Inclisiran API Manufacturer in India

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

About Inclisiran API

High-Purity Inclisiran API for Advanced Lipid-Lowering Therapy

Inclisiran API is a pharmaceutical-grade small interfering RNA (siRNA) therapeutic designed to reduce low-density lipoprotein cholesterol (LDL-C) by selectively inhibiting the production of proprotein convertase subtilisin/kexin type 9 (PCSK9) in the liver. By suppressing PCSK9 synthesis, Inclisiran increases LDL receptor availability, leading to enhanced clearance of LDL cholesterol from the bloodstream.

Inclisiran is indicated for the treatment of primary hypercholesterolemia, mixed dyslipidemia, and patients with atherosclerotic cardiovascular disease (ASCVD) requiring additional LDL-C reduction. Its long-lasting mechanism allows infrequent dosing while maintaining effective cholesterol control.

Manufactured under WHO-GMP-certified facilities, our Inclisiran API is produced using advanced oligonucleotide manufacturing technology to ensure exceptional purity, biological activity, stability, and batch-to-batch consistency. Every batch is supplied with complete regulatory documentation including Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and Product Specifications.

Key Features

  • High-purity pharmaceutical-grade siRNA API
  • Novel PCSK9-targeted RNA interference therapy
  • Long-lasting LDL cholesterol reduction
  • High biological activity
  • Excellent stability
  • Low impurity profile
  • WHO-GMP certified manufacturing
  • Complete CoA, MSDS & TDS
  • Batch-to-batch consistency
  • Worldwide bulk supply

Applications

  • Primary hypercholesterolemia
  • Mixed dyslipidemia
  • Atherosclerotic cardiovascular disease (ASCVD)
  • LDL cholesterol reduction
  • Injectable lipid-lowering formulations
  • Cardiovascular pharmaceutical 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 Inclisiran API used for?

Inclisiran API is used in injectable pharmaceutical formulations for lowering LDL cholesterol in patients with primary hypercholesterolemia, mixed dyslipidemia, and atherosclerotic cardiovascular disease.

2. How does Inclisiran work?

Inclisiran uses RNA interference (RNAi) technology to inhibit hepatic PCSK9 production, increasing LDL receptor expression and enhancing LDL cholesterol clearance from the bloodstream.

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

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