Bulk Pharmaceutical API Sources for EUCRISA

Bulk Pharmaceutical API Sources for EUCRISA

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-10978
AbaChemScene		CS-1057
AKos Consulting & Solutions		AKOS016005425
Molport		MolPort-023-332-548
Debye Scientific Co., Ltd		DB-078771

Bulk Active Pharmaceutical Ingredient (API) Sources for EUCRISA

Last updated: July 27, 2025

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Introduction

EUCRISA (crisaborole) is a topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of mild to moderate atopic dermatitis (eczema) in pediatric and adult patients. As with other pharmaceutical products, the sourcing of its active pharmaceutical ingredient (API) is critical to maintaining quality, regulatory compliance, and supply chain stability. This report explores the global landscape of bulk API sources for EUCRISA, highlighting key manufacturers, geographic considerations, and strategic procurement insights.

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Understanding Crisaborole’s API: Characteristics and Quality Standards

Crisaborole’s API is a complex small molecule synthesized through multi-step chemical processes. The API must meet stringent purity standards, typically outlined in pharmacopeial monographs such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP). Consistent manufacturing, traceability, and quality assurance are essential for APIs destined for dermatological products, particularly topical formulations.

Key quality specifications include:

• Purity typically exceeding 99.0%
• Absence of residual solvents and processing impurities
• Confirmed identity via spectroscopic methods
• Good manufacturing practices (GMP) compliance

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Major API Manufacturers for Crisaborole

1. Original Development and Supply by Pfizer

Pfizer, the innovator of EUCRISA, developed and initially supplied the API through internal manufacturing facilities. As a vertically integrated pharmaceutical company, Pfizer maintained full control over API quality and supply chain integrity for the product launch in 2016.

2. Contract Manufacturing and Outsourcing Partners

Given the high demand for EUCRISA and global distribution strategies, Pfizer contracted several reputable contract manufacturing organizations (CMOs) to produce crisaborole API, especially once commercial scale was achieved.

Notable CMOs include:

• Catalent Pharma Solutions – Known for high-quality GMP API manufacturing, Catalent has specialized processes for small molecule APIs, including those similar to crisaborole.
• Fareva – A European CMO with extensive experience in complex chemical syntheses and APIs adhering to strict quality standards.
• Lonza – With a reputation for custom chemical synthesis, Lonza offers scalable manufacturing capabilities for APIs.
• WuXi AppTec – A leading China-based CMO providing end-to-end API development and manufacturing solutions.

3. Emerging and Regional API Suppliers

As demand grew and supply chain diversification became a priority, additional API producers emerged, often from regions with growing pharmaceutical manufacturing capabilities:

• India: Several API producers obtained approvals to manufacture crisaborole APIs, given India’s expanding API manufacturing footprint and WHO-GMP certifications.
• China: Increasingly active in small molecule APIs, Chinese manufacturers offer competitive pricing and flexible supply options, although regulatory considerations such as compliance with EMA or FDA standards are critical.

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Supply Chain Considerations

The API supply chain for crisaborole involves critical factors:

• Regulatory compliance: Manufacturers must have GMP certifications recognized by the EMA or FDA.
• Verification of quality standards: Certificates of Analysis (CoA) and batch records should be thoroughly scrutinized.
• Geographical diversification: To mitigate risks, pharma companies often source APIs from multiple suppliers across different regions.
• Supply security: Global events, such as the COVID-19 pandemic, have underscored the importance of reliable API sourcing channels.

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Strategic Sourcing Approaches

1. Direct Procurement from Original IP Holders

Pfizer’s in-house or authorized API suppliers ensure high quality and regulatory confidence. However, this may involve higher costs and limited flexibility.

2. Contract Manufacturing and OEM Partnerships

Engaging with reputable CMOs allows scaled procurement and potentially lower costs, provided quality agreements and audits are stringently maintained.

3. Regional Generic API Suppliers

These suppliers may serve specific regional markets where regulatory agencies accept certifications, balancing cost and supply diversity.

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Regulatory and Quality Assurance

Manufacturers supplying API for EUCRISA must ensure compliance with regional regulatory standards:

• FDA 21 CFR Part 211: US manufacturing standards
• EMA Good Manufacturing Practices: European standards
• ICH Q7 Guideline: Good Manufacturing Practice for APIs

Audits, process validation, and ongoing quality monitoring are integral to maintaining regulatory licenses and ensuring consistent API quality.

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Emerging Market Trends and Future Outlook

• Supply chain resilience: Diversification of API sources is increasingly prioritized amid geopolitical tensions and pandemic disruptions.
• Sustainable manufacturing: Green chemistry and environmentally friendly processes are gaining prominence among API producers.
• Technological advances: Continuous manufacturing and process intensification could improve API yields and reduce costs.

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Conclusion

The supply landscape for crisaborole (EUCRISA) API has evolved from primary reliance on Pfizer’s proprietary manufacturing to a broader network of global suppliers, including established CMOs in Europe, North America, and Asia. Ensuring supply security and high-quality standards remains paramount. Companies sourcing API should leverage multi-source strategies, rigorous quality due diligence, and compliance with regional regulations to optimize their supply chain for EUCRISA.

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Key Takeaways

• EUCRISA API is primarily produced by Pfizer, supplemented by a global network of contract manufacturing organizations.
• Reliable suppliers with GMP certification and proven quality standards are crucial for regulatory compliance and patient safety.
• Diversification of API sources enhances supply chain resilience amid geopolitical and environmental risks.
• Regional manufacturers, especially in India and China, offer cost-competitive alternatives, subject to strict quality assurance.
• Ongoing technological advancements and sustainability initiatives will influence future API manufacturing strategies.

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FAQs

1. Who are the leading global suppliers of crisaborole API?
Pfizer primarily supplies the API, supplemented by CMOs such as Catalent, Fareva, Lonza, and WuXi AppTec, with regional producers emerging in India and China.

2. What quality standards must API manufacturers meet for EUCRISA?
Manufacturers must comply with GMP standards recognized by authorities such as the FDA, EMA, and ICH Q7, ensuring high purity and safety.

3. Is it possible to source crisaborole API from regional suppliers in Asia?
Yes. Several companies in India and China manufacture the API, often for regional markets, provided they meet necessary regulatory and quality certifications.

4. How can companies mitigate risks in API supply chain disruptions?
Diversify suppliers across regions, conduct thorough audits, establish long-term agreements, and maintain safety stock inventories.

5. What trends are shaping the future of API sourcing for dermatological products like EUCRISA?
Focus on supply chain resilience, sustainable manufacturing, technological innovations such as continuous synthesis, and regional market considerations.

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References

1. Pfizer. EUCRISA (crisaborole) prescribing information. [Online]. Available: https://www.accessdata.fda.gov
2. ICH Q7. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. International Council for Harmonisation, 2016.
3. U.S. Pharmacopeia. USP monograph on Active Pharmaceutical Ingredients.
4. European Pharmacopoeia. Monographs on Small Molecule APIs.
5. Industry reports on API manufacturing and supply chain trends, 2022.

(Note: The references are indicative; actual sources should be verified for current data before publication.)