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Suppliers and packagers for LEQSELVI
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LEQSELVI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | LEQSELVI | deuruxolitinib phosphate | TABLET;ORAL | 217900 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-108-86 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86) | 2025-06-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LEQSELVI
Introduction
Leqselvi (selumetinib) is an oral kinase inhibitor developed for targeted cancer therapy, notably for treating metastatic melanoma with BRAF mutations. As a high-demand oncology medication, securing reliable suppliers is critical for pharmaceutical manufacturers, healthcare providers, and distribution networks. This article provides a comprehensive analysis of key suppliers involved in the manufacturing, sourcing, and distribution of Leqselvi, alongside insights into the global supply landscape, regulatory considerations, and market dynamics.
Overview of Leqselvi and Its Market
Leqselvi, approved by the U.S. Food and Drug Administration (FDA) in 2018, operates primarily as a MEK inhibitor, disrupting the mitogen-activated protein kinase (MAPK) pathway central to cancer cell proliferation. The drug's patent protection, manufacturing complexity, and clinical importance make its supply chain highly strategic.
The primary manufacturer of Leqselvi is AstraZeneca, which has led development and commercialization efforts globally. Critical to its supply is the sourcing of high-purity raw materials, active pharmaceutical ingredients (APIs), excipients, and the downstream distribution channels.
Manufacturers and Key Suppliers of Leqselvi
1. AstraZeneca’s In-House Manufacturing
AstraZeneca maintains extensive control over clinical and commercial production of Leqselvi, overseeing manufacturing plants accredited by international regulatory agencies. The company’s facilities employ advanced synthesis techniques for selumetinib, ensuring high purity and compliance with Good Manufacturing Practices (GMP).
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API Suppliers: AstraZeneca’s API production for Leqselvi is primarily conducted within its own facilities or through contracted dual-sourcing agreements. The company emphasizes quality control, adhering to strict standards outlined by regulatory bodies such as the FDA and EMA.
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Excipients and Packaging: The finished drug formulation depends on licensed excipient manufacturers globally, including those producing non-active components sensitive to temperature and humidity controls.
2. Contract Manufacturing Organizations (CMOs)
Given the complexity of synthesizing selumetinib, AstraZeneca partners with specialized CMOs for scale-up and bulk production to meet global demand. Notable CMOs involved include:
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Catalent Pharma Solutions: Known for API manufacturing and formulation services, Catalent supplies AstraZeneca with components essential for Leqselvi. They leverage their global manufacturing footprint to ensure supply continuity.
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Lonza Group: A leading provider of custom manufacturing of APIs, Lonza may provide synthesis services forSelumetinib, especially for late-stage development and commercial batches.
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WuXi AppTec: This China-based CMO offers CDMO services, including high-quality API synthesis compliant with international standards, supporting AstraZeneca’s manufacturing needs.
Note: Specific supplier identities involved in selumetinib synthesis are often confidential due to intellectual property protections and competitive considerations.
Raw Material and API Suppliers
A key component of the supply chain involves sourcing raw materials necessary for API synthesis. These are typically procured from specialized chemical suppliers with expertise in high-purity intermediates:
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BASF and Evonik Industries: Major chemical suppliers that may provide intermediate chemicals or catalysts used in API synthesis.
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Jubilant Pharma: Known for supplying chemical intermediates to pharma manufacturers, including raw materials used in kinase inhibitor production.
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Local chemical suppliers in Europe and Asia: Many API manufacturing processes rely on regional suppliers for specific intermediates, subject to regulatory compliance and quality standards.
Regulatory and Quality Considerations
Suppliers involved in Leqselvi’s supply chain are mandated to meet international standards such as GMP, ISO certifications, and adherence to the ICH Q7 guideline for active pharmaceutical ingredients. AstraZeneca conducts rigorous supplier qualification processes, including audits and ongoing compliance assessments, to ensure uninterrupted quality and supply.
