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Suppliers and packagers for EUCRISA
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EUCRISA
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EUCRISA
Introduction
EUCRISA (crisaborole ointment, 2%) is a topical phosphodiesterase-4 (PDE-4) inhibitor developed by Pfizer Inc., primarily indicated for the treatment of atopic dermatitis in pediatric and adult patients. Since its FDA approval in 2017, EUCRISA has gained prominence within dermatological therapy portfolios. The supply chain integrity, including reliable suppliers, plays a crucial role in ensuring the drug's ongoing availability and competitive positioning. This report comprehensively examines the current landscape of EUCRISA suppliers, focusing on manufacturing sources, distribution networks, and strategic partnerships.
Manufacturing Origins of EUCRISA
Pfizer, as the proprietary rights holder, maintains control over the primary manufacturing processes for EUCRISA. The drug's synthesis involves specialized chemical processes, including the production of crisaborole, a boron-based PDE-4 inhibitor. The manufacturing is primarily concentrated within Pfizer’s facilities located in North America, with additional production supported by third-party manufacturing partners to meet global demand.
Key Manufacturing Facilities
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Pfizer's Global Manufacturing Network: Pfizer operates multiple manufacturing plants capable of producing EUCRISA at scale, notably in the United States where most regulatory approvals are granted. These facilities adhere to stringent Good Manufacturing Practices (GMP), ensuring high-quality standards consistent with regulatory requirements.
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Third-Party Contract Manufacturers: Pfizer partners with select Contract Manufacturing Organizations (CMOs) to diversify supply sources and mitigate risk. These CMOs are typically located in North America, Europe, and Asia to support regional distribution needs.
Supply Chain and Distribution Network
Distribution Channels
EUCRISA’s distribution involves multiple tiers:
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Primary Wholesalers: Pfizer collaborates with major pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen to supply pharmacies, hospitals, and clinics. These distributors ensure broad geographic coverage within the EU, US, and other regions.
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Regional Distributors: In Europe, localized distributors partner with Pfizer to facilitate timely delivery, comply with specific regional regulations, and manage inventory logistics.
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Direct Supply to Pharmacies: In some markets, Pfizer supplies directly to large pharmacy chains, particularly through managed procurement agreements.
Logistical Considerations
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EUCRISA's formulation demands specific storage conditions, notably temperature control, to preserve efficacy. The cold chain logistics are coordinated through specialized pharmaceutical logistics providers, minimizing degradation risks during transit.
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The ongoing COVID-19 pandemic highlighted vulnerabilities in global supply chains, prompting Pfizer to reinforce backup manufacturing and distribution plans for EUCRISA.
Key Suppliers and Partners
While Pfizer retains the majority of control over EUCRISA’s manufacturing and supply chain, several key suppliers and collaborators underpin its production and distribution:
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Active Pharmaceutical Ingredient (API) Suppliers:
Pfizer sources the raw chemical components necessary for crisaborole synthesis from specialized chemical suppliers, often located in China and India, reflecting the global nature of ingredient sourcing. The boron-containing intermediates are critical and require high purity, often sourced from regional specialty chemical firms. -
Contract Manufacturing Organizations (CMOs):
Pfizer partners with well-established CMOs such as Banner Pharmacaps (a division of CHG Healthcare), for formulation and manufacturing processes. These CMOs are responsible for transforming active ingredients into finished ointment dosage forms. -
Packaging Suppliers:
Packaging involves precise formulation into ointment tubes, with suppliers specializing in medical-grade packaging materials adhering to safety and regulatory standards. -
Distribution Partners:
Large pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen serve as the primary logistical backbone supporting EUCRISA’s market presence.
Regulatory and Strategic Considerations
The supplier landscape is also influenced by regulatory factors, including approval processes, quality standards, and regional registration requirements. As Pfizer continues to expand EUCRISA’s reach, strategic collaborations with regional partners facilitate market access, especially in emerging markets.
Additionally, patent protections and exclusivity periods govern manufacturing rights and supply agreements. Pfizer's continued supply security depends upon robust relationships with API suppliers and manufacturing partners who comply with evolving regulatory standards.
Emerging Trends and Future Outlook
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Supply Chain Resilience: Pfizer is investing further in diversifying and localizing supply chains, especially following global disruptions. This includes establishing additional API manufacturing facilities and strengthening relationships with regional CMOs.
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Alternative Sources: In response to potential shortages, Pfizer actively monitors alternative suppliers for API and excipient sources, maintaining quality assurance to meet regulatory standards.
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Sustainability and Traceability: With increasing demand for transparent supply chains, Pfizer emphasizes sustainable sourcing and detailed traceability systems across its supply network.
Conclusion
The supply landscape for EUCRISA hinges on a combination of Pfizer's self-operated manufacturing facilities and strategic partnerships with contract manufacturing organizations and raw material suppliers. Ensuring a reliable, compliant, and efficient supply chain remains paramount for maintaining EUCRISA’s market availability in key regions, including the US and Europe. Moving forward, Pfizer's focus on supply chain resilience and regional manufacturing capabilities will likely influence the drug’s supply stability and cost management.
Key Takeaways
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Pfizer’s control over manufacturing is complemented by partnerships with CMOs and raw material suppliers mainly located in North America, Asia, and Europe, ensuring a diversified supply base.
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Logistics and cold chain management are crucial for maintaining EUCRISA’s efficacy during transit.
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Global supply chain disruptions have prompted Pfizer to strengthen backup plans, diversify sourcing, and localize manufacturing capacities.
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Regulatory compliance influences supplier selection, especially for raw materials and manufacturing partners.
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Emerging trends suggest continued investment in supply chain robustness, sustainability, and regional manufacturing to support global market expansion.
FAQs
1. Who are the primary manufacturers of EUCRISA?
Pfizer directly manufactures EUCRISA at its GMP-certified facilities, with supplementary production support from approved contract manufacturing organizations (CMOs).
2. Where are EUCRISA’s raw materials sourced from?
The active pharmaceutical ingredient (API), crisaborole, and other raw materials are primarily sourced from chemical suppliers in China, India, and North America, adhering to strict quality and regulatory standards.
3. How does Pfizer ensure a stable supply of EUCRISA?
Pfizer employs diversified manufacturing partners, maintains multiple regional supply chains, invests in backup manufacturing capacity, and closely monitors logistics to mitigate disruptions.
4. Are there other suppliers involved in the packaging of EUCRISA?
Yes, specialized packaging suppliers provide medical-grade ointment tubes and labels, ensuring rigorous quality and safety standards.
5. What future developments could impact EUCRISA’s supply chain?
Potential impacts include regional manufacturing expansions, regulatory changes, raw material price fluctuations, and global supply chain resilience initiatives by Pfizer.
Sources
[1] Pfizer Inc. EUCRISA (crisaborole) prescribing information.
[2] U.S. Food and Drug Administration (FDA). EUCRISA approval announcement.
[3] Industry reports on pharmaceutical supply chain management.
[4] Pfizer’s corporate disclosures on manufacturing and supply chain strategy.
[5] Global chemical supplier directories providing insight into API raw material sources.
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