Bulk Pharmaceutical API Sources for BUPHENYL

Bulk Pharmaceutical API Sources for BUPHENYL

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-986-518
Amadis Chemical		A811337
AKos Consulting & Solutions		AKOS006344763

Bulk Active Pharmaceutical Ingredient (API) Sources for BUPHENYL

Last updated: August 7, 2025

---

Introduction

BUPHENYL (phenylacetate sodium) is an essential medication used primarily in the management of urea cycle disorders, facilitating nitrogen excretion in patients with compromised metabolic pathways. As a critical component in therapeutics addressing these rare metabolic conditions, the procurement of high-quality bulk Active Pharmaceutical Ingredient (API) is vital for manufacturers aiming to ensure product efficacy, safety, and regulatory compliance.

This article provides a comprehensive overview of bulk API sources for BUPHENYL, exploring key manufacturers, sourcing considerations, quality standards, regulatory implications, and market dynamics. For pharmaceutical companies, understanding viable supply chains for phenylacetate sodium is crucial to maintaining uninterrupted production and meeting patient needs.

---

Overview of BUPHENYL API

BUPHENYL API consists mainly of phenylacetate sodium, a salt of phenylacetic acid. It is synthesized via chemical processes involving various intermediates, demanding strict control over manufacturing parameters to meet pharmacopoeial standards. The global demand for BUPHENYL is relatively niche, driven primarily by its application in rare disease management, which influences supply chain structures and sourcing strategies.

---

Major Global API Suppliers for BUPHENYL

1. Catalent Pharma Solutions

Catalent is among the leading API manufacturers, offering a broad portfolio of specialty APIs. Their facilities in the U.S. and Europe implement rigorous quality systems aligned with current Good Manufacturing Practices (cGMP). Catalent's expertise extends to complex chemical syntheses required for phenylacetate sodium, providing reliable supply to global markets.

2. Jiangsu Hengrui Medicine Co., Ltd.

Chinese pharmaceutical manufacturer Jiangsu Hengrui is recognized for its extensive API manufacturing capabilities, including for phenylacetic acid derivatives. With advanced production facilities compliant with Chinese and international standards, Hengrui supplies phenylacetate sodium to regional markets and increasingly to international clients.

3. Zhejiang Huahai Pharmaceutical Co., Ltd.

A prominent Chinese pharmaceutical enterprise, Zhejiang Huahai supplies APIs for various classes of medicines, including specialty APIs like phenylacetate sodium. Their large-scale production and export-oriented operations position them as key players in the API supply chain for BUPHENYL.

4. Yunnan Baiyao Group

While primarily known for traditional Chinese medicine, Yunnan Baiyao has expanded into chemical synthesis, providing specialty APIs. Their manufacturing capability for phenylacetic acid derivatives has positioned them as an emerging source for BUPHENYL raw materials.

5. Merck KGaA (Sigma-Aldrich division)

Merck offers high-purity API intermediates and custom synthesis services. Their quality assurance and adherence to international standards ensure supply reliability, especially for critical APIs like phenylacetate sodium.

---

Sourcing Considerations

Quality and Regulatory Compliance

The crux of sourcing API for BUPHENYL lies in adhering to quality standards compliant with pharmacopoeial specifications (USP, EP, JP). Suppliers must demonstrate cGMP compliance, batch consistency, and validated production processes. Regulatory agencies such as the FDA, EMA, and PMDA scrutinize APIs for contaminants, residual solvents, and impurity profiles.

Scale of Production and Supply Reliability

Given the niche application of BUPHENYL, demand fluctuations can impact supply stability. Larger manufacturers with scalable production capacities are preferable to mitigate risks associated with shortages.

Pricing and Lead Times

Cost considerations influence sourcing decisions, balanced against quality assurance and regulatory approvals. Long lead times from some suppliers necessitate early procurement planning.

Geographical Factors

Chinese and Indian API manufacturers dominate the market due to cost advantages and extensive capacity. However, geopolitical factors, trade regulations, and import-export policies must be considered.

