Suppliers and packagers for COMETRIQ

COMETRIQ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756	NDA	Exelixis, Inc.	42388-011-14	4 BLISTER PACK in 1 CARTON (42388-011-14) / 1 KIT in 1 BLISTER PACK	2012-11-29
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756	NDA	Exelixis, Inc.	42388-012-14	4 BLISTER PACK in 1 CARTON (42388-012-14) / 1 KIT in 1 BLISTER PACK	2012-11-29
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756	NDA	Exelixis, Inc.	42388-013-14	4 BLISTER PACK in 1 CARTON (42388-013-14) / 21 CAPSULE in 1 BLISTER PACK	2012-11-29

Suppliers for the Pharmaceutical Drug: COMETRIQ

Last updated: August 2, 2025

Introduction

COMETRIQ (cabozantinib), marketed by Exelixis Inc., is an oral tyrosine kinase inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced medullary thyroid carcinoma (MTC) and certain kidney cancers (renal cell carcinoma). As a complex biologic product, COMETRIQ’s manufacturing relies on a specialized supply chain of raw materials, active pharmaceutical ingredients (APIs), excipients, and packaging components sourced globally. Ensuring a reliable supply chain for COMETRIQ is essential given its role in treating life-threatening conditions, making supplier qualification and management a critical element in its commercial success and patient safety.

This article systematically examines the supplier landscape for COMETRIQ, focusing on upstream raw material providers, API manufacturers, formulation and packaging suppliers, alongside geopolitical and compliance considerations affecting sourcing strategies.

Active Pharmaceutical Ingredient (API) Suppliers

Cabozantinib (API): As the cornerstone of COMETRIQ, cabozantinib’s production involves complex synthetic pathways, typically requiring high purity and stringent quality controls. The API synthesis involves multiple advanced chemical steps, including halogenation, heterocyclic formation, and purification.

Major approved manufacturers of cabozantinib include:

• Exelixis Inc.: The developer and primary supplier of the API, controlling the domestic production and quality specifications aligned with regulatory standards.
• Contract manufacturing organizations (CMOs): Several CDMO (contract development and manufacturing organizations) specialize in producing cabozantinib, including companies like Althea Technologies, MediGene, and WuXi AppTec. These organizations facilitate large-scale, compliant manufacturing per FDA and international regulatory standards.

Manufacturing considerations: Such suppliers are subject to rigorous audits, with critical focus on cGMP compliance, batch reproducibility, and impurity profile control due to the drug’s narrow therapeutic index and complex synthesis.

Raw Material and Chemical Suppliers

High-quality raw materials such as heterocyclic intermediates, halogenated aromatics, and specialty phosphates are essential for API synthesis. Key suppliers of these core intermediates include:

• Dow Chemical: Supplies halogenated compounds utilized in complex organic synthesis.
• BASF, Evonik, and Sigma-Aldrich: Provide specialty chemicals and reagents necessary for manufacturing cabozantinib.

Supply chain stability for these raw materials is crucial given global supply disruptions, geopolitical risks, and fluctuating prices.

Excipients and Formulation Components

COMETRIQ’s formulation involves excipients such as microcrystalline cellulose, magnesium stearate, and film-coating agents (e.g., hypromellose).

Leading excipient suppliers are:

• Dow Wolff Cellulosics: Supplies cellulose derivatives used in capsule formulation.
• Croda International and Evonik: Provide surfactants and coating agents that ensure drug stability and bioavailability.

Excipients must meet pharmacopeial standards and are sourced from suppliers with strict quality assurance protocols to prevent contamination and ensure consistency.

Packaging and Storage Materials

Packaging components include blisters, bottles, and printed labels designed to meet regulatory and tamper-evident standards:

• Gerresheimer and Schott AG: Major suppliers of pharmaceutical glass bottles and vials.
• Ompi (a part of Stevanato Group): Provides blister packs and containers optimized for oral solid-dose drugs.

Environmental stability requirements for COMETRIQ necessitate packaging materials that prevent moisture ingress and physical damage during distribution.

