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Mitotane bulk supplier for pharma manufacturers

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.

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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.

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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.

Yes, Mitotane 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, Mitotane 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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