ISATUXIMA API Manufacturer in India

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

About Isatuximab API

High-Purity Isatuximab API for Multiple Myeloma Treatment

Isatuximab API is a pharmaceutical-grade humanized IgG1 monoclonal antibody that selectively targets the CD38 receptor, a cell surface glycoprotein highly expressed on multiple myeloma cells. Binding to CD38 induces tumor cell death through multiple mechanisms, including antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and direct apoptosis.

Isatuximab is approved for use in combination with other antimyeloma therapies for the treatment of relapsed or refractory multiple myeloma in adult patients. It is administered as an intravenous infusion and represents an important targeted immunotherapy in hematologic oncology.

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

Key Features

  • High-purity recombinant monoclonal antibody
  • Humanized Anti-CD38 antibody
  • Excellent biological activity
  • Targeted immunotherapy for multiple myeloma
  • Suitable for injectable formulations
  • WHO-GMP certified manufacturing
  • Low impurity profile
  • Complete CoA, MSDS & TDS
  • Batch-to-batch consistency
  • Worldwide bulk supply

Applications

  • Multiple myeloma
  • Relapsed multiple myeloma
  • Refractory multiple myeloma
  • Hematologic oncology
  • Injectable biologic formulations
  • Monoclonal antibody manufacturing
  • Biopharmaceutical development
  • Clinical research

Why Choose Swapnroop Pharma

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

Packaging & Supply

Available Packaging

  • 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 Isatuximab API used for?

Isatuximab API is used in injectable biopharmaceutical formulations for the treatment of relapsed or refractory multiple myeloma in combination with other anticancer agents.

2. How does Isatuximab work?

Isatuximab binds to the CD38 protein on myeloma cells, triggering immune-mediated tumor cell destruction through ADCC, CDC, ADCP, and apoptosis.

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 Isatuximab API in commercial quantities for pharmaceutical and biopharmaceutical manufacturing worldwide.

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