Suppliers and packagers for LUNESTA

LUNESTA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476	NDA	Waylis Therapeutics LLC	80725-010-30	30 TABLET, COATED in 1 BOTTLE (80725-010-30)	2023-08-15
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476	NDA	Waylis Therapeutics LLC	80725-011-30	30 TABLET, COATED in 1 BOTTLE (80725-011-30)	2023-08-15
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476	NDA	Waylis Therapeutics LLC	80725-012-30	30 TABLET, COATED in 1 BOTTLE (80725-012-30)	2023-08-15

Suppliers for the Pharmaceutical Drug: Lunesta

Last updated: July 27, 2025

Introduction

Lunesta (generic name: eszopiclone) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia. As a hypnotic agent, Lunesta influences gamma-aminobutyric acid (GABA) receptors to induce sleep. Given its widespread prescription, the supply chain for Lunesta involves a complex network of active pharmaceutical ingredient (API) manufacturers, formulation facilities, and distribution channels. Understanding the key suppliers and their strategic positions provides insights into the drug’s manufacturing resilience, regulatory landscape, and potential risks.

Manufacturing and Supply Chain Overview

Lunesta’s manufacturing process necessitates sourcing high-quality APIs, excipients, and employing rigorous quality controls. The supply chain can be segmented into:

• API Suppliers: The core raw material providers.
• Formulation and Packaging Manufacturers: Facilities that produce the final dosage form.
• Distribution Networks: Logistics channels ensuring drug availability across regions.

The API is the most critical component, with its suppliers directly influencing drug availability, regulatory compliance, and cost dynamics.

Key API Suppliers for Eszopiclone (Lunesta)

1. Contract Manufacturing Organizations (CMOs) and APIs Suppliers

The API for Lunesta, eszopiclone, is produced by specialized chemical and pharmaceutical manufacturers, often operating on a contract basis owing to regulatory, quality, and scalability considerations.

• Selick Pharmaceutical: Historically, some reports indicated Selick’s involvement in the production of eszopiclone APIs. As a private company, detailed production capacity is limited, but it has played a role in the supply chain.

• Mitsubishi Chemical Corporation: A prominent global chemical company, Mitsubishi has a significant role in producing APIs, including psychoactive compound APIs used across multiple therapeutic areas. Mitsubishi’s extensive manufacturing capabilities and compliance with international standards make it a notable supplier in this space.

• Hetero Labs: An Indian API producer with a broad portfolio, including CNS-active compounds. Hetero’s APIs are frequently used internationally, and they possess the capacity to produce eszopiclone APIs for generic formulations or biosimilar options.

• CordenPharma/Alvogen: As a contract manufacturer with a focus on complex APIs, CordenPharma has been involved in producing active ingredients for sleep aids, including compounds similar or related to eszopiclone.

2. European and Asian API Producers

Because the healthcare industry heavily relies on Asian manufacturing, several other Asian companies supply APIs for psychiatric and sleep disorder medications:

• Shanghai Smistyle Pharmaceutical: Based in China, Shanghai Smistyle specializes in small-molecule APIs, including CNS therapeutics, potentially including eszopiclone.

• Abohar Pharma (India): An emerging API supplier capable of producing CNS-active compounds, including sleep medication APIs.

3. Supply Chain Dynamics and Challenges

The API supply chain for Lunesta faces multifaceted challenges:

• Regulatory Compliance: API suppliers must adhere to Good Manufacturing Practices (GMP) stipulated by stringent agencies like the FDA and EMA, impacting manufacturing consistency.

• Supply Disruptions: Political, logistical, or pandemic-related disruptions can impact API production, leading to shortages or increased costs.

• Patent and Patent-Expirations: Eszopiclone’s patent expiration (in some jurisdictions) has opened the market to generic producers, increasing the number of suppliers but also intensifying price competition.

Formulation and Commercial Production Suppliers

• Purdue Pharmaceuticals originally developed Lunesta, but production has often been licensed to other pharmaceutical companies, particularly generic manufacturers once patents expired.
• Teva Pharmaceutical Industries: A major generic drug producer and distributor, Teva supplies generic eszopiclone tablets in multiple markets. They rely on APIs sourced from the aforementioned companies or other global suppliers.
• Mylan (now part of Viatris): Has been involved in manufacturing generic formulations of Lunesta, utilizing APIs from multiple sourced suppliers.

Distribution and Supply Chain Management

• Major pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health handle the distribution of Lunesta to pharmacies and healthcare providers.
• Manufacturing facilities around the U.S., Europe, and Asia ensure market reach and stock availability.

Regulatory and Quality Considerations

Suppliers must meet FDA, EMA, and other regional compliance standards. The escalation of biosimilar and generic alternatives necessitates rigorous quality controls, traceability, and transparency throughout the supply chain, influencing supplier choice and procurement strategies.

Emerging Trends and Future Outlook

• Global API Production Shifts: Increasing manufacturing capacity in India and China aims to meet rising demand and reduce costs.
• Supply Chain Resilience: Companies are diversifying suppliers and investing in supply chain transparency to mitigate risks.
• Sustainability Initiatives: Environmental regulations influence API manufacturing practices, pushing suppliers toward greener processes.

Conclusion

The supply of eszopiclone, marketed as Lunesta, depends on a global network of API manufacturers, formulation specialists, and logistics providers. Key players include Mitsubishi Chemical Corporation and Indian API producers like Hetero Labs, supported by several Asian and European suppliers. The increasing market for generic Lunesta has broadened the supplier base, but regulatory, quality, and geopolitical factors remain critical in ensuring a stable supply chain.

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Key Takeaways

• API Suppliers Are Critical: Mitsubishi Chemical and Indian producers like Hetero Labs are primary sources for eszopiclone APIs.
• Global Supply Chain Risks: Disruptions and regulatory changes impact drug availability and costs.
• Market Dynamics: Patent expirations foster generic competition, broadening supplier options.
• Regulatory Compliance Is Paramount: Suppliers must adhere to stringent GMP standards, affecting sourcing and quality assurance.
• Future Trends: Growth in Asian manufacturing, supply chain diversification, and sustainability initiatives will shape Lunesta’s supply landscape.

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FAQs

1. Who are the main API suppliers for Lunesta (eszopiclone)?
The primary API suppliers include Mitsubishi Chemical Corporation, Indian manufacturers like Hetero Labs, and specialized contract manufacturers such as CordenPharma.

2. How does patent expiration affect the supply chain?
Patent expirations facilitate entry for generic manufacturers, expanding the supplier pool and increasing market competition, which can impact pricing and supply stability.

3. Are there risks associated with API sourcing for Lunesta?
Yes. Risks include regulatory non-compliance, geopolitical tensions, logistical disruptions, and dependency on specific suppliers, which can lead to shortages or quality concerns.

4. How do regulatory agencies influence API suppliers?
Agencies like the FDA and EMA enforce GMP standards, compelling suppliers to maintain high-quality manufacturing practices and undergo regular audits to ensure safety and efficacy.

5. What is the outlook for Lunesta’s supply chain?
The trend toward increased Asian production, supply chain diversification, and regulatory compliance improvements suggest a resilient but evolving supply chain, capable of adapting to market and geopolitical shifts.

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Sources

1. FDA Drug Approval Database. (2023).
2. European Medicines Agency (EMA). (2023).
3. IMS Health Reports. (2022).
4. Company websites: Mitsubishi Chemical Corporation, Hetero Labs, CordenPharma.
5. Industry analyses on pharmaceutical API markets (e.g., IQVIA, PharmaBusiness International).