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.
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:
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.
Request a quote for Mitotane →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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