Suppliers and packagers for trifluridine

trifluridine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	TRIFLURIDINE	trifluridine	SOLUTION/DROPS;OPHTHALMIC	074311	ANDA	Sandoz Inc	61314-044-75	1 BOTTLE, PLASTIC in 1 CARTON (61314-044-75) / 7.5 mL in 1 BOTTLE, PLASTIC	2001-05-14

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: TRIFLURIDINE

Introduction
Trifluridine is a nucleoside metabolic inhibitor primarily used in the treatment of certain types of cancers, notably in combination therapy for refractory metastatic colorectal carcinoma and as part of antiviral regimens. As a synthetic fluorinated pyrimidine analog, trifluridine’s manufacturing, sourcing, and distribution involve a complex network of suppliers spanning active pharmaceutical ingredient (API) producers, formulation specialists, and distribution channels. This report provides an in-depth analysis of the key suppliers involved in the supply chain for trifluridine, the market dynamics influencing supply, and strategic considerations for stakeholders.

Overview of Trifluridine and Its Market
Trifluridine is marketed notably as part of combination drugs like Lonsurf (trifluridine and tipiracil), which has gained FDA approval for treating metastatic colorectal cancer, and other regional formulations. Its synthesis involves multi-step chemical processes, often manufactured under strict Good Manufacturing Practice (GMP) standards to ensure pharmaceutical-grade purity and regulatory compliance.

Globally, the demand for trifluridine is driven by the ongoing need for effective chemotherapeutic and antiviral agents, with key markets in North America, Europe, and Asia-Pacific. Manufacturers and suppliers must navigate patent protections, regulatory approvals, and quality standards, which influence the selection of suppliers and the stability of the supply chain.

Key Suppliers of Trifluridine API

1. Huahai Pharmaceutical Co., Ltd. (China)
   Huahai is among the leading producers of active pharmaceutical ingredients (APIs) including trifluridine. Their capabilities include large-scale synthesis under GMP standards, serving both domestic and international markets. The company’s integrated chemical manufacturing process ensures consistent API quality, with a focus on meeting regulatory compliance for broad distribution.

2. Zhejiang Sinopharm Holdings Co., Ltd. (China)
   Sinopharm specializes in pharmaceutical raw materials and APIs, with an extensive portfolio that includes nucleoside analogs like trifluridine. They leverage advanced chemical synthesis techniques and rigorous quality controls to supply APIs globally, especially to Asia and emerging markets.

3. Hanlim Pharmaceutical Co., Ltd. (South Korea)
   Known for API manufacturing with a focus on oncology and antiviral drugs, Hanlim produces trifluridine APIs with high purity levels. Their capacity includes both bulk manufacturing and custom synthesis for specialty applications, supporting their role as a key supplier in the Asian pharmaceutical landscape.

4. Sanghai ChemCen Laboratory & Chemical Co., Ltd. (China)
   Specializing in chemical intermediates, ChemCen provides trifluridine intermediates and APIs to pharmaceutical firms seeking reliable chemical synthesis options. Their expertise in fluorinated pyrimidine derivatives underpins their role in the supply chain.

5. European and US-Based API Suppliers
   Due to regulatory requirements, some European and US companies either produce or import APIs like trifluridine from Asian manufacturers, often through licensing or import arrangements. Examples include:

   • Targeted APIs Inc. (USA): Specializes in sourcing and supplying high-purity APIs, including nucleoside analogs, aligning with stringent FDA standards.
   • Boehringer Ingelheim (Germany): While primarily focused on proprietary compounds, they maintain a portfolio that includes antiviral nucleosides, and may serve as co-developers or secondary suppliers for trifluridine.

Formulation and Finished Dosage Suppliers

Once the API is procured, pharmaceutical companies rely on formulation specialists to produce the final drug product, whether in capsules, tablets, or injectable forms. Large pharmaceutical companies such as Janssen Pharmaceuticals, AbbVie, and Eli Lilly have integrated supply chains, sourcing APIs either via direct manufacture or licensed production from API suppliers.

Distribution Channels and Regional Distributors

The distribution of trifluridine products involves regional distributors, licensed pharmacies, and hospital procurement systems. In jurisdictions like the US, distributing agencies conform to strict regulatory compliance via the Food and Drug Administration (FDA) and other authorities such as the European Medicines Agency (EMA).

Most supply is channeled through authorized distributors, which verify API and drug product quality, ensuring traceability and regulatory adherence throughout the supply chain. The global logistics network relies heavily on temperature-controlled transportation to preserve drug integrity.

