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Gemtuzumab Ozogamicin bulk supplier for pharma manufacturers

Gemtuzumab Ozogamicin Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 4.5 mg

Reference Brands: Mylotarg (USA)

Category: Oncology Cancer Care

Gemtuzumab Ozogamicin is available in Injection and strengths such as 4.5 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, Gemtuzumab Ozogamicin 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)

Gemtuzumab Ozogamicin 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:

Gemtuzumab ozogamicin is a humanized monoclonal antibody–drug conjugate used in the treatment of acute myelogenous leukemia. It is designed to target CD33-positive leukemic cells, allowing the attached cytotoxic agent to be delivered directly into malignant cells. This targeted mechanism helps concentrate the therapeutic effect on cancer cells while reducing exposure to healthy tissues, making it an important option in specific leukemia treatment protocols.

During therapy, gemtuzumab ozogamicin has been associated with transient elevations in serum liver enzymes, reflecting its impact on hepatic function. In some patients, treatment has also been linked to the development of acute sinusoidal obstruction syndrome, a serious liver-related complication that may occur during or after therapy. While this condition is not uncommon, its severity can vary, and in rare cases it may be life-threatening.

Due to these potential risks, gemtuzumab ozogamicin is administered under strict medical supervision with careful patient selection and monitoring of liver function. It is typically used in specialized oncology settings where the benefits of targeted leukemia therapy can be balanced against the known safety considerations.

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Frequently Asked Questions


Gemtuzumab ozogamicin is used for the treatment of CD33-positive acute myeloid leukemia in adults and pediatric patients, including newly diagnosed as well as relapsed or refractory cases.


Gemtuzumab ozogamicin is made from a humanized monoclonal antibody chemically conjugated to a cytotoxic antibiotic, forming an antibody–drug conjugate.


The trade name of gemtuzumab ozogamicin is Mylotarg.


Gemtuzumab ozogamicin is manufactured and marketed by Pfizer.


The generic name of Gemtuzumab is gemtuzumab ozogamicin.


The brand name of Gemtuzumab is Mylotarg.


Gemtuzumab ozogamicin is manufactured in GMP-compliant pharmaceutical facilities, primarily in the USA and EU.

Yes, Gemtuzumab Ozogamicin 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, Gemtuzumab Ozogamicin 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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