GLYCEROL PHENYLBUTYRATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ph Health	GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	LIQUID;ORAL	205742	ANDA	Par Health USA, LLC	49884-264-95	1 BOTTLE in 1 CARTON (49884-264-95) / 25 mL in 1 BOTTLE	2025-10-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Glycerol phenylbutyrate (GPB) is a vital pharmaceutical used primarily in the management of urea cycle disorders (UCD), a rare genetic condition disrupting the body's ability to eliminate ammonia from the bloodstream. Its role in reducing hyperammonemia has made it a critical therapeutic agent globally. The manufacturing and supply chain of GPB are complex, involving specialized chemical synthesis and stringent regulatory standards. This report comprehensively explores the key suppliers involved in the production of glycerol phenylbutyrate, the global manufacturing landscape, and factors influencing supply continuity.

Manufacturing Overview of Glycerol Phenylbutyrate

Glycerol phenylbutyrate is a prodrug of phenylacetic acid, designed for oral administration to facilitate ammonia detoxification. Its synthesis involves chemical conjugation of glycerol with phenylbutyrate or related derivatives. The drug's production necessitates high-quality raw materials, advanced chemical processing, and adherence to Good Manufacturing Practices (GMP). As an orphan drug, GPB's supply chain is concentrated among specialized pharmaceutical manufacturers.

Leading Suppliers and Manufacturers

1. Orphan Drug Developers

Allergan (AbbVie):
Now part of AbbVie, Allergan developed Ravicti (glycerol phenylbutyrate), underscoring its prominent position in manufacturing and supplying GPB. Allergan's production facilities in the United States produce pharmaceutical-grade GPB under rigorous GMP standards, supplying global markets. Their integrated supply chain includes proprietary synthesis routes, quality control systems, and distribution networks.
Ipsen:
The French biopharmaceutical company has been involved in developing Ravicti and managing the global distribution of glycerol phenylbutyrate. Ipsen sources raw materials and oversees manufacturing, ensuring compliance with international regulatory standards.
Crinetics Pharmaceuticals:
A newer player focusing on rare diseases, Crinetics is advancing alternative formulations and exploring manufacturing partnerships to expand GPB supply.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of GPB synthesis, pharmaceutical companies often leverage CMOs for production scalability and quality assurance.

Recipharm:
A leading CMO headquartered in Sweden, Recipharm provides contract manufacturing services for pharmaceutical intermediates and finished products, including GPB. Their facilities are GMP-compliant, with expertise in complex chemical synthesis.
CordenPharma:
This global CMO specializes in building APIs and intermediates for small-molecule drugs. CordenPharma’s facilities in the U.S. and Europe provide custom synthesis services for glycerol derivatives, including GPB.
Laboratorios Grifo: (Spain)
A regional manufacturer capable of producing pharmaceutical intermediates, including conjugated glycerol derivatives, potentially contributing to the supply chain.

3. Raw Material Suppliers

The production of GPB hinges on sourcing high-purity raw chemicals:

Glycerol (Glycerin):
Major suppliers include Merck KGaA, BASF, and Croda International. These companies supply pharmaceutical-grade glycerol complying with USP and EP standards necessary for API synthesis.
Phenylacetic Acid and Phenylbutyrate Precursors:
Sourced from chemical manufacturers like Eastman Chemical Company, Evonik Industries, and Sigma-Aldrich. They provide high-purity chemical feeds crucial for the conjugation process.

Geographical Distribution and Market Dynamics

Most pharmaceutical-grade GPB is produced in North America and Europe, regions with advanced chemical manufacturing infrastructure and stringent regulatory oversight (FDA and EMA). The United States, through Allergan/AbbVie, represents a significant source of commercially available GPB, with multiple global distributors ensuring accessibility in over 50 countries.

Emerging markets, including China and India, are gradually developing domestic capabilities to produce glycerol derivatives, potentially impacting future supply dynamics. However, current capacity constraints and regulatory barriers limit widespread local production of high-purity GPB.

Regulatory and Supply Chain Considerations

Regulatory Approvals:
Suppliers must adhere to stringent regulatory approvals from agencies like the FDA and EMA. This compliance ensures manufacturing quality, safety, and efficacy, which are crucial for raw materials and APIs.
Supply Chain Risks:
Since GPB is a niche medication, supply disruptions are primarily due to raw material shortages, manufacturing delays, or regulatory hurdles. The COVID-19 pandemic exemplified vulnerabilities in chemical supply chains, prompting some manufacturers to diversify supplier bases.
Strategic Stockpiling & Partnerships:
To mitigate shortages, pharmaceutical companies often establish long-term partnerships with raw material vendors and CMOs, investing in redundancy and geographic diversification.

Future Outlook

The global demand for GPB is expected to grow with increased diagnosis of UCD and expanded orphan drug markets. Manufacturers are investing in scalable synthesis processes and establishing regional manufacturing hubs. Furthermore, biosimilar and generic entrants are anticipated as patents expire or as new formulations receive regulatory approval, broadening the supplier base.

Key Takeaways

Major Suppliers: Allergan/AbbVie leads in manufacturing and distributing Glycerol phenylbutyrate, supported by specialized CMOs such as Recipharm and CordenPharma.
Raw Material Providers: Trusted chemical suppliers like Merck, BASF, and Sigma-Aldrich ensure the availability of high-grade glycerol and phenylacetic acid derivatives integral to GPB synthesis.
Geographic Concentration: North America and Europe dominate the GPB supply chain, with emerging regional players poised to expand.
Supply Risks: Raw material shortages and regulatory delays pose persistent risks; diversification and strategic partnerships are critical.
Growth Trends: Increasing prevalence of urea cycle disorders and orphan drug incentives will likely drive demand, prompting supply chain expansion and innovation.

FAQs

1. Who are the primary global manufacturers of glycerol phenylbutyrate?
The leading manufacturer is Allergan (now part of AbbVie), with regional support from CMOs like Recipharm and CordenPharma, primarily based in North America and Europe.

2. What raw materials are essential for glycerol phenylbutyrate production?
High-purity glycerol and phenylacetic acid derivatives are essential. These are supplied by chemical companies such as Merck, BASF, and Sigma-Aldrich.

3. Are there regional differences in GPB supply?
Yes. North America and Europe dominate production due to regulatory and infrastructure advantages. Emerging markets are developing capabilities but currently have limited supply roles.

4. How does regulatory compliance influence GPB suppliers?
Suppliers must meet strict GMP standards and approval from agencies like the FDA and EMA, ensuring safety, quality, and consistency of the final product.

5. What is the future outlook for GPB supply chain stability?
While current supply chains are robust, they remain vulnerable to raw material shortages and regulatory changes. Diversification, regional manufacturing expansion, and technological innovation are critical to ensure supply continuity.

References

[1] FDA Drug Approval Records, Ravicti (Glycerol Phenylbutyrate).
[2] Allergan/AbbVie Corporate Website, Glycerol Phenylbutyrate Manufacturing & Supply.
[3] CordenPharma Consultant Reports, API Production Capabilities.
[4] Sigma-Aldrich Chemical Supply Data, Raw Material Standards.
[5] MarketAnalysis, Orphan Drugs and Rare Disease Treatment Trends (2022).

Suppliers and packagers for GLYCEROL PHENYLBUTYRATE