Bulk Pharmaceutical API Sources for micafungin sodium

Bulk Pharmaceutical API Sources for micafungin sodium

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-028-720-447
AvaChem Scientific		208538-73-2
AvaChem Scientific		2670S
TargetMol		T1794

Bulk Active Pharmaceutical Ingredient (API) Sources for: MICAFUNGIN SODIUM

Last updated: August 1, 2025

Introduction

Micafungin sodium, an echinocandin antifungal agent, plays a pivotal role in the treatment of invasive fungal infections, notably candidemia and esophageal candidiasis. Its clinical efficacy, safety profile, and increasing global demand have prompted pharmaceutical companies to explore reliable sources of bulk API procurement. This report delivers a comprehensive analysis of the current API suppliers and manufacturing landscape for micafungin sodium, offering insights crucial for pharmaceutical companies, healthcare providers, and regulatory authorities.

Manufacturers of Micafungin Sodium

Several global players dominate the micafungin sodium API market, distinguished by their manufacturing capabilities, regulatory compliance, and supply reliability.

1. Astellas Pharma Inc.

Astellas Pharma, headquartered in Japan, holds primary rights over micafungin sodium, holding the original patent and manufacturing license. It manufactures the API and supplies it through regulated channels worldwide. Their production facilities adhere to stringent cGMP standards, ensuring high purity and consistent quality.

2. Le Kun Pharmaceutical (Suzhou) Co., Ltd.

Based in China, Le Kun Pharmaceutical manufactures micafungin sodium API, leveraging extensive experience in complex API synthesis. Their facilities conform to both Chinese and international standards, including compliance with FDA and EMA guidelines, facilitating export to global markets.

3. Chongqing Ruxin Pharmaceutical Co., Ltd.

Another Chinese manufacturer, Ruxin Pharmaceutical, offers micafungin sodium API globally. Known for cost-effective production, Ruxin emphasizes robust quality control processes aligned with international standards, making their supplies attractive for generic formulations.

4. Other Chinese API Suppliers

A proliferation of smaller Chinese API manufacturers also supplies micafungin sodium. These entities often offer competitive pricing but vary significantly in manufacturing quality, regulatory compliance, and certification. Due diligence is advised when sourcing from such suppliers.

Emerging and Potential API Sources

The expansion of micafungin sodium manufacturing capacity hinges on innovation, regulatory acceptance, and regional market demands.

• India: Though currently limited, IFRS standards are prompting Indian API manufacturers to develop capabilities for complex APIs like micafungin sodium. Companies such as Dr. Reddy’s Laboratories and Cipla are exploring or developing formulations, raising the possibility of future API supply.

• South Korea: Known for high-quality pharmaceutical manufacturing, South Korean firms may pursue licensing agreements or develop indigenous manufacturing for niche antifungal APIs.

Regulatory and Quality Considerations

For pharmaceutical companies, sourcing micafungin sodium API involves rigorous evaluation of quality standards, regulatory compliance, and supply stability:

• Regulatory Certifications: Suppliers should possess current cGMP certifications, FDA registration, EMA approval, or equivalent certifications, indicating adherence to international quality benchmarks.

• Purity and Impurity Profile: API specifications must meet pharmacopeial standards, including high purity levels (>99%), low endotoxin levels, and characterized impurity profiles.

• Traceability and Documentation: Adequate batch records, analytical certificates, and stability data bolster supply chain integrity and regulatory approval processes.

Market Trends and Challenges

The global demand for antifungal APIs, including micafungin sodium, is strengthening amid rising fungal infections and limited alternatives. However, challenges persist:

• Manufacturing Complexity: Synthesis of micafungin sodium entails complex chemical processes with multiple purification steps, requiring substantial technical expertise and manufacturing infrastructure.

• Intellectual Property: Patent protections may limit generic manufacturing, particularly for licensors like Astellas, though patent expiry or licensing agreements could open opportunities for new entrants.

• Supply Chain Risks: Limited API sources and regional manufacturing concentration pose risks of supply disruption, emphasizing the need for diversified sourcing strategies.

Conclusion

The bulk API sourcing landscape for micafungin sodium revolves primarily around licensed manufacturers like Astellas Pharma and Chinese API producers such as Le Kun Pharmaceutical and Ruxin Pharmaceutical. While the existing suppliers demonstrate robust quality and regulatory compliance, emerging regional players could influence future dynamics. Strategic sourcing decisions should prioritize regulatory adherence, quality assurance, and supply chain resilience to ensure market stability and regulatory compliance.

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Key Takeaways

• The primary API producer for micafungin sodium is Astellas Pharma, holding patent rights and supplying high-quality API globally.
• Several Chinese manufacturers, including Le Kun Pharmaceutical and Ruxin Pharmaceutical, serve as key secondary sources, offering cost-effective alternatives.
• Regulatory compliance and rigorous quality assurance are vital when selecting API suppliers to ensure product safety, efficacy, and market authorization.
• The complex manufacturing process and patent landscape influence supply availability and cost; emerging players could reshape the market.
• Diversification of sourcing and robust supplier qualification are essential to mitigate risks associated with regional manufacturing concentration and supply disruptions.

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FAQs

1. What factors should be considered when sourcing micafungin sodium API?
Suppliers’ regulatory certifications, purity levels, impurity profiles, manufacturing capacity, compliance with cGMP standards, and supply reliability are critical factors.

2. Are there any regional limitations on micafungin sodium API supply?
While global sources are available, regional manufacturing capacity limitations, patent restrictions, and export regulations may influence availability and pricing.

3. What is the typical lead time for sourcing micafungin sodium API?
Lead times vary depending on supplier location and regulatory clearance but generally range from 8 to 20 weeks, factoring in quality checks and shipping.

4. How does patent status impact API sourcing strategies?
Patent protections restrict generic manufacturing; however, patent expiry or licensing agreements can facilitate the entry of new suppliers and influence market prices.

5. Is there an increasing trend in regional manufacturing for micafungin sodium?
Yes, regions like China and India are expanding manufacturing capacities, driven by rising demand and technological advancements, potentially improving supply stability.

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References

[1] Astellas Pharma Inc. Annual Report 2022.
[2] Chinese API Manufacturer Regulatory Reports.
[3] Global API Market Analysis 2022.
[4] WHO Guidelines on Quality of Pharmaceutical Products.
[5] Industry insights into antifungal API manufacturing.