Bulk Pharmaceutical API Sources for TIVOZANIB HYDROCHLORIDE

Bulk Pharmaceutical API Sources for TIVOZANIB HYDROCHLORIDE

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
AA BLOCKS		AA00FGKO

Bulk Active Pharmaceutical Ingredient (API) Sources for: Tivozanib Hydrochloride

Last updated: August 1, 2025

Overview

Tivozanib Hydrochloride (commercially referred to as AV-951) is a potent, selective vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor primarily used in the treatment of advanced renal cell carcinoma (RCC). As a relatively new entrant into oncology therapeutics, Tivozanib’s manufacturing and sourcing present unique challenges and opportunities for pharmaceutical companies seeking reliable API suppliers. This article explores the current landscape of bulk API sources for Tivozanib Hydrochloride, emphasizing quality standards, regulatory considerations, and key industry players.

Chemical Profile and Manufacturing Complexity

Tivozanib Hydrochloride is synthesized through a multistep chemical process involving complex heterocyclic chemistry and purification protocols to ensure high purity and consistency. Its molecular formula is C₂₁H₂₃ClN₄O₂, and it requires strict adherence to Good Manufacturing Practice (GMP) standards to meet the quality and safety standards mandated by regulatory authorities such as the FDA and EMA.

The manufacturing complexity dictates that only specialized, experienced API suppliers with robust quality control (QC) and quality assurance (QA) systems can reliably produce Tivozanib Hydrochloride at commercial scales. This specialty status limits the number of potential sources and increases the importance of strategic supplier selection.

Major API Suppliers and Manufacturers

The sourcing of Tivozanib Hydrochloride involves globally dispersed manufacturers, including both originators and contract manufacturing organizations (CMOs). Key entities in the supply chain include:

1. Helsinn Group / Aveo Oncology

While Helsinn, a Swiss-based pharmaceutical company, originally developed Tivozanib, they have engaged in partnerships to manufacture and commercialize the drug. Their manufacturing facilities are equipped for high-potency APIs with strict compliance to GMP standards. These facilities serve as primary sources for clinical-grade and commercial API supplies, offering high-quality standards aligned with regulatory expectations.

2. Contract Manufacturing Organizations (CMOs)

Several CMOs in Asia and Europe have developed capabilities to produce Tivozanib Hydrochloride under confidential agreements for licensed pharmaceutical companies. Notable firms include:

• R-Pharma / Dr. Reddy’s Laboratories: Known for their expertise in complex chemical APIs, they have scaled processes for similar tyrosine kinase inhibitors, potentially extending their capabilities to Tivozanib.
• Hetero Drugs: An Indian CMO with extensive experience in high-potency APIs, capable of custom synthesis, purification, and GMP-compliant manufacturing.
• Resonance Labs: A specialty API manufacturer with experience in VEGFR inhibitors, offering custom synthesis and scale-up services.

3. Chinese API Manufacturers

China remains a dominant player in the global API markets due to cost advantages and manufacturing scalability. Several Chinese API producers, such as:

• Hainan Biotech Co., Ltd.
• Sino-American Pharmaceutical Equipment Co., Ltd.
• Qingdao Seebio Biotech Inc.

claim capabilities to produce Tivozanib Hydrochloride at various scales. However, regulatory concerns regarding quality assurance and documentation necessitate rigorous validation and qualification processes before integration into reputable supply chains.

4. European API Manufacturers

European manufacturers tend to focus on high-quality, GMP-compliant APIs for western markets, including firms like:

• Evonik Industries: Known for specialty chemical synthesis, with capabilities for complex molecules.
• Lonza: A global leader in custom manufacturing, including high-potency compounds, with validated process development for VEGFR inhibitors.

Sourcing Considerations

• Regulatory Compliance: Suppliers must meet strict GMP standards, with documented quality assurance systems aligned with ICH guidelines.
• Certifications & Documentation: ISO 9001, ISO 13485, and DMF filings are crucial for seamless regulatory approval processes.
• Supply Scalability & Reliability: Given the clinical and commercial demand, suppliers with proven capacity for scale-up without compromising quality are preferred.
• Cost & Lead Time: While Chinese suppliers often offer cost advantages, European and North American suppliers may provide shorter lead times and higher regulatory confidence.

