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Mitotane bulk supplier for pharma manufacturers

Mitotane 500 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 500 mg

Reference Brands: Lysodren (USA)

Category: Oncology Cancer Care

Mitotane is a Oncology Cancer Care product available as Tablets in strengths 500 mg. It corresponds to the reference brand Lysodren (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:

Mitotane, marketed under the brand name Lysodren, is a steroidogenesis inhibitor and cytostatic antineoplastic agent used primarily in the treatment of adrenocortical carcinoma (ACC) and, in some cases, Cushing's syndrome. It is a synthetic derivative of the insecticide DDT and an isomer of p,p'-DDD, also known as 2,4'-(dichlorodiphenyl)-2,2-dichloroethane (o,p'-DDD). Mitotane selectively destroys adrenal cortex cells and inhibits steroid synthesis, reducing tumor growth and hormone overproduction associated with ACC.

Lysodren is indicated for patients with persistent or metastatic adrenocortical carcinoma, those who are not candidates for surgery, or patients at high risk of recurrence following surgical resection. Clinical studies have shown that adjuvant therapy with Mitotane after radical surgery significantly prolongs the recurrence-free interval compared to surgery alone. The medication is available in oral tablet form, with a carefully titrated dosing regimen to balance efficacy and tolerability. Mitotane’s dual role in controlling tumor proliferation and abnormal steroid production makes it a cornerstone in the management of ACC and certain endocrine disorders. As an orphan drug, Lysodren addresses the needs of a rare patient population with advanced adrenal tumors.

Mitotane — third party manufacturing & bulk supply

Mitotane 500 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 Mitotane 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

Mitotane is used for the treatment of adrenocortical carcinoma (ACC), a rare cancer of the adrenal cortex. It is indicated for adjuvant therapy after surgery or for inoperable ACC to inhibit tumor growth and reduce excess steroid production.

Mitotane is a synthetic derivative of the insecticide dichlorodiphenyltrichloroethane (DDT). It selectively destroys adrenal cortex cells and inhibits steroidogenesis.

The trade name of Mitotane is Lysodren.

Lysodren (Mitotane) is manufactured and marketed by HRA Pharma in the USA and other regulated markets.

The generic name is mitotane.

The brand name is Lysodren.

Mitotane is manufactured in GMP-approved facilities by HRA Pharma and its contract manufacturing partners in the USA and Europe.

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