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Gemtuzumab Ozogamicin bulk supplier for pharma manufacturers

Gemtuzumab Ozogamicin 4.5 mg Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 4.5 mg

Reference Brands: Mylotarg (USA)

Category: Oncology Cancer Care

Gemtuzumab Ozogamicin is a Oncology Cancer Care product available as Injection in strengths 4.5 mg. It corresponds to the reference brand Mylotarg (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:

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.

Gemtuzumab Ozogamicin — third party manufacturing & bulk supply

Gemtuzumab Ozogamicin 4.5 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 Gemtuzumab Ozogamicin 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


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.

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