabolites that interfere with normal blood cell differentiation. Rather than directly killing cancer cells, the drug promotes the maturation of malignant cells into more normal forms, thereby slowing disease progression.

Enasidenib mesylate is classified as an enzyme inhibitor and is available as an oral tablet for once-daily administration. Commonly reported side effects include nausea, vomiting, diarrhea, reduced appetite, and elevated bilirubin levels. Due to potential risks to fetal and infant development, its use is not recommended during pregnancy or breastfeeding. Careful patient monitoring is essential throughout treatment.

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Frequently Asked Questions

Enasidenib mesylate is used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have an IDH2 mutation.

Enasidenib mesylate is a small-molecule targeted inhibitor formulated as a mesylate salt, specifically designed to selectively inhibit mutant IDH2 enzymes.

The trade name of enasidenib mesylate is Idhifa.

Idhifa was developed by Agios Pharmaceuticals and is marketed in collaboration with Bristol Myers Squibb.

The complete generic name is enasidenib mesylate.

The approved brand name is Idhifa.

Enasidenib mesylate tablets are manufactured in GMP-approved facilities located in the USA and other regulated pharmaceutical manufacturing regions, depending on the authorized supplier and market.

Yes, Enasidenib Mesylate 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, Enasidenib Mesylate 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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