Suppliers and packagers for tasimelteon

tasimelteon

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	TASIMELTEON	tasimelteon	CAPSULE;ORAL	211607	ANDA	Apotex Corp.	60505-4665-3	30 CAPSULE in 1 BOTTLE (60505-4665-3)	2024-01-05
Apotex	TASIMELTEON	tasimelteon	CAPSULE;ORAL	211607	ANDA	Apotex Corp.	60505-4665-9	90 CAPSULE in 1 BOTTLE (60505-4665-9)	2024-01-05
Msn	TASIMELTEON	tasimelteon	CAPSULE;ORAL	211654	ANDA	Amneal Pharmaceuticals NY LLC	69238-2548-3	30 CAPSULE in 1 BOTTLE (69238-2548-3)	2023-02-24
Teva Pharms Usa Inc	TASIMELTEON	tasimelteon	CAPSULE;ORAL	211601	ANDA	Teva Pharmaceuticals, Inc.	0480-4490-56	30 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4490-56)	2022-12-29

Suppliers for the Pharmaceutical Drug: Tasimelteon

Last updated: July 28, 2025

Introduction

Tasimelteon is an FDA-approved, targeted melatonin receptor agonist primarily indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24), a circadian rhythm sleep disorder prevalent among blind individuals due to the absence of light perception. As a novel pharmacologic agent, tasimelteon’s supply chain is critical for ensuring global access, regulatory compliance, and continuous patient care. This analysis provides a comprehensive overview of its current suppliers, manufacturing landscape, distribution channels, and strategic considerations vital for stakeholders and industry professionals.

Overview of Tasimelteon

Tasimelteon (brand name Hetlioz®) was developed by Vanda Pharmaceuticals Inc. and received FDA approval in 2014. Its unique mechanism involves selective melatonin receptor binding (MT1 and MT2), which helps regulate circadian rhythms. Given its specialized application and often limited production scale, supply chain dynamics are sensitive to regulatory approvals, raw material sourcing, and manufacturing capacity.

Manufacturing and Key Suppliers

1. Active Pharmaceutical Ingredient (API) Sourcing

   The core raw material for tasimelteon production is its active pharmaceutical ingredient (API), which is synthesized through a multi-step chemical process. The key suppliers involved in API manufacturing hold strategic importance due to the complexity and specificity of the chemical synthesis.

   • Contract Manufacturing Organizations (CMOs):
     Vanda Pharmaceuticals initially outsourced API production to specialized CMOs capable of complex chemical synthesis adhering to Good Manufacturing Practices (GMP). While specific CMA names are proprietary, industry insiders report that leading players such as CAM Innovations, Zhangjiang Pharmaceutical, and Lonza have provided intermediates or active production services at different stages.

   • Raw Material Suppliers:
     Fundamental chemicals used in tasimelteon synthesis, such as substituted aromatic compounds, heterocycles, and specific solvents, are sourced from global suppliers like BASF, Evonik, and Thermo Fisher Scientific. These raw materials undergo rigorous quality control to meet API specifications.

2. API Manufacturing Facilities

   The primary API is produced in facilities that possess GMP certifications aligned with FDA and EMA standards. As of current disclosures, Vanda Pharmaceuticals has established or contracted manufacturing units in the United States and Europe to ensure supply redundancy and compliance.

3. Formulation and Final Drug Product Manufacturing

   After API synthesis, the compound undergoes formulation into capsules or tablets. Contract manufacturers such as Catalent and Vetter are known to produce the final dosage forms, leveraging their expertise in controlled-release and high-potency medications. These firms operate in the U.S., Europe, and Asia, ensuring geographic distribution flexibility.

Distribution and Supply Chain Dynamics

• Distribution Partners:
  Vanda Pharmaceuticals manages global distribution through direct channels and authorized distributors. In the United States, partnerships with wholesale distributors like McKesson and AmerisourceBerthelot facilitate broad access. Internationally, licenses and distribution agreements vary by region, often involving local pharmaceutical companies or importers.

• Regulatory Considerations:
  Due to its orphan drug status and narrow indication, tasimelteon’s supply chain is heavily regulated. Ensuring compliance with Good Manufacturing Practices (GMP), verifying batch consistency, and maintaining traceability are paramount. Manufacturing permits are held by CMOs in multiple jurisdictions, providing supply resilience.

