Mitotane Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 500 mg
Reference Brands: Lysodren (USA)
Category:
Oncology Cancer Care
Mitotane is available in Tablets
and strengths such as 500 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, Mitotane 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) |
Mitotane 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.
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.
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