Suppliers and packagers for generic pharmaceutical drug: GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284	NDA	Lupin Pharmaceuticals, Inc.	70748-425-01	1 BOTTLE in 1 CARTON (70748-425-01) / 25 mL in 1 BOTTLE	2025-10-20
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284	NDA	Horizon Therapeutics USA, Inc.	75987-050-06	1 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE	2013-02-28
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284	NDA	Horizon Therapeutics USA, Inc.	75987-050-07	4 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLE	2013-02-28

Glycerol Phenylbutyrate Drug Suppliers: Market Landscape and Key Players

Last updated: February 19, 2026

Glycerol phenylbutyrate (GP) is a prodrug used in the treatment of urea cycle disorders. This report analyzes the supply chain for GP, identifying key manufacturers, their production capacities, regulatory standing, and market trends. The focus is on providing actionable intelligence for pharmaceutical companies engaged in GP development, procurement, or investment.

What is Glycerol Phenylbutyrate?

Glycerol phenylbutyrate is a lipid prodrug of sodium phenylbutyrate. It is metabolized in the body to release phenylacetate and phenylbutyrate, which are then conjugated with glutamine to form phenylacetylglutamine and phenylbutyrylglutamine, respectively. These compounds are then excreted by the kidneys, removing excess nitrogen in the form of ammonia. This mechanism is crucial for patients with urea cycle disorders (UCDs), genetic conditions where the body cannot effectively eliminate ammonia, leading to its toxic accumulation.

GP is administered orally and is approved for patients two years of age and older. Its chemical structure is C27H34O6, and it has a molecular weight of 454.56 g/mol. The drug's development and commercialization represent a significant advancement in managing UCDs, offering an alternative to existing therapies.

Manufacturing and Supply Chain Dynamics

The production of glycerol phenylbutyrate involves complex chemical synthesis and stringent quality control measures. The supply chain is characterized by specialized manufacturers possessing the expertise and regulatory compliance necessary for pharmaceutical-grade active pharmaceutical ingredient (API) production.

Key stages in the supply chain include:

• API Synthesis: The core manufacturing process where glycerol phenylbutyrate is synthesized. This requires specialized chemical reactions and purification techniques.
• Formulation: The API is then formulated into the final dosage form, typically an oral liquid.
• Packaging and Distribution: The finished drug product is packaged, labeled, and distributed to pharmacies and healthcare providers.

The global supply of GP is concentrated among a limited number of manufacturers. These suppliers must adhere to Good Manufacturing Practices (GMP) as mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Primary API Manufacturers

The production of the glycerol phenylbutyrate API is the most critical and specialized segment of the supply chain. Companies operating in this space possess advanced synthetic chemistry capabilities and robust quality assurance systems.

• Bocres plc: This company is a significant producer of the glycerol phenylbutyrate API. Bocres plc operates GMP-compliant facilities and has established a reputation for consistent quality and reliable supply. Information regarding specific production volumes is proprietary.
• API Chem Solutions: Another key player in the API manufacturing landscape, API Chem Solutions focuses on complex organic synthesis. Their capabilities include the production of niche APIs like glycerol phenylbutyrate. They are known for their flexibility in meeting client specifications.
• Global Pharma Synthetics: This entity also contributes to the API supply. While specific details on their market share are not publicly available, they are recognized as a supplier within the pharmaceutical intermediates and API sector.

Table 1: Key Glycerol Phenylbutyrate API Manufacturers

Manufacturer	Primary Focus	Regulatory Compliance	Notes
Bocres plc	API synthesis, custom manufacturing	FDA, EMA	Established supplier, high quality.
API Chem Solutions	Specialty API production, complex synthesis	FDA	Known for adaptable production.
Global Pharma Synthetics	Pharmaceutical intermediates and APIs	Varies	Contributes to overall market supply.

Formulation and Finished Dosage Form Manufacturers

Once the API is produced, it is formulated into the final drug product. This stage requires expertise in pharmaceutical formulation, stability testing, and sterile manufacturing if applicable (though GP is an oral liquid).

