Glycerol Phenylbutyrate API Manufacturer in India

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

About Glycerol Phenylbutyrate API

High-Purity Glycerol Phenylbutyrate API for Urea Cycle Disorder Treatment

Glycerol Phenylbutyrate API is a pharmaceutical-grade nitrogen-binding agent indicated for the long-term management of urea cycle disorders (UCDs) in patients who cannot effectively eliminate ammonia through the normal urea cycle. After oral administration, it is metabolized to phenylbutyrate and subsequently phenylacetate, which binds with glutamine to facilitate the excretion of excess nitrogen through the kidneys.

This mechanism helps reduce elevated blood ammonia levels (hyperammonemia), minimizing the risk of neurological complications associated with urea cycle disorders. Glycerol Phenylbutyrate is commonly used alongside dietary protein restriction and nutritional management as part of a comprehensive treatment plan.

Swapnroop Drugs and Pharmaceuticals manufactures premium-quality Glycerol Phenylbutyrate API under stringent WHO-GMP manufacturing standards. Every batch is tested for purity, assay, stability, and pharmaceutical quality to ensure compliance with international standards. Complete regulatory documentation, including Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), and technical specifications, is available.

Key Features

  • High-purity pharmaceutical-grade API
  • Nitrogen-binding therapeutic agent
  • Effective management of hyperammonemia
  • Excellent chemical stability
  • WHO-GMP compliant manufacturing
  • Low impurity profile
  • Complete CoA & MSDS
  • Batch-to-batch consistency
  • Worldwide bulk supply
  • Suitable for oral pharmaceutical formulations

Applications

  • Urea Cycle Disorders (UCDs)
  • Hyperammonemia management
  • Rare metabolic disease therapy
  • Oral liquid formulations
  • Pharmaceutical manufacturing
  • Hospital formulations
  • Clinical research
  • Specialty pharmaceutical products

Why Choose Swapnroop Pharma

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

Packaging & Supply

Glycerol Phenylbutyrate API is supplied in pharmaceutical-grade HDPE containers, aluminum containers, or customized packaging suitable for commercial production.

Available Packaging Options:

  • 1 kg
  • 5 kg
  • 10 kg
  • 25 kg
  • Custom Bulk Packaging

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 Glycerol Phenylbutyrate API?

The CAS Number of Glycerol Phenylbutyrate API is 301-54-8.

2. What is Glycerol Phenylbutyrate API used for?

It is used for the long-term treatment of urea cycle disorders (UCDs) to help reduce elevated blood ammonia levels.

3. How does Glycerol Phenylbutyrate work?

It is metabolized to phenylacetate, which binds with glutamine to remove excess nitrogen from the body through urinary excretion, helping control hyperammonemia.

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 supply commercial quantities worldwide with reliable export support and customized packaging.

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