Bulk Pharmaceutical API Sources for SYNRIBO

Bulk Pharmaceutical API Sources for SYNRIBO

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-983-592
TimTec		ST056357
Finetech Industry Limited		FT-0627081
AbaChemScene		CS-2872
MedChemexpress MCE		HY-14944

Bulk Active Pharmaceutical Ingredient (API) Sources for SYNRIBO

Last updated: July 28, 2025

Introduction

Synribo (omacetaxine mepesuccinate) is an injectable anti-cancer agent used predominantly for treating chronic myeloid leukemia (CML), particularly in cases resistant or intolerant to tyrosine kinase inhibitors (TKIs) such as imatinib. As a synthetic peptide-based drug, Synribo’s manufacturing relies heavily on high-quality active pharmaceutical ingredient (API) sourcing. Ensuring a reliable, compliant, and cost-effective supply chain for API production is critical for maintaining drug availability and meeting global demand. This article provides a comprehensive overview of API sourcing options for Synribo, addressing manufacturers, regulatory considerations, and supply chain robustness.

---

Understanding Synribo’s API: Chemical and Manufacturing Aspects

Synribo's API, omacetaxine mepesuccinate, is a synthetic analog of the natural product homoharringtonine—a plant alkaloid with complex stereochemistry. The manufacturing process involves multiple synthesis and purification steps to ensure the API's purity and potency. Because of its complex structure, sourcing the API requires advanced chemistry expertise, strict quality control, and adherence to regulatory standards.

The global demand for Synribo is relatively niche, with specific needs for high purity and consistent supply. Consequently, the choice of API sources encompasses both specialized chemical synthesis vendors and companies with extensive experience in peptide and complex small-molecule APIs.

---

Global API Supply Landscape for Synribo

1. Major Manufacturers of Omacetaxine Mepesuccinate

Several firms are recognized for producing high-quality APIs suitable for commercial use, including:

• Fujifilm Toyama Chemical
  As the original developer of Synribo, Fujifilm Toyama Chemical (a subsidiary of Fujifilm Corporation) is a primary source for API bulk material. They possess proprietary manufacturing processes, ensuring high purity and compliance with international standards. Their integrated supply chain guarantees stable API availability tailored to regulatory requirements for the US, Europe, and Japan.

• J&K Scientific Ltd.
  A global contract manufacturer specializing in complex APIs, J&K Scientific offers custom synthesis services for APIs like omacetaxine. Their facilities are cGMP-compliant, and they serve clients seeking quality API manufacturing for clinical and commercial purposes.

• Accord Pharma
  An Indian pharmaceutical company with extensive experience in complex peptide synthesis, Accord Pharma produces APIs under strict quality standards, including cGMP certifications, suitable for global markets.

• CordenPharma (a part of Mercachem)
  Renowned for its expertise in complex and peptide APIs, CordenPharma provides custom synthesis,-scale-up, and manufacturing services that could support Synribo API supply, especially for supply chain diversification.

• Other Specialized API Manufactures
  Numerous smaller or emerging API producers in China, India, and Eastern Europe can offer custom synthesis. However, buyers should rigorously evaluate their quality compliance, regulatory track records, and capacity.

2. Contract Research Organizations and CROs with API Manufacturing Capabilities

Some CROs with integrated API manufacturing services can serve as secondary sources, especially during supply disruptions. Their capabilities include synthesis, purification, and packaging, providing strategic flexibility.

---

Supply Chain Considerations

Quality and Regulatory Compliance

API sourcing for Synribo necessitates strict adherence to cGMP standards, comprehensive documentation, and robust quality assurance processes. Manufacturers with established US FDA, EMA, or PMDA inspections are preferred to ensure seamless regulatory submissions and minimize supply chain risks.

Supply Chain Security and Diversification

Given the critical role of API in Synribo production, companies should consider supplier diversification. Relying solely on a single manufacturer escalates risks related to production delays, regulatory compliance issues, or geopolitical factors. Establishing secondary sources or geographically dispersed suppliers enhances resilience.