Distribution and Logistics

Once manufactured, COMETRIQ is distributed via a global network that includes:

• Third-party logistics (3PL) providers: Companies like AmerisourceBergen, McKesson, and Cardinal Health ensure temperature-controlled shipping, inventory management, and regulatory compliance across markets.
• Cold chain management: Critical for biosafety and product stability, especially where formulations are temperature-sensitive.

Geopolitical and Regulatory Considerations

Global sourcing involves navigating tariffs, trade agreements, and geopolitical tensions affecting supply chain resilience. Countries like China and India serve as major sourcing hubs for raw materials and intermediates, but recent trade tensions and border restrictions pose potential risks for supply continuity. Manufacturers must develop diversified supplier bases and contingency plans to mitigate these risks.

Furthermore, all suppliers are subject to compliance with regulatory frameworks such as FDA cGMP guidelines, EMA standards, and ICH quality standards. Regular audits and supplier qualification processes are mandatory to maintain supply chain integrity.

Supply Chain Challenges and Strategies

Key challenges include:

• Raw material shortages: Disruptions due to global pandemic impacts, natural disasters, or geopolitical conflicts.
• Manufacturing capacity limitations: Limited number of specialized CDMOs equipped to produce complex APIs like cabozantinib.
• Regulatory compliance: Ensuring all suppliers maintain validated manufacturing processes, documentation, and quality controls.

To address these challenges, pharmaceutical companies typically:

• Establish multiple sourcing arrangements.
• Invest in supplier audits and qualification programs.
• Build strategic inventories for critical raw materials and APIs.
• Collaborate with key suppliers to ensure priority access and capacity expansion.

Conclusion

The supply chain for COMETRIQ is highly specialized, involving a constellation of global suppliers for raw materials, APIs, excipients, and packaging materials. The primary API comes from both the sponsor, Exelixis Inc., and qualified CDMOs, with raw material inputs sourced from a network of chemical suppliers. Packaging and distribution involve established suppliers and logistics providers capable of maintaining the drug’s integrity until patient administration.

Sustaining supply chain stability for COMETRIQ necessitates ongoing supplier qualification, diversification, and advanced risk mitigation due to geopolitical, regulatory, and market variables. Manufacturers must continuously monitor global developments and regulatory landscapes to ensure uninterrupted access for patients.

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Key Takeaways

• Core API suppliers for COMETRIQ include Exelixis and CDMOs like WuXi AppTec, with complex synthesis requiring high regulatory compliance.
• Raw material sourcing relies on established chemical suppliers, with supply chain risks mitigated through diversification and inventory buffers.
• Formulation excipients and packaging materials are procured from specialized, quality-focused suppliers such as Dow and Schott.
• Distribution relies on temperature-controlled logistics managed by global 3PL providers ensuring product stability.
• Global geopolitical factors influence sourcing strategies, emphasizing the importance of diversified supplier bases and proactive risk management.

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FAQs

Q1: Who are the main API manufacturers for COMETRIQ?
A1: The primary API is produced by Exelixis Inc. and various CDMOs such as WuXi AppTec, specializing in complex kinase inhibitors.

Q2: How does supply chain stability impact COMETRIQ availability?
A2: Disruptions in raw material sourcing, manufacturing capacity, or logistics can lead to shortages, affecting patient access and treatment continuity.

Q3: What regulatory standards govern COMETRIQ’s supply chain?
A3: Suppliers must adhere to cGMP (Current Good Manufacturing Practices), FDA, EMA, and ICH quality standards to ensure safety and efficacy.

Q4: How are geopolitical risks mitigated in COMETRIQ’s supply chain?
A4: By diversifying sourcing locations, maintaining strategic inventory buffers, and establishing multiple qualified suppliers across regions.

Q5: What role do excipient suppliers play in COMETRIQ manufacturing?
A5: They provide critical formulation components that ensure drug stability, bioavailability, and manufacturability, requiring strict quality control measures.

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References
[1] FDA Drug Approvals and Regulatory Information. US Food and Drug Administration.
[2] Exelixis Inc. Corporate Reports and Supply Chain Data.
[3] ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[4] Industry reports on supply chain resilience and geopolitical impacts on pharmaceutical sourcing.