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Inotuzumab Ozogamicin bulk supplier for pharma manufacturers

Inotuzumab Ozogamicin Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 1 mg

Reference Brands: Besponsa (USA/LATAM)

Category: Oncology Cancer Care

Inotuzumab Ozogamicin is available in Injection and strengths such as 1 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, Inotuzumab 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)

Inotuzumab 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:

Inotuzumab ozogamicin is a targeted anticancer therapy classified as a monoclonal antibody–drug conjugate (ADC) used primarily for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The medicine combines a humanized monoclonal antibody that specifically targets the CD22 antigen found on malignant B cells with a potent cytotoxic agent called calicheamicin. Once the drug binds to CD22-positive leukemia cells, it is internalized into the cell, where the cytotoxic component is released to damage DNA and trigger cell death. This targeted approach helps deliver the chemotherapy directly to cancer cells while limiting exposure to normal tissues.

Inotuzumab ozogamicin has shown significant effectiveness in patients who have not responded well to previous treatments or whose disease has returned after therapy. It can help achieve remission and may serve as a bridge to stem cell transplantation in eligible patients. However, treatment requires careful monitoring because the drug can cause side effects, including low blood cell counts, infections, and liver-related complications. One of the most important risks associated with this therapy is sinusoidal obstruction syndrome, a serious liver condition that can occur during or after treatment. Due to these potential risks, therapy is typically managed by oncology specialists with regular clinical and laboratory monitoring to ensure patient safety and treatment effectiveness.

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Frequently Asked Questions

Inotuzumab ozogamicin is used for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. It is prescribed when the disease has returned after previous treatment or has not responded to other therapies.

Inotuzumab ozogamicin is an antibody–drug conjugate composed of a monoclonal antibody that targets the CD22 protein on B cells, linked to a cytotoxic agent that helps destroy leukemia cells after the drug binds to them.

The primary trade name of Inotuzumab ozogamicin is Besponsa.

Inotuzumab ozogamicin (Besponsa) is developed and marketed by Pfizer.

The generic name is Inotuzumab ozogamicin.

The main brand name is Besponsa.

Inotuzumab ozogamicin is manufactured in GMP-certified biologics production facilities approved by regulatory authorities such as the US FDA, EMA, and other international agencies depending on the region of supply.

Yes, Inotuzumab 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, Inotuzumab 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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