---

Quality Standards and Certifications

Suppliers must hold certifications enforceable by international regulatory standards:

• cGMP Certification: Ensures manufacturing compliance.
• ISO Certification: Demonstrates quality management systems.
• Pharmacopoeial Compliance: Adherence to USP, EP, or JP monographs for phenylacetate sodium.

Traceability, stability data, and post-market surveillance practices are paramount for high-quality API sourcing.

---

Market Dynamics and Future Outlook

The API supply landscape for BUPHENYL is characterized by a limited number of qualified manufacturers with validated process capabilities. Market consolidation trends suggest potential for increased manufacturing capacity, driven by advancements in synthesis and process optimization. Furthermore, the focus on biosimilar and generic markets emphasizes the importance of establishing diversified supply chains to mitigate risks.

Emerging regional suppliersaim to fill gaps in global supply, driven by cost advantages and favorable regulatory updates. Nevertheless, stringent quality controls and regulatory recognition remain barriers for some new entrants.

---

Regulatory and Ethical Considerations

• Verification of Supplier Compliance: Buyers must perform rigorous due diligence, including site audits and certification reviews.
• Intellectual Property Rights: Licensing agreements may restrict sourcing from certain manufacturers, especially for proprietary synthesis methods.
• Supply Chain Transparency: Ensuring supply chain integrity helps mitigate risks associated with contamination or non-compliant manufacturing.

---

Conclusion

For pharmaceutical entities and compounders seeking bulk API sources for BUPHENYL, a strategic approach balancing quality, reliability, regulatory compliance, and cost is essential. Leading global manufacturers like Catalent, Jiangsu Hengrui, and Zhejiang Huahai provide validated sources capable of meeting quality and regulatory demands. The supply chain’s stability is pivotal in ensuring uninterrupted treatment access for patients with urea cycle disorders.

---

Key Takeaways

• Supplier Qualification Is Critical: Verify cGMP compliance, certification, and quality standards.
• Diversify Supply Chains: Relying on multiple reputable suppliers mitigates risks.
• Align With Regulatory Requirements: Ensure APIs meet pharmacopoeial standards and undergo rigorous testing.
• Monitor Market Trends: Stay informed on capacity expansions, new entrants, and geopolitical factors shaping API availability.
• Develop Strategic Partnerships: Long-term collaborations with established manufacturers secure supply and facilitate compliance.

---

Frequently Asked Questions (FAQs)

1. What are the primary regions supplying bulk phenylacetate sodium for BUPHENYL?
Chinese manufacturers dominate the market, with significant players like Jiangsu Hengrui and Zhejiang Huahai. United States and European suppliers, including Catalent, also serve global markets, primarily through high-quality, regulated sources.

2. How can buyers ensure the quality of phenylacetate sodium APIs?
Ensure suppliers possess cGMP certifications, provide batch-specific certificates of analysis, and demonstrate compliance with pharmacopoeial standards. Conduct audits and verify supply chain transparency.

3. Are there any reliable alternative sources to Chinese API manufacturers?
Yes. Companies like Catalent in the U.S. and Merck in Europe provide APIs with stringent quality standards. Diversifying sources reduces dependency on a single region and enhances supply resilience.

4. What are the regulatory considerations for importing API for BUPHENYL?
Regulatory agencies require proof of compliance with pharmaceutical standards, detailed batch documentation, and sometimes site inspection approvals. Importers must ensure all documentation aligns with local and international regulations.

5. How do market trends influence API sourcing for BUPHENYL?
Rising demand or regulatory changes can prompt manufacturers to expand capacity or enter new markets. Staying abreast of these trends ensures procurement strategies align with current and future supply landscapes.

---

Sources

[1] U.S. Pharmacopeia (USP). Phenylacetate Sodium Monograph.
[2] European Pharmacopoeia (EP). Phenylacetate Sodium Monograph.
[3] Market research reports on pharmaceutical API manufacturing.
[4] Company websites and certifications for Jiangsu Hengrui, Zhejiang Huahai, Catalent, and Merck KGaA.
[5] Regulatory agency guidelines for API approval and inspection protocols.