Suppliers and packagers for CABOMETYX

CABOMETYX

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 Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692	NDA	Exelixis, Inc.	42388-023-26	30 TABLET in 1 BOTTLE (42388-023-26)	2016-04-25
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692	NDA	Exelixis, Inc.	42388-023-36	30 TABLET in 1 BOTTLE (42388-023-36)	2016-04-25
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692	NDA	Exelixis, Inc.	42388-023-37	15 TABLET in 1 BOTTLE (42388-023-37)	2016-04-25
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692	NDA	Exelixis, Inc.	42388-023-46	1 BOTTLE in 1 CARTON (42388-023-46) / 30 TABLET in 1 BOTTLE	2016-04-25

Suppliers for the Pharmaceutical Drug: CABOMETYX

Last updated: July 28, 2025

Introduction

CABOMETYX (cabozantinib) is an oral tyrosine kinase inhibitor used primarily in the treatment of renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Since its initial approval by the FDA in 2016, CABOMETYX has gained prominence as a key therapeutic agent, powering a competitive landscape involving multiple suppliers, manufacturers, and distribution channels. Understanding the supplier network for CABOMETYX is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and investors, aiming to navigate supply chain dynamics and assess risks related to drug availability.

Manufacturers and Development Partners

1. Exelixis, Inc.

Exelixis, a biotechnology company based in the United States, is the primary developer and marketer of CABOMETYX. The company holds the patent rights and is responsible for manufacturing, regulatory approval, and distribution. Exelixis’s involvement extends to worldwide commercial licensing agreements that facilitate the global reach of CABOMETYX.

The company's manufacturing operations are centralized in the US, leveraging its extensive R&D capabilities. Exelixis has established partnerships with contract manufacturing organizations (CMOs) to ensure steady supply chains and quality control. These collaborations reduce manufacturing risks and facilitate capacity scaling aligned with global demand.

2. Contract Manufacturing Organizations (CMOs)

Pharmaceutical manufacturing, especially for biologics and complex small molecules like cabozantinib, often relies on CMOs for production, quality assurance, and supply diversification.

• Patheon (a part of Thermo Fisher Scientific): Reports indicate that Patheon has been involved in the manufacturing of cabozantinib for Exelixis, providing scalable manufacturing capacity to meet rising demand.

• Catalent: Known for its robust biologics and small molecule manufacturing, Catalent may also participate in the supply chain for some forms of cabozantinib, although specific contractual details remain proprietary.

By leveraging multiple CMOs, Exelixis mitigates supply disruptions attributable to capacity constraints, geopolitical issues, or manufacturing failures.

Distribution and Supply Chain Partners

3. Global Distributors and Wholesalers

CABOMETYX is distributed globally via a network of pharmaceutical distributors and wholesalers—entities that handle distribution to hospitals, clinics, and pharmacy chains.

• McKesson Corporation: As one of the largest pharmaceutical distributors in the US, McKesson handles a significant portion of CABOMETYX distribution within North America, ensuring reliable access through a network of retail and specialty pharmacies.

• Cardinal Health and AmerisourceBergen: Other key players in the US supply chain, responsible for widespread distribution of cancer medications, including CABOMETYX.

Internationally, distribution partnerships are often managed through regional agencies or direct licensing agreements in collaboration with regional pharmaceutical companies.

4. Licensing Partners and Market-Specific Collaborations

Exelixis has entered into licensing and commercialization agreements with pharmaceutical firms in different regions to expand CABOMETYX’s reach.

• Ipsen: In certain markets, Ipsen holds rights to commercialize cabozantinib, including CABOMETYX, particularly in the European Union. Ipsen’s role encompasses distribution, marketing, and local regulatory compliance.

• Eisai Co., Ltd.: In Japan, Eisai has been involved in the distribution and marketing of cabozantinib, facilitating local manufacturing and compliance.

