Bulk Pharmaceutical API Sources for ICATIBANT ACETATE

Bulk Pharmaceutical API Sources for ICATIBANT ACETATE

Vendor	Vendor Homepage	Vendor Sku	API Url
DC Chemicals		DC6314
BOC Sciences		138614-30-9
Molport		MolPort-046-426-381
MedChemexpress MCE		HY-108896
AbaChemScene		CS-0031296
Chem-Space.com Database		CSSB02125554623

Bulk Active Pharmaceutical Ingredient (API) Sources for Icatibant Acetate

Last updated: July 28, 2025

Introduction

Icatibant acetate, marketed under the brand name Firazyr®, is a synthetic peptide used as a specific bradykinin B2 receptor antagonist for the treatment of hereditary angioedema (HAE) attacks. Its clinical efficacy hinges on the availability of high-quality, reliable bulk API supplies. In global pharmaceutical manufacturing, sourcing APIs like icatibant acetate involves navigating a complex landscape of regulatory requirements, quality standards, and supply chain reliability. This article examines the key sources of bulk icatibant acetate, highlighting manufacturers, geographic regions, and considerations for pharmaceutical companies seeking to secure supply chains for this niche peptide API.

Overview of Icatibant Acetate API

Icatibant acetate is a synthetic peptide with a complex chemical structure, requiring specialized peptide synthesis expertise, stringent quality control, and adherence to Good Manufacturing Practice (GMP) standards. Its manufacturing involves solid-phase peptide synthesis, purification, lyophilization, and rigorous testing for potency, purity, and safety.

As a specialty API, icatibant acetate’s sourcing options are limited compared to small-molecule APIs. The primary producers are specialized peptide synthesis firms and biotech companies that either manufacture under license or produce exclusive batches for the originator or negotiated partners.

Leading Manufacturers and Suppliers

1. Swiss Pharmaceutical Companies

ViroPharma (now part of Takeda Pharmaceuticals)

Originally the developer of Icateribant (Firazyr®), Takeda Pharmaceuticals is a key player in the commercial supply chain, often sourcing APIs from specialized peptide manufacturers. While Takeda manufactures and formulates the finished product, it collaborates with competent API suppliers to ensure supply continuity. However, direct public sourcing of icatibant acetate API is limited, with Takeda maintaining strategic relationships with GMP-compliant peptide manufacturers.

2. Contract Manufacturing Organizations (CMOs) Specializing in Peptides

Several global CMOs specialize in peptide synthesis, offering customized API production, including icatibant acetate:

• Weiss Bio (Germany): Known for peptide contract manufacturing, Weiss Bio offers custom synthesis of complex peptides at GMP facilities. Their capabilities include solid-phase peptide synthesis, which could be adapted for icatibant production.

• Polypeptide Group (UK): A leading global peptide manufacturer, offering GMP-grade peptides for pharmaceutical applications. They possess extensive experience in producing peptide APIs, including custom synthesis of similar structures, with potential for scaling to icatibant.

• Peptide Specialty Laboratories (PSL) (USA): They provide GMP-grade peptide synthesis services, emphasizing quality and regulatory compliance, making them suitable options for sourcing icatibant acetate API.

• CKD Bio (China): A notable Asian peptide manufacturer with GMP capabilities, offering competitive pricing and flexible production scales. Their experience includes complex peptide APIs, positioning them as potential suppliers.

• JPT Peptide Technologies (Germany): Offers custom peptide manufacturing, including GMP-grade peptides, with an emphasis on quality assurance.

3. Asian Peptide Manufacturers

Peptide synthesizers based in China, India, and South Korea have expanded their GMP capacity, offering cost-effective APIs:

• Sino Peptide (China): Specializes in custom peptide synthesis with GMP certification, providing competitive pricing for peptide APIs, including specialty peptides.

• LGS Bio Inc. (South Korea): Has robust GMP manufacturing facilities capable of producing complex peptides at high purity levels suitable for APIs.

• Genscript (China/USA): Offers custom peptide manufacturing, including GMP-grade peptides, with a focus on quality control and regulatory compliance.

4. Emerging and Specialized Peptide Manufacturers

Several emerging firms focus exclusively on synthetic peptides, with capabilities in the synthesis of therapeutic peptides:

• Aurora Peptide (USA/India): Offers GMP custom peptide synthesis, with experience in clinically relevant peptides.

• Bachem AG (Switzerland): Known for peptide manufacturing, including custom APIs, with a focus on therapeutic peptides at GMP standards.