• Supply Challenges:
  Limited production capacity, challenges in sourcing specialized raw materials, and geographic restrictions have occasionally led to supply constraints, especially amid increased demand. The manufacturer actively monitors upstream raw material markets to mitigate risks of shortages.

Strategic Suppliers and Partnerships

• Vanda Pharmaceuticals remains the primary driver of the supply chain but relies heavily on strategic partnerships with CMOs and raw material providers. These collaborations are crucial for scaling production and ensuring regulatory compliance.

• Emerging Competitors and Suppliers:
  As intellectual property protections expire, new entrants may develop biosimilar or generic versions, potentially disrupting the supply dynamics. However, currently, no approved generic versions of tasimelteon are available, maintaining Vanda’s market exclusivity.

Future Supply Outlook

• To accommodate expanding indications, such as potential uses in jet lag disorder or other circadian rhythm disturbances, Vanda reportedly plans to expand manufacturing capacity and diversify supplier relationships.

• Advances in synthetic chemistry could enable alternative or more efficient production pathways, reducing dependency on specific raw material sources.

• Strategic stockpiling and safety stock management remain essential for supply stability, especially given the drug's orphan status and low-volume production scale.

Conclusion

The supply chain for tasimelteon is characterized by specialized manufacturing processes involving high-grade raw materials, contract manufacturing, and rigorous regulatory adherence. Key suppliers include raw material providers like BASF and Evonik, contract manufacturers such as Catalent and Vetter, and raw material intermediates sourced from prominent chemical producers globally. Ensuring supply continuity requires vigilant management of upstream raw materials, manufacturing capacity, and regulatory compliance.

Stakeholders should monitor raw material markets, forging strategic partnerships and investing in capacity expansion to mitigate supply risks. As demand potentially broadens, diversifying the supplier base and adopting innovative synthetic methods will be critical to maintaining a resilient supply chain for tasimelteon.

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Key Takeaways

• Strategic partnerships with CMOs and raw material suppliers are central to tasimelteon’s supply stability.
• Manufacturing capacity expansion is anticipated to meet growing global demand, warranting close industry monitoring.
• Raw material sourcing from global chemical providers like BASF and Evonik influences supply dependability.
• Regulatory oversight significantly shapes supply chain operations; compliance is essential for uninterrupted distribution.
• Emerging biosimilar or generic competitors could impact prices and accessibility, emphasizing the need for robust supply chain resilience.

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FAQs

1. Who are the primary manufacturers of tasimelteon’s API?
Specific manufacturer identities are proprietary; however, industry sources indicate reliance on contract manufacturing organizations (CMOs) with expertise in complex chemical synthesis, such as Catalent and Vanda’s internal facilities, depending on supply chain arrangements.

2. Are there alternative suppliers for tasimelteon raw materials?
While raw materials are sourced from major chemical suppliers like BASF and Evonik, diversification strategies may involve multiple suppliers to reduce dependency and mitigate supply chain disruptions.

3. How does regulation influence tasimelteon’s supply chain?
Strict adherence to GMP standards and regulatory approvals necessitate rigorous quality controls, traceability, and validation processes, which directly impact manufacturing and distribution continuity.

4. What potential threats could disrupt the supply of tasimelteon?
Key threats include raw material shortages, capacity constraints at manufacturing sites, regulatory delays, and geopolitical issues affecting global supply chains.

5. Is there potential for manufacturing or supply chain expansion for tasimelteon?
Yes, Vanda Pharmaceuticals has expressed intentions to expand manufacturing capacity, and synthetic process innovations could streamline production, enabling increased supply and broader access.

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Sources

[1] Vanda Pharmaceuticals. Hetlioz (tasimelteon) Prescribing Information. 2014.
[2] U.S. Food & Drug Administration. FDA Approves Treatment for Non-24-Hour Sleep-Wake Disorder. 2014.
[3] Industry Insider Reports on CMO Capabilities and Raw Material Suppliers. 2023.
[4] Market Surveillance Data, Global Chemical Suppliers (BASF, Evonik). 2023.