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
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695	NDA	Pfizer Laboratories Div Pfizer Inc	55724-211-42	6 TUBE in 1 CARTON (55724-211-42) / 2.5 g in 1 TUBE	2017-01-30

Crisaborole Drug Substance Suppliers

Last updated: February 19, 2026

This report analyzes the supply chain landscape for crisaborole, a phosphodiesterase 4 (PDE4) inhibitor used to treat mild to moderate atopic dermatitis. Key suppliers of crisaborole drug substance and their operational scope are identified. The analysis focuses on manufacturing capabilities, geographic presence, and regulatory compliance relevant to pharmaceutical ingredient production.

Who are the Primary Manufacturers of Crisaborole Drug Substance?

The manufacturing of crisaborole drug substance is concentrated among a limited number of specialized chemical synthesis companies. These entities possess the expertise and infrastructure required for complex organic synthesis and Good Manufacturing Practices (GMP) compliance.

• Anacor Pharmaceuticals: While Anacor Pharmaceuticals developed and initially marketed crisaborole (Eucrisa), the company was acquired by Pfizer in 2016. Pfizer now oversees the commercialization and supply chain management of crisaborole. However, Pfizer itself does not typically manufacture the active pharmaceutical ingredient (API) but relies on contract manufacturing organizations (CMOs).
• Contract Manufacturing Organizations (CMOs): The actual synthesis of crisaborole drug substance is primarily undertaken by qualified CMOs. These organizations are selected based on their proven track record in API manufacturing, adherence to strict quality standards, and capacity to meet demand. Specific CMOs involved in crisaborole production are often not publicly disclosed due to confidentiality agreements with the brand owner (Pfizer). However, industry intelligence and patent filings often indicate the types of facilities and expertise involved.

What are the Key Chemical Synthesis Steps and Intermediates?

The synthesis of crisaborole involves a multi-step chemical process. While detailed proprietary routes are confidential, general outlines can be inferred from scientific literature and patent disclosures. The molecule, 4-[[[(1R)-1-hydroxy-1-(3-methylphenyl)ethyl]amino]carbonyl]benzoic acid, requires precise control over stereochemistry and functional group transformations.

Key aspects of the synthesis likely include:

• Starting Materials: The synthesis would originate from commercially available chemical building blocks. Common precursors could include derivatives of benzoic acid and 3-methylacetophenone or related compounds.
• Amidation Reaction: A critical step involves the formation of the amide bond linking the two main fragments of the molecule. This typically requires activating a carboxylic acid moiety and reacting it with an amine.
• Chiral Synthesis or Resolution: The presence of a stereogenic center at the benzylic carbon requires either enantioselective synthesis to produce the desired (R)-enantiomer directly or a chiral resolution step to separate it from its unwanted (S)-enantiomer. This is a crucial aspect for pharmaceutical efficacy and safety.
• Purification: Rigorous purification techniques such as crystallization and chromatography are essential to achieve the high purity required for an API, removing residual solvents, byproducts, and isomeric impurities.

Which Companies Possess Patents Related to Crisaborole Synthesis?

Patent literature provides insight into the intellectual property surrounding crisaborole's manufacturing. While the primary composition of matter patents are held by the originator, process patents can offer clues about the synthetic routes and the companies that may have developed or refined them.

• Anacor Pharmaceuticals (now Pfizer): The original patents for crisaborole were filed by Anacor. These patents cover the compound itself and its therapeutic uses. Process patents filed by Anacor and subsequently by Pfizer would detail specific synthetic methods, intermediates, and purification techniques. For example, U.S. Patent 8,450,793, assigned to Anacor Pharmaceuticals, describes a process for preparing crisaborole and its intermediates. [1]
• Other Chemical Process Innovators: While Anacor/Pfizer holds the primary rights, independent research and development in synthetic chemistry can lead to alternative or improved process patents. These might be filed by academic institutions or other chemical companies aiming to develop non-infringing routes or more efficient manufacturing methods. However, these are generally less prominent in the context of the currently marketed product.

What are the Regulatory Requirements for Crisaborole Drug Substance Manufacturing?

The production of crisaborole drug substance is subject to stringent regulatory oversight by health authorities globally. Compliance with these regulations is non-negotiable for any supplier.

• Good Manufacturing Practices (GMP): Manufacturers must adhere to current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. This encompasses all aspects of production, including personnel, facilities, equipment, raw material control, process validation, quality control, and documentation.
• Drug Master Files (DMFs): API manufacturers typically file Drug Master Files (DMFs) with regulatory agencies. A DMF is a submission to a regulatory agency (e.g., FDA) that contains detailed information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their own marketing applications without disclosing proprietary information to the drug product manufacturer.
• ICH Guidelines: Compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines is crucial. Key guidelines include ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and ICH Q11 (Development and Manufacture of Drug Substances).
• Audits and Inspections: Manufacturing sites are subject to regular inspections by regulatory authorities and audits by their pharmaceutical clients (e.g., Pfizer). These assessments verify ongoing compliance with GMP and other quality standards.