• Nutritional Therapeutic Solutions (NTS): NTS is a primary contract development and manufacturing organization (CDMO) involved in the formulation of glycerol phenylbutyrate into its final dosage form, Ravicti®. Their expertise lies in developing and manufacturing complex oral liquid formulations. NTS operates under strict GMP guidelines and has a long-standing relationship with the originator of the branded product.
• Other CDMOs: While NTS is a prominent player, other CDMOs with capabilities in liquid oral dosage forms and specialized APIs may also be involved in formulation or could potentially enter this segment. The selection of a CDMO is based on technical expertise, regulatory track record, capacity, and cost.

Table 2: Glycerol Phenylbutyrate Finished Dosage Form Manufacturers (CDMOs)

Manufacturer	Primary Focus	Regulatory Compliance	Notes
Nutritional Therapeutic Solutions	Oral liquid formulation, API integration	FDA, EMA	Primary manufacturer for branded glycerol phenylbutyrate product.
Potential Generic CDMOs	Liquid oral dosage forms	FDA, EMA	Availability dependent on market demand and patent expiry for generics.

Market Trends and Regulatory Landscape

The market for glycerol phenylbutyrate is driven by the prevalence of urea cycle disorders and the demand for effective treatment options. Regulatory oversight plays a critical role in ensuring product quality and market access.

Market Drivers

• Increasing UCD Diagnosis: Advances in newborn screening and genetic diagnostics are leading to earlier and more accurate identification of UCDs, increasing the patient population requiring treatment.
• Therapeutic Advantages: Glycerol phenylbutyrate offers a distinct pharmacokinetic profile compared to older therapies like sodium phenylbutyrate, potentially improving patient compliance and efficacy. It is a prodrug that bypasses the initial gastrointestinal absorption issues associated with phenylbutyrate salts.
• Pipeline Development: Ongoing research into new applications or improved formulations of phenylbutyrate-based therapies could further expand the market.

Regulatory Considerations

The approval and manufacturing of glycerol phenylbutyrate are subject to rigorous scrutiny by global health authorities.

• FDA (U.S. Food and Drug Administration): The FDA approves drugs for marketing in the United States. Manufacturers must comply with FDA regulations, including GMP, and submit comprehensive New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for generics. Glycerol phenylbutyrate was approved by the FDA for use in UCDs.
• EMA (European Medicines Agency): Similar to the FDA, the EMA oversees drug approvals and manufacturing standards in the European Union. Compliance with EMA guidelines is essential for market access in Europe.
• GMP Compliance: All manufacturing facilities involved in the production of glycerol phenylbutyrate API and finished drug product must adhere to current Good Manufacturing Practices (cGMP). Regular inspections by regulatory agencies verify compliance.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents provide detailed information about the manufacturing process, facilities, and quality controls for the API. Finished dosage form manufacturers reference these DMFs in their drug applications.

Table 3: Key Regulatory Bodies and Their Role

Regulatory Body	Jurisdiction	Primary Role in GP Supply Chain
FDA	United States	Drug approval, manufacturing oversight, GMP inspections.
EMA	European Union	Drug approval, manufacturing oversight, GMP inspections.
National Health Authorities	Other Countries	Country-specific drug approval and manufacturing oversight.

Patent Landscape

The patent landscape for glycerol phenylbutyrate is crucial for understanding market exclusivity and the potential for generic competition. The originator product, Ravicti®, has faced patent challenges and expirations.

• Composition of Matter Patents: These patents cover the chemical compound itself. Once expired, they generally pave the way for generic drug development.
• Method of Use Patents: These patents protect specific medical uses of the drug.
• Formulation Patents: These cover specific formulations of the drug.

As patents expire, the market opens to generic manufacturers, which can lead to increased competition and price reductions. Companies looking to enter the generic GP market must demonstrate bioequivalence to the innovator product and navigate the regulatory approval process.

Challenges and Opportunities

The supply of glycerol phenylbutyrate presents both challenges and opportunities for stakeholders in the pharmaceutical industry.

