Bulk Pharmaceutical API Sources for ANGIOTENSIN II ACETATE

Bulk Pharmaceutical API Sources for ANGIOTENSIN II ACETATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		172197
ABI Chem		AC1L58RQ
Chembase.cn		156581
ChemTik		CTK2F5080
Aurora Fine Chemicals LLC		A17.890.777
abcr GmbH		AB348778
Alfa Chemistry		68521-88-0

Bulk Active Pharmaceutical Ingredient (API) Sources for Angiotensin II Acetate

Last updated: July 28, 2025

Introduction

Angiotensin II acetate is a synthetic analogue of the endogenous peptide hormone angiotensin II, primarily used for diagnostic purposes, research, and potentially in pharmaceutical formulations targeting the renin-angiotensin system. Given its specialized application, sourcing high-quality bulk APIs is critical for pharmaceutical development, clinical research, and regulatory compliance. This article offers a comprehensive overview of global sources for bulk angiotensin II acetate, analyzing key manufacturers, geographic regions, and considerations for procurement, to inform manufacturers, research institutions, and regulatory authorities seeking reliable supply chains.

Understanding Angiotensin II Acetate

Angiotensin II acetate is a peptide hormone with the chemical formula C50H69N13O11, designated chemically as a synthetic peptide of eight amino acids (octapeptide). It functions as a potent vasoconstrictor, impacting blood pressure regulation, and is used mainly in diagnostic tests such as the angiotensin II infusion test to evaluate adrenal and renal function.

The quality of the API directly influences experimental consistency, regulatory approval, and safety. Consequently, suppliers must adhere to rigorous manufacturing standards, typically Good Manufacturing Practice (GMP), and provide comprehensive analytical data. The primary distinctions among sources include certification levels, purity, stability, and regulatory approvals.

Major API Suppliers for Angiotensin II Acetate

1. Leading Global Pharmaceutical Peptide Manufacturers

a. NovoNordisk (Denmark)

As a pioneer in peptide synthesis, NovoNordisk offers high-grade peptides, including angiotensin II acetate, primarily for research and diagnostic purposes. Their manufacturing adheres to strict GMP standards, ensuring product consistency, stability, and regulatory compliance. Though primarily focused on clinical therapeutics, their peptide APIs are often available for research institutions and biotech firms.

b. Bachem (Switzerland)

Bachem specializes in peptide synthesizing services and bulk APIs for research and pharmaceutical development. Their portfolio encompasses custom synthesis of peptides, including angiotensin II acetate, with an emphasis on purity (>98%) and batch traceability. Bachem's products are compliant with international standards, making them suitable for clinical research and regulatory submission.

c. PolyPeptide Laboratories (Denmark and the US)

PolyPeptide produces a range of peptides and APIs, including angiotensin II acetate, with a focus on GMP-certified manufacturing, high purity, and research-grade supplies. Their capabilities extend across large-scale production, supporting pharmaceutical companies and research institutes.

2. Specialized Peptide API Manufacturers

a. AnaSpec (USA)

AnaSpec supplies custom peptide APIs, including angiotensin II acetate, targeting research institutions and biotech firms. Their products are available in research quantities, with high purity standards suitable for in vitro and in vivo studies.

b. Peptides International (USA)

A prominent supplier of peptides and APIs for research and clinical development, Peptides International offers synthesized angiotensin II acetate with purity levels exceeding 99%. Their products come with detailed analytical certificates, ensuring regulatory tractability.

c. CSL Limited (Australia)

While primarily a biopharmaceutical company, CSL offers peptide synthesis services, including angiotensin peptides suitable for diagnostic applications, adhering to strict GMP standards.

3. Asian Manufacturers and Suppliers

a. Zhejiang Hisun Pharmaceutical Co., Ltd (China)

A leading Chinese API manufacturer, Hisun produces peptides, including angiotensin II acetate, targeting both domestic and international markets. Their manufacturing complies with Chinese GMP standards, with increasing adherence to international regulatory requirements.

b. Hangzhou Peptide Bioengineering Co., Ltd (China)

Specialized in peptide synthesis, this company supplies research-grade angiotensin II acetate to global markets, with certifications aligning with ISO and some GMP standards.

c. Chinese Peptide Suppliers (various)

Numerous small- and medium-scale Chinese companies offer angiotensin II acetate API, often at competitive prices. However, quality assurance and regulatory compliance vary, necessitating due diligence before procurement.