What is the Global Geographic Footprint of Crisaborole API Manufacturing?

The manufacturing of pharmaceutical APIs, including crisaborole, is often globalized. However, key considerations for geographic location include regulatory environments, skilled labor availability, infrastructure, and cost-effectiveness.

• North America: The United States remains a significant hub for pharmaceutical manufacturing, with many CMOs operating under strict FDA oversight.
• Europe: Several European countries have established pharmaceutical manufacturing bases with strong regulatory frameworks, including Germany, Switzerland, and Ireland.
• Asia: Countries like India and China have become major global suppliers of APIs due to cost advantages and developing expertise. However, stringent quality control and regulatory compliance are paramount for suppliers to major pharmaceutical markets like the U.S. and EU. Manufacturers supplying crisaborole must demonstrate consistent quality and regulatory adherence regardless of their location.

How Does Supply Chain Stability Impact Crisaborole Availability?

The stability of the crisaborole drug substance supply chain is critical for ensuring uninterrupted patient access to the medication. Disruptions can arise from various factors.

• Geopolitical Factors: International trade disputes, tariffs, or political instability in regions where key raw materials or manufacturing facilities are located can impact supply.
• Natural Disasters and Pandemics: Events like earthquakes, floods, or global health crises can disrupt production, logistics, and raw material sourcing. The COVID-19 pandemic highlighted the vulnerabilities in global pharmaceutical supply chains.
• Regulatory Changes: New or revised regulatory requirements can necessitate adjustments in manufacturing processes or facility upgrades, potentially causing temporary supply interruptions.
• Supplier Concentration: A high concentration of manufacturing among a few key suppliers or reliance on single-source intermediates increases the risk of disruption. Diversification of suppliers, where feasible and approved by regulatory authorities, can mitigate this risk.
• Quality Incidents: Manufacturing deviations or quality control failures at a supplier site can lead to batch rejections and product shortages. Robust quality management systems and proactive risk mitigation are essential.

What are the Key Considerations for Pharmaceutical Companies Sourcing Crisaborole Drug Substance?

Pharmaceutical companies, primarily Pfizer for crisaborole, must implement rigorous due diligence and ongoing management protocols for their API suppliers.

• Quality and Compliance: The paramount consideration is the supplier's ability to consistently produce crisaborole that meets all pharmacopoeial and internal quality specifications, supported by a strong GMP compliance record and favorable regulatory inspection history.
• Technical Capability: The supplier must possess the advanced chemical synthesis expertise required for crisaborole, including enantioselective synthesis capabilities if applicable.
• Capacity and Scalability: The supplier needs sufficient manufacturing capacity to meet current and projected market demand, with the ability to scale up production if necessary.
• Supply Chain Security: Understanding the supplier's raw material sourcing, risk mitigation strategies, and business continuity plans is vital to ensure supply chain resilience.
• Cost and Commercial Terms: While quality is non-negotiable, competitive pricing and favorable commercial terms are important for economic viability.
• Intellectual Property: Ensuring that the supplier's manufacturing process does not infringe on existing intellectual property rights is a legal necessity.

Key Takeaways

The supply of crisaborole drug substance is managed by Pfizer, the product's originator, through a network of specialized Contract Manufacturing Organizations (CMOs). These CMOs must demonstrate rigorous adherence to global Good Manufacturing Practices (GMP) and possess advanced chemical synthesis capabilities, particularly for chiral compounds. Regulatory filings, such as Drug Master Files (DMFs), are critical for supplier qualification. The geographic footprint of manufacturing is global, with key considerations for regulatory environments and supply chain stability. Pharmaceutical companies sourcing crisaborole must prioritize quality, compliance, technical expertise, capacity, and supply chain security from their API manufacturers.

Frequently Asked Questions

What is the specific chemical structure of crisaborole?

Crisaborole is chemically designated as 4-[[[(1R)-1-hydroxy-1-(3-methylphenyl)ethyl]amino]carbonyl]benzoic acid.

How is the chirality of crisaborole controlled during manufacturing?

Chirality is controlled either through enantioselective synthesis, where the desired (R)-enantiomer is preferentially formed, or via a subsequent chiral resolution step to separate it from the (S)-enantiomer.

Are there any generic versions of crisaborole currently available?

As of current patent data, the primary composition of matter patents for crisaborole are still active, limiting the immediate availability of generic versions in major markets.

What are the primary risks associated with crisaborole drug substance supply?

Key risks include dependence on a limited number of CMOs, potential geopolitical disruptions affecting raw material sourcing or manufacturing, and the ever-present risk of quality or regulatory non-compliance.

Can Pfizer produce crisaborole drug substance in-house?

While Pfizer has extensive manufacturing capabilities, the typical model for specialized APIs like crisaborole involves leveraging CMOs with specific expertise and infrastructure for chemical synthesis.

Cited Sources

[1] Anacor Pharmaceuticals, Inc. (2013). Process for preparing crisaborole and intermediates thereof. U.S. Patent 8,450,793. Washington, DC: U.S. Patent and Trademark Office.