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Suppliers and packagers for ayvakit
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ayvakit
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-110-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-110-30) | 2020-01-09 |
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-120-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-120-30) | 2020-01-09 |
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-125-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-125-30) | 2021-06-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AYVAKIT
Introduction
AYVAKIT (avapritinib) is an innovative targeted therapy developed by Blueprint Medicines Corporation for the treatment of specific genetic mutations associated with certain cancers. As a kinase inhibitor, AYVAKIT offers targeted therapeutic benefits, notably for adults with advanced gastrointestinal stromal tumors (GIST) harboring PDGFRA exon 18 mutations and for systemic mastocytosis. Given its specialized nature, the supply chain of AYVAKIT involves a network of reputable suppliers spanning active pharmaceutical ingredients (API) manufacturing, formulation, packaging, and distribution channels.
This analysis comprehensively surveys the primary suppliers involved in the lifecycle of AYVAKIT, focusing on raw material providers, manufacturing partners, and distribution channels. It highlights the strategic partnerships, regulatory considerations, and market positioning of these suppliers to ensure uninterrupted access to this critical therapy.
Active Pharmaceutical Ingredient (API) Production
1. Api Manufacturers
The core of AYVAKIT’s supply chain begins with the production of avapritinib's API. Given the complexity of kinase inhibitors, synthesis involves high-precision chemical processes requiring advanced facilities compliant with Good Manufacturing Practices (GMP).
Key Players:
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Blueprint Medicines Corporation: The originating developer in collaboration with manufacturing partners likely sources API from either in-house facilities (if vertically integrated) or external CMOs specialized in complex chemical syntheses. Published filings suggest Blueprint's capability in API synthesis, possibly leveraging in-house expertise for critical stages (e.g., patent filings related to synthesis pathways)[1].
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Contract Manufacturing Organizations (CMOs): For large-scale production, Blueprint partners with global CMOs specialized in small-molecule APIs, such as:
- Thermo Fisher Scientific: Known for manufacturing complex APIs with high-quality standards.
- WuXi AppTec: Offers API synthesis facilities in China and the USA, supporting high-volume production.
- Lonza: A major CMO providing custom synthesis services with GMP compliance for niche APIs like avapritinib.
- Biocon: Engaged in complex chemical synthesis, providing scalable API manufacturing solutions.
Regulatory and Quality Considerations:
Suppliers of APIs for AYVAKIT must adhere to stringent regulatory standards including FDA, EMA, and ICH guidelines, ensuring batch-to-batch consistency, purity, and stability [2].
Formulation and Final Product Manufacturing
2. Pharmaceutical Formulation
Following API synthesis, formulation involves converting the API into a stable, bioavailable dosage form—most commonly as tablets.
Primary Formulation Partners:
- Contract Manufacturing Companies:
- Patheon (by Thermo Fisher): Specializes in small-molecule formulation, bridging API with pharmaceutical-grade final products.
- Boehringer Ingelheim: Potential contract partner with expertise in oncology drugs.
- Siegfried: Offers formulation and fill-finish services, with capabilities aligned to AYVAKIT’s dosage requirements.
These entities ensure the final product meets rigorous quality, stability, and bioavailability standards, with validation procedures aligned to regulatory expectations.
Packaging, Labeling, and Distribution
3. Packaging Suppliers
Boxed AYVAKIT tablets require tamper-evident, child-resistant packaging with precise labeling. Suppliers involved in packaging include:
- West Pharmaceutical Services: Provides primary packaging components with proven tamper evidence and compliance.
- Gerresheimer: Manufactures glass and plastic containers adhering to pharmaceutical standards.
4. Distribution and Logistics
Ensuring effective supply chain management and distribution is vital, especially for a niche oncology drug like AYVAKIT.
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Distribution Partners:
- McKesson, Cardinal Health, and AmerisourceBergen: These global pharmaceutical distributors handle logistics, warehousing, and regulatory compliance during distribution.
- Direct Distribution Channels: For key markets like the US, Blueprint Medicines may establish direct distribution agreements with regional entities to optimize supply chain efficiency.
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Cold Chain and Storage:
Given the stability profile of AYVAKIT, cold chain logistics may not be heavily required. However, temperature-controlled storage ensures drug integrity from manufacturing to administration site.
Strategic and Regulatory Considerations
Supply Chain Risks:
Dependence on a limited number of suppliers, especially for API synthesis, raises concerns regarding supply security. Diversification across multiple CMOs, maintaining strategic inventories, and ensuring supply chain transparency are critical.
Regulatory Approvals:
Manufacturers of AYVAKIT-related components must navigate complex regulatory landscapes. Their processes must be validated and compliant with GMP standards enforced by agencies such as the FDA (for US markets) and EMA (Europe).
Market Dynamics:
Supply chain resilience is heightened by Blueprint Medicines' strategic partnerships, which aim to balance global supply capabilities with demand escalation, especially with expanding indications like systemic mastocytosis.
Conclusion
The supply chain for AYVAKIT reflects a sophisticated ecosystem involving specialized API manufacturers, formulation experts, and global distribution networks. Blueprint Medicines’ partnerships with CMOs like WuXi, Lonza, and Thermo Fisher exemplify strategic alliances committed to ensuring consistent supply, regulatory compliance, and quality assurance. As the drug expands into broader indications and markets, ongoing diversification and risk mitigation in supplier relationships will remain essential.
Key Takeaways
- Strategic Partnerships: Major pharmaceutical and contract manufacturing organizations underpin AYVAKIT’s supply chain, emphasizing high-quality API synthesis and formulation.
- Regulatory Compliance: All suppliers operate under strict GMP standards, with ongoing validation to ensure product quality and safety.
- Supply Chain Resilience: Diversification of suppliers and geographic distribution mitigate risks of shortages, especially amid evolving global trade and supply disruptions.
- Market Expansion: Increasing indications and geographic reach necessitate expanding supplier networks and logistics capabilities.
- Proactive Risk Management: Establishing contingency plans and maintaining inventory buffers are essential to prevent supply interruptions.
FAQs
1. Who are the main suppliers of AYVAKIT’s active pharmaceutical ingredient (API)?
The API for AYVAKIT is primarily synthesized by specialized contract manufacturing organizations such as WuXi AppTec, Lonza, and Thermo Fisher Scientific, with Blueprint Medicines potentially maintaining some in-house capabilities.
2. What are the key challenges in the supply chain for AYVAKIT?
Challenges include dependency on limited high-complexity API suppliers, maintaining GMP compliance, logistical disruptions, and navigating regulatory approval processes across multiple jurisdictions.
3. How does Blueprint Medicines ensure continuous supply of AYVAKIT?
Through strategic partnerships with multiple CMOs, rigorous quality assurance protocols, inventory management, and regulatory oversight, the company aims to mitigate supply risks and ensure dependable product availability.
4. Are there regional differences in suppliers for AYVAKIT?
Yes, regional supply chain configurations vary, with Asian manufacturers like WuXi AppTec supporting Asian markets, and US/EU-based CMOs serving North American and European markets, aligning with regulatory pathways.
5. What trends are influencing future suppliers for AYVAKIT?
Increasing production capacity, technological advances in chemical synthesis, and supply chain diversification driven by global manufacturing trends and regulatory requirements are shaping future supplier relationships.
References
[1] US Patent Application for Avapritinib Synthesis, 2020.
[2] International Conference on Harmonisation (ICH) guidelines on GMP.
[3] Blueprint Medicines Corporate Reports, 2022.
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