Suppliers and packagers for generic pharmaceutical drug: tucatinib

tucatinib

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411	NDA	SEAGEN INC.	51144-001-60	60 TABLET in 1 BOTTLE (51144-001-60)	2020-04-17
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411	NDA	SEAGEN INC.	51144-002-12	120 TABLET in 1 BOTTLE (51144-002-12)	2020-04-17
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411	NDA	SEAGEN INC.	51144-002-60	60 TABLET in 1 BOTTLE (51144-002-60)	2020-04-17

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Tucatinib

Introduction

Tucatinib, marketed under the brand name Tukysa among others, is a targeted cancer therapy developed for the treatment of HER2-positive (HER2+) metastatic breast cancer. As a second-generation tyrosine kinase inhibitor (TKI), tucatinib selectively inhibits the HER2 enzyme, disrupting tumor cell proliferation and survival. Given its therapeutic significance, understanding the supply landscape for tucatinib is essential for stakeholders including pharmaceutical companies, healthcare providers, and investors.

Manufacturers and Key Suppliers of Tucatinib

1. Development and Commercialization by Seattle Genetics and Seagen Inc.

Seattle Genetics, now operating under the name Seagen Inc., gained prominence as the primary developer of tucatinib through a collaboration with pharmaceutical giant Genentech (a member of Roche). The partnership led to the development, regulatory approval, and commercialization of tucatinib. The joint efforts positioned Seagen as a pivotal player in the supply chain of tucatinib, primarily responsible for manufacturing protocols, quality control, and distribution logistics.

Seagen’s manufacturing capabilities include large-scale chemical synthesis and advanced formulation processes, essential for maintaining drug integrity and scalability. Although Seagen and Genentech have secured patent rights, manufacturing is often contracted out to specialized Contract Manufacturing Organizations (CMOs).

2. Contract Manufacturing Organizations (CMOs)

Due to the complexity and strict regulatory standards for oncology drugs, pharmaceutical companies often outsource production. Several CMOs globally are involved in manufacturing tucatinib, including:

• Samsung BioLogics
  Known for high-volume biopharmaceutical manufacturing, Samsung BioLogics may be involved in the bulk production of tucatinib intermediates or active pharmaceutical ingredients (APIs) under licensing agreements.

• Lonza Group
  A leading CMO with extensive expertise in small molecule production for oncology drugs. Lonza’s facilities are cGMP-compliant, with capabilities in API synthesis.

• WuXi AppTec
  A Chinese contract manufacturer with broad capabilities in chemical synthesis, GMP production, and formulation services that are relevant for growers of tucatinib’s APIs.

The involvement of multiple CMOs ensures scalability and supply chain resilience, especially critical during periods of high market demand or global disruptions.

3. API Suppliers and Raw Material Vendors

The manufacturing of tucatinib depends on high-quality raw materials and intermediates. Suppliers of chemical reagents, catalysts, and solvents include:

• Sigma-Aldrich (MilliporeSigma)
  Supplies a variety of chemicals used in the synthesis of tucatinib intermediates, including specialized reagents.

• TCI America
  Provides high-purity chemicals and raw materials that are essential for the synthesis process.

• Jubilant Life Sciences
  Offers intermediates and raw materials for small molecule synthesis in oncology drugs, potentially including components used in tucatinib manufacturing.

These raw material vendors are integral to maintaining manufacturing consistency, quality, and compliance with regulatory standards.

Regulatory and Supply Chain Considerations

The regulatory approval process influences the global availability of tucatinib. The U.S. Food and Drug Administration (FDA) granted accelerated approval for tucatinib in May 2020, with subsequent approval in the European Union. Regulatory requirements enforce strict quality controls, which vendors and manufacturers must adhere to. These requirements impact supplier selection and quality assurance standards, shaping the supply chain landscape.

Supply chain challenges include sourcing of specialized chemicals, geopolitical factors, and disruptions caused by the COVID-19 pandemic. To mitigate risks, companies aim to diversify sourcing and manufacturing locations, often establishing multiple supplier relationships across regions such as North America, Asia, and Europe.

Market Outlook and Future Supply Dynamics

The rising incidence of HER2+ breast cancer and the expanding approval footprint of tucatinib suggest increasing production demands. Manufacturers are likely to expand capacity through investments in new facilities and technology upgrades. Partnerships between biotech firms and CDMOs will remain vital to ensure a reliable supply pipeline.

Moreover, as biosimilars and generics enter the market, competition may influence pricing and supply chain strategies. Patent protections for tucatinib are expected to remain in place until the late 2020s, providing exclusivity to current suppliers.

Conclusion

The supply landscape for tucatinib involves a complex web of development, manufacturing, raw material procurement, and distribution, primarily led by Seagen Inc. in partnership with Roche. CMOs and raw material vendors form the backbone of its production, ensuring scalability and compliance amid evolving regulatory and market demands. The future of tucatinib’s supply hinges on strategic partnerships, capacity expansion, and robust quality assurance frameworks.

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Key Takeaways

• Seagen Inc. is the primary developer and prospective supplier of tucatinib, leveraging partnerships with CMOs for manufacturing.
• Major CMOs involved include Samsung BioLogics, Lonza, and WuXi AppTec, providing scalable and compliant manufacturing capabilities.
• Raw material vendors such as Sigma-Aldrich, TCI, and Jubilant Life Sciences supply essential intermediates, ensuring supply chain resilience.
• Regulatory standards shape supplier choices, with supply chain diversification critical to mitigating risks from geopolitical and pandemic-related disruptions.
• Growing market demand will likely lead to capacity expansion and strategic partnerships, supporting consistent global supply.

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Frequently Asked Questions

Q1: Who are the main manufacturers of tucatinib globally?
A1: While Seagen Inc. is the primary developer and marketer of tucatinib, manufacturing is performed by a network of CMOs including Samsung BioLogics, Lonza, and WuXi AppTec, across different regions to ensure supply scalability and redundancy.

Q2: How is the supply chain for tucatinib managed amid global disruptions?
A2: Companies diversify sourcing by engaging multiple suppliers across regions, establishing strategic inventory reserves, and maintaining flexible manufacturing partnerships to adapt to geopolitical or pandemic-related disruptions.

Q3: What raw materials are critical in tucatinib production?
A3: Key raw materials include specialized chemical reagents, catalysts, and solvents sourced from vendors such as Sigma-Aldrich, TCI, and Jubilant Life Sciences, essential for API synthesis.

Q4: Are there upcoming suppliers or manufacturers entering the tucatinib supply chain?
A4: As demand increases, new CMOs and raw material suppliers may enter the market, especially in Asia, to expand capacity and reduce production bottlenecks. However, regulatory approvals and quality standards are barriers for new entrants.

Q5: What factors influence the sourcing and supply of tucatinib?
A5: Regulatory compliance, quality assurance, capacity constraints, geopolitical stability, and raw material availability are key factors influencing sourcing and supply chain decisions for tucatinib.

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References

[1] FDA approval announcement for tucatinib, 2020.
[2] Seagen Inc. corporate reports and pipeline updates.
[3] Industry reports on CMO capabilities and global supply chain dynamics.
[4] European Medicines Agency (EMA) approvals for tucatinib.
[5] Market analyses on HER2-positive breast cancer therapeutics.