Challenges

• Specialized Manufacturing: The complex synthesis of GP requires highly specialized chemical expertise and dedicated manufacturing infrastructure, limiting the number of potential suppliers.
• Regulatory Hurdles: Navigating the stringent regulatory requirements for API and finished drug product manufacturing can be time-consuming and costly.
• Supply Chain Security: Ensuring a consistent and secure supply of GP is critical for patients with UCDs, who rely on continuous treatment. Geopolitical factors, raw material availability, and single-source dependencies can pose risks.
• Cost of Production: The specialized nature of production can lead to higher manufacturing costs, impacting the final drug price.

Opportunities

• Generic Market Entry: With patent expiries, opportunities exist for generic manufacturers to enter the market, potentially increasing access and affordability.
• CDMO Growth: Contract Development and Manufacturing Organizations (CDMOs) with expertise in complex API synthesis and oral liquid formulations can find opportunities in supporting both innovator and generic companies.
• Supply Chain Optimization: Companies can explore strategies to diversify suppliers, enhance supply chain resilience, and improve cost-efficiency in GP production.
• Emerging Markets: As diagnostic capabilities improve in emerging economies, the demand for UCD treatments like GP is expected to grow, creating new market opportunities.

Key Takeaways

The glycerol phenylbutyrate supply chain is characterized by specialized API manufacturers and CDMOs for finished product formulation, operating under strict regulatory oversight. Key players include Bocres plc and API Chem Solutions for API production, and Nutritional Therapeutic Solutions for finished dosage forms. Market growth is driven by increased UCD diagnosis and the therapeutic advantages of GP. Regulatory compliance with FDA and EMA standards is paramount. Patent expiries present opportunities for generic market entry. Challenges include specialized manufacturing requirements and supply chain security, while opportunities lie in generic development and emerging markets.

Frequently Asked Questions

What are the primary raw materials for glycerol phenylbutyrate synthesis?

The primary raw materials are phenylbutyric acid or its derivatives and glycerol or its derivatives. Specific precursors and reaction pathways are proprietary to individual manufacturers but generally involve esterification reactions.

What is the typical lead time for API production of glycerol phenylbutyrate?

Lead times for specialized APIs like glycerol phenylbutyrate can range from 6 to 12 months, depending on the manufacturer's current production schedule, batch size, and the complexity of the synthesis and purification steps.

How does the regulatory approval process impact the glycerol phenylbutyrate supply chain?

Regulatory approval, particularly GMP certification of manufacturing facilities, is a critical gatekeeper. Any disruption or failure to meet regulatory standards by an API or finished product manufacturer can lead to supply shortages and impact patient access. Post-approval inspections and quality control are ongoing requirements.

Are there any biosimil or bioequivalent versions of glycerol phenylbutyrate currently available?

As of the latest available information, there are generic versions of glycerol phenylbutyrate that have received regulatory approval in various markets, demonstrating bioequivalence to the innovator product. The number of approved generics can vary by region.

What are the storage and handling requirements for glycerol phenylbutyrate API?

Glycerol phenylbutyrate API is typically stored in tightly sealed containers, protected from light and moisture, at controlled room temperatures (e.g., 20°C to 25°C). Specific conditions may vary slightly based on the manufacturer's stability data and recommendations.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Approval Process. Retrieved from https://www.fda.gov/patients/drug-development-process/drug-approval-process

[2] European Medicines Agency. (n.d.). How we assess medicines. Retrieved from https://www.ema.europa.eu/en/about-ema/how-ema-assesses-medicines

[3] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practices (GMP). Retrieved from https://www.fda.gov/inspections-compliance-enforcement/compliance-topics/good-manufacturing-practices-gmp

[4] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files-dmfs/drug-master-files-dmfs

[5] Food and Drug Administration. (2023, November 1). Ravicti® (glycerol phenylbutyrate) Oral Liquid. [Labeling]. Retrieved from FDA Approved Drug Products Database (Specific link may vary based on search results and product updates).

[6] Pharmaceutical Technology. (n.d.). Contract Manufacturing Organizations (CMOs). Retrieved from https://www.pharmaceutical-technology.com/features/contract-manufacturing-organizations-cmo-survey/

[7] ClinicalTrials.gov. (n.d.). Glycerol Phenylbutyrate. Retrieved from https://clinicaltrials.gov/ (Search for glycerol phenylbutyrate to find related studies and development information).