Suppliers and packagers for koselugo

koselugo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756	NDA	AstraZeneca Pharmaceuticals LP	0310-0610-28	28 CAPSULE in 1 BOTTLE (0310-0610-28)	2020-04-16
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756	NDA	AstraZeneca Pharmaceuticals LP	0310-0610-60	60 CAPSULE in 1 BOTTLE (0310-0610-60)	2020-04-16
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756	NDA	AstraZeneca Pharmaceuticals LP	0310-0625-28	28 CAPSULE in 1 BOTTLE (0310-0625-28)	2020-04-16
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756	NDA	AstraZeneca Pharmaceuticals LP	0310-0625-60	60 CAPSULE in 1 BOTTLE (0310-0625-60)	2020-04-16

Suppliers for the Pharmaceutical Drug: Koselugo

Last updated: July 27, 2025

Introduction

Koselugo (selumetinib) is an FDA-approved targeted therapy for the treatment of neurofibromatosis type 1 (NF1) — a genetic disorder characterized by the development of benign tumors on nerve tissue. As a MEK inhibitor, Koselugo holds a significant market position within the niche of precision oncology and genetic disorder therapeutics. Understanding its supplier landscape is crucial for stakeholders involved in supply chain management, pharmaceutical procurement, and competitive intelligence.

Manufacturing and Primary Suppliers

Koselugo is developed and marketed by AstraZeneca, a global biopharmaceutical leader. The active pharmaceutical ingredient (API), selumetinib, is produced through complex chemical synthesis processes that involve multiple specialized suppliers, primarily for key raw materials and intermediates.

Active Pharmaceutical Ingredient (API) Suppliers

AstraZeneca’s supply chain for selumetinib’s API is characterized by a combination of proprietary manufacturing processes complemented by strategic partnerships with specialized chemical manufacturers. Although AstraZeneca maintains control over its core API manufacturing, external suppliers contribute critical raw materials and intermediates at various stages:

• Specialized Chemical Raw Material Suppliers: Suppliers providing complex organic compounds are integral in the synthesis of selumetinib’s API. These compounds require high purity and consistent quality, often sourced from custom manufacturing chemical plants in China, India, and Europe.

• Contract Manufacturing Organizations (CMOs): AstraZeneca collaborates with several CMOs globally for API production, primarily in regions with robust chemical manufacturing infrastructure such as India, China, and Europe. For instance, Dr. Reddy’s Laboratories and Mylan have historically provided APIs or intermediates for other oncology drugs, indicating potential for involvement in similar processes for targeted therapies like Koselugo.

Formulation and Final Product Suppliers

Beyond API supply, the finished drug product’s manufacturing involves packaging and formulation specialists:

• Pharmaceutical Contract Manufacturers (CMOs): AstraZeneca partners with several CMOs for final formulation, manufacturing, and packaging. These include firms with expertise in solid oral dosage forms, complying with Good Manufacturing Practices (GMP).

• Packaging Suppliers: The supply chain involves companies specializing in child-resistant blister packs and tamper-evident containers designed for oral medications.

Supply Chain Considerations

AstraZeneca’s strategic focus ensures reliable supply, but external pressures such as geopolitical tensions, raw material scarcity, and regulatory complexities influence the supply chain landscape:

• Raw Material Sourcing: The synthesis of selumetinib involves complex heterocyclic intermediates, often sourced from limited suppliers due to proprietary processes and quality requirements.
• Manufacturing Capacity: To meet global demand, AstraZeneca may rely on multiple facilities across regions, creating a diversified but complex supply chain.
• Regulatory Compliance: Suppliers must adhere to strict regulatory standards, including FDA, EMA, and respective regional authorities, to ensure uninterrupted supply.

Emerging Suppliers and Market Dynamics

The strategic importance of reliable suppliers has driven AstraZeneca to explore partnerships with emerging chemical manufacturers, especially in Asia, to diversify supply sources and mitigate risks associated with geopolitical or environmental disruptions.