Market Dynamics Affecting Supply

• Regulatory Approvals and Patent Status
  The patent expiration timelines of drugs incorporating trifluridine, notably Lonsurf, influence supplier dynamics. As patent protections expire, generic manufacturers gain access to formulations, increasing supplier options. Regulatory approval procedures also constrain the number of compliant suppliers, creating barriers to entry for new players.

• Manufacturing Capacity and Quality Standards
  API supply is sensitive to manufacturing capacity constraints, especially since fluorinated pyrimidine synthesis involves complex chemical processes requiring high safety and purity standards. Industry-leading suppliers typically invest heavily in GMP-certified facilities, which can limit the entry of smaller manufacturers.

• Raw Material Availability and Supply Chain Risks
  Trifluridine synthesis depends on high-purity fluorinated intermediates, which are sourced from specialized fluorochemical suppliers. Scarcity or disruption in fluorinated chemical markets can impact overall API production.

• Trade Policies and International Sanctions
  Geopolitical tensions, export restrictions, and trade sanctions can impact supply chains, particularly suppliers based in regions with trade restrictions.

Strategic Considerations for Stakeholders

• Diversification of Supplier Base: To mitigate supply risks, pharmaceutical companies should diversify API sourcing across multiple approved suppliers, especially between China, South Korea, and Europe.

• Quality Assurance and Regulatory Compliance: Ongoing audits and quality control are essential to ensure supplier compliance with GMP and other regulatory standards.

• Long-term Supply Agreements: Establishing strategic contracts can secure supply commitments amid fluctuating demand and manufacturing capacity constraints.

• Investment in Supplier Relationships: Collaborative R&D and capacity-building can foster resilience and priority access to critical APIs.

Conclusion
The supply chain for trifluridine involves a selective group of high-capacity Asian manufacturers, complemented by regional distributors and formulators adhering to stringent quality standards. As the pharmaceutical landscape evolves with patent expirations and emerging markets, supply dynamics are poised for diversification and increased resilience. Stakeholders must prioritize supplier quality, regulatory adherence, and strategic sourcing to ensure uninterrupted supply of this critical antiviral and chemotherapeutic agent.

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Key Takeaways

• Major API Suppliers: Huahai Pharmaceutical, Zhejiang Sinopharm, Hanlim Pharmaceutical, and regional Asian manufacturers dominate API production for trifluridine.
• Regulatory Landscape: Stringent GMP standards and regulatory approvals define supplier eligibility and influence market access.
• Market Trends: Patent expirations and regional demand fluctuations drive diversification and the emergence of generics.
• Supply Chain Risks: Chemical synthesis complexity, geopolitical factors, and raw material availability pose ongoing challenges.
• Strategic Actions: Building robust supplier relationships, diversifying sources, and investing in quality assurance are essential for secure supply.

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FAQs

Q1: Which companies are the main producers of trifluridine API globally?
A1: The top API producers include Huahai Pharmaceutical (China), Zhejiang Sinopharm (China), and Hanlim Pharmaceutical (South Korea). European and US-based firms often source from these manufacturers or operate under licensing arrangements.

Q2: Are there generic alternatives to branded trifluridine formulations?
A2: Yes, as patents expire, generic manufacturers can produce trifluridine-based drugs, increasing supply options and potentially lowering costs.

Q3: What are the regulatory challenges associated with importing trifluridine APIs?
A3: Suppliers must meet strict GMP standards and obtain necessary approvals from agencies like the FDA and EMA. Cross-border transportation also involves compliance with customs, import tariffs, and trade policies.

Q4: How does market demand influence trifluridine supply chain stability?
A4: Growing demand for chemotherapeutic and antiviral agents prompts manufacturing expansion, but capacity constraints and raw material shortages can threaten supply stability.

Q5: What strategic steps should pharmaceutical companies take to ensure a reliable supply of trifluridine?
A5: Companies should diversify suppliers, establish long-term contracts, maintain rigorous quality controls, and monitor geopolitical developments affecting supply routes.

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Sources

1. [1] "Global API Market Report," Pharmaceutical Technology, 2022.
2. [2] "Regulatory Standards for Active Pharmaceutical Ingredients," US Food and Drug Administration.
3. [3] "Chemical Synthesis of Fluorinated Pyrimidine Derivatives," Journal of Medicinal Chemistry, 2021.
4. [4] "Market Trends in Oncology and Antiviral Drugs," McKinsey & Company, 2022.
5. [5] "Supply Chain Disruptions in Pharmaceutical Industry," WHO Technical Report, 2021.