Cost Factors

While quality and compliance are non-negotiable, cost competitiveness remains relevant, especially for commercial-scale manufacturing. Indian and Chinese API suppliers often offer competitive pricing but require rigorous due diligence regarding quality standards and regulatory track record.

Intellectual Property and Licensing

Synribo’s proprietary synthesis methods may restrict direct API sourcing from certain manufacturers without licensing agreements. Collaborations or licensing arrangements with original developers or authorized suppliers are integral to legal and regulatory compliance.

---

Emerging Trends and Future Outlook

Advances in Synthetic Chemistry

Recent advances in peptide synthesis and scalable manufacturing processes may facilitate more diverse API sourcing options. Innovations in continuous flow synthesis and process intensification could reduce costs and lead times.

Regulatory Pathways and Approvals

FDA and EMA increasingly emphasize supply chain transparency and quality management. Demonstrating reliable API sourcing and building strong supplier relationships will be advantageous during regulatory reviews.

Partnerships and Strategic Alliances

Collaborating with experienced contract manufacturing organizations (CMOs) and SMEs with proven compliance histories can mitigate risks. Strategic alliances also facilitate technological transfer and capacity scaling as demand for Synribo fluctuates.

---

Conclusion

Securing a dependable API supply for Synribo (omacetaxine mepesuccinate) hinges on selecting manufacturers with proven quality, regulatory compliance, and manufacturing capacity. The primary source remains Fujifilm Toyama Chemical, given their original development role and integrated production capabilities. Secondary sources include specialized CMOs and API manufacturers from India, China, and Europe, which offer potential supply chain diversification.

Impressively, the API’s complex synthesis underscores the importance of partnering with experienced, high-quality manufacturers capable of adhering to stringent standards. As the global pharmaceutical landscape evolves, manufacturers and pharmaceutical companies must prioritize supply chain resilience, regulatory compliance, and technological innovation to ensure continuous supply of this niche but vital oncologic therapy.

---

Key Takeaways

• Primary API source: Fujifilm Toyama Chemical maintains the main supply chain for Synribo's API, owing to their proprietary manufacturing processes.
• Secondary sources: Contract manufacturers with cGMP capacity, such as J&K Scientific, Accord Pharma, and CordenPharma, present potential secondary sourcing options.
• Regulatory compliance: Ensuring API suppliers meet international standards (FDA, EMA, PMDA) is critical for seamless drug approval and market access.
• Supply chain resilience: Diversification across multiple manufacturers reduces risk, mitigates shortages, and supports global distribution.
• Future advancements: Innovations in peptide synthesis and process optimization are expected to broaden sourcing options and reduce costs.

---

FAQs

1. What are the primary considerations when sourcing API for Synribo?
Quality, regulatory compliance, manufacturing capacity, cost, and supply chain stability are paramount. Suppliers must adhere to cGMP standards and have proven regulatory track records.

2. Can Synribo API be sourced from manufacturers outside Japan?
Yes. Several reliable manufacturers in India, China, and Europe can produce the API at scale, provided they meet quality and regulatory standards.

3. How does supply chain diversification benefit Synribo manufacturing?
It reduces dependency on a single supplier, mitigates risks from geopolitical or production disruptions, and ensures consistent drug supply.

4. Are there licensing restrictions for API manufacturing of Synribo?
Yes. As Synribo's synthesis is proprietary, licensing agreements or collaborations with the original developer or authorized suppliers are typically required to produce the API legally.

5. What future developments could influence API sourcing for Synribo?
Advances in synthetic chemistry, regulatory emphasis on supply chain transparency, and strategic industry partnerships will shape future sourcing options and supply security.

---

References

[1] Fujifilm Toyama Chemical. Synribo (omacetaxine mepesuccinate) API manufacturing details.
[2] Contract Manufacturing Organizations’ capacity reports and cGMP compliance records.
[3] Regulatory guidelines from FDA, EMA, and PMDA on API quality standards.
[4] Industry reports on peptide synthesis advances and complex API manufacturing trends.