Bulk Pharmaceutical API Sources for CRISABOROLE

Bulk Pharmaceutical API Sources for CRISABOROLE

Vendor	Vendor Homepage	Vendor Sku	API Url
Anward		ANW-65536
ChemTik		CTK8C0958
Ark Pharm, Inc.		AK102641
MedChemexpress MCE		HY-10978
AbaChemScene		CS-1057
AKos Consulting & Solutions		AKOS016005425
Aurum Pharmatech LLC		W-5676

Bulk Active Pharmaceutical Ingredient (API) Sources for: Crisaborole

Last updated: July 28, 2025

Introduction

Crisaborole is a non-steroidal anti-inflammatory agent marketed primarily under the trade name Eucrisa®, used for the topical treatment of mild to moderate atopic dermatitis. Its mechanism involves phosphodiesterase 4 (PDE4) inhibition, reducing inflammatory cytokine production. Its unique chemical profile has prompted many pharmaceutical companies to seek reliable, high-quality API sources for manufacturing and research purposes. This article evaluates the landscape of bulk API suppliers for crisaborole, examining manufacturing status, geographic distribution, quality compliance, and sourcing trends.

Overview of Crisaborole API Market

The crisaborole API market remains relatively niche because its commercialization is concentrated among a handful of producers. Developed and marketed by Pfizer, the original API production is primarily internalized, but external sourcing has become more prominent following patent expiry, licensing agreements, and the rising trend of outsourcing manufacturing [1].

Major API Suppliers and Manufacturing Landscape

1. Pfizer Inc.

Pfizer remains the principal producer of crisaborole API, leveraging its proprietary synthetic pathways developed during the drug’s initial development phase. Their manufacturing facilities in the United States and Europe have been validated for high-purity production consistent with cGMP standards. external supply from Pfizer is typically limited to custom synthesis agreements for research and clinical development, owing to intellectual property considerations [2].

2. Contract Manufacturing Organizations (CMOs)

The limited number of publicly disclosed external suppliers has led to an increasing reliance on CMOs specializing in complex heterocyclic APIs:

• Bachem AG: A Swiss-based manufacturer with extensive expertise in alkaloids and heterocycles, Bachem has capabilities for custom synthesis of APIs like crisaborole under strict quality standards. Their facilities are GMP-certified, supporting both clinical and commercial batches [3].

• SAFC (a division of Merck KGaA): Known for scalable API synthesis, SAFC provides custom manufacturing services for specialty APIs, including those with complex heterocyclic structures. Their global network ensures supply continuity for research and early commercial production [4].

• Thermo Fisher Scientific: Some divisions offer API development and synthesis for research purposes. While not a primary manufacturer, their infrastructure supports small to medium batch production with validated quality for investigational products [5].

3. Chinese and Indian API Manufacturers

The rise of emerging markets in pharmaceutical manufacturing has also influenced crisaborole API sourcing:

• Shanghai Sunbright Chemicals and Shaanxi Top Pharm Chemical in China have begun to offer synthetic intermediates and APIs for select heterocyclic compounds, including PDE4 inhibitors similar to crisaborole. However, their capacity for large-scale, high-purity API manufacturing remains under validation.

• Dr. Reddy’s Laboratories and Hetero Labs in India are known for generic and specialty APIs, with some emerging capability in heterocyclic API synthesis. Quality standards and regulatory approval status are critical factors influencing their sourcing potential [6].

Quality Standards and Regulatory Compliance

Key aspects to consider when sourcing crisaborole API include:

• GMP Compliance: Ensuring suppliers follow Good Manufacturing Practices is essential for product safety and regulatory approval. Many established CMOs in Europe and the US maintain strict GMP certification, which is mandatory for APIs intended for clinical or commercial use.

• Quality Certifications: ISO certifications, US FDA approval for manufacturing facilities, and adherence to pharmacopoeia standards ensure API purity, stability, and consistency.

• Regulatory Documentation: Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and detailed manufacturing process documentation are necessary for regulatory submissions, especially in key markets like the US, EU, and Japan.

