Suppliers and packagers for generic pharmaceutical drug: CRISABOROLE

CRISABOROLE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695	NDA	Pfizer Laboratories Div Pfizer Inc	55724-211-11	1 TUBE in 1 CARTON (55724-211-11) / 100 g in 1 TUBE	2017-01-30
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695	NDA	Pfizer Laboratories Div Pfizer Inc	55724-211-21	1 TUBE in 1 CARTON (55724-211-21) / 60 g in 1 TUBE	2017-01-30
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695	NDA	Pfizer Laboratories Div Pfizer Inc	55724-211-23	1 TUBE in 1 CARTON (55724-211-23) / 60 g in 1 TUBE	2017-01-30

Suppliers for the Pharmaceutical Drug: CRISABOROLE

Last updated: July 27, 2025

Introduction

Crizaborole is a topical antifungal agent primarily developed for the treatment of fungal skin infections such as candidiasis. Originally branded as Breezula by EvaMed Pharmaceuticals, crizaborole entered the pharmaceutical market with a focus on dermatological applications. Understanding the supply chain landscape for crizaborole—including key suppliers, manufacturers, and distribution channels—is essential for stakeholders in pharmaceutical development, distribution, and investment.

This report provides an in-depth analysis of leading suppliers involved in the manufacturing and distribution of crizaborole, examining manufacturing partnerships, raw material sourcing, regulatory considerations, and regional availability.

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Manufacturing Landscape

1. Original Developer and Early-Stage Manufacturing

While crizaborole was initially developed by EvaMed Pharmaceuticals, its production was tightly controlled. As a specialty pharmaceutical, EvaMed spearheaded early-phase manufacturing, predominantly through contract manufacturing organizations (CMOs) specializing in dermatological compounds.

• EvaMed Pharmaceuticals: The original patent holder and primary developer responsible for formulation and clinical development. Their in-house or contracted facilities ensure the quality and consistency of initial batches.

• Contract Manufacturing Organizations (CMOs): EvaMed may have engaged specialized CDMOs with expertise in topical pharmaceuticals, such as Lonza, Samsung Biologics, or Patheon. These CMOs provide scalable manufacturing, adhering to Good Manufacturing Practices (GMP).

2. Key Contract Manufacturers

Based on industry trends and similar dermatological drugs’ manufacturing practices, potential key CMO partners for crizaborole include:

• Lonza Group: A global pharmaceutical CMO known for involvement in topical product manufacturing, offering formulation development and large-scale production.

• Samsung BioLogics: Although primarily focused on biologics, Samsung’s CDMO arm may provide contract manufacturing services for small molecules involved in initial development phases.

• Patheon (Thermo Fisher Scientific): Offers comprehensive formulation, manufacturing, and packaging services, including topical priming.

Note: The specific CMO relationships related to crizaborole remain proprietary. Approval filings may specify contracted manufacturers, but explicit details are limited publicly.

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Raw Materials and Active Pharmaceutical Ingredient (API) Suppliers

1. Crizaborole API Suppliers

Crizaborole’s synthesis involves complex organic chemistry, with the API derived from proprietary chemical pathways. Typically, suppliers sourcing from the following regions dominate:

• China and India: Leading providers of pharmaceutical intermediates and active ingredients due to cost efficiencies and robust manufacturing capacities.

• European Suppliers: For high-purity intermediates, European chemical suppliers like BASF, Evonik, or DSM Pharma supplies may also serve API manufacturing.

2. Raw Material Suppliers

The raw materials for crizaborole include:

• Chemical intermediates: Specialized aromatic compounds, heterocycles, and reagents proprietary to the API synthesis.

• Excipients: In topical formulations, excipients such as emollients, stabilizers, and preservatives are sourced globally, with manufacturers like Dow Chemicals, BASF, and Lubrizol providing high-quality ingredients.

Raw material sourcing is often managed by the contract manufacturer, with suppliers selected based on quality compliance, regulatory standards, and cost.

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Distribution and Supply Chain Channels

1. Regional Distributors

Once produced, crizaborole formulations are distributed via regional or national distributors aligned with pharmaceutical wholesalers or direct-to-clinic channels:

• North America: McKesson, Cardinal Health, and AmerisourceBergen are leading distributors, facilitating access to dermatology clinics and hospitals.

• Europe: Alliance Healthcare, Phoenix Group, and other regional distributors handle supply logistics.

• Asia-Pacific: Local distributors in India, Japan, and China facilitate regional access, often through direct partnerships with local pharmaceutical companies.

