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Glycerol Phenylbutyrate bulk supplier for pharma manufacturers

Glycerol Phenylbutyrate 1.1 g/mL Suppliers & Bulk Manufacturers

Available Forms: Oral Solution

Available Strengths: 1.1 g/mL

Reference Brands: Ravicti (USA)

Category: Orphan Drugs

Glycerol Phenylbutyrate is a Orphan Drugs product available as Oral Solution in strengths 1.1 g/mL. It corresponds to the reference brand Ravicti (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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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.

Glycerol Phenylbutyrate — third party manufacturing & bulk supply

Glycerol Phenylbutyrate 1.1 g/mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Glycerol Phenylbutyrate listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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.

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