Last updated: August 16, 2025
Introduction
Fotivda (tivozanib) is an oral tyrosine kinase inhibitor developed primarily for the treatment of renal cell carcinoma (RCC). Marketed by AVEO Pharmaceuticals, Fotivda offers targeted therapy by inhibiting vascular endothelial growth factor receptors (VEGFRs), thereby impeding tumor angiogenesis. As a specialized oncology drug, Fotivda’s supply chain involves a select number of manufacturers and licensing agreements, given its complex synthesis process, regulatory requirements, and market exclusivity. Understanding the key suppliers involved in Fotivda’s production and distribution network is critical for stakeholders, including pharmaceutical companies, healthcare providers, and investors.
Manufacturing and Supply Chain Overview
Fotivda’s production hinges upon the complex synthesis of tivozanib, a small-molecule compound. Its manufacturing process demands high purity, stringent quality control, and adherence to Good Manufacturing Practices (GMP). Consequently, the primary suppliers are typically contracted manufacturing organizations (CMOs) equipped with specialized facilities capable of producing oncology pharmaceuticals at scale.
Key Suppliers and Contract Manufacturers
1. AVEO Pharmaceuticals
AVEO holds the original patent rights, clinical development, and commercialization rights for Fotivda globally. As the innovator company, AVEO is responsible for overseeing development and distribution strategies. Moreover, AVEO often collaborates with CMOs for large-scale manufacturing, ensuring compliance with regulatory standards.
2. Contract Manufacturing Organizations (CMOs)
Major pharmaceutical CMOs involved in the synthesis and production of tivozanib include:
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Hetero Labs Limited (India): Known for its expertise in complex chemical synthesis and bulk pharmaceutical ingredients (APIs), Hetero has a proven track record in manufacturing oncology drugs, with facilities approved by agencies like the US FDA and European EMA. Hetero is likely involved in the synthesis of tivozanib’s API, given its capacity and experience with VEGFR inhibitors.
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Famar Health Care Services (Greece): An established CMO that handles fill-finish operations, formulation, and packaging for specialty drugs. While primarily involved in secondary manufacturing, Famar’s advanced facilities support the supply chain by ensuring proper distribution-ready Batch production.
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WuXi AppTec (China): A global leader in drug discovery and manufacturing, WuXi offers comprehensive CMO services, including chemical synthesis and API manufacturing processes that could be utilized for tivozanib, especially during late-stage clinical development and commercial supply.
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Samsung Biologics & LG Chem (South Korea): While primarily known for biologics, these companies also have capabilities in small molecule manufacturing, potentially contributing to Fotivda’s supply chain, particularly for early-stage production or certain formulation components.
3. Raw Material Suppliers
The synthesis of tivozanib relies on high-quality chemical precursors sourced globally. Primary suppliers of critical raw materials include:
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Sigma-Aldrich (Merck): Supplies intermediates and chemical reagents crucial for API synthesis, including heterocyclic compounds and specialized catalysts.
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Alfa Aesar (Thermo Fisher Scientific): Provides specialty chemicals used in the chemical reactions during API manufacturing.
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Indigenous Chemical Suppliers in China and India: Local suppliers provide certain intermediates and raw materials, often needed for cost-effective bulk production.
Regulatory and Quality Certification
Suppliers involved in Fotivda’s production typically possess certifications including ISO 9001, GMP compliance, and approvals from agencies like the US FDA, EMA, or corresponding local authorities. These certifications are vital to maintain the integrity and regulatory acceptance of the API and finished drug product.
Distribution Partners
Once manufactured, Fotivda’s distribution network involves licensing and distribution agreements with global pharmaceutical distributors, including:
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Oncologists and hospitals under direct supply agreements in major markets (U.S., EU, Japan).
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Distribution companies such as McKesson, Cardinal Health, and Alliance Healthcare facilitate logistics, storage, and delivery of Fotivda to end-users, ensuring cold chain integrity where necessary.
Market Dynamics and Strategic Sourcing
Given Fotivda’s niche market, AVEO Pharmaceuticals employs strategic sourcing to mitigate supply chain risks, often entering dual-sourcing arrangements with multiple CMOs and raw material suppliers to ensure steady supply and regulatory compliance. The COVID-19 pandemic underscored the importance of diversified supply chains, prompting AVEO to expand its supplier base.
Challenges in the Supply Chain
- Manufacturing Complexity: The intricate synthesis path for tivozanib increases risks of bottlenecks, delays, and quality variances.
- Regulatory Approvals: Suppliers must adhere to stringent regulatory oversight, limiting the pool of qualified manufacturers.
- Raw Material Availability: Fluctuations in global raw material markets can impact API prices and availability.
- Geopolitical Risks: Dependence on Asia-based raw material suppliers exposes supply chains to geopolitical disruptions and trade restrictions.
Future Outlook and Supply Chain Enhancements
With increasing demand, AVEO and its manufacturing partners are investing in capacity expansion, automation, and supply chain resilience initiatives. Developing more direct manufacturing capabilities and local sourcing in key markets could further stabilize supply and reduce dependency on single sources.
Key Takeaways
- The supply of Fotivda (tivozanib) hinges upon specialized CMOs with proven GMP standards, primarily in Asia and Europe.
- Raw material sourcing involves high-quality chemical suppliers globally, with potential reliance on regional intermediaries.
- The complex synthesis process and regulatory compliance requirements limit the pool of qualified manufacturing partners.
- Diversification and strategic sourcing remain critical to mitigate supply risks for this niche oncology drug.
- Ongoing capacity expansion and supply chain resilience are priorities for stakeholders involved in Fotivda’s production.
FAQs
Q1: Who are the main manufacturers involved in the production of Fotivda?
A1: The primary manufacturing partners include contract manufacturing organizations such as Hetero Labs (India), WuXi AppTec (China), and Famar (Greece), which handle API synthesis and formulation.
Q2: What raw materials are essential for the production of tivozanib?
A2: High-purity intermediates like heterocyclic compounds and specialized chemical reagents sourced from global suppliers like Sigma-Aldrich and Alfa Aesar are essential.
Q3: How does AVEO Pharmaceuticals ensure supply chain stability?
A3: AVEO employs dual-sourcing strategies, engages multiple qualified CMOs, and maintains diversified raw material sourcing to mitigate supply disruptions.
Q4: What challenges exist in sourcing raw materials for Fotivda?
A4: Challenges include market fluctuations, geopolitical risks, supply shortages, and strict quality standards that limit supplier options.
Q5: Are there upcoming suppliers or manufacturing strategies for Fotivda?
A5: Yes, AVEO is exploring local manufacturing initiatives in key markets and expanding capacity with existing partner CMOs to ensure steady supply amid rising demand.
References
- AVEO Pharmaceuticals. (2022). Fotivda (tivozanib) Prescribing Information.
- U.S. Food and Drug Administration. (2022). Listing of approved manufacturing facilities.
- Contract Manufacturing Organizations. (2023). Company websites and public disclosures.
- Market analysis reports on oncology drug manufacturing.
