Inotuzumab Ozogamicin API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

About Inotuzumab Ozogamicin API

High-Purity Inotuzumab Ozogamicin API for Targeted Hematologic Oncology

Inotuzumab Ozogamicin API is a pharmaceutical-grade CD22-directed antibody-drug conjugate (ADC) designed for the treatment of relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL). It combines a humanized monoclonal antibody targeting CD22 with the potent cytotoxic agent calicheamicin, enabling selective delivery of the drug to malignant B cells.

After binding to CD22-expressing cells, the conjugate is internalized, releasing calicheamicin intracellularly. The cytotoxic payload induces DNA double-strand breaks, leading to apoptosis of cancer cells while minimizing exposure to healthy tissues.

Manufactured under WHO-GMP-certified biopharmaceutical facilities, our Inotuzumab Ozogamicin API is produced using advanced recombinant biotechnology and conjugation technologies to ensure exceptional purity, biological activity, stability, and batch-to-batch consistency. Every batch undergoes rigorous quality testing and is supplied with comprehensive regulatory documentation, including Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and Product Specifications.

Key Features

  • High-purity biopharmaceutical API
  • CD22-targeted antibody-drug conjugate (ADC)
  • Humanized monoclonal antibody technology
  • Potent calicheamicin cytotoxic payload
  • High biological activity
  • Excellent product stability
  • WHO-GMP certified manufacturing
  • Low impurity profile
  • Complete CoA, MSDS & TDS
  • Worldwide bulk supply

Applications

  • B-cell precursor Acute Lymphoblastic Leukemia (ALL)
  • Relapsed or refractory ALL
  • Hematologic malignancies
  • Targeted oncology therapy
  • Injectable biologic formulations
  • Antibody-drug conjugate development
  • Biopharmaceutical manufacturing
  • Clinical research

Why Choose Swapnroop Pharma

  • WHO-GMP Certified Manufacturing
  • Advanced Biopharmaceutical & ADC Manufacturing
  • High-Purity Oncology APIs
  • Comprehensive Quality Control
  • Complete Regulatory Documentation
  • Competitive Bulk Pricing
  • Reliable Worldwide Export
  • Technical & Regulatory Support
  • Consistent Batch Quality
  • Customized Packaging Solutions

Packaging & Supply

Available Packaging

  • 50 mg
  • 100 mg
  • 500 mg
  • 1 g
  • Custom Bulk Packaging Available

Documentation Provided

  • Certificate of Analysis (CoA)
  • Material Safety Data Sheet (MSDS)
  • Technical Data Sheet (TDS)
  • Product Specification Sheet
  • Batch Manufacturing Record

Frequently Asked Questions (FAQs)

1. What is Inotuzumab Ozogamicin API used for?

Inotuzumab Ozogamicin API is used in injectable biopharmaceutical formulations for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

2. How does Inotuzumab Ozogamicin work?

It binds to the CD22 antigen on B lymphocytes and delivers the cytotoxic agent calicheamicin directly into cancer cells, causing DNA damage and programmed cell death.

3. Is regulatory documentation available?

Yes. We provide CoA, MSDS, Technical Data Sheet (TDS), Product Specifications, and complete regulatory documentation with every shipment.

4. Is bulk commercial supply available?

Yes. We supply Inotuzumab Ozogamicin API in commercial quantities for pharmaceutical and biopharmaceutical manufacturing worldwide.

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