Suppliers and packagers for generic pharmaceutical drug: SELUMETINIB SULFATE

SELUMETINIB SULFATE

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

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: Selumetinib Sulfate

Introduction
Selumetinib sulfate is an oral selective inhibitor of MEK1 and MEK2, components of the mitogen-activated protein kinase (MAPK) pathway, which is implicated in several cancers, notably neurofibromatosis type 1 (NF1) related tumors, melanoma, and lung cancers. Approved by the U.S. Food and Drug Administration (FDA) in 2020 for pediatric patients with NF1-related plexiform neurofibromas, selumetinib has garnered significant interest among pharmaceutical companies and research institutions. Its complex synthesis, regulatory profile, and patent landscape influence the landscape of its suppliers. This article analyzes current suppliers, manufacturing sources, and market dynamics associated with selumetinib sulfate.

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Manufacturers and Licensed Suppliers of Selumetinib Sulfate

1. AstraZeneca
AstraZeneca developed and commercialized selumetinib (trade name Vu tourn, by AZ) after acquiring the rights from Array BioPharma, which initially conducted phase 1 and 2 trials. According to regulatory filings and press releases, AstraZeneca is the primary commercial manufacturer of the active pharmaceutical ingredient (API). The company's manufacturing facilities in the U.S. and Europe produce selumetinib sulfate under Good Manufacturing Practice (GMP) standards to meet clinical and commercial demand. AstraZeneca's robust API supply chain is supported by strategic manufacturing partnerships and proprietary synthesis processes.

2. Contract Manufacturing Organizations (CMOs)
Due to high research and development costs and complex synthesis routes, several CMOs are involved in the production of selumetinib sulfate for clinical trial supply and early commercial batches. Notable CMOs include:

• Thermo Fisher Scientific
  Thermo Fisher Scientific provides custom synthesis and GMP manufacturing services for small molecules like selumetinib sulfate. Their facilities support early-stage development and scale-up for clinical phases.

• Samsung Biologics
  Specialized in the production of small molecule APIs, Samsung Biologics offers manufacturing capacity that may be utilized under licensing agreements with the originator or third-party developers.

• Novasep
  A key player in complex chemical synthesis, Novasep offers manufacturing services for kinase inhibitors, including MEK inhibitors, leveraging proprietary processes to optimize purity and yield.

The involvement of these CMOs varies depending on licensing arrangements, production scale, and regional distribution needs.

3. Licensees and Regional Distributors
In certain regions, local pharmaceutical companies have obtained manufacturing or distribution licenses for selumetinib sulfate, primarily to meet regulatory or commercial needs in Asia, Europe, and emerging markets. These companies often source APIs from primary suppliers, ensuring compliance with regional standards.

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Regulatory and Supply Chain Considerations

Regulatory Approvals
AstraZeneca’s approval of selumetinib sulfate by the FDA has established a stringent regulatory framework, demanding high-quality GMP manufacturing. Similar standards are enforced by EMA and other global agencies, influencing the selection of licensed suppliers and CMOs.

Supply Chain Challenges
The synthesis of selumetinib sulfate involves multi-step chemical processes with precision purity requirements. Supply disruptions can occur due to raw material shortages or complex manufacturing steps. To mitigate these risks, manufacturers often diversify sources across multiple suppliers and regions.

Key Raw Materials
Critical starting materials include specific heterocyclic compounds and intermediates that demand specialized synthesis expertise. Supplier relationships for these intermediates are often tightly controlled, and availability influences overall supply stability.

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Market Dynamics and Future Trends

Emerging Generic Competition
With patents expiring or nearing expiration—particularly in key jurisdictions—generic manufacturers aim to produce biosimilar or generic versions of selumetinib sulfate. Companies like Zydus Cadila and Teva Pharmaceuticals may seek to enter the market once exclusivity ends, relying on licensed or independently sourced APIs.

Partnerships and Licensing Agreements
Ongoing licensing agreements facilitate API supply and distribution. AstraZeneca continues to partner with regional distributors to expand access, especially in Asia. The dynamic landscape encourages regional manufacturers to establish relationships with established API producers.

Research and Development Pipeline
Innovations in synthesis and formulation may lead to alternative manufacturing routes, potentially reducing costs and increasing supply resilience. Active collaborations between academic institutions and industry aim to develop more efficient synthetic methods.

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Conclusion

The primary supplier of selumetinib sulfate remains AstraZeneca, supported by a network of CMOs and regional licensees that ensure global distribution. The complexity of its synthesis, regulatory standards, and patent landscape shape its supply chain structure. With upcoming patent expirations and ongoing research, the supplier landscape is poised for diversification and increased generic entry. Business professionals must monitor licensing agreements, manufacturing capacities, and regional regulatory policies to effectively navigate the supply of selumetinib sulfate.

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Key Takeaways

• AstraZeneca is the principal licensed manufacturer of selumetinib sulfate, with GMP facilities supporting global supply.
• Contract manufacturing organizations like Thermo Fisher, Samsung Biologics, and Novasep play crucial roles in early-stage production.
• Regional licensing agreements facilitate localized distribution, especially in Asia and Europe.
• Complex synthesis and raw material sourcing influence supply chain stability, necessitating diversified sourcing strategies.
• Expiration of patents could lead to increased generic competition, impacting pricing and supply dynamics.

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Frequently Asked Questions (FAQs)

1. Who are the main manufacturers of selumetinib sulfate globally?
AstraZeneca is the primary licensed manufacturer, supported by contract manufacturing organizations (CMOs) such as Thermo Fisher Scientific, Samsung Biologics, and Novasep under various licensing and partnership agreements.

2. What are the challenges involved in the manufacturing of selumetinib sulfate?
The synthesis involves multiple complex chemical steps requiring high purity and strict regulatory compliance. Raw material availability and process scalability also pose challenges, impacting supply consistency.

3. Are there generic versions of selumetinib sulfate available?
Currently, no generic versions are commercially available, as the drug is under patent protection. However, patents are nearing expiration in certain jurisdictions, paving the way for potential generic entry.

4. How does regional regulation influence the supply chain of selumetinib sulfate?
Regional regulatory standards dictate manufacturing quality and approval processes. Licensed suppliers and local distributors must meet these standards, influencing sourcing and distribution channels.

5. What is the outlook for the future supply of selumetinib sulfate?
The supply landscape is expected to expand with patent expirations, increased manufacturing capacity from existing CMOs, and potential new entrants in the generic market, enhancing global availability.

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References
[1] AstraZeneca Annual Report 2022.
[2] FDA Drug Approval document for selumetinib (2020).
[3] ClinicalTrials.gov entries on selumetinib.
[4] Contract manufacturing capabilities of Thermo Fisher Scientific and Samsung Biologics.
[5] Patent expiration timelines for selumetinib in key markets.