Inotersen API Manufacturer in India

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

About Inotersen API

High-Purity Inotersen API for Hereditary Transthyretin Amyloidosis

Inotersen API is a pharmaceutical-grade antisense oligonucleotide (ASO) designed for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy. It selectively binds to transthyretin (TTR) messenger RNA (mRNA), promoting its degradation and reducing the production of transthyretin protein responsible for amyloid deposition.

By lowering circulating transthyretin levels, Inotersen helps slow disease progression, preserve neurological function, and improve quality of life in patients with hereditary transthyretin amyloidosis. It is administered as a subcutaneous injectable formulation.

Manufactured under WHO-GMP-certified facilities, our Inotersen API is produced using advanced oligonucleotide synthesis technologies to ensure exceptional purity, stability, biological activity, 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 pharmaceutical-grade API
  • Advanced antisense oligonucleotide technology
  • Selective transthyretin (TTR) mRNA inhibition
  • High biological activity
  • Excellent stability
  • WHO-GMP certified manufacturing
  • Low impurity profile
  • Complete CoA, MSDS & TDS
  • Batch-to-batch consistency
  • Worldwide bulk supply

Applications

  • Hereditary transthyretin amyloidosis (hATTR)
  • Polyneuropathy treatment
  • Neurological disorders
  • Injectable formulations
  • Oligonucleotide therapeutics
  • Biopharmaceutical manufacturing
  • Clinical research
  • Biotechnology research

Why Choose Swapnroop Pharma

  • WHO-GMP Certified Manufacturing
  • Advanced Oligonucleotide API Manufacturing
  • High-Purity Pharmaceutical 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
  • 5 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 Inotersen API used for?

Inotersen API is used in injectable pharmaceutical formulations for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.

2. How does Inotersen work?

Inotersen binds to transthyretin (TTR) mRNA, promoting its degradation and reducing TTR protein production, thereby limiting amyloid deposition.

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

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