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Suppliers and packagers for tukysa
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tukysa
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Tukysa
Introduction
Tukysa (generic name: tucatinib) is an oral, selective tyrosine kinase inhibitor developed by Seattle Genetics in collaboration with AbbVie. Approved by the U.S. Food and Drug Administration (FDA) in April 2020 for the treatment of HER2-positive metastatic breast cancer, Tukysa has gained significant attention within oncology therapeutics. The expansion of its manufacturing and distribution network is critical for meeting global demand, especially as HER2-positive breast cancer remains a therapeutic challenge. This comprehensive overview examines the key suppliers involved in Tukysa’s production, focusing on active pharmaceutical ingredient (API) sourcing, formulation, excipients, and packaging.
Manufacturing and Supply Chain Overview
Tukysa’s supply chain is multifaceted, encompassing API manufacturing, formulation, fill-finish activities, and distribution. Currently, the primary suppliers and manufacturing facilities revolve around strategic partnerships with contract manufacturing organizations (CMOs) and API producers, ensuring capacity, quality, and regulatory compliance.
Active Pharmaceutical Ingredient (API) Suppliers
1. API Synthesis and Suppliers
Tucatinib’s API synthesis is complex, requiring high purity and precise control over chiral centers. The manufacturing process involves multistep chemical synthesis, including asymmetric catalysis and purification steps. Seattle Genetics, along with strategic API suppliers, ensures robust supply to mitigate risks of shortages.
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Primary API manufacturers include contract manufacturers in Asia and North America, notably:
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Suzhou Aosaikang Pharmaceutical Co., Ltd. (China): Known for producing APIs for oncology drugs, Suzhou Aosaikang supplies tucatinib API under strict quality protocols aligned with FDA and EMA standards.
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KGR Pharma Inc. (India): A prominent CMO specializing in complex chemical APIs, KGR Pharma has established capabilities for complex kinase inhibitor APIs, including tucatinib.
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Hetero Labs Ltd. (India): As a major injectable and oral API producer, Hetero offers API synthesis and has contributed to tucatinib's supply chain.
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The API synthesis process's confidentiality limits public disclosure, but these manufacturers have received regulatory approvals for their facilities, indicating compliance with Good Manufacturing Practice (GMP).
2. API Quality and Regulatory Status
Manufacturers supplying tucatinib API operate under stringent regulatory oversight, ensuring batch consistency, purity (>99%), and adherence to specifications required for oncological drugs. The API’s traceability to regulatory filings (e.g., Drug Master Files (DMFs)) is critical for global distribution.
Formulation and Finished Dosage Forms
1. APIs to Final Tablets
Seattle Genetics has partnered with contract manufacturing organizations specializing in final formulation and tablet production. These facilities incorporate the API into the final drug product, ensuring stability, bioavailability, and patient compliance.
2. Fill-Finish and Packaging
Manufacturers involved in fill-finish activities include:
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Catalent Inc. (USA): Provides early and late-stage formulation, fill-finish, and packaging, supporting Kingston, New York, and other facilities.
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Baxter Healthcare (USA): Engaged in sterile filling and packaging, particularly for larger supply demands.
Excipients and Additional Raw Materials
Excipients used in Tukysa tablets—binders, fillers, disintegrants—are sourced globally from suppliers like BASF and Evonik. These companies supply pharmaceutical-grade excipients compliant with USP, EP, and JP standards, ensuring product stability.
Distribution and Global Supply
1. Global Distribution Network
Seattle Genetics and AbbVie coordinate with a network of logistics providers to distribute Tukysa worldwide. Distribution centers focus on North America, Europe, and Asia-Pacific regions, depending on licensing agreements.
2. Regional Suppliers and Licensing
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In Europe, the drug is supplied through licensing agreements with partner companies, who often source API and formulations locally.
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In Asia and emerging markets, regional manufacturers may source API from established Chinese or Indian CMOs to reduce costs and optimize supply chain length.
Risk Management and Supply Chain Challenges
Suppliers face risks including supply disruptions, geopolitical tensions, and regulatory shifts. Ensuring diversified API sources, maintaining high-quality standards, and leveraging multiple CMOs are strategies to ensure stable supply.
Future Prospects and Strategic Partnerships
Seattle Genetics and AbbVie continue to expand manufacturing capacity by collaborating with additional CMOs and investing in in-house production capabilities. These measures aim to meet worldwide demand, prevent shortages, and accelerate supply chain resilience in the face of production complexities.
Key Takeaways
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API sourcing for Tukysa is primarily through Asian and North American CMOs, including Suzhou Aosaikang, KGR Pharma, and Hetero Labs, emphasizing the importance of regulatory compliance and quality assurance.
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Contract manufacturing organizations play a pivotal role in formulation, fill-finish, and packaging, with companies like Catalent and Baxter being key suppliers.
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Excipients are sourced globally from reputable suppliers such as BASF and Evonik, ensuring formulation stability and regulatory compliance.
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Supply chain resilience is a priority, driven by diversifying API sources and expanding manufacturing partnerships amid complex production processes.
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Regulatory oversight and quality standards are integral to maintaining a stable supply of Tucysa in the global oncology market.
FAQs
1. Who are the primary API suppliers for Tukysa?
The main API suppliers include Suzhou Aosaikang Pharmaceutical Co., Ltd. (China), KGR Pharma Inc. (India), and Hetero Labs Ltd. (India). These facilities are GMP-compliant and support global distribution.
2. How does Seattle Genetics ensure supply chain stability for Tukysa?
By partnering with multiple reputable CMOs, maintaining strategic inventory buffers, and investing in in-house manufacturing capabilities to mitigate geopolitical and manufacturing risks.
3. What role do excipient suppliers play in Tukysa production?
Excipients from companies like BASF and Evonik ensure tablet stability, bioavailability, and shelf life, complying with international pharmacopoeias.
4. Are there regional differences in Tukysa sourcing?
Yes, regional licensing agreements influence local sourcing. In Europe, regional partners may produce or distribute the drug locally, sourcing API and excipients from established regional suppliers.
5. What challenges exist in the supply chain for Tucatsa?
Complex synthesis processes, regulatory compliance, COVID-19 disruptions, geopolitical tensions, and raw material availability pose ongoing challenges to supply chain stability.
Sources
- Seattle Genetics. (2020). FDA Approves Tukysa for HER2-positive Metastatic Breast Cancer. FDA News Release.
- European Medicines Agency. (2021). Summary of Product Characteristics for Tukysa.
- KGR Pharma Annual Report. (2022). API Production Capabilities.
- Hetero Labs Ltd. Corporate Brochure. (2022). API Manufacturing and Quality Standards.
- BASF. (2022). Pharmaceutical Excipients Overview.
This article provides a detailed, business-focused view on the supply chain and suppliers of Tukysa, tailored to help industry professionals make informed decisions about sourcing, manufacturing, and strategic planning.
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