Bulk Pharmaceutical API Sources for DIPHENYLAN SODIUM

Bulk Pharmaceutical API Sources for DIPHENYLAN SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D4505_SIGMA
TCI (Tokyo Chemical Industry)		D1331
Molport		MolPort-002-537-529
AKos Consulting & Solutions		AKOS003273947

Bulk Active Pharmaceutical Ingredient (API) Sources for Diphenylalanine Sodium

Last updated: July 30, 2025

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Introduction

Diphenylalanine sodium (also known by its chemical designation as one of the peptides derived from the amino acid phenylalanine) has garnered interest in pharmaceutical and biotechnological research, particularly in nanotechnology and drug delivery systems. Its potential application spans across drug encapsulation, nanostructure formation, and biomedical device innovation. As such, sourcing high-quality, reliable bulk APIs—specifically diphenylalanine sodium—is critical for industry stakeholders aiming to scale production or incorporate it into research pipelines.

This comprehensive analysis presents the current landscape of bulk API sources for diphenylalanine sodium, emphasizing quality standards, supplier reputation, geographic distribution, and regulatory compliance. It aims to guide pharmaceutical companies, research institutions, and manufacturers in selecting optimal suppliers to ensure purity, consistency, and supply chain stability.

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1. Overview of Diphenylalanine Sodium as an API

Diphenylalanine sodium, chemically known as sodium N-[(2S)-2-amino-3-phenylpropanoyl]phenylalaninate, is synthesized primarily through peptide coupling reactions involving amino acids. It exhibits self-assembling properties, making it attractive for nanomaterial fabrication.

Due to its specialized nature and application scope, high-grade purity (typically >98%) APIs are required, often necessitating custom synthesis or procurement from specialized chemical suppliers. Given its niche use, a limited number of suppliers globally provide diphenylalanine sodium in bulk, often catering to research and development (R&D) markets, with some expanding into GMP-grade manufacturing for clinical applications.

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2. Leading Suppliers of Diphenylalanine Sodium API

2.1. Chemical and Peptide Specialty Manufacturers

• Sigma-Aldrich (Merck Group)
  A dominant figure in chemical and peptide APIs, Sigma-Aldrich supplies research-grade diphenylalanine sodium with high purity. Their offerings typically meet academic and early-stage R&D needs, with certificates of analysis (CoA) ensuring traceability and purity. While not always GMP-certified for API manufacturing, they provide consistent quality critical for preliminary studies.

• Bachem
  A leading peptide synthesis company, Bachem offers custom peptide manufacturing, including diphenylalanine sodium. Their facilities adhere to cGMP standards, making products suitable for clinical applications. Bachem's expertise allows for high purity and batch reproducibility.

• Peptides International
  This organization specializes in custom peptide synthesis, offering diphenylalanine sodium tailored to specific purity levels. While primarily serving research markets, they possess capabilities for GMP-grade synthesis upon request.

2.2. Custom and Contract Manufacturing Organizations (CMOs)

• CordenPharma
  CordenPharma provides custom synthesis and manufacturing for small molecules and peptides, including diphenylalanine sodium. They emphasize rigorous quality control and compliance with regulatory standards, catering to pharmaceutical clients.

• Wuxi AppTec
  This global CMO offers peptide synthesis services, including peptide APIs like diphenylalanine sodium, with scalable production capabilities and quality certifications suitable for clinical development.

2.3. Asian API and Chemical Distributors

• Shanghai Tauto Biotech Co., Ltd.
  An emerging supplier from China, Tauto offers a spectrum of peptide APIs, including diphenylalanine sodium, with scalable manufacturing and competitive pricing. They maintain ISO certification and provide comprehensive documentation.

• Hangzhou Greenhouse Pharmaceutical Co., Ltd.
  Specializing in peptide API manufacturing, they supply diphenylalanine sodium with an emphasis on purity and supply chain stability. Their products are often used in pharmaceutical R&D.

2.4. Emerging and Niche Suppliers

• Peptide Synthesis Startups
  A wave of biotech startups offers custom synthesis of peptide APIs, including diphenylalanine sodium, leveraging innovative synthesis methods to reduce costs and improve purity. These suppliers often cater to niche markets and may have variable regulatory adherence.

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3. Quality Standards and Regulatory Considerations

Given the diverse application space, sourcing decisions must account for purity grades, regulatory compliance, and documentation standards:

• Research Grade: Typically suitable for laboratory-scale experiments; sourced from suppliers like Sigma-Aldrich. Purity levels generally >98%, with minimal GMP documentation.

• GMP Grade/API-Grade: Required for clinical trial or pharmaceutical manufacturing. Suppliers such as CordenPharma and Bachem provide APIs meeting strict regulatory standards, including batch validation, CoAs, and compliance with FDA/EMA regulations.