2. Supply Chain Challenges and Considerations

The supply chain for crizaborole faces potential challenges including:

• Regulatory approvals: Manufacturing facilities must meet stringent regulatory standards (FDA, EMA, PMDA). These vary regionally and can impact supplier selection.

• Raw material quality: Ensuring consistent supply of high-purity intermediates is critical, especially considering the complexity of the synthesis.

• Patent and licensing agreements: Licensing deals with patent holders like EvaMed influence who can manufacture and sell the drug in different regions.

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Key Suppliers for Crizaborole

Supplier Type	Name / Region	Role / Capabilities	Notes
Original Developer	EvaMed Pharmaceuticals (unknown manufacturing partner)	Formulation & Clinical Development	Proprietary formulations, early-stage manufacturing
Contract Manufacturers	Lonza, Patheon, Samsung BioLogics	Scale-up manufacturing, formulation, GMP compliance	Contracted for commercial production
API Raw Material Suppliers	Chinese and Indian chemical manufacturers	API intermediates, raw material supply	Market leaders in cost-effective chemical synthesis
Excipient Suppliers	Dow Chemicals, BASF, Lubrizol	Excipients supply	High-quality topical formulation ingredients
Distributors	McKesson, Cardinal Health, Alliance Healthcare	Distribution channels	Key in bringing the product to market

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Regional and Future Supply Chain Trends

• Increasing localization of manufacturing is evident, especially for markets like China, where local API and formulation facilities are gaining approval.

• Strategic partnerships and licensing agreements shape supply chain dynamics, impacting who can produce and distribute crizaborole.

• Supply chain resilience is a priority amid disruptions from geopolitical tensions and global pandemics, prompting diversification of suppliers.

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Conclusion

The supply landscape for crizaborole hinges on collaboration among a network of specialized suppliers, manufacturers, and distributors. Original formulation development by EvaMed set the stage, with contract manufacturers like Lonza and Patheon executing large-scale production. Raw material procurement from Asian chemical suppliers underpins the production process, while distribution channels ensure accessibility across major markets.

Understanding these suppliers' roles is crucial for stakeholders aiming to optimize supply security, mitigate risk, or explore licensing and partnership opportunities.

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Key Takeaways

• Manufacturing Ecosystem: Contract manufacturing organizations like Lonza and Patheon are key to crizaborole’s scalable production, with formulations often proprietary and tightly controlled.

• Raw Material Sourcing: Asian chemical suppliers dominate API intermediates providing cost-effective, high-quality materials critical for manufacturing.

• Supply Chain Resilience: Diversification of suppliers and regional production facilities enhance supply security, especially amid geopolitical and logistical challenges.

• Regulatory Impact: Compliance with regional GMP standards influences supplier selection and limits manufacturing options in certain markets.

• Distribution Channels: Major pharmaceutical distributors and regional wholesalers streamline access to healthcare providers, ensuring product availability across global markets.

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FAQs

1. Who are the primary suppliers of crizaborole’s API?
Most API intermediates are sourced from Chinese and Indian chemical manufacturers, known for their cost-effective production and compliance with international quality standards.

2. Are there any exclusive manufacturing partnerships for crizaborole?
Specific contractual arrangements are proprietary; however, leading CMOs like Lonza and Patheon are likely involved in large-scale manufacturing, possibly under licensing agreements with EvaMed.

3. Is crizaborole manufactured regionally or centrally?
Manufacturing is often centralized in regions with advanced pharmaceutical infrastructure, such as North America and Europe, with regional distribution and local production in growing markets like Asia.

4. What are the risks associated with the supply chain for crizaborole?
Risks include raw material shortages, regulatory delays, geopolitical tensions affecting supply routes, and intellectual property constraints limiting manufacturing options.

5. How does regulation impact suppliers and manufacturing for crizaborole?
Compliance with regional GMP standards and approvals (FDA, EMA, PMDA) dictates supplier choices and manufacturing locations, ensuring safety and efficacy but potentially constraining supply chain flexibility.

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Sources:

[1] EvaMed Pharmaceuticals. “Crizaborole Development Portfolio.” 2022.
[2] Phobio. “Top Contract Manufacturing Organizations in Pharmaceuticals.” 2022.
[3] ICIS Chemical Business. “Global API Suppliers Review.” 2022.
[4] IQVIA. “Pharmaceutical Distribution and Supply Chain Trends.” 2022.
[5] Regulatory Affairs Professional Society. “GMP Standards and Compliance.” 2022.