Furthermore, with the increasing demand for personalized medicine and targeted therapies, suppliers capable of producing high-quality intermediates at scale are in high demand. Companies such as Hikal Ltd. and Lanxess have been identified as key intermediates suppliers for similar drugs and could be potential contributors to Koselugo’s supply chain.

Regulatory and Quality Assurance

Suppliers of Koselugo must maintain rigorous compliance with GMP standards to ensure product safety and efficacy. Regular audits by AstraZeneca and regulatory bodies govern these suppliers' quality systems:

• Qualification and Auditing: AstraZeneca conducts annual audits to validate supplier compliance with regulatory standards.
• Traceability and Transparency: Traceability of raw materials from supplier to final product is critical, especially given the genetic targeted nature of Koselugo.

Market and Competition

While AstraZeneca maintains tight control over its supply chain, the proliferation of biosimilar and small-molecule manufacturers underscores the importance of diversified supplier relationships. Competitive suppliers might emerge from regions with increasing chemical manufacturing capabilities, such as Southeast Asia and Latin America.

Conclusion

The supply chain for Koselugo hinges on specialized chemical raw material providers, strategic CMOs for API and formulation, and robust quality assurance protocols. AstraZeneca’s global partnerships, especially in Asia and Europe, underpin the drug’s consistent availability. The ongoing diversification of suppliers and ongoing regulatory compliance remain pivotal in maintaining uninterrupted global supply.

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Key Takeaways

• Koselugo’s active ingredient, selumetinib, relies on complex chemical synthesis involving high-purity raw materials sourced globally.
• AstraZeneca collaborates with regional CMOs and chemical suppliers in Asia and Europe to meet manufacturing needs.
• Supplier quality and regulatory compliance are paramount given the drug's targeted and genetic therapy profile.
• Regional diversification in suppliers minimizes supply chain risks amid geopolitical and environmental challenges.
• Emerging suppliers in Asia could influence future supply chain dynamics, offering cost advantages and increased capacity.

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FAQs

1. Who are the primary suppliers involved in the manufacturing of Koselugo?

AstraZeneca relies on a network of specialized chemical intermediates suppliers and contract manufacturing organizations in Europe, India, and China. While specific supplier identities remain confidential, notable firms include regional pharmaceutical CMOs and chemical raw material providers capable of producing high-purity intermediates required for selumetinib synthesis.

2. What are the critical raw materials used in making selumetinib?

The synthesis of selumetinib involves heterocyclic intermediates, including complex aromatic and heteroaromatic compounds requiring advanced organic synthesis techniques. These raw materials are sourced from specialized chemical suppliers with capabilities in producing high-purity, GMP-compliant chemicals.

3. How does AstraZeneca ensure supply chain reliability for Koselugo?

AstraZeneca employs comprehensive qualification, auditing, and validation processes for its suppliers. The company maintains multiple manufacturing sites and suppliers across different regions to mitigate risks and ensure adherence to strict regulatory standards, ensuring continuous supply.

4. Are there any known emerging suppliers for Koselugo?

While specific emerging suppliers are not publicly disclosed, companies in Asia such as Hikal Ltd. and Lanxess could potentially play roles in future supply chains, especially given their capabilities in high-quality chemical manufacturing for the pharmaceutical industry.

5. What risks are associated with the supply chain of Koselugo?

Risks include raw material shortages, geopolitical tensions affecting manufacturing regions, regulatory compliance issues, and environmental factors impacting chemical synthesis. Diversification of suppliers and regional manufacturing bases serve as mitigation strategies.

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Sources

[1] AstraZeneca. “Koselugo (selumetinib) – FDA approval documentation.”
[2] U.S. Food and Drug Administration. “FDA Label for Koselugo.”
[3] GlobalData. “Pharmaceutical supply chain analysis for targeted oncology drugs.”
[4] Chemical & Engineering News. “Chemical intermediates in pharmaceutical manufacturing.”
[5] Industry reports on API sourcing and supply chain diversification strategies.