Bulk Pharmaceutical API Sources for saralasin acetate

Bulk Pharmaceutical API Sources for saralasin acetate

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A2275_SIGMA
NovoSeek		11954381
ABI Chem		AC1O44IX
Chembase.cn		129383

Bulk Active Pharmaceutical Ingredient (API) Sources for Saralasin Acetate

Last updated: August 6, 2025

Introduction

Saralasin acetate is a synthetic peptide used primarily as a pharmacological tool and investigational drug to study the renin-angiotensin system (RAS). Its role as an angiotensin II receptor antagonist has rendered it significant in research contexts, notably in cardiovascular studies. As a peptide-based API, sourcing high-quality saralasin acetate at a commercial scale involves navigating a complex supply landscape characterized by specialized manufacturers, regional manufacturing hubs, and stringent regulatory standards. This article provides a comprehensive overview of potential bulk API sources for saralasin acetate, emphasizing quality, reliability, and regulatory compliance critical for pharmaceutical development and research applications.

Manufacturing Overview of Saralasin Acetate

Saralasin acetate is synthesized via peptide synthesis techniques, typically through solid-phase peptide synthesis (SPPS). The process requires skilled manufacturing expertise, high-purity raw materials, and controlled environments to ensure quality standards such as Good Manufacturing Practices (GMP). The peptide's complex synthesis, coupled with the acetate salt formation, necessitates specialized facilities often found within peptide synthesis and custom API providers.

Regional API Suppliers for Saralasin Acetate

1. North America

a. Bachem

• Overview: Bachem, a Swiss-founded company with manufacturing plants in Torrance, California, supplies custom peptides and APIs. Their extensive GMP-certified facilities enable large-scale peptide synthesis.
• Capabilities: Bachem offers custom peptide manufacturing, including complex peptides like saralasin acetate, adhering to high-quality standards suitable for research and clinical applications.
• Regulatory Compliance: Bachem complies with FDA and global GMP standards, providing supply chain integrity.

b. Peptide Specialty Labs (PSL)

• Overview: Based in the United States, PSL specializes in peptide synthesis services, including APIs for research purposes.
• Capabilities: Their expertise includes GMP-grade peptides and peptidomimetics, suitable for preclinical and early clinical development.

2. Europe

a. Polypeptide Group

• Overview: Located in the UK, the Polypeptide Group operates multiple GMP-certified manufacturing facilities for custom peptides.
• Capabilities: They produce high-purity peptides at large scales, serving academic, biotech, and pharma clients.
• Application Scope: Their capacity covers research-grade APIs, with options for regulatory-compliant materials.

b. Pepticom

• Overview: An Israeli-based peptide manufacturer producing high-quality peptides, including custom APIs.
• Capabilities: Pepticom emphasizes rapid synthesis with rigorous quality controls suitable for drug development.

3. Asia-Pacific

a. WuXi AppTec

• Overview: A global leader in pharmaceutical CDMO services, WuXi offers peptide synthesis at scale with regulatory compliance.
• Capabilities: Their facilities accommodate GMP production of APIs including peptides like saralasin acetate for research and clinical trial material.

b. China Peptides

• Overview: A rapidly growing peptide manufacturer offering bulk API synthesis for research and early-stage development.
• Capabilities: They provide competitive pricing and flexible quantities, although regulatory compliance varies regionally.

4. Custom and Contract Manufacturing Organizations (CMOs)

Many CMOs globally provide peptide API synthesis on a custom basis, leveraging advanced peptide synthesis technologies. Sourcing from CMOs requires thorough vetting for quality standards, capacity, and regulatory compliance.

Key Factors in Selecting API Suppliers for Saralasin Acetate

Quality Assurance and Purity Standards

The critical parameters for sourcing saralasin acetate include purity levels (usually >95%) and compliance with pharmacopeial standards such as USP or EP. GMP certification ensures batch-to-batch consistency and regulatory compliance, especially important for clinical or investigational use.

