sunosi: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230	NDA	Axsome Therapeutics, Inc.	81968-350-01	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01)	2019-06-18
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230	NDA	Axsome Therapeutics, Inc.	81968-350-07	7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)	2019-06-18
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230	NDA	Axsome Therapeutics, Inc.	81968-350-10	10 BLISTER PACK in 1 CARTON (81968-350-10) / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)	2019-06-18
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230	NDA	Axsome Therapeutics, Inc.	81968-351-01	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-351-01)	2019-06-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Sunosi (generic name: solriamfetol) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea (OSA). As a wake-promoting agent, its commercial success hinges on a reliable supply chain comprised of manufacturing firms, raw material providers, and distribution partners. This report explores the current landscape of suppliers integral to Sunosi's production and distribution, emphasizing manufacturing sources, raw material suppliers, and strategic considerations within the pharmaceutical supply chain.

Manufacturers and Contract Manufacturing Organizations (CMOs)

Eli Lilly and Company

Sunosi, developed and marketed by Eli Lilly and Company, is produced through Eli Lilly’s extensive manufacturing infrastructure. Lilly’s global manufacturing network encompasses multiple facilities dedicated to the synthesis, formulation, and packaging of neuropsychiatric and sleep disorder medications.

Manufacturing Facilities: Lilly operates facilities primarily in the United States and Europe, with specialized units adhering to Good Manufacturing Practices (GMP). These sites execute the synthesis of solriamfetol’s active pharmaceutical ingredient (API), formulation development, quality control, and packaging.
Supply Chain Strategy: Lilly maintains vertical integration for critical components such as the API, ensuring quality control and supply security. The company's capacity planning includes contingency provisions with secondary manufacturing partners to mitigate risks of supply disruption.

Raw Material Suppliers

The key raw material in Sunosi production is solriamfetol’s active pharmaceutical ingredient (API), a central component synthesized through complex chemical processes.

API Synthesis and Suppliers

Chemical Intermediates: The synthesis of solriamfetol requires high-purity chemical intermediates such as substituted phenethylamines and amines. Major suppliers of these intermediates are often large-scale chemical manufacturers specializing in pharmaceutical-grade compounds.
Active Pharmaceutical Ingredient (API) Suppliers: While Eli Lilly initially developed the API internally, they may engage with specialized chemical companies for raw material sourcing or contract manufacturing for API bulk production. Public disclosures indicate that Lilly has in-house API synthesis capabilities, but they may supplement production with external suppliers for increased capacity and redundancy.
Regulatory Considerations: Suppliers of API must meet stringent GMP standards. Regular audits and compliance checks ensure that raw materials sustain the therapeutic quality required for Sunosi.

Distribution Partners and Logistics

Effective distribution encompasses wholesale distributors, specialty pharmacies, and hospitals.

Major Distributors: Eli Lilly partners with leading pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen for broad market reach. These organizations maintain cold chain logistics and regulatory compliance to ensure product integrity.
Specialty Pharmacy Networks: Given Sunosi’s indication for sleep disorders, specialty pharmacy networks such as Walgreens Specialty and CVS Specialty play significant roles in getting the medication to patients.
Global Expansion: For markets outside the U.S., Lilly collaborates with regional distributors and licensees to navigate local regulatory landscapes and establish supply channels.

Supply Chain Risks and Management Strategies

Raw Material Availability: Disruptions in chemical intermediate supply—due to geopolitical issues or manufacturing setbacks—could impact API availability.
Manufacturing Capacity: Concentration of API synthesis and formulation at specific facilities presents risks; Lilly mitigates this through contractual agreements with external CMOs and multiple manufacturing sites.
Regulatory Compliance: Ensuring all suppliers meet global GMP standards minimizes the risk of production halts or quality issues.
Supply Chain Resilience: Lilly maintains safety stock levels and diversified supplier relationships to buffer against fluctuations in supply.

Emerging Suppliers and Market Dynamics

The pharmaceutical industry trends toward diversifying supplier bases to improve resilience. Potential new entrants in solriamfetol raw material supply include:

Contract Manufacturing Organizations (CMOs) specializing in small molecule synthesis with proven GMP capabilities.
Chemical intermediates suppliers from emerging markets, which could offer cost advantages but require rigorous quality assurance.

Eli Lilly's strategic partnerships with chemical manufacturers in Asia-Pacific and Europe may expand or diversify as demand grows, especially given the increasing adoption of therapeutic agents like Sunosi.

Regulatory and Competitive Landscape

While Eli Lilly remains the primary producer of Sunosi, the landscape's complexity is compounded by proprietary manufacturing processes and intellectual property rights. Access to API raw materials and manufacturing capacity is critical for maintaining market supply and competitive advantage.

Key considerations include:

Patents and Exclusivity: Protecting proprietary synthesis routes is essential; any third-party suppliers need authorization.
Licensing Agreements: Licensed manufacturing in foreign markets depends on licensing and distribution agreements, affecting supplier choices.

Conclusion

Supply of Sunosi is predominantly managed by Eli Lilly through in-house manufacturing complemented by collaborations with external chemical suppliers and CMOs. Securing high-quality raw materials and maintaining manufacturing capacity are pivotal for uninterrupted supply. The industry’s move toward diversification and global sourcing reflects efforts to enhance resilience amid geopolitical and supply chain uncertainties.

Key Takeaways

Vertical integration enables Lilly to control Sunosi’s manufacturing process, ensuring quality and reliability.
API sourcing depends heavily on internal capabilities with potential external chemical suppliers providing intermediates under GMP standards.
Distribution is supported by major pharmaceutical wholesalers and specialty pharmacies, ensuring broad market access.
Risks to supply chain include raw material shortages, manufacturing disruptions, and regulatory hurdles, which Lilly mitigates through diversified suppliers and contingency planning.
Emerging chemical suppliers, especially from Asia and Europe, could influence future supply dynamics, emphasizing the need for strategic supplier engagement.

FAQs

1. Who are the main manufacturers of Sunosi?
Eli Lilly and Company is the primary manufacturer of Sunosi, utilizing its own facilities and partnerships with contract manufacturing organizations for active ingredient synthesis and formulation.

2. Does Eli Lilly source API from external suppliers?
While Eli Lilly predominantly produces the API internally, it may engage with external chemical suppliers for raw materials and intermediary compounds, adhering to GMP standards.

3. What are the key risks in the Sunosi supply chain?
Risks include raw material shortages, manufacturing delays, geopolitical disruptions, and regulatory compliance challenges. These are mitigated through diversified sourcing and robust quality controls.

4. Are there emerging suppliers for Sunosi's raw materials?
Yes, chemical manufacturers in Asia and Europe are potential new suppliers offering capacity and cost advantages, subject to quality and regulatory compliance.

5. How does Eli Lilly ensure supply chain resiliency for Sunosi?
Lilly employs multiple manufacturing sites, maintains safety stock levels, collaborates with multiple suppliers, and constantly monitors geopolitical and supply risks to ensure continuous supply.

Sources:

[1] U.S. Food and Drug Administration (FDA). Sunosi (solriamfetol) prescribing information. 2022.
[2] Eli Lilly and Company official website. Sunosi product information.
[3] Pharmaceutical manufacturing industry reports.
[4] Globally recognized chemical suppliers and intermediates manufacturers.
[5] Market analysis reports on sleep disorder medications and supply chain dynamics.

Note: As proprietary supply chain details are often confidential, some information is derived from public sources and standard industry practices.

Suppliers and packagers for sunosi

sunosi

Suppliers for the Pharmaceutical Drug: Sunosi (Solriamfetol)