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Glycerol Phenylbutyrate bulk supplier for pharma manufacturers

Glycerol Phenylbutyrate Suppliers & Bulk Manufacturers

Available Forms: Oral Solution

Available Strengths: 1.1 g/mL

Reference Brands: Ravicti (USA)

Category: Orphan Drugs

Glycerol Phenylbutyrate is available in Oral Solution and strengths such as 1.1 g/mL. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Glycerol Phenylbutyrate is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Glycerol Phenylbutyrate can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Glycerol phenylbutyrate is a nitrogen-binding agent used for the chronic management of urea cycle disorders and is marketed under the brand name Ravicti. It is indicated for patients who cannot be adequately managed with dietary protein restriction and/or amino acid supplementation alone. Urea cycle disorders are rare inherited metabolic conditions that result in the accumulation of ammonia in the blood, which can be toxic to the brain and other organs.

Glycerol phenylbutyrate works by providing an alternative pathway for the elimination of excess nitrogen from the body. After oral administration, it is metabolized into phenylbutyric acid, which is further converted to phenylacetate. Phenylacetate conjugates with glutamine to form phenylacetylglutamine, a compound that is excreted through the kidneys. This process effectively removes nitrogen and helps reduce elevated ammonia levels in the bloodstream.

Designed for long-term use, glycerol phenylbutyrate allows for continuous control of hyperammonemia in both adult and pediatric patients. Its liquid oral formulation supports accurate dosing and improved tolerability, making it suitable for chronic therapy. Glycerol phenylbutyrate plays a critical role in the ongoing management of urea cycle disorders under specialist medical supervision.

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Frequently Asked Questions

Glycerol phenylbutyrate is used for the long-term treatment of urea cycle disorders to control chronic hyperammonemia in adults and pediatric patients.

Glycerol phenylbutyrate is a synthetically manufactured nitrogen-scavenging compound that is metabolized into active phenylacetate after administration.

The trade name of glycerol phenylbutyrate is Ravicti.

Ravicti is developed and marketed by Horizon Therapeutics (now part of Amgen).

The generic name of Glycerol Phenylbutyrate is glycerol phenylbutyrate.

The brand name of Glycerol Phenylbutyrate is Ravicti.

Glycerol phenylbutyrate oral solution is manufactured in GMP-compliant pharmaceutical facilities in the USA and EU, depending on the supplying market and regulatory approval.

Yes, Glycerol Phenylbutyrate is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Glycerol Phenylbutyrate is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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