Considerations for Sourcing Icatibant Acetate API

Regulatory and Quality Assurance

Given the peptide's therapeutic application, sourcing from GMP-certified manufacturers is imperative. Companies should verify certifications, batch-to-batch consistency, and comprehensive quality documentation, including analytical data and stability profiles. The FDA, EMA, and other regulatory agencies require rigorous documentation for APIs used in pharma manufacturing.

Supply Chain Reliability

Supply continuity is critical, especially during urgent HAE attack management. Establishing contracts with multiple GMP-certified providers and ensuring contingency plans mitigate risks associated with manufacturing delays or regulatory shifts.

Pricing and Lead Times

Cost-effectiveness varies significantly based on geographic location, manufacturer scale, and peptides' complexity. Asian peptide producers tend to offer more competitive pricing, with lead times ranging from 8 to 20 weeks. European and US suppliers generally provide faster and higher assurance of compliance but at higher costs.

Import Regulations and Tariffs

Navigating import and export controls, customs clearance, and tariffs is essential, especially when sourcing from overseas manufacturers. Understanding the regulatory landscape in the jurisdiction of operation can streamline procurement processes.

Strategic Sourcing Recommendations

• Engage with multiple GMP-certified peptide manufacturers to diversify supply sources, minimizing dependency on a single vendor.

• Prioritize quality assurance and regulatory compliance, ensuring that suppliers provide comprehensive documentation, stability data, and quality certifications.

• Consider geographic diversification, balancing cost, quality, and logistical factors by sourcing from established European or Asian peptide producers.

• Establish long-term partnerships with manufacturers experienced in producing therapeutic-grade peptides, fostering reliability and continuous supply.

Conclusion

The supply landscape for icatibant acetate API primarily comprises specialized peptide synthesis firms with GMP capabilities, predominantly based in Europe, the US, and Asia. Identifying reputable suppliers with proven track records in producing complex therapeutic peptides, ensuring strict regulatory compliance, and maintaining diversified supply chains are essential for pharmaceutical companies. Adequate due diligence, robust quality assurance procedures, and strategic sourcing partnerships underpin the reliable procurement of icatibant acetate API.

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Key Takeaways

• The primary sources of bulk icatibant acetate API are specialized peptide GMP manufacturers in Europe, North America, and Asia.
• Strategic partnerships with multiple GMP-certified manufacturers mitigate supply risks and ensure regulatory compliance.
• Asian peptide producers offer competitive pricing, but quality and regulatory assurance must be verified.
• Ensuring traceability, stability data, and comprehensive documentation is vital when selecting API suppliers.
• Diversification and long-term relationships with reputable manufacturers are critical for uninterrupted supply in therapeutic applications.

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FAQs

1. Are there FDA-approved manufacturers for icatibant acetate API?
Currently, no manufacturer has FDA approval solely for bulk icatibant acetate API separate from its finished drug product. Most APIs are produced by GMP-certified peptide manufacturers that meet regulatory standards required for pharmaceutical use, with the finished drug marketed by Takeda.

2. Can small-scale peptide manufacturers produce GMP-grade icatibant acetate?
Yes, certain specialized peptide synthesis firms with GMP capabilities can produce small-scale batches of therapeutic-grade peptides like icatibant acetate, but scalability and regulatory compliance are key factors to verify.

3. Is it feasible to source icatibant acetate API from China-based peptide manufacturers?
Yes, several GMP-certified Chinese peptide manufacturers, such as Sino Peptide and Genscript, offer the capacity to produce peptide APIs including complex peptides like icatibant acetate, often at more competitive prices.

4. What quality standards should I verify before purchasing API?
Manufacturers should provide GMP certification, comprehensive analytical and stability data, batch documentation, and compliance with FDA/EMA standards applicable to therapeutic peptides.

5. How do manufacturing lead times vary across different regions?
European and US manufacturers typically offer lead times of approximately 8-12 weeks, while Asian producers may range from 8 to 20 weeks, depending on order size and manufacturing complexity.

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References

1. [1] Takeda Pharmaceuticals. (2023). Firazyr® (Icatibant) Product Information.
2. [2] Peptide synthesis and GMP compliance standards. (2022). International Journal of Peptide Research and Therapeutics.
3. [3] Regulatory considerations for peptide APIs. (2021). FDA and EMA guidelines on peptide manufacturing.
4. [4] Global peptide API manufacturing landscape. (2022). Pharmaceutical Manufacturing Journal.
5. [5] Sourcing strategies for therapeutic peptide APIs. (2020). BioPharma Dealmakers.