Ipilimumab API Manufacturer in India

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

About Ipilimumab API

High-Purity Ipilimumab API for Cancer Immunotherapy

Ipilimumab API is a pharmaceutical-grade fully human monoclonal antibody that targets Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), an immune checkpoint receptor that negatively regulates T-cell activation. By blocking CTLA-4, Ipilimumab enhances the body's immune response against cancer cells, improving antitumor activity.

Ipilimumab is approved for the treatment of unresectable or metastatic melanoma and is also used in combination with other immune checkpoint inhibitors for the treatment of renal cell carcinoma, hepatocellular carcinoma, non-small cell lung cancer (NSCLC), malignant pleural mesothelioma, microsatellite instability-high (MSI-H) colorectal cancer, and other advanced malignancies.

Manufactured under WHO-GMP-certified biopharmaceutical facilities, our Ipilimumab 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
  • CTLA-4 immune checkpoint inhibitor
  • Potent cancer immunotherapy agent
  • High biological activity
  • Excellent stability
  • WHO-GMP certified manufacturing
  • Low impurity profile
  • Complete CoA, MSDS & TDS
  • Batch-to-batch consistency
  • Worldwide bulk supply

Applications

  • Metastatic melanoma
  • Renal cell carcinoma
  • Hepatocellular carcinoma
  • Non-small cell lung cancer (NSCLC)
  • Malignant pleural mesothelioma
  • MSI-H colorectal cancer
  • Combination immunotherapy
  • Biopharmaceutical manufacturing

Why Choose Swapnroop Pharma

  • WHO-GMP Certified Manufacturing
  • Advanced Monoclonal Antibody Production
  • High-Purity Biopharmaceutical 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 Ipilimumab API used for?

Ipilimumab API is used in injectable immunotherapy formulations for the treatment of melanoma and several advanced cancers through immune checkpoint inhibition.

2. How does Ipilimumab work?

Ipilimumab blocks the CTLA-4 receptor on T cells, enhancing immune activation and enabling the immune system to recognize and destroy cancer cells more effectively.

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

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