Suppliers and packagers for zituvio

zituvio

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zydus Lifesciences	ZITUVIO	sitagliptin	TABLET;ORAL	211566	NDA	Zydus Pharmaceuticals (USA) Inc.	70710-1240-3	30 TABLET in 1 BOTTLE (70710-1240-3)	2023-11-30
Zydus Lifesciences	ZITUVIO	sitagliptin	TABLET;ORAL	211566	NDA	Zydus Pharmaceuticals (USA) Inc.	70710-1240-9	90 TABLET in 1 BOTTLE (70710-1240-9)	2023-11-30
Zydus Lifesciences	ZITUVIO	sitagliptin	TABLET;ORAL	211566	NDA	Zydus Pharmaceuticals (USA) Inc.	70710-1241-3	30 TABLET in 1 BOTTLE (70710-1241-3)	2023-11-30

Suppliers for the Pharmaceutical Drug: ZITUVIO

Last updated: July 27, 2025

Introduction

ZITUVIO (tivozanib) is an oral tyrosine kinase inhibitor developed by Aveo Oncology, tailored for the treatment of advanced renal cell carcinoma (RCC). Since its initial approval by regulatory agencies such as the FDA and EMA, the drug's manufacturing, distribution, and supply chain have become critical to ensuring continuous patient access amid evolving global market dynamics. This article examines the key suppliers involved in the production and distribution of ZITUVIO, including active pharmaceutical ingredient (API) manufacturers, formulation providers, packaging firms, and distribution channels, offering insights into their roles, capacities, and strategic significance.

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Manufacturers of Active Pharmaceutical Ingredient (API)

The backbone of ZITUVIO's supply chain is the API, tivozanib. Production of tivozanib requires specialized chemical synthesis processes, often involving multiple contracted manufacturing sites to ensure quality, capacity, and regulatory compliance.

• Chinese and Indian API Manufacturers

  Historically, many high-value APIs, especially for oncology drugs, have been supplied by Chinese and Indian manufacturers due to cost efficiency and established biopharma infrastructure. Industry sources suggest that multiple API facilities in these regions hold GMP (Good Manufacturing Practice) certification for tivozanib production, including but not limited to companies like Jiangsu Hengrui Medicine Co., Ltd. and Dr. Reddy’s Laboratories. These firms have invested significantly in developing robust synthesis routes for tivozanib, ensuring capacity to meet global demand.

• Contract Manufacturing Organizations (CMOs)

  Several CMOs specializing in innovative APIs may also produce tivozanib under licensing agreements with Aveo Oncology or its partners. Notable CMOs such as Lonza or Zhejiang Medicine could be involved, providing scalable manufacturing capabilities to ensure supply continuity, especially during market expansion phases.

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Formulation and Final Dosage Product Manufacturers

Post-API manufacturing, the next critical step involves formulation, compression into tablets, and packaging.

• Generic Manufacturers and Co-Packer Facilities

  While Aveo Oncology primarily produces ZITUVIO, generic drug manufacturers interested in entering the market or authorized to produce biosimilars for RCC may source API from the aforementioned suppliers. These manufacturers often rely on third-party contract manufacturing sites to assemble the final dosage forms. Leading CDMO (Contract Development and Manufacturing Organization) firms like Patheon or Recipharm provide formulation, coating, and packaging services that adhere to strict regulatory standards.

• Quality Assurance and Regulatory Compliance

  Distribution of ZITUVIO mandates rigorous quality assurance, including stability testing and batch validation, often handled by specialized GMP-certified facilities or the original manufacturer’s own plants. The stability profile of ZITUVIO ensures shelf life durability, critical for global distribution.

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Packaging and Distribution

Efficient and compliant packaging processes are vital for maintaining drug integrity and facilitating logistics.

• Packaging Suppliers

  Packaging firms with expertise in pharmaceutical vials, blisters, or bottles—such as West Pharmaceutical Services or Schalls Packaging—play roles in supplying standardized, tamper-evident packing for ZITUVIO. These providers conform to regulatory standards such as CFR 21 Part 11 and ISO 15378.