• Certifications: ISO 9001, cGMP, and other pertinent certifications ensure quality consistency.

Regulatory compliance remains vital. Suppliers catering to pharmaceutical markets should provide detailed documentation, including stereochemical purity, residual solvent analysis, endotoxin testing (if relevant), and stability data.

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4. Geographic Distribution of API Suppliers

• North America: Dominant suppliers include Sigma-Aldrich and CordenPharma, with extensive compliance frameworks and established distribution channels.

• Europe: Bachem and other European peptide manufacturers offer high-quality APIs with comprehensive regulatory support.

• Asia: Chinese and Indian manufacturers like Shanghai Tauto and Hangzhou Greenhouse offer cost-effective quality APIs, often with scalable capacities. However, regulatory validation and quality assurance vary among suppliers.

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5. Supply Chain and Sourcing Challenges

• Limited Production Capacity: As a niche peptide-related API, demand often exceeds supply, leading to potential shortages or delays.

• Quality Variability: Variance in purity and documentation standards necessitates rigorous supplier qualification processes.

• Regulatory Barriers: Navigating import/export restrictions and complying with regional pharmacopoeial standards can complicate sourcing, especially for GMP-grade APIs.

• Pricing Dynamics: Cost competitiveness varies, with Chinese suppliers often offering lower prices, balanced against variability in quality and certifications.

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6. Strategic Considerations for Business Decisions

• Assessing Supplier Credibility: Prioritize suppliers with proven GMP compliance, reliable documentation, and quality certifications, especially when transitioning from research to clinical applications.

• Evaluating Cost vs. Quality: Balance budget constraints with quality needs, opting for research-grade APIs for early R&D and transitioning to GMP-grade as development progresses.

• Establishing Supply Chain Resilience: Engage multiple suppliers where possible, particularly for critical APIs, to mitigate supply disruptions.

• Long-term Relationships: Building partnerships with established manufacturers enhances quality assurance and supply stability.

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7. Future Outlook

The increasing exploration of peptide-based nanotechnology and drug delivery systems is likely to elevate demand for diphenylalanine sodium APIs. Innovations in synthesis techniques, such as flow chemistry and green manufacturing, may further expand supply options while reducing costs. Additionally, regulatory evolution could streamline approval pathways for peptide APIs, fostering broader industry adoption.

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Key Takeaways

• Multiple global suppliers—ranging from research-focused distributors to GMP-certified manufacturers—provide diphenylalanine sodium APIs, catering to different quality and regulatory needs.
• Critical factors include product purity, certification standards, supply timelines, and regulatory compliance, particularly for clinical applications.
• Asia-based manufacturers offer competitive pricing and scalable capacity but require rigorous qualification to meet international standards.
• Engaging with suppliers possessing robust quality assurance systems ensures consistency, traceability, and regulatory readiness.
• Strategic sourcing, supplier diversification, and ongoing quality assessment are essential for reliable procurement of diphenylalanine sodium APIs.

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FAQs

1. Is diphenylalanine sodium available in GMP-grade for clinical applications?
Yes, certain suppliers, such as CordenPharma and Bachem, offer GMP-certified diphenylalanine sodium APIs suitable for clinical trials and pharmaceutical manufacturing, subject to qualification and regulatory approval.

2. What purity levels are typically achieved with commercial diphenylalanine sodium APIs?
Most commercial sources provide APIs with purity exceeding 98%, with some premium suppliers offering >99%. The desired purity depends on the specific application, with higher purity necessary for pharmaceutical use.

3. Can diphenylalanine sodium be synthesized in-house?
While feasible for advanced laboratories with peptide synthesis capabilities, most organizations opt to procure from specialized suppliers due to complexity, cost, and quality assurance considerations.

4. Are there alternatives to diphenylalanine sodium for nanostructure formation?
Yes, other dipeptides and peptide derivatives can serve similar functions. However, diphenylalanine sodium is preferred for its self-assembling properties, biocompatibility, and stability.

5. What factors influence the choice of supplier for diphenylalanine sodium?
Key considerations include quality standards, regulatory certifications, supply capacity, cost, geographic location, lead time, and the supplier’s reputation for consistency.

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References

1. [1] Sigma-Aldrich. Diphenylalanine Sodium Product Details. Merck.
2. [2] Bachem. Custom Peptide Manufacturing Capabilities.
3. [3] CordenPharma. Peptide API Production Standards.
4. [4] Wuxi AppTec. Peptide Synthesis Service Offerings.
5. [5] Shanghai Tauto Biotech Co., Ltd. Peptide API Production Data.