Glucarpidase API Manufacturer in India

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

About Glucarpidase API

High-Purity Glucarpidase API for Oncology Emergency Care

Glucarpidase API is a pharmaceutical-grade recombinant enzyme used for the emergency treatment of toxic plasma methotrexate concentrations in patients experiencing delayed methotrexate clearance due to impaired renal function. The enzyme rapidly hydrolyzes methotrexate into inactive metabolites, significantly reducing circulating methotrexate levels and helping minimize life-threatening toxicity.

Glucarpidase plays a critical role in oncology supportive care, particularly following high-dose methotrexate therapy. It provides rapid detoxification when conventional supportive treatments alone are insufficient, helping protect patients from severe renal, hepatic, hematologic, and gastrointestinal toxicities.

Swapnroop Drugs and Pharmaceuticals manufactures premium-quality Glucarpidase API under stringent WHO-GMP manufacturing standards. Every batch undergoes rigorous quality testing for purity, biological activity, sterility, stability, and consistency. Complete regulatory documentation, including Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), and technical specifications, is provided.

Key Features

  • High-purity recombinant enzyme API
  • Rapid methotrexate detoxification
  • Excellent biological activity
  • High pharmaceutical stability
  • WHO-GMP compliant manufacturing
  • Low impurity profile
  • Sterile manufacturing process
  • Complete CoA & MSDS
  • Batch-to-batch consistency
  • Worldwide commercial supply

Applications

  • High-dose methotrexate toxicity management
  • Delayed methotrexate clearance
  • Oncology supportive care
  • Emergency hospital treatment
  • Injectable enzyme formulations
  • Cancer treatment support
  • Biopharmaceutical manufacturing
  • Clinical research

Why Choose Swapnroop Pharma

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

Packaging & Supply

Glucarpidase API is supplied in validated sterile pharmaceutical packaging suitable for commercial manufacturing and clinical applications.

Available packaging options:

  • Sterile Glass Vials
  • Clinical Trial Packaging
  • Commercial Bulk Packaging
  • Custom Packaging Available

Each shipment includes:

  • Certificate of Analysis (CoA)
  • Material Safety Data Sheet (MSDS)
  • Product Specification Sheet
  • Batch Manufacturing Record
  • Stability Data
  • Product Label
  • Technical Documentation

Frequently Asked Questions (FAQs)

1. What is the CAS Number of Glucarpidase API?

The CAS Number of Glucarpidase API is 129727-39-9.

2. What is Glucarpidase API used for?

Glucarpidase API is used for the emergency treatment of toxic methotrexate levels in patients with delayed methotrexate clearance due to impaired kidney function.

3. How does Glucarpidase work?

Glucarpidase rapidly breaks down methotrexate into inactive metabolites, lowering blood methotrexate concentrations and reducing the risk of severe toxicity.

4. Is regulatory documentation available?

Yes. We provide Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), technical specifications, and complete regulatory documentation.

5. Is bulk commercial supply available?

Yes. We offer commercial bulk quantities with reliable worldwide export support.

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