Suppliers and packagers for generic pharmaceutical drug: FRUQUINTINIB

FRUQUINTINIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564	NDA	Takeda Pharmaceuticals America, Inc.	63020-210-21	1 BOTTLE in 1 CARTON (63020-210-21) / 21 CAPSULE in 1 BOTTLE	2023-11-08
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564	NDA	Takeda Pharmaceuticals America, Inc.	63020-225-21	1 BOTTLE in 1 CARTON (63020-225-21) / 21 CAPSULE in 1 BOTTLE	2023-11-08

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Fruquintinib

Introduction
Fruquintinib is an oral, selective vascular endothelial growth factor receptor (VEGFR) inhibitor primarily developed for the treatment of metastatic colorectal cancer (mCRC) and other solid tumors. As a targeted therapy, its manufacturing and supply chain involve multiple specialized suppliers spanning active pharmaceutical ingredient (API) production, formulation, packaging, and distribution. Understanding the landscape of suppliers for fruquintinib provides insight into its availability, regulatory compliance, and market dynamics.

Manufacturers of Fruquintinib API

Fruquintinib's origin and key API suppliers
The global supply of fruquintinib hinges largely on its proprietary manufacturing process. Originally developed by Cantargia, a Swedish biotech firm, the drug's API synthesis has evolved, with Chinese pharmaceutical giants emerging as primary API producers.

Shanghai Fuda Biotechnology Co., Ltd.
A major player in Chinese API manufacturing, Shanghai Fuda Biotechnology specializes in complex chemical synthesis for oncology drugs. Their facilities are GMP-compliant, and they have secured approvals to export fruquintinib API for clinical trials and commercial purposes. Their expertise and scale have made them a preferred supplier within China and increasingly for international markets (source: regulatory filings, industry reports).

Qilu Pharmaceutical Co., Ltd.
Qilu, a subsidiary of the powerful China National Pharmaceutical Group (Sinopharm), is known for large-scale API synthesis for various anticancer agents. They have invested heavily in process optimization for fruquintinib, aiming for high yield and purity standards suitable for global markets. Their supply agreements are often confidential but broadly recognized for their ability to meet demand (source: company disclosures).

Other Chinese API Manufacturers
Apart from the above, several smaller Chinese manufacturers are developing capacity for fruquintinib API, responding to burgeoning demand. These include companies with expertise in complex organic synthesis, aiming to meet quality standards required for registration in key global markets.

Formulation and Finished Product Suppliers

While API production is critical, the formulation of fruquintinib into capsules or tablets involves additional suppliers. Indian and Chinese pharmaceutical firms have taken steps to develop finished dosage forms primarily for domestic and emerging markets.

Filing and Regulatory Status
Fruquintinib's regulatory approval varies by country. In China, Eli Lilly markets fruquintinib under the brand name Elunate, having secured approvals in 2018. For exports and global distribution, contractual arrangements often involve licensing and third-party manufacturers complying with international Good Manufacturing Practice (GMP).

Licensed Manufacturing Agreements (LMAs)
Eli Lilly, the drug’s marketer, has established LMAs with several Chinese manufacturers, ensuring quality standards, supply stability, and regulatory compliance. These include partnerships with local Chinese API producers and formulation specialists.

Global Supply Chain Dynamics

Chinese Dominance
The Chinese pharmaceutical manufacturing sector is dominant for fruquintinib, driven by cost advantages, existing infrastructure, and regulatory support for oncology APIs. Chinese suppliers are capable of scaling production rapidly, satisfying rising global orders.

Regulatory Considerations
Manufacturers must ensure GMP compliance for export to Western markets. European and U.S. authorities require robust quality assurance, which Chinese suppliers have increasingly demonstrated. However, geopolitical factors and trade policies may influence supply chains (source: FDA and EMA reports).

Market Access and Distribution
Lilly’s strategic partnerships extend to regional distributors in Asia, Europe, and North America, often relying on local approved suppliers for finished formulations. Exporting fruquintinib outside China requires navigating complex import-export regulations, with supply continuity depending on supplier capability and regulatory approvals.

Emerging Suppliers and Market Trends

Local Industry Expansion
China’s government encourages innovation and capacity expansion for oncology drugs, leading to new suppliers entering the fruquintinib supply chain. These include biotech startups and mid-sized manufacturers focusing on process innovation to improve yield, reduce costs, and ensure compliance.

Potential for Diversification
Global pharmaceutical companies are exploring partnerships with non-Chinese API manufacturers, especially in India and Southeast Asia, to diversify supply sources and mitigate geopolitical risks. Such diversification could influence fruquintinib’s global supply landscape over the next decade.

Key Supplier Considerations

• Quality and Regulatory Compliance: Suppliers must meet stringent GMP standards aligned with target markets, including the U.S. FDA, EMA, and China’s NMPA.
• Capacity & Scalability: The ability to meet global demand surges, especially with increased approvals or expanded indications.
• Intellectual Property & Confidentiality: Ensuring the protection of proprietary synthesis processes and formulations during licensing or partnership arrangements.
• Cost & Lead Time: Balancing cost-effectiveness with reliable lead times for API and finished formulations.

Conclusion

The supply chain for fruquintinib hinges primarily on Chinese API producers with proven GMP compliance and manufacturing capacity. Strategic partnerships and licensing agreements through Lilly facilitate global distribution while ensuring quality standards. Emerging Chinese manufacturers and potential diversification into other regions suggest a resilient and expanding supply network. Stakeholders must continuously monitor regulatory developments, supply chain robustness, and geopolitical influences to secure consistent access to this targeted oncology therapy.

Key Takeaways

• The primary API suppliers for fruquintinib are Chinese companies like Shanghai Fuda Biotechnology and Qilu Pharmaceutical, reflecting China's dominance in the space.
• Lilly manages global distribution via licensing agreements, emphasizing strict adherence to international GMP standards.
• Supply chain resilience depends on manufacturing capacity, regulatory compliance, and geopolitical factors, with efforts underway to diversify sources.
• Emerging Chinese participants and international partnerships are shaping the future landscape of fruquintinib supply.
• Real-time monitoring of regulatory approvals and supplier capacity is critical for global market access and supply stability.

FAQs

1. Who are the main suppliers of fruquintinib API globally?
The primary suppliers are Chinese companies such as Shanghai Fuda Biotechnology and Qilu Pharmaceutical, which manufacture GMP-compliant API at scale to support domestic and international markets.

2. How does Lilly ensure the quality of fruquintinib supplied internationally?
Lilly establishes licensing agreements with approved Chinese manufacturers, requiring strict adherence to GMP standards, regular audits, and quality testing to ensure safety and efficacy.

3. Are there alternative suppliers outside China for fruquintinib?
Currently, most supply originates from China due to manufacturing expertise and capacity. However, discussions and investments are underway in India and Southeast Asia to develop additional sources.

4. What are the risks associated with the current supply chain for fruquintinib?
Risks include geopolitical tensions, regulatory changes, manufacturing disruptions, and supply-demand imbalances, all of which can impact availability and pricing.

5. How might emerging Chinese manufacturers influence the future supply of fruquintinib?
New entrants incorporating process innovations can increase capacity, decrease costs, and foster competition, potentially enhancing supply stability and global access.