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