Quality Assurance & Validation

Given the targeted nature of Tivozanib Hydrochloride, API quality directly influences clinical efficacy and safety. Suppliers must provide:

• Certificate of Analysis (CoA)
• Certificates of Compliance (CoC)
• Stability data
• Process validation documentation

Verifying these documents during supplier qualification minimizes risks associated with impurities, variability, and batch failures.

Emerging Trends & Future Perspectives

As Tivozanib gains approval in broader markets, the demand for high-quality bulk API will escalate. Strategic partnerships, vertical integration, and Contract Development and Manufacturing Organizations (CDMOs) play vital roles in ensuring reliable sourcing. Additionally, regulatory agencies increasingly scrutinize API sourcing, favoring suppliers with comprehensive quality dossiers and proven compliance histories.

Challenges and Opportunities

Challenges:

• Limited number of specialized manufacturers with proven expertise in similarly complex VEGFR inhibitors.
• Potential supply chain disruptions due to geopolitical issues or raw material shortages.
• Variability in quality control standards among different regions.

Opportunities:

• Developing long-term partnerships with reputable manufacturers to ensure supply stability.
• Engaging with multiple suppliers to diversify risk.
• Emphasizing quality assurance measures to meet global regulatory standards.

Summary

Finding reliable bulk API sources for Tivozanib Hydrochloride hinges on balancing quality, regulatory compliance, cost, and supply capacity. The landscape predominantly features European and Asian manufacturers with specialized capabilities. Companies should rigorously evaluate suppliers through validation of quality systems, supply track record, and regulatory documentation to mitigate risks and secure a sustainable supply chain.

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Key Takeaways

• Prioritize GMP-compliant suppliers with proven expertise in complex tyrosine kinase inhibitors for sourcing Tivozanib Hydrochloride API.
• Chinese manufacturers offer cost advantages but require thorough validation to meet Western regulatory standards.
• European and North American firms provide high-quality APIs, often with faster lead times and higher regulatory assurance.
• Establishing long-term partnership models and diversifying supply sources reduce supply chain risks.
• Continuous supplier audits and validation are essential to ensure API quality, safety, and regulatory compliance.

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FAQs

1. What are the primary challenges in sourcing Tivozanib Hydrochloride API?
The main challenges involve limited supplier availability due to the molecule's chemical complexity, ensuring GMP compliance, maintaining consistent quality, and managing supply chain risks, especially from regions with varying regulatory standards.

2. Which regions dominate the API supply market for Tivozanib Hydrochloride?
Asia (notably China and India) and Europe are the dominant regions, with China offering cost advantages and European firms emphasizing regulatory compliance and high-quality standards.

3. How do regulatory requirements influence API sourcing decisions for Tivozanib?
Regulatory bodies mandate strict documentation, process validation, and GMP adherence. Suppliers with validated processes and robust quality systems facilitate smoother regulatory submissions and product approvals.

4. Can contract manufacturing organizations (CMOs) produce Tivozanib Hydrochloride at scale?
Yes. Several CMOs with expertise in complex APIs can scale production through validated synthetic routes, provided technical transfer and quality systems are aligned.

5. What future trends are expected in the supply chain for Tivozanib Hydrochloride API?
Increasing regulatory scrutiny will drive demand for suppliers with proven compliance. Strategic partnerships and diversified sourcing will become essential, alongside technological innovations that streamline synthesis and purification processes.

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Sources

[1] Helsinn Group corporate filings and recent press releases.
[2] Industry reports on VEGFR inhibitors manufacturing.
[3] Asian API manufacturers’ capacity and certification disclosures.
[4] European API manufacturer pipelines and process development data.
[5] Regulatory guidelines from FDA and EMA regarding API quality standards.