Enasidenib Mesylate bulk supplier for pharma manufacturers

Enasidenib Mesylate 100 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 100 mg

Reference Brands: Idhifa (USA)

Enasidenib Mesylate is a Oncology Cancer Care product available as Tablets in strengths 100 mg. It corresponds to the reference brand Idhifa (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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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.

Enasidenib Mesylate — third party manufacturing & bulk supply

Enasidenib Mesylate 100 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.

Indicative minimum order quantity

Enasidenib Mesylate is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Enasidenib Mesylate listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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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.