Bulk Pharmaceutical API Sources for FOTIVDA

Bulk Pharmaceutical API Sources for FOTIVDA

Vendor	Vendor Homepage	Vendor Sku	API Url
Lan Pharmatech		LAN-B80249
BenchChem		B1194695
MedChemexpress MCE		HY-10977A
AbaChemScene		CS-0069958
Macsen Labs		MAC00146
Hangzhou APIChem Technology		AC-37190

Bulk Active Pharmaceutical Ingredient (API) Sources for FOTIVDA

Last updated: July 29, 2025

Introduction

FOTIVDA (tivozanib) is a targeted cancer therapy drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsing, refractory, or metastatic renal cell carcinoma (RCC). As a potent VEGFR (vascular endothelial growth factor receptor) tyrosine kinase inhibitor, FOTIVDA's efficacy depends heavily on the availability of high-quality, reliable API sources. The supply chain for tivozanib's API must meet rigorous regulatory standards, ensuring purity, stability, and consistency, which are critical for patient safety and therapeutic effectiveness.

This analysis examines the primary sources and manufacturers of tivozanib API, their strategic positioning within the pharmaceutical supply chain, and considerations for identifying reliable procurement pathways.

Manufacturers and Suppliers of Tivozanib API

1. Aveo Pharmaceuticals and Partner Collaborations

While Aveo Pharmaceuticals initially developed tivozanib, their in-house capability for manufacturing the API has historically been limited, often relying on partnerships with external CMOs (contract manufacturing organizations). These partnerships enable scalable production to meet global demand, particularly post-approval in key markets like the U.S. and Europe.

2. Contract Manufacturing Organizations (CMOs)

Major pharmaceutical CMOs specializing in complex kinase inhibitors, including APIs like tivozanib, represent the backbone of bulk API sourcing. Their capabilities encompass synthesis, purification, quality control, and compliance with cGMP (current Good Manufacturing Practice) standards.

Notable CMOs involved in comparable VEGFR inhibitors include:

• Thermo Fisher Scientific (Patheon)
• Samsung Biologics
• Lonza
• Catalent

While these organizations primarily produce other kinase inhibitors, their infrastructure can often be adapted for tivozanib synthesis, subject to specific process licensing agreements.

3. Chinese and Indian API Manufacturers

The Asia-Pacific region, notably China and India, dominates global bulk API manufacturing due to cost advantages and well-established API production ecosystems.

Chinese Manufacturers:

• North China Pharmaceutical Group Corp. (NCPC)
• Shanghai International Pharmaceutical & Laboratory (SIPL)
• Zhejiang Huajing Pharmaceutical

These companies have increased emphasis on high-potency API manufacturing, including kinase inhibitors. They often serve as direct suppliers to pharmaceutical companies or export APIs globally.

Indian Manufacturers:

• Lupin Limited
• Sun Pharmaceutical Industries Ltd.
• Aurobindo Pharma
• Dr. Reddy’s Laboratories

Indian APIs are recognized for high quality, compliance with international standards, and cost competitiveness. These firms possess extensive experience in synthesizing complex molecules like VEGFR inhibitors, including process optimization for large-scale API production.

Criteria for Reliable API Sourcing

1. Regulatory Compliance: Manufacturers must demonstrate cGMP compliance, validated manufacturing processes, and thorough documentation to meet FDA, EMA, and other regulatory standards.

2. Quality & Purity: APIs must meet strict specifications, typically ≥99.0% purity, with low levels of residual solvents, impurities, and related substances.

3. Manufacturing Capacity & Scalability: The capacity to fulfill current and forecasted demand is critical, especially for a marketed, targeted cancer therapy.

4. Supply Chain Transparency: Traceability from raw materials to finished API ensures compliance and quality assurance.

5. Intellectual Property & Licensing: Given the proprietary nature of tivozanib synthesis, licensing agreements with patent holders or developers are necessary for legal procurement.

Recent Developments and Strategic Considerations

Following FDA approval in 2021, Aveo Pharmaceuticals announced collaborations aimed at scalable API production, including licensing agreements with international API manufacturers. Such partnerships aim to secure supply chains aligned with global demand forecasts and circumvent potential bottlenecks associated with sole-source sourcing.

In addition, the trend toward more integrated supply chains emphasizes quality assurance, with some pharmaceutical companies establishing long-term exclusivity agreements with high-grade API manufacturers to mitigate risks associated with supply disruptions and quality variability.

Supply Chain Challenges

• Intellectual Property Constraints: Patented synthesis routes can limit the number of authorized API producers.
• Regulatory Variability: Differing standards among regional regulatory bodies necessitate adaptable manufacturing and documentation.
• Geopolitical Risks: Trade disputes and export controls can impact API availability, especially from China and India.

Conclusion

The landscape for bulk API sourcing of tivozanib is characterized by a blend of regional players with proven expertise in kinase inhibitor synthesis, partnerships with CMOs, and a focus on regulatory compliance. While specific, publicly available information on the exclusive API manufacturers for FOTIVDA remains limited—owing to proprietary considerations—key sourcing strategies involve leveraging high-quality, compliant manufacturers within North America, Europe, China, and India.

Ensuring robust due diligence, compliance with international standards, and diversification of suppliers are essential strategies to guarantee an uninterrupted and high-quality API supply for FOTIVDA.

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Key Takeaways

• Multiple high-quality sources exist globally, primarily within China, India, and well-regulated Western markets.
• Due diligence on regulatory compliance and manufacturing capacity is crucial for reliable API procurement.
• Strategic partnerships and licensing agreements are integral for securing scaled API supply, especially for proprietary drugs like tivozanib.
• Regional geopolitical and regulatory factors can influence API availability; diversification mitigates risks.
• Ongoing collaboration with CMOs enables scalability and compliance with evolving international standards.

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FAQs

1. Are there exclusive API manufacturers for FOTIVDA globally?
Currently, specific proprietary manufacturing agreements for FOTIVDA’s API are not publicly disclosed. Major API manufacturing hubs in China and India are probable sources, with collaborations possibly ongoing with Aveo Pharmaceuticals or its partners.

2. What quality standards must API manufacturers meet for cancer therapies like tivozanib?
Manufacturers must adhere to cGMP standards, producing APIs that meet purity levels of ≥99%, with extensive validation, documentation, and QC testing aligned with FDA, EMA, and other authorities’ regulations.

3. Can regional manufacturing variations affect API quality for FOTIVDA?
Yes. While standards are harmonized under international regulations, regional differences in enforcement and infrastructure can impact quality. Due diligence and certification verification are necessary when sourcing from diverse regions.

4. How does API sourcing impact FOTIVDA’s market supply stability?
A diversified supplier base and long-term licensing agreements enhance resilience, mitigate supply disruptions, and ensure consistent manufacturing of high-quality API essential for effective patient treatment.

5. What role do CMOs play in API supply for proprietary drugs like FOTIVDA?
CMOs provide specialized manufacturing capabilities, scale-up expertise, and quality control, allowing companies like Aveo Pharmaceuticals to meet global demand efficiently while maintaining compliance with regulatory standards.

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Sources:
[1] U.S. Food and Drug Administration (FDA) - FOTIVDA labeling and approval history.
[2] Pharma intelligence industry reports on kinase inhibitor manufacturing.
[3] Global API production capacity analyses from industry publications.
[4] Aveo Pharmaceuticals partnership disclosures.
[5] WHO and Indian pharmaceutical industry manufacturing guidelines.