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

Fruquintinib Suppliers: Contract Manufacturers, API Sources, and Key Supply Risks

Last updated: May 25, 2026

Fruquintinib is a small-molecule oncology kinase inhibitor marketed as fruquintinib (commercial names include Fruzaqla in the US/UK market context). Supplier selection for fruquintinib typically centers on (1) active pharmaceutical ingredient (API) manufacture and (2) finished-dose supply (tablet manufacturing, packaging, and release testing). The supplier universe is shaped by IP-protected intermediates and drug-substance/drug-product process controls, plus regulatory qualification tied to drug master file (DMF) access for US FDA and similar filings elsewhere.

No defensible, complete supplier list (named companies tied to specific fruquintinib drug-substance or drug-product registrations) can be produced from the information available in this chat.

Which companies supply fruquintinib API and finished tablets?

Featured-snippet answer: A complete, verified list of fruquintinib API and finished-dose suppliers requires mapping confirmed DMF holders and inspected manufacturing sites to fruquintinib’s labeled products and regulatory submissions. That mapping is not provided here, so a definitive company list cannot be compiled.

What determines fruquintinib API supplier eligibility?

• DMF/ASMF pathway: US filings often reference a DMF for drug substance; EU/UK use similar submission constructs for API and manufacturing process disclosures.
• Process and intermediate protection: Fruquintinib synthesis includes steps whose intermediates and reaction conditions can be locked by patents. Supplier changes can create IP design-around constraints even when the final API is identical.
• Quality system fit: GMP track record, validation package completeness, and impurity control (including genotoxic or process-related impurities) drive qualification.
• Stability and polymorph control: Solid form and dissolution behavior affect tablet bio-performance, forcing tighter control on API spec and incoming release testing.

What raw material and intermediate suppliers support fruquintinib manufacturing?

Featured-snippet answer: For fruquintinib, upstream suppliers are typically scoped to custom chemical intermediates used in kinase inhibitor scaffolds. A public, complete intermediate supplier map is not available here.

Common upstream categories (without company names)

• Key scaffold intermediates (heteroaryl-linked fragments and functionalized carbonyl/amine precursors)
• Chiral or late-stage functionalization reagents (where applicable to final substitution patterns)
• Catalysts and solvents qualified under GMP for residual limits
• Starting material and grade-controlled reagents to manage impurities and trace elements

How do fruquintinib supply chain constraints affect contract manufacturing?

Featured-snippet answer: Contract manufacturing risk is dominated by (1) API upstream continuity, (2) validated solid-form behavior for tablets, and (3) release testing throughput for oncology dose manufacturing. Named supplier dependency cannot be stated here without specific source records.

Drug-product manufacturing constraints for fruquintinib tablets/capsules

• Blend uniformity and content uniformity testing strategy
• Compression and tablet defect rate controls (capping, lamination)
• Analytical method transfer for assay and impurity panels
• Stability program match to labeled storage conditions
• Packaging and serialization capability where required by market regulations

What does the Orange Book list for fruquintinib that signals supplier relationships?

Featured-snippet answer: Orange Book listings provide patents and exclusivity status, not supplier names directly. Supplier signals may appear indirectly through manufacturer-of-record, labeler of record, and referenced submissions, but those specific linkages are not contained here.

What generic or biosimilar entry risk changes the supplier landscape for fruquintinib?

Featured-snippet answer: Fruquintinib is a small molecule, so the main competitive threat is generic small-molecule entry, not biosimilars. Supplier changes become more feasible as design-around IP narrows and regulatory approvals diversify qualified sources. A litigation and generic entry timeline is not available here, so specific supplier-shift triggers cannot be quantified.

How strong is fruquintinib patent coverage as a supply barrier for new suppliers?

Featured-snippet answer: Patent coverage can block access to protected intermediates, manufacturing methods, or formulation details, limiting alternative supplier onboarding. The underlying patent estate and its expiration schedule are not provided here.

Key Takeaways

• Fruquintinib supply is split into API sourcing and finished-dose manufacturing, with quality-system fit, impurity control, and solid-form/tables-compression validation as primary constraints.
• A specific, defensible list of named API and finished-dose suppliers cannot be produced from the information available in this chat.
• Patent protection and DMF-linked regulatory submissions can restrict supplier substitution even when the final API is technically producible.

FAQs

1) How do I identify the correct fruquintinib API supplier for my regulatory submission?
Use DMF/ASMF linkage to the labeled product’s regulatory references and confirm GMP site status. Supplier identification is not possible from this chat content.

2) What documents prove a fruquintinib contract manufacturer is qualified?
Typical proof includes GMP certificates, method transfer evidence, validation summaries, and CoA release test capability for assay and impurities.

3) Can a different API polymorph be used for fruquintinib tablets?
Switching solid form can require bridging studies and tighter controls. Whether it is permitted depends on regulatory and formulation/patent constraints not supplied here.

4) What are the main quality risks in fruquintinib manufacturing?
Content uniformity, impurity control, and stability behavior under labeled storage conditions.

5) Does fruquintinib face biosimilar competition?
No, as it is a small-molecule drug; the competition framework is generic small-molecule entry.

References

No sources were provided in the prompt, and no external documents were supplied for citation.