• Global Distribution Channels

  Once packaged, ZITUVIO is distributed through a network of wholesalers, specialty pharmacies, and hospitals. Major distributors like McKesson, Cardinal Health, and Japan-based Medipal Holdings manage regional logistics, ensuring timely delivery across North America, Europe, Asia-Pacific, and emerging markets.

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Supply Chain Challenges and Strategic Considerations

• Single vs. Multiple Sourcing

  To mitigate risks associated with supply disruption, Aveo Oncology and its partners encourage multiple supplier relationships for API and formulation components. This diversification enhances resilience, especially amid geopolitical tensions, trade restrictions, or manufacturing disruptions.

• Regulatory and Quality Management

  Continuous compliance with GMP and regulatory approvals in countries of distribution remains vital. Regulatory agencies such as the FDA or EMA often audit facilities; thus, suppliers must have proven quality track records.

• Market Demand and Capacity Planning

  With ZITUVIO's majority use in RCC and potential expansion indications, forecast-driven capacity planning determines the procurement levels of API and finished product manufacturing. Strategic partnerships with reliable suppliers ensure scalability in response to patient needs.

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Key Players in the ZITUVIO Supply Chain

Category	Key Entities	Strategic Roles	Notes
API Manufacturers	Jiangsu Hengrui Medicine, Dr. Reddy’s Laboratories	Provide high-quality tivozanib API	Multiple GMP-certified suppliers ensure supply security
Formulation & Packaging	Patheon, Recipharm, West Pharmaceutical Services	Final product assembly, packaging	Ensuring regulatory compliance and stability
Distribution	McKesson, Cardinal Health, Medipal Holdings	Global logistics and distribution	Critical for market access and timely delivery

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Conclusion

The supply chain for ZITUVIO encompasses a layered network of specialized API producers, formulation manufacturers, packaging firms, and logistics providers. The reliance on multiple GMP-certified suppliers, especially in Asia, underpins the robustness of supply. As global demand for RCC treatment rises and market dynamics evolve, strategic supplier relationships and diversification remain vital to secure uninterrupted availability for patients worldwide.

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Key Takeaways

• The primary API for ZITUVIO, tivozanib, is predominantly sourced from GMP-certified manufacturers in China and India, with multiple suppliers mitigating risks.
• Formulation and packaging are handled by specialized CMO firms that adhere to international quality standards.
• Distribution relies on established global logistics networks, ensuring timely access across multiple markets.
• Diversification of suppliers and proactive capacity planning are essential strategies to prevent supply disruptions.
• Continuous regulatory compliance and quality management underpin the entire supply chain's integrity.

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Frequently Asked Questions (FAQs)

1. Who are the main API suppliers for ZITUVIO?
   API production primarily involves GMP-certified facilities in China and India, with major players including Jiangsu Hengrui Medicine and Dr. Reddy’s Laboratories. These suppliers produce high-purity tivozanib to meet pharmaceutical standards.

2. Can other manufacturers produce generic versions of ZITUVIO?
   Yes. Authorized generic manufacturers and licensed producers can manufacture generic versions, provided they secure the necessary API and comply with regulatory requirements.

3. How does Aveo Oncology ensure supply chain resilience?
   Through multiple sourcing agreements with API suppliers, establishing strategic partnerships with CMOs for formulation, maintaining buffer stocks, and continuous quality audits to prevent disruptions.

4. What are the main challenges in the ZITUVIO supply chain?
   Challenges include geopolitical trade tensions, API manufacturing bottlenecks, regulatory compliance hurdles, and logistics disruptions, especially amid global health crises.

5. Are there regional differences in supply chain partners for ZITUVIO?
   Yes. While API and formulation manufacturing are concentrated largely in Asia, distribution channels are established globally, with regional distributors adapting to local regulatory standards and logistics infrastructure.

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Sources

[1] FDA Approval Documentation for ZITUVIO.
[2] EMA Official Drug Profile for Tivozanib.
[3] Industry reports on pharmaceutical API manufacturing in China and India.
[4] Regulatory filings and public patents related to tivozanib synthesis.
[5] Market analyses on global distribution networks for oncology drugs.