Suppliers and packagers for pyquvi

pyquvi

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aucta	PYQUVI	deflazacort	SUSPENSION;ORAL	219417	ANDA	Aucta Pharmaceuticals, Inc.	73289-0089-1	13 mL in 1 BOTTLE (73289-0089-1)	2025-06-30

Suppliers for the Pharmaceutical Drug: Pyquvi (Cabozantinib)

Last updated: August 7, 2025

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Introduction

Pyquvi, known generically as cabozantinib, is an oral tyrosine kinase inhibitor approved primarily for the treatment of medullary thyroid carcinoma, advanced renal cell carcinoma, and hepatocellular carcinoma. As a targeted therapy, cabozantinib’s manufacturing and supply chain dynamics are critical factors influencing market stability, pricing, and access.

This article provides a comprehensive overview of suppliers involved in the production and distribution of cabozantinib, highlighting the key manufacturers, their manufacturing capabilities, regulatory landscapes, and implications for stakeholders.

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Overview of Pyquvi (Cabozantinib)

Cabozantinib was developed by Exelixis, Inc., with subsequent licensing agreements to global pharmaceutical players. It inhibits multiple receptor tyrosine kinases, including MET, VEGFR2, RET, and others, to exert antitumor effects. The drug’s complex synthesis process and stringent quality controls necessitate specialized suppliers.

Key Manufacturers and Suppliers

1. Exelixis, Inc. – The Originator and Primary Developer

• Role: Exelixis holds the original patents and marketing rights for cabozantinib, making it the primary source for commercial supply.
• Manufacturing Capabilities: The company partners with Contract Manufacturing Organizations (CMOs) for large-scale production, leveraging proven facilities with Good Manufacturing Practice (GMP) compliance.
• Supply Chain: Exelixis coordinates global distribution, working closely with logistics providers to ensure timely delivery.

2. Contract Manufacturing Organizations (CMOs)

Given the complex synthesis process of cabozantinib, Exelixis relies heavily on CMOs to meet global demand.

• Select Contract Manufacturers:
  • Shanghai Sunway Biotech Co., Ltd.: A notable Chinese CMO with capabilities for API synthesis and formulation, providing cost-effective production options aligned with regulatory standards.
  • Fareva: A multinational CMO with facilities dedicated to oncology drug manufacturing, including API production and finished dosage forms.
  • Samsung Biologics: Engaged in biopharmaceutical production, with expanding capabilities in small-molecule synthesis for drugs like cabozantinib.

3. API Suppliers

Active Pharmaceutical Ingredient (API) suppliers are crucial for ensuring quality, compliance, and capacity.

• Major API Suppliers:
  • Hetero Labs Ltd.: An India-based API manufacturer with experience in kinase inhibitors, supplying raw API to downstream manufacturers.
  • Dr. Reddy's Laboratories: Also in India, known for producing generic APIs, including molecules similar to cabozantinib, with stringent quality controls.
  • WuXi AppTec: Based in China, providing API synthesis, with facilities adhering to global regulatory standards.

4. Finished Dosage Form Manufacturers

• Global Pharmaceutical Companies: Several generic and branded drug producers manufacture finished cabozantinib tablets under licensing agreements, often sourcing APIs from established suppliers.
• Regional Generics Companies: In markets such as India, China, and Latin America, local manufacturers produce cost-effective versions, often relying on API sourced from Indian or Chinese suppliers.

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Regional Supply Dynamics

North America and Europe

• Mainly supplied by Exelixis’ licensed manufacturing partners.
• Greater regulatory scrutiny ensures high-quality standards, with suppliers typically complying with FDA, EMA, and other regional regulations.

Asia-Pacific

• Dominated by Indian and Chinese API suppliers (e.g., Hetero, Dr. Reddy’s, WuXi), providing cost-efficient manufacturing.
• Increasing regulatory harmonization (e.g., Chinese CFDA, Indian DCGI) enhances API quality and supply stability.

Emerging Markets

• Local manufacturers often rely on imported APIs, with some developing capabilities to produce generic versions under licensing agreements.

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Regulatory and Quality Considerations

Suppliers of cabozantinib must adhere to stringent quality standards, including Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and compliance with regional regulatory agencies like the FDA (United States), EMA (Europe), and comparable authorities elsewhere.

Quality concerns, especially among generic suppliers, influence supply stability and market acceptance. Increased regulatory scrutiny has prompted many suppliers to upgrade facilities and pursue accreditation, such as the WHO GMP certification.

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Market Dynamics and Impact on Supply

• Patent Status: Exelixis holds patents until their expiration, after which generic manufacturers could enter the market, increasing supply options.
• Manufacturing Bottlenecks: Complex synthesis and market demand fluctuations can create supply constraints, highlighting the importance of diversified suppliers.
• Supply Chain Risks: Geopolitical factors, trade tensions, and regional regulations can impact supplier reliability.

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Emerging Trends

• Diversification of API Suppliers: Pharmaceutical companies are increasingly seeking multiple API sources to mitigate risks.
• Advanced Manufacturing: Suppliers are adopting continuous manufacturing processes to enhance efficiency and quality.
• Vertical Integration: Larger pharmaceutical firms are acquiring or establishing in-house manufacturing capabilities to control supply.

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Key Takeaways

• The supply of pyquvi (cabozantinib) primarily hinges on a handful of original developers, licensed manufacturers, and regional API producers.
• India and China dominate as API sourcing regions, offering cost advantages but necessitating rigorous quality oversight.
• Regulatory compliance and quality assurance are vital to supply stability, particularly in emerging markets.
• Diversifying API sources and adopting advanced manufacturing techniques are strategic priorities for ensuring consistent supply.
• Patent expirations and regulatory developments will influence the global supplier landscape, potentially expanding access and reducing costs.

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FAQs

Q1: Who are the main manufacturers of cabozantinib API?
A1: Major API producers include Hetero Labs, Dr. Reddy’s Laboratories, and WuXi AppTec, primarily based in India and China.

Q2: Are there regional variations in cabozantinib suppliers?
A2: Yes. In North America and Europe, supply is primarily controlled by licensed manufacturers adhering to strict regulatory standards. In Asia-Pacific, multiple domestic API suppliers serve regional markets, often at lower costs.

Q3: How does patent expiry influence supplier options for cabozantinib?
A3: Post-patent expiry, generic manufacturers could enter the market, broadening supplier options and potentially reducing costs but also complicating the supply chain with additional quality control considerations.

Q4: What challenges do supply chains for cabozantinib face?
A4: Challenges include complex manufacturing processes, regional regulatory differences, geopolitical risks, and quality assurance standards.

Q5: Is there a trend toward in-house manufacturing of cabozantinib by pharmaceutical companies?
A5: While some companies may develop in-house capabilities, most rely on CMOs and external API suppliers due to the molecule’s complexity and cost considerations.

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References

[1] Exelixis. “Cabozantinib (Cabometyx, Cometriq): Overview of FDA approval.” Exelixis, 2023.
[2] U.S. Food & Drug Administration. “Drug Approvals and Databases.” FDA.gov, 2023.
[3] GlobalData. “Pharmaceutical API Market Analysis.” 2023.
[4] WHO. “Good Manufacturing Practices for Active Pharmaceutical Ingredients.” WHO, 2022.
[5] Indian Pharmaceutical Industry Reports. “API Manufacturing Capabilities and Trends,” 2022.