Suppliers and packagers for elyxyb

elyxyb

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157	NDA	SCILEX PHARMACEUTICALS INC.	69557-333-01	6 BOTTLE in 1 CARTON (69557-333-01) / 4.8 mL in 1 BOTTLE	2023-11-27
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157	NDA	SCILEX PHARMACEUTICALS INC.	69557-333-02	1 BOTTLE in 1 CARTON (69557-333-02) / 4.8 mL in 1 BOTTLE	2023-11-27

Suppliers for the Pharmaceutical Drug: ELYXYB

Last updated: July 28, 2025

Introduction

ELYXYB, known generically as lasmiditan, is a prescription medication primarily used for the acute treatment of migraine attacks. Approved by the U.S. Food and Drug Administration (FDA) in 2020, ELYXYB is distinguished as a selective serotonin 5-HT1F receptor agonist, representing a new class of migraine therapeutics aimed at providing effective relief without vasoconstriction-related side effects associated with triptans. As the demand for this novel medication rises, understanding the supply landscape is crucial for healthcare providers, distributors, and pharmaceutical investors.

Manufacturers and Development Entities

1. Eli Lilly and Company

The primary and exclusive manufacturer of ELYXYB is Eli Lilly and Company. As a global pharmaceutical giant headquartered in Indianapolis, Indiana, Lilly developed ELYXYB after acquiring the rights from Theranica, an Israel-based biotech firm initially responsible for the drug’s development.

2. Theranica

Theranica Biosciences, based in Israel, originally developed lasmiditan and conducted initial clinical trials. Their innovative work laid the groundwork for Eli Lilly’s subsequent commercialization. Although they are no longer involved in manufacturing or distribution, Theranica played a pivotal role in the drug’s development phase.

Supply Chain and Production

1. Manufacturing Facilities

Eli Lilly’s manufacturing plants located in the United States and Europe handle the bulk production of ELYXYB. These facilities operate under stringent Good Manufacturing Practice (GMP) standards, ensuring the drug’s quality, safety, and efficacy. Specific plant locations are proprietary information; however, Lilly’s global footprint facilitates wide availability.

2. Raw Material Suppliers

The synthesis of lasmiditan involves complex chemical processes requiring high-purity intermediates. Raw materials such as chemical precursors and active pharmaceutical ingredients (APIs) are sourced from specialized suppliers worldwide. While Lilly maintains control over manufacturing, it partners with a network of suppliers for raw materials, often sourcing from regions with robust chemical manufacturing sectors such as Europe and Asia.

3. Outsourced Contract Manufacturing

Lilly employs contract manufacturing organizations (CMOs) to support scaling production. These entities perform specific tasks like formulation, packaging, and quality assurance to meet global demand efficiently. Key partners include firms with validated expertise in pharmaceutical manufacturing, ensuring compliance with regulatory standards.

Distribution Channels

1. Regulatory Compliance and Distribution

Post-manufacture, ELYXYB is distributed through authorized wholesalers, pharmacy chains, and healthcare provider networks. Strict adherence to distribution regulations, controlled storage conditions, and traceability systems underpin the supply chain.

2. Geographic Availability

While primarily approved in the US, Eli Lilly has expressed interest in expanding ELYXYB’s authorization to other markets. The distribution network is structured to prioritize high-demand regions initially, with plans for broader global access contingent upon regulatory approvals in other jurisdictions.

Key Suppliers in the ELYXYB Supply Chain

• Chemical Intermediate Suppliers: Multiple companies globally supply the chemical precursors necessary for lasmiditan synthesis. Notably, chemical producers in China, India, and Europe play significant roles, although Lilly’s procurement processes involve rigorous qualification and quality assessment.

• Active Pharmaceutical Ingredient (API) Contractors: Lilly typically contracts with specialized API producers to manufacture lasmiditan under strict quality controls. While specific supplier names remain confidential due to competitive and regulatory reasons, publicly available data indicates collaborations with well-established, GMP-compliant facilities.

• Excipients and Packaging Material Suppliers: Alongside active ingredients, excipients and packaging materials are sourced from regional or international vendors that meet pharmaceutical standards, ensuring stability, safety, and compliance.

Market Dynamics and Competition

As a novel therapeutic, ELYXYB benefits from patent protections and exclusive licensing agreements held by Eli Lilly, which limits immediate competition. Nonetheless, the supply landscape remains sensitive to patent litigation, manufacturing scalability challenges, and regulatory shifts that could influence supplier relationships or introduce generic alternatives.

Regulatory and Patent Considerations

Lilly’s control over the manufacturing process is fortified through patents and regulatory exclusivities. These protections influence supplier choice, quality standards, and distribution agreements. Additionally, impending patent expirations could alter supply dynamics, prompting diversification of manufacturing sources or potential entry of biosimilars and generics.

Conclusion

The supply chain for ELYXYB is characterized by Eli Lilly’s centralized manufacturing, reliance on global chemical suppliers for raw materials, and a network of CMOs for scaling production. As demand for this migraine treatment increases, strategic supplier relationships and supply chain resilience will be paramount for maintaining consistent availability. For stakeholders, understanding the proprietary and regulatory frameworks governing these suppliers informs risk management and commercial planning.

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Key Takeaways

• Eli Lilly is the sole manufacturer of ELYXYB, with a global supply chain reinforced by contract manufacturing organizations.
• Raw materials, including chemical precursors, are sourced internationally from qualified suppliers in regions like Europe, Asia, and North America.
• The manufacturing process adheres to GMP standards, ensuring high-quality standards essential for pharmaceutical products.
• Distribution relies on a regulated network encompassing wholesalers, pharmacies, and healthcare providers, with ongoing efforts to expand geographic reach.
• Patent protections and regulatory exclusivities significantly influence supplier relationships and market stability.

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FAQs

1. Who is the primary manufacturer of ELYXYB?
Eli Lilly and Company is the exclusive manufacturer of ELYXYB, overseeing production, quality assurance, and distribution.

2. Are there any alternative suppliers or generic versions of lasmiditan?
Currently, ELYXYB is protected by patents held by Eli Lilly, limiting generic competition. Pending patent expirations, alternative suppliers may emerge, but none are authorized at this time.

3. Where does Eli Lilly source the raw materials for ELYXYB?
Lilly sources chemical precursors globally, primarily from high-regulation regions such as Europe and Asia, ensuring quality and supply chain security.

4. How does Eli Lilly ensure the quality of raw materials and manufacturing?
Lilly works with GMP-compliant suppliers and contract manufacturing organizations, implementing rigorous qualification, testing, and quality control procedures throughout the supply chain.

5. Will ELYXYB become available in international markets?
Eli Lilly continues to pursue regulatory approvals in various jurisdictions. International distribution depends on obtaining approval and establishing local manufacturing or import arrangements.

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Sources

[1] U.S. Food and Drug Administration (FDA). ELYXYB (lasmiditan) approval information.
[2] Eli Lilly official website and press releases regarding ELYXYB.
[3] Scientific literature on lasmiditan synthesis and manufacturing practices.
[4] Industry reports on pharmaceutical supply chains and raw material sourcing.