Such regional collaborations enable faster market penetration and mitigate risks associated with exporting from the US.

Supply Chain Challenges and Contingencies

Despite a robust network, several factors impact the supply chain of CABOMETYX:

• Manufacturing complexities: Cabozantinib synthesis involves complex chemical processes requiring high-quality raw materials and precise control measures, which can sometimes result in delays.

• Raw material sourcing: Suppliers for key starting materials may present constraints, especially amid global supply chain disruptions caused by geopolitical tensions or pandemic-related issues.

• Regulatory compliance: Manufacturing sites must adhere to Good Manufacturing Practices (GMP), and any non-compliance can lead to production halts.

• Market demand fluctuations: As CABOMETYX's indications expand, increased demand necessitates capacity expansion, which may take time to implement.

Exelixis’s strategic engagement with CMOs and regional partners helps mitigate these issues, ensuring consistent supply.

Key Suppliers and Raw Material Providers

Specific raw suppliers for cabozantinib’s key intermediates are generally not publicly disclosed due to confidentiality but are believed to include:

• Specialized chemical manufacturers specializing in the synthesis of tyrosine kinase inhibitors (TKIs).

• Bulk chemical suppliers providing intermediates conforming to pharmaceutical standards.

Securing a diversified supplier base for raw materials reduces vulnerability to supply disruptions.

Future Outlook and Market Dynamics

The future of CABOMETYX supply hinges on several factors:

• Expansion into new indications: Ongoing clinical trials for additional cancer types may increase demand, requiring expansion of manufacturing capacity and supplier capacity.

• Generic competition: When patents expire, generic manufacturers could enter the market, potentially disrupting the supply chain landscape.

• Supply chain resilience initiatives: Exelixis and partners are investing in supply chain diversification and capacity expansion to counter potential disruptions.

Conclusion

The supply ecosystem for CABOMETYX comprises a concentrated manufacturing base led by Exelixis, supported by contract manufacturing organizations, regional licensing partners, and robust distribution networks. Ensuring consistent supply involves managing the complexities of chemical synthesis, sourcing raw materials from diversified providers, and maintaining regulatory compliance across jurisdictions. As demand for cabozantinib grows, ongoing investments in manufacturing capacity and strategic regional partnerships will remain pivotal for supply stability.

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Key Takeaways

• Primary manufacturer: Exelixis oversees the manufacturing and global distribution of CABOMETYX, utilizing partnerships with CMOs for capacity scaling.

• Distribution network: Major US distributors include McKesson, Cardinal Health, and AmerisourceBergen; international markets utilize regional licensing partners such as Ipsen and Eisai.

• Supply chain risks: Complex manufacturing processes, raw material sourcing issues, and regulatory compliance pose challenges. Strategic diversification and capacity expansion are critical.

• Market expansion impact: Growth into new indications and regions will necessitate increased manufacturing capacity and potentially new raw material suppliers.

• Future landscape: Patent expirations and evolving clinical data will influence supply dynamics, fostering opportunities for generic entrants and new suppliers.

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FAQs

1. Who are the main manufacturers of CABOMETYX?
Exelixis is the primary manufacturer and rights holder for CABOMETYX, partnering with contract manufacturing organizations to produce the drug at scale.

2. What regions rely on licensing partners for CABOMETYX distribution?
Europe relies on Ipsen, and Japan on Eisai, among others, to handle regional marketing and distribution.

3. Are raw material suppliers for cabozantinib publicly known?
No, specific raw material suppliers are typically confidential due to proprietary manufacturing processes, but they include specialized chemical producers.

4. How does the supply chain mitigate disruptions?
Through strategic partnerships with multiple CMOs, diversified raw material sourcing, and regional licensing agreements, supply risks are minimized.

5. What factors could impact future CABOMETYX supply?
Increased demand, manufacturing capacity constraints, raw material shortages, regulatory hurdles, and patent expirations could influence future supply stability.