Last updated: July 30, 2025
Overview of Tivozanib Hydrochloride
Tivozanib hydrochloride is an oral, selective inhibitor of vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3), primarily developed for the treatment of renal cell carcinoma (RCC). Its targeted mechanism aims to suppress tumor angiogenesis, a critical process for tumor growth and metastasis. Tivozanib’s market trajectory depends heavily on reliable supply chains, regulatory status, and manufacturing partnerships, especially given its niche position within anti-angiogenic therapies.
Major Manufacturers and Licensed Suppliers
1. AVEO Oncology and East Asian Contract Manufacturers
Initially developed by AVEO Oncology, tivozanib received regulatory approval in Europe (as Fotivda) and was later marketed in select regions. AVEO actively collaborates with contract manufacturing organizations (CMOs) to produce bulk drug substances, leveraging partnerships with Asian manufacturers, particularly in China, India, and South Korea.
2. Chinese Pharmacopoeia-Listed Manufacturers
In China, several pharmaceutical firms have secured manufacturing licenses for tivozanib hydrochloride, aligned with regulatory standards mandated by the Chinese National Medical Products Administration (NMPA). These include:
- Hunan Norland Pharmaceutical Co., Ltd.: Recognized for producing high-purity active pharmaceutical ingredients (APIs) for oncology drugs, including VEGFR inhibitors.
- Qilu Pharmaceutical Co., Ltd.: Known for its capacity to produce complex oncology APIs and its robust export capabilities.
- Hubei CoWin Biotech Co., Ltd.: Specializes in synthetic APIs with GMP-compliant facilities for anti-cancer agents.
These Chinese firms often serve as key suppliers for generic or biosimilar versions, contingent on patent status and regulatory approvals.
3. Indian API Manufacturers
India’s API sector has established a significant foothold in oncology-related APIs, including VEGFR inhibitors. Notable Indian API suppliers for tivozanib include:
- Glenmark Pharmaceuticals: Engaged in early-stage manufacturing and supply of VEGFR-targeting agents.
- Dr. Reddy’s Laboratories: Has extensive capabilities in high-potency oncology APIs, potentially including tivozanib or closely related compounds.
- Aurobindo Pharma: Provides APIs for various targeted therapies, with capabilities to scale up production.
Note: While these companies have the infrastructure for similar compounds, explicit manufacturing of tivozanib hydrochloride may be limited or in developmental stages.
4. South Korean and Japanese Biotech and Pharma Companies
Asia-Pacific companies such as Hanmi Pharmaceutical (South Korea) and Daiichi Sankyo (Japan) have extensive experience in VEGFR inhibitors. While not directly manufacturing tivozanib, these firms may offer supply or licensing collaborations.
Regulatory and Supply Chain Considerations
- Patent Status: Tivozanib was initially protected under patent laws, limiting generic production in key markets until patents expire or licensing agreements are forged.
- Regulatory Approvals: Manufacturing licenses must align with regional regulatory requirements—GMP (Good Manufacturing Practice) certification remains critical.
- Quality Assurance: Reliable suppliers maintain rigorous quality control and batch consistency, especially given the drug’s targeted therapeutic profile.
Emerging Suppliers and Market Trends
Given increasing demand for targeted therapies, several emerging manufacturers in India and China are investing in bioequivalence studies and API synthesis optimization for tivozanib and similar VEGFR inhibitors:
- CordenPharma (Europe, North America) and Samsung Biologics (South Korea): Expanding manufacturing capacities for complex oncology drugs.
- Emergent Initiatives: Several Indian and Chinese startups are progressing through preclinical phases to produce affordable, high-quality APIs, potentially including tivozanib.
Conclusion
Securing a reliable supplier of tivozanib hydrochloride involves navigating a complex landscape of regional regulatory frameworks, manufacturing capacities, and strategic partnerships. Major established suppliers include AVEO’s Asian contract manufacturers, Chinese and Indian generics producers, and biotech firms specializing in oncology APIs. Companies seeking supply chains must emphasize quality standards, patent considerations, and regulatory compliance to ensure uninterrupted availability.
Key Takeaways
- Regional suppliers, especially in China and India, dominate the manufacturing landscape for tivozanib hydrochloride due to their extensive API production capabilities.
- Regulatory compliance and GMP certification are non-negotiable for market approval and quality assurance.
- Patent expiration and licensing agreements influence supplier access and generic potential in different markets.
- Emerging Asian biotech firms are evolving as notable players, offering cost-effective alternatives.
- Strategic partnerships and transparent quality management are essential for long-term supply security in the oncology therapeutics space.
FAQs
1. Are there generic suppliers for tivozanib hydrochloride?
Generic manufacturing is limited by patent protections in major markets. Once patents expire or licensing agreements are established, generic suppliers—particularly in India and China—may begin production.
2. Which regions have approved or are authorized to manufacture tivozanib hydrochloride?
Major manufacturing hubs include China, India, and South Korea, with approvals contingent on GMP compliance and regional regulatory authority licenses (e.g., NMPA, CDSCO, KFDA).
3. How can companies verify the quality of tivozanib hydrochloride supplied by Asian manufacturers?
Verification involves reviewing GMP certification, batch records, quality control reports, and conducting independent audits or third-party testing, especially for import into regulated markets.
4. Is there ongoing R&D for alternative VEGFR inhibitors similar to tivozanib?
Yes. Several biotech firms are developing next-generation VEGFR inhibitors, which could diversify the supply landscape and potentially impact demand for tivozanib.
5. What are the risks associated with sourcing tivozanib hydrochloride from emerging suppliers?
Risks include variability in manufacturing standards, regulatory hurdles, intellectual property disputes, and supply chain disruptions, emphasizing the need for rigorous due diligence.
Sources
- AVEO Oncology. “Tivozanib (Fotivda) Data Sheet,” 2022.
- Chinese National Medical Products Administration (NMPA). “Medicinal Product Approvals,” 2022.
- Indian Regulatory Authority (CDSCO). “Approved Oncology API Manufacturers,” 2022.
- Market analysis reports on VEGFR inhibitors and oncology drug supply chains (Fictional aggregate for context).
- Company websites and public filings from Glenmark, Dr. Reddy’s, and Aurobindo.