Sourcing Trends and Future Outlook

The reliance on a handful of primary suppliers of crisaborole API suggests a consolidating supply chain. However, market forces such as patent expiries, increased demand, and regional manufacturing capacity expansion are likely to diversify the sourcing landscape:

• Emerging Manufacturing Regions: Southeast Asia and Latin America are gradually increasing API production capabilities, driven by government policy incentives and market expansion.

• Supply Chain Resilience: Companies are increasingly seeking multiple sources to mitigate risks related to geopolitical uncertainties, regulatory challenges, and quality concerns.

• Synthetic Innovation: Development of cost-effective, scalable synthetic routes for crisaborole could lead to new supplier entrants and reduced production costs. Process engineering improvements by contract manufacturers are vital in this regard.

Challenges in sourcing Crisaborole API

• Intellectual Property Restrictions: Patent protections in key markets restrict external manufacturing unless licensing agreements are in place.

• Limited Availability: Despite rising demand, crisaborole’s synthesis complexity limits the number of competent producers, leading to supply bottlenecks.

• Regulatory Barriers: Federal and international regulations necessitate rigorous quality verification, which can extend lead times and elevate costs.

Conclusion

The primary source of high-quality crisaborole API remains Pfizer's proprietary manufacturing, with select CMOs serving as critical external suppliers. While emerging markets are developing capabilities, quality assurance and regulatory compliance remain paramount. The landscape is expected to evolve with increased manufacturing capacity, synthetic process innovations, and strategic diversification of suppliers. For stakeholders, ensuring supply chain resilience and compliance with regulatory standards will be fundamental to leveraging crisaborole’s therapeutic potential effectively.

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Key Takeaways

• Pfizer is the main producer of crisaborole API, primarily for its own commercial needs, with limited external supply options.

• Contract manufacturing organizations such as Bachem and SAFC play vital roles in providing high-quality, GMP-certified synthetically derived crisaborole for research and early commercialization.

• Emerging pharmaceutical hubs in China and India are beginning to offer capabilities in heterocyclic API synthesis, but regulatory and quality validations are ongoing.

• Sourcing considerations include strict adherence to GMP standards, regulatory approval, and supply chain robustness.

• Future growth hinges on synthetic process innovations, diversification of suppliers, and regional capacity expansions to meet increasing global demand.

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FAQs

1. What are the primary synthetic challenges in manufacturing crisaborole API?
Crisaborole's synthesis involves complex heterocyclic chemistry, including the formation of a boron-containing heterocycle with specific stereochemistry. Ensuring high purity, controlling the formation of by-products, and maintaining consistent yields are significant challenges.

2. Are there alternative sources for mechanistic studies of PDE4 inhibitors like crisaborole?
Yes. Several research-grade PDE4 inhibitors are available from chemical suppliers for in vitro and in vivo studies, but sourcing pharmaceutical-grade crisaborole API requires suppliers with GMP certification.

3. Is it possible to custom-synthesize crisaborole API for clinical trials?
Yes. Several CMOs offer custom synthesis services for investigational quantities of crisaborole API, provided compliance with regulatory standards is maintained, and intellectual property considerations are respected.

4. How does the patent status affect external API sourcing for crisaborole?
Patents restrict external manufacturing unless licensing or authorized agreements are in place. Patent expiry or licensing agreements are necessary for generic or third-party production.

5. What quality attributes are essential for crisaborole API in pharmaceutical manufacturing?
High chemical purity (>99%), compliance with pharmacopeial standards, consistent batch-to-batch reproducibility, low residual solvents, and documented stability are crucial for API quality assurance.

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References

[1] Pfizer Press Release, “Pfizer Announces Launch of Eucrisa (crisaborole) Topical Ointment,” 2016.
[2] Patent US Patent No. 8,753,679 B2.
[3] Bachem AG Corporate Website. “Custom API Synthesis Capabilities,” 2023.
[4] Merck KGaA SAFC. “Advanced APIs for Specialty Therapeutics,” 2023.
[5] Thermo Fisher Scientific, “API Development and Production,” 2023.
[6] Reddy’s Laboratories Quarterly Report, “Emerging API Capabilities,” 2022.