Regulatory and Certification Credentials

Suppliers should possess certifications like ISO 9001 and GMP accreditation. For clinical applications, adherence to FDA, EMA, or other regional regulatory standards enhances supply chain reliability.

Manufacturing Scale and Lead Times

Depending on project scope—research, preclinical, or clinical development—scale and delivery timelines are pivotal. Established suppliers typically offer scalable manufacturing capacities with transparent lead times.

Cost and Contractual Flexibility

Pricing varies significantly across regions and suppliers. Establishing clear contractual agreements regarding confidentiality, supply guarantees, and quality control is essential.

Supply Chain and Reliability

Due diligence involves assessing supplier reputation, history of regulatory compliance, and risk management strategies, critical in reducing supply disruptions.

Emerging Trends and Alternatives

While traditional peptide synthesis remains the primary method for API production, emerging techniques like peptide mimetics and advanced biotechnological methods may influence future API sourcing. Additionally, companies innovating in peptide synthesis scalability and purity are expanding options for saralasin acetate procurement.

Regulatory and Ethical Considerations

Sourcing APIs like saralasin acetate requires adherence to international trade regulations, import/export controls, and respective pharmacovigilance standards. Ensuring that API suppliers conform to ethical manufacturing practices minimizes legal risks and enhances product integrity.

Conclusion

Securing high-quality bulk saralasin acetate requires strategic evaluation of multiple factors, including regional manufacturing capabilities, quality standards, regulatory compliance, and supply reliability. Leading global players such as Bachem, Polypeptide Group, and WuXi AppTec offer robust options aligned with pharmaceutical-grade requirements, especially for research and early clinical development. Companies should perform due diligence, prioritize GMP-certified sources, and establish comprehensive supply agreements to mitigate risks and ensure consistent quality in their research and development endeavors.

Key Takeaways

• Prioritize GMP-certified suppliers to ensure quality and regulatory compliance for saralasin acetate API.
• Regional manufacturing hubs in North America, Europe, and Asia provide diverse sourcing options, each with specific advantages.
• Customization and scalability are essential; select suppliers capable of meeting your project’s scale and timeline.
• Supply chain integrity depends on conducting thorough background checks and verifying supplier certifications.
• Emerging manufacturing technologies may influence future sourcing strategies, offering potential improvements in cost and quality.

FAQs

Q1: Is saralasin acetate available from commercial API suppliers for large-scale purchase?
A1: Yes, several peptide manufacturing companies, especially those with GMP facilities like Bachem and Polypeptide Group, can supply saralasin acetate at bulk quantities, typically for research and preclinical use.

Q2: What quality standards should I expect from API suppliers of saralasin acetate?
A2: High-quality suppliers offer APIs meeting USP, EP, or other pharmacopeial standards, with GMP certification, ensuring purity (>95%), stability, and traceability.

Q3: Are synthetic peptides like saralasin acetate subject to regulatory restrictions?
A3: While research-grade peptides are often exempt, clinical-grade APIs require compliance with regional regulations such as FDA or EMA standards and proper documentation.

Q4: Can I source saralasin acetate for clinical trials?
A4: Yes, but ensure the selected supplier can provide cGMP-grade material compliant with regulatory requirements specific to clinical trials.

Q5: How do regional differences impact sourcing options for saralasin acetate?
A5: Regional manufacturing capacities, regulatory frameworks, and cost considerations influence supplier selection. North America and Europe generally offer higher regulatory standards, while Asia provides cost-effective options with varying certification levels.

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Sources:

[1] Bachem AG. Peptide Synthesis Capabilities.
[2] Polypeptide Group. Custom Peptide Manufacturing.
[3] WuXi AppTec. Peptide API Production Services.
[4] European Pharmacopoeia. Standards for Peptides.
[5] U.S. FDA. Good Manufacturing Practices (GMP) for Pharmaceuticals.