Bulk Pharmaceutical API Sources for JUBLIA

Bulk Pharmaceutical API Sources for JUBLIA

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-15660
AbaChemScene		CS-3500
ChemShuttle		136183
AKos Consulting & Solutions		AKOS027323571
Molport		MolPort-039-139-376
AbovChem LLC		HY-15660
abcr GmbH		AB456675

Bulk Active Pharmaceutical Ingredient (API) Sources for Jublia

Last updated: July 28, 2025

Introduction

Jublia (efinaconazole) is a topical antifungal medication approved for the treatment of onychomycosis of the toenails. As a key component in the pharmaceutical supply chain, the sourcing of high-quality bulk Active Pharmaceutical Ingredients (APIs) is critical for manufacturers to ensure product efficacy, safety, and regulatory compliance. This analysis delineates the leading API sources for efinaconazole, considering manufacturing origins, quality standards, regulatory status, and market dynamics.

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Overview of Efinaconazole

Efinaconazole is a triazole antifungal agent with excellent nail penetration capabilities, making it effective against dermatophyte infections. Its chemical complexity requires stringent manufacturing processes aligned with Good Manufacturing Practices (GMP). The global API market for efinaconazole is concentrated among specialized pharmaceutical ingredient suppliers that emphasize quality assurance and regulatory compliance.

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Major API Manufacturers for Efinaconazole

1. M/S Mitsui Chemicals, Inc.

A prominent Japanese chemical company, Mitsui Chemicals has expanded into the pharmaceutical API segment, including antifungal agents. The company's integrated manufacturing processes emphasize purity, batch consistency, and adherence to international quality standards such as USP, EP, and JP. Mitsui’s APIs are favored in regulated markets owing to their rigorous quality management systems.

2. Sino Biopharmaceutical Limited

Based in China, Sino Biopharmaceutical is increasingly emerging as a significant supplier of antifungal APIs, including efinaconazole. Their manufacturing facilities hold GMP certifications recognized by major regulatory agencies like the FDA and EMA. The company leverages robust R&D capabilities to optimize API synthesis, ensuring high purity and bioavailability.

3. Zhejiang Hisun Pharmaceutical Co., Ltd.

This Chinese pharmaceutical manufacturer specializes in antifungal and dermatological APIs. Their efinaconazole API production lines are compliant with international standards, with a focus on scalability and cost competitiveness. Hisun’s APIs are supplied to global markets, including North America and Europe, with quality documentation suitable for regulatory submissions.

4. API Suppliers in India (e.g., Granules India, Hetero Labs)

India remains a vital hub for bulk API manufacturing across various therapeutic classes. While primarily known for generic APIs, some Indian firms have initiated or proposed efinaconazole production. Their manufacturing units are often certified with WHO-GMP, with some aiming for US FDA approval for high-quality exports.

5. Contract Manufacturing Organizations (CMOs)

Several CMOs globally provide custom API synthesis, including efinaconazole, leveraging proprietary or licensed production processes. These entities cater to pharmaceutical companies seeking reliable sources without investing in in-house manufacturing. CMO options often include supply chain assurances with verified GMP compliance.

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Market Dynamics and Sourcing Considerations

Regulatory Compliance: For markets like the U.S., Europe, and Japan, API suppliers must demonstrate compliance with respective regulatory standards—USP, EP, JP, or FDA. Rigorous audits and documentation support quality claims.

Quality Assurance: High purity levels, low impurity profiles, and batch-to-batch consistency are non-negotiable in sourcing APIs for antifungal products. Suppliers with robust QA/QC frameworks are preferred.

Cost and Supply Chain Stability: While cost competitiveness influences sourcing decisions, supply chain reliability and capacity to meet demand are critical, especially given the niche nature of efinaconazole.

Geopolitical Factors: Tariffs, trade policies, and regional regulations impact sourcing options. Many pharmaceutical companies prefer suppliers within stable jurisdictions with established GMP infrastructure.

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Emerging Trends in API Sourcing for Jublia

• Shift Towards Regional Production: To mitigate supply chain disruptions, manufacturers increasingly prefer regional suppliers within North America, Europe, and Asia with proven GMP standards.

• Enhanced Quality Certifications: Suppliers achieving certifications such as ISO 9001, ISO 13485 (medical devices), and ICH Q7 (API manufacturing) gain a competitive edge.

• Strategic Partnerships and Long-Term Supply Agreements: These foster stability and ensure continuous supply, especially amid fluctuating global demand patterns.

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Challenges in API Sourcing for Efinaconazole

• Manufacturing Complexity: Efinaconazole's synthesis involves multiple steps requiring precise control, making manufacturing sensitive to deviations.

• Limited Number of Suppliers: Due to the niche nature of efinaconazole, fewer suppliers possess the requisite capabilities, constraining options.

• Intellectual Property Constraints: Some suppliers may face patent limitations or licensing restrictions, affecting availability and licensing costs.

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Conclusion

The procurement of bulk efinaconazole API for Jublia production hinges on sourcing from reputable, GMP-compliant manufacturers capable of delivering high purity, consistent quality, and reliable supply. Key suppliers include Mitsui Chemicals, Sino Biopharmaceutical, Zhejiang Hisun Pharmaceutical, and select Indian manufacturers. As the antifungal market evolves, strategic partnerships and rigorous quality vetting remain paramount to maintaining supply chain integrity.

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Key Takeaways

• Quality and Compliance are Paramount: Ensure API suppliers possess recognized GMP certifications and adhere to international standards (USP, EP, JP).
• Diversity in Sourcing: Diversify suppliers to mitigate risks associated with geopolitical or manufacturing disruptions.
• Emphasize Supply Chain Stability: Prioritize suppliers with proven track records of consistent delivery and capacity.
• Monitor Regulatory Developments: Stay abreast of evolving regulatory requirements affecting API imports and approvals.
• Leverage Strategic Partnerships: Long-term arrangements can secure supply stability and potentially lower costs.

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FAQs

1. Who are the leading global suppliers of efinaconazole API for Jublia?
Mitsui Chemicals and Sino Biopharmaceutical are among the primary suppliers, with additional sources in China, India, and through CMOs offering scalable manufacturing and GMP compliance[1].

2. What quality standards should API suppliers meet for antifungal medications like Jublia?
Suppliers must adhere to Good Manufacturing Practices (GMP), and APIs should conform to pharmacopeial standards such as USP, EP, or JP, with rigorous QA/QC protocols ensuring high purity and low impurity levels.

3. How does geopolitical stability influence API sourcing for efinaconazole?
Regional stability affects supply reliability; regions with robust regulatory frameworks and stable political environments are preferred to mitigate risks of manufacturing disruption or regulatory hurdles.

4. Are Indian API manufacturers viable sources for efinaconazole?
Yes, several Indian organizations such as Hetero Labs and Granules India have GMP-certified facilities that could produce efinaconazole, although capacity and certification levels vary, necessitating due diligence.

5. What challenges do manufacturers face when sourcing efinaconazole APIs?
Challenges include limited supplier pools due to complex synthesis, patent protections, meeting stringent quality standards, and ensuring consistent supply amid global demand fluctuations.

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References

[1] Industry Reports on API Manufacturing; World Health Organization API standards; Company websites and GMP certification documentation.