Inebilizumab API Manufacturer in India

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

About Inebilizumab API

High-Purity Inebilizumab API for Autoimmune Disease Therapy

Inebilizumab API is a pharmaceutical-grade humanized anti-CD19 monoclonal antibody developed for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. It selectively binds to the CD19 antigen expressed on B lymphocytes, resulting in targeted depletion of B cells that contribute to autoimmune disease progression.

By reducing pathogenic B-cell populations, Inebilizumab helps decrease relapse rates and neurological damage associated with autoimmune disorders. It is formulated as an intravenous injectable biologic and represents an important advancement in targeted immunotherapy.

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

Key Features

  • High-purity biopharmaceutical API
  • Humanized Anti-CD19 monoclonal antibody
  • Targeted B-cell depletion therapy
  • High biological activity
  • Excellent stability
  • WHO-GMP certified manufacturing
  • Low impurity profile
  • Complete CoA, MSDS & TDS
  • Suitable for injectable formulations
  • Worldwide bulk supply

Applications

  • Neuromyelitis Optica Spectrum Disorder (NMOSD)
  • Autoimmune neurological disorders
  • Injectable biologic formulations
  • Immunotherapy products
  • Monoclonal antibody manufacturing
  • Biopharmaceutical development
  • Clinical research
  • Biotechnology 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 Inebilizumab API used for?

Inebilizumab API is used in injectable biopharmaceutical formulations for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) and related autoimmune disorders.

2. How does Inebilizumab work?

Inebilizumab binds to the CD19 antigen on B lymphocytes, leading to targeted depletion of pathogenic B cells involved in autoimmune disease progression.

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 Inebilizumab API in commercial quantities for pharmaceutical and biopharmaceutical manufacturing with worldwide export support.

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