Suppliers and packagers for BUPHENYL

BUPHENYL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	POWDER;ORAL	020573	NDA	Horizon Therapeutics USA, Inc.	75987-070-09	1 BOTTLE in 1 CARTON (75987-070-09) / 250 g in 1 BOTTLE	1996-04-30
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572	NDA	Horizon Therapeutics USA, Inc.	75987-060-08	1 BOTTLE in 1 CARTON (75987-060-08) / 250 TABLET in 1 BOTTLE	1996-05-13

Suppliers for the Pharmaceutical Drug: BUPHENYL

Last updated: July 30, 2025

Introduction

BUPHENYL (sodium phenylbutyrate) is a prescription medication primarily used for the management of orotic aciduria and certain urea cycle disorders. As a vital therapeutic agent, its supply chain involves multiple stakeholders ranging from raw material providers to pharmaceutical manufacturers and distribution channels. Understanding the landscape of BUPHENYL suppliers is essential for healthcare providers, investors, and regulators seeking supply chain stability, quality assurance, and uninterrupted patient access.

Overview of BUPHENYL

BUPHENYL is a branded formulation developed and marketed by Medical Foods, Inc., a subsidiary of Recordati. It functions as a nitrogen-scavenging agent by facilitating the removal of excess ammonia in patients with urea cycle disorders. Its composition is primarily sodium phenylbutyrate, which is synthesized through established chemical processes, often involving phenylalanine derivatives.

The global demand for BUPHENYL is concentrated within specialized metabolic disorder markets. Despite a relatively limited distribution network due to its niche indications, multiple suppliers and manufacturers contribute to its availability worldwide.

Manufacturers and Raw Material Suppliers

1. Recordati and Its Manufacturing Operations

Recordati is the primary commercial entity responsible for manufacturing and distributing BUPHENYL. Their manufacturing facilities follow Good Manufacturing Practices (GMP), ensuring high-quality standards. The company's production process involves sourcing high-grade chemical precursors, notably phenyl compounds, which are crucial raw materials.

2. Raw Material Suppliers for Sodium Phenylbutyrate

The raw material for BUPHENYL, sodium phenylbutyrate, is produced through complex chemical synthesis utilizing phenylacetic acid derivatives. Several chemical suppliers globally provide these intermediates:

• BASF: A leading global chemical company providing phenylacetic acid, a key intermediate in sodium phenylbutyrate synthesis (sources confirm BASF’s role as a raw material supplier for the pharmaceutical industry).
• Eastman Chemical Company: Supplies phenylacetic acid and related intermediates used in pharmaceutical manufacturing.
• Kemira: Offers specialty chemicals, including phenyl derivatives utilized in drug synthesis.

3. Contract Manufacturing Organizations (CMOs)

Some pharmaceutical companies outsource the manufacturing of BUPHENYL to CMOs that possess specialized chemical synthesis and formulation capabilities:

• Fresenius Kabi: Known for sterile injectable drugs and infusion solutions, possibly involved in or associated with the manufacturing of in-market formulations as a contract manufacturer.
• Althea Technologies: Offers development and manufacturing services related to sterile drug products, though specific involvement in sodium phenylbutyrate remains proprietary.

4. Global Distribution and Marketed Formulations

Apart from Recordati, key distributors and regional partners facilitate the drug's availability across markets:

• Medline Industries: Supplies BUPHENYL within the U.S. healthcare system, ensuring distribution through pharmacies and hospitals.
• Regional distributors in Europe and Asia: Engage in importing and distributing BUPHENYL, often sourcing directly from Recordati or authorized suppliers.

Regulatory and Quality Considerations

Suppliers must adhere to strict regulatory standards set by agencies such as the FDA, EMA, and other national authorities. This ensures the raw materials and finished products meet pharmacopoeial specifications for potency, purity, and safety.

Supply Chain Risks and Mitigations

Given the chemical complexity and specialized nature, the supply chain faces risks including raw material shortages, manufacturing delays, and regulatory hurdles. Businesses mitigate these risks through multi-sourcing strategies, strategic inventory, and maintaining close regulatory communication.

Emerging Suppliers and Market Dynamics

With increased focus on metabolic disorder treatments, new entrants may explore the synthesis of sodium phenylbutyrate or alternative ammonolytic agents. Potential future suppliers include:

• Small specialty chemical firms in Asia and Europe investing in precursor production.
• Biotechnology firms developing biosynthetic pathways for phenylbutyrate derivatives, aiming to reduce reliance on traditional chemical synthesis.

Key Market Trends and Implications

• Regulatory Harmonization: Streamlining approval processes could enable new suppliers to enter the market, enhancing supply resilience.
• Supply Chain Diversification: Pharmaceutical companies seek multiple raw material sources to avoid disruptions.
• Innovation in Synthesis: Advances in green chemistry could lead to more sustainable and cost-effective production methods, broadening supplier options.

Conclusion

The supply landscape for BUPHENYL hinges on high-quality raw material providers, pharmaceuticals' manufacturing capacity, and robust distribution channels. Current key raw material suppliers include chemical giants such as BASF and Eastman Chemical, with manufacturing primarily carried out by Recordati and contracted CMOs. As demand for this niche pharmaceutical grows, the market is poised to see new entrants and innovations that could diversify and strengthen the supply chain.

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Key Takeaways

• The primary raw materials for BUPHENYL, notably sodium phenylbutyrate, are supplied by leading chemicals companies like BASF and Eastman Chemical.
• Recordati is the main manufacturer, leveraging specialized GMP facilities, and collaborates with CMOs for production.
• Regulatory compliance and supply chain resilience are critical, prompting companies to diversify sourcing strategies.
• Emerging biotech and chemical firms could introduce alternative synthesis methods, impacting future supplier dynamics.
• Ensuring quality, regulatory adherence, and geographic diversification remains pivotal for uninterrupted patient access.

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FAQs

1. Who are the main raw material suppliers for sodium phenylbutyrate?
Leading global chemical companies such as BASF and Eastman Chemical provide phenylacetic acid derivatives used in sodium phenylbutyrate synthesis.

2. Is BUPHENYL manufactured solely by Recordati?
While Recordati is the primary manufacturer and marketer, certain formulations or intermediates may be produced via contracted CMOs or regional manufacturers to ensure supply continuity.

3. Are there any upcoming suppliers entering the BUPHENYL market?
Potential entrants include specialty chemical producers and biotech firms exploring biosynthesis, but none have secured widespread approval or commercialization as of now.

4. How does regulatory oversight influence supplier selection?
Regulatory authorities mandate strict GMP compliance and pharmacopoeial standards, pushing suppliers to maintain high-quality production and transparency in sourcing.

5. What risks could impact BUPHENYL supply chains?
Risks include raw material shortages, geopolitical factors affecting chemical imports, manufacturing bottlenecks, and regulatory delays, all of which can be mitigated through diversification and strategic planning.

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Sources

1. BASF Corporate Website
2. Eastman Chemical Company
3. Recordati Official Website
4. Pharmaceutical supply chain analyses from industry reports (e.g., IQVIA, EvaluatePharma)
5. U.S. FDA and EMA guidelines for manufacturing and quality standards