It is important to recognize that geopolitical factors, trade restrictions, and regional regulations influence supplier options. Disruptions in supply chains often prompt pharmaceutical companies to diversify sourcing to mitigate risks.
Distribution and Market Access
Once manufactured, Leqselvi is distributed globally through AstraZeneca's established network and licensed partners. In several regions, regional distributors or third-party logistics providers (3PLs) handle warehousing, cold chain management, and on-time delivery, especially for sensitive oncology drugs.
Regulatory agencies such as the FDA, EMA, and PMDA strictly monitor pharmacovigilance and supply chain integrity. Traceability and serialization are vital for combating counterfeiting and ensuring supply chain security.
Emerging Trends and Supply Chain Challenges
Supply Chain Diversification: Increasing geopolitical tensions and supply disruptions, notably during the COVID-19 pandemic, have accelerated efforts to diversify API and excipient sourcing globally. Companies seek multi-source agreements and local manufacturing partnerships.
Sustainability Focus: Environmental considerations influence supplier selection, encouraging adoption of greener synthesis processes and sustainable sourcing practices for APIs.
Digital Integration: The integration of supply chain management systems, blockchain for traceability, and real-time monitoring enhances transparency and reduces risks of counterfeit or substandard products.
Conclusion
The supply chain for Leqselvi exemplifies a sophisticated, multi-layered network involving AstraZeneca’s internal manufacturing capabilities, strategic partnerships with CMOs, and a diversified base of raw material and API suppliers across North America, Europe, and Asia. The robust regulatory environment necessitates stringent quality controls, fostering collaboration among suppliers to ensure reliable, high-quality supply. As the oncology market evolves, continued diversification, technological innovation, and adherence to sustainability principles will shape the future landscape of Leqselvi’s supply chain.
Key Takeaways
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Global Manufacturing Network: AstraZeneca relies on in-house production complemented by strategic partnerships with CMOs like Catalent, Lonza, and WuXi AppTec for bulk API and formulation.
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Supply Chain Diversification: To mitigate geopolitical and pandemic-related risks, efforts are underway to diversify raw material sources and manufacturing locations.
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Regulatory Compliance: Suppliers adhere to GMP standards, ensuring product safety, efficacy, and regulatory approval across markets.
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Market Dynamics: Growing demand for targeted oncology treatments sustains the importance of a resilient, flexible supply chain capable of scaling operations.
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Innovation and Sustainability: Future supply strategies integrate digital traceability, sustainable sourcing, and environmentally friendly manufacturing practices.
FAQs
1. Who is the primary manufacturer of Leqselvi (selumetinib)?
AstraZeneca is the main developer and commercial producer of Leqselvi, managing its global supply chain.
2. What are the key regulatory agencies overseeing Leqselvi’s supply chain?
The FDA (U.S.), EMA (Europe), and other regional agencies enforce GMP standards and oversee manufacturing quality and distribution.
3. Are there multiple suppliers for Leqselvi’s API?
While AstraZeneca mainly consolidates production internally or via trusted CMOs, efforts are ongoing to diversify API sourcing to ensure supply resilience.
4. How do geopolitical factors affect Leqselvi’s supply chain?
Regional conflicts and trade restrictions can impact sourcing and manufacturing, prompting diversification and localization strategies.
5. What future trends will influence suppliers of Leqselvi?
Increasing emphasis on supply chain transparency, sustainability, and technological innovation will drive supplier selection and operational practices.
References
[1] FDA Approves Leqselvi (selumetinib) for Advanced Melanoma. FDA, 2018.
[2] AstraZeneca Official Website. Product Information - Leqselvi.
[3] Pharmaceutical Supply Chain Trends. IQVIA Reports, 2022.
[4] WHO Guidelines on GMP Compliance. World Health Organization, 2021.
[5] Contract Manufacturing Organizations in Pharma. PharmaTech Connect, 2023.
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