4. Emerging and Regional Suppliers

Several new entrants and regional suppliers across Eastern Europe, India, and Southeast Asia have entered the market, providing affordable APIs. Compliance with international standards remains variable, emphasizing the importance of certifications, analytical validation, and supplier audits.

Qualitative Factors Influencing API Sourcing

• Regulatory Compliance: Suppliers should demonstrate adherence to GMP, ISO certifications, and provide comprehensive analytical and stability data.
• Purity and Quality: High-purity (>98%), endotoxin-free, and stable formulations are essential, especially for diagnostic and research applications.
• Traceability: Batch records, stability data, and documentation facilitate regulatory approval and quality assurance.
• Pricing and Lead Time: The balance between cost-effectiveness and quality, coupled with supply reliability, must influence procurement decisions.
• Supply Chain Transparency: Manufacturers with transparent sourcing, consistent batch production, and certification reputation are preferred.

Regulatory Considerations and Due Diligence

Purchasing angiotensin II acetate API involves navigating regulatory landscapes across regions such as the US (FDA), Europe (EMA), and China (NMPA). Suppliers must comply with local Good Manufacturing Practices, and products should have appropriate certificates of analysis (CoA), stability data, and traceability documentation.

Due diligence includes audits (on-site or remote), product validation, and verification of certifications. Importantly, companies should review supplier compliance records, track record in quality assurance, and assess the capacity to meet demand scale.

Emerging Trends in API Sourcing for Angiotensin II Acetate

• Shift towards GMP-certified suppliers to streamline clinical trial approvals.
• Increased adoption of regional manufacturing to reduce costs and lead times.
• Enhanced supply chain oversight via technology to ensure quality and compliance.
• Development of synthetic and alternative peptides with longer shelf-life and improved stability.

Conclusion

Reliable sourcing of angiotensin II acetate API is integral to the success of diagnostic, research, and pharmaceutical applications. Leading peptide manufacturers such as NovoNordisk, Bachem, and PolyPeptide balance quality, compliance, and supply reliability, making them preferred choices for high-stakes applications. Asian manufacturers offer competitive pricing but require rigorous vetting for quality assurance. Regional suppliers and emerging players provide additional options but necessitate comprehensive due diligence.

Global buyers must align procurement strategies with regulatory requirements, quality standards, and supply chain robustness to mitigate risks and ensure the integrity of their products.

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Key Takeaways

• The global market for angiotensin II acetate API is dominated by established peptide manufacturers adhering to GMP standards, ensuring quality and regulatory compliance.
• Major suppliers include NovoNordisk, Bachem, PolyPeptide, and specialized research-focused companies like AnaSpec and Peptides International.
• Asian manufacturers, primarily from China, offer competitive options—suppliers should verify certifications and quality assurance documentation.
• Sourcing decisions should prioritize product purity, stability, traceability, and regulatory compliance to facilitate clinical development and diagnostics.
• Due diligence, including supplier audits and certification verification, remains critical, especially when procuring from emerging regional suppliers.

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FAQs

1. What are the primary uses of angiotensin II acetate API?
Angiotensin II acetate is used mainly in diagnostic testing (e.g., blood pressure regulation studies), research on the renin-angiotensin system, and as a reference peptide in pharmaceutical development.

2. How do I evaluate the quality of angiotensin II acetate API from different suppliers?
Assess suppliers' certifications (GMP compliance), review Certificates of Analysis, verify purity levels (>98%), and source from reputable manufacturers with validated manufacturing processes.

3. Are GMP-certified angiotensin II acetate APIs suitable for clinical applications?
Yes. GMP certification ensures the API meets regulatory standards for clinical testing, clinical trials, and regulatory submissions.

4. What factors influence pricing and supply reliability for angiotensin II acetate API?
Factors include manufacturing scale, supplier reputation, regional manufacturing standards, certification levels, order volume, and lead times.

5. What should companies consider when importing angiotensin II acetate APIs from China?
Verify the supplier’s certifications, request detailed analytical data, conduct quality audits if possible, and ensure compliance with local import regulations and standards.

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References

1. [1] Bachem AG. Peptide Products Portfolio. Available at: https://www.bachem.com
2. [2] PolyPeptide Laboratories. Peptide Synthesis and APIs. Available at: https://www.polypeptide.com
3. [3] NovoNordisk Peptide Services. Corporate Overview. Available at: https://www.novonordisk.com
4. [4] Regulatory guidelines for peptide API manufacturing, WHO, 2021.
5. [5] "Peptides in diagnostics," Journal of Peptide Science, 2020.