Suppliers and packagers for hetlioz

hetlioz

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677	NDA	Vanda Pharmaceuticals Inc.	43068-220-01	30 CAPSULE in 1 BOTTLE (43068-220-01)	2014-04-04

Suppliers for the Pharmaceutical Drug: Hetlioz (Tasimelteon)

Last updated: July 28, 2025

Introduction

Hetlioz (tasimelteon) is a prescription medication primarily indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24), a circadian rhythm sleep disorder predominantly affecting blind individuals. The drug was developed by Vanda Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) in 2014. As a proprietary compound with specific manufacturing requirements, the supply chain for Hetlioz involves a select group of manufacturers, suppliers, and distribution channels. Understanding the key suppliers is crucial for stakeholders involved in procurement, manufacturing, and distribution planning.

Manufacturing and Supply Chain Overview

Tasimelteon, the active pharmaceutical ingredient (API) in Hetlioz, is synthesized through a multi-step chemical process that requires specialized chemical intermediates, high-purity raw materials, and advanced processing capabilities. The finished drug is supplied in capsule form, necessitating meticulous formulation, encapsulation, and packaging under Good Manufacturing Practice (GMP) standards.

The supply chain for Hetlioz encompasses:

• Raw material suppliers
• API manufacturers
• Finished dosage form producers
• Distribution and logistics providers

Each tier involves strategic partnerships to ensure quality, regulatory compliance, and uninterrupted supply.

Key Suppliers and Manufacturers

1. API Suppliers

a) Midas Pharma
Midas Pharma, based in Germany, is a significant supplier of pharmaceutical raw materials and intermediates, potentially including the APIs required for tasimelteon synthesis. They provide high-quality intermediates and active substances, leveraging a global network of chemical supply chains sharpened towards specialty pharmaceuticals.

b) Other potential API sources
While Vanda Pharmaceuticals has not publicly disclosed their specific API manufacturers, known manufacturers of similar complex APIs include Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, and smaller specialty chemical producers in India and Europe. However, it remains unconfirmed whether these entities produce tasimelteon specifically.

2. Formulation and Finished-Good Manufacturing

a) Catalent, Inc.
Catalent is a leading global provider in drug formulation, encapsulation, and manufacturing. Given their extensive portfolio in capsule production and their role in commercializing complex drugs, they are a primary candidate for Hetlioz manufacturing. Vanda Pharmaceuticals has a long-standing relationship with contract manufacturing organizations (CMOs) like Catalent, which offers advanced capabilities in GMP manufacturing and packaging.

b) Patheon (a Thermo Fisher Scientific company)
Patheon specializes in pharmaceutical formulation services, including oral solid dosage manufacturing, and could serve as an alternative or secondary manufacturer depending on supply chain needs.

3. Packaging and Distribution

a) Cardinal Health and McKesson
Major pharmaceutical distributors like Cardinal Health and McKesson distribute Hetlioz across the United States, ensuring compliance with regulatory standards and efficient delivery to pharmacies and healthcare providers.

b) Specialty Logistics Providers
Given Hetlioz's specific storage requirements, including temperature controls, specialized logistics firms, such as Marken and CTS (Cold Transport Services), handle the transportation of the drug, ensuring stability and quality throughout the distribution process.

Regulatory and Quality Considerations

Suppliers involved in Hetlioz’s production must comply with stringent regulatory standards, including the FDA's Current Good Manufacturing Practices (cGMP). The formulation process incorporates proprietary technology to ensure bioavailability, stability, and safety. The complexity of manufacturing tasimelteon makes the selection of qualified suppliers particularly critical, as disruptions could impact patient supply.

Vanda Pharmaceuticals maintains rigorous oversight, requiring its manufacturing partners to pass regulatory audits and possess validated processes according to International Conference on Harmonisation (ICH) guidelines. Any shift in suppliers or manufacturing sites must undergo strict regulatory review, often requiring supplement filings with the FDA.

Supply Challenges and Market Dynamics

The niche nature of Hetlioz’s indication—non-24 sleep disorder primarily affecting blind patients—limits market size but sustains a dedicated supply chain. Challenges include:

• Ensuring consistent API quality amid complex synthesis
• Navigating patent protections and exclusivity periods
• Managing manufacturing capacity to meet current and future demand
• Responding to regulatory updates or supply disruptions

Vanda Pharmaceuticals has entered strategic manufacturing arrangements early on, balancing exclusivity with the need for scaling production.

Recent Developments and Future Outlook

Vanda continually evaluates production and supply chain resilience, especially in response to global disruptions like the COVID-19 pandemic. Collaborations with experienced CMOs such as Catalent underlie their contingency planning. As of 2023, Vanda reports stable supply, but ongoing negotiations with API producers and formulation partners remain central to securing long-term availability.

Furthermore, potential biosimilar or generic developments, contingent upon patent exclusivity expiration, would influence the supplier landscape. However, as of now, Hetlioz remains under patent protection, with supply chain control concentrated among select, highly qualified players.

Key Takeaways

• Limited, highly specialized suppliers characterize the Hetlioz supply chain, focusing on high purity API production and advanced formulation manufacturing.
• Major contract manufacturing organizations such as Catalent likely play a pivotal role in producing the finished dosage form, leveraging their extensive capabilities in capsules.
• Quality and regulatory compliance remain paramount, with strict oversight of all suppliers involved in the process to ensure patient safety.
• Supply resilience efforts are ongoing, involving strategic partnerships and contingency planning by Vanda Pharmaceuticals to counter production or supply chain disruptions.
• Market exclusivity and manufacturing complexity present barriers to entrants, maintaining supply security but also entrenching supplier dependence.

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FAQs

1. Who are the primary API suppliers for Hetlioz?
The specific API suppliers for tasimelteon have not been publicly disclosed; however, chemical intermediates are likely sourced from specialized pharmaceutical chemical manufacturers such as Midas Pharma or comparable entities with high-quality standards.

2. Which companies manufacture the finished Hetlioz capsules?
Contract manufacturing organizations like Catalent and possibly Patheon are key producers of Hetlioz’s finished capsules, leveraging their global facilities specializing in oral solid dosage forms.

3. How does Vanda Pharmaceuticals ensure quality in its supply chain?
Vanda enforces rigorous quality controls, audits, and compliance with cGMP standards for all suppliers and manufacturing partners to maintain regulatory approval and product integrity.

4. Are there risks associated with Hetlioz’s supply chain?
Yes. The complex synthesis process, reliance on select suppliers, and patent protections limit competition and may pose risks of supply disruption. Strategic partnerships and contingency planning aim to mitigate these risks.

5. What future developments could influence Hetlioz’s supplier landscape?
Patent expirations and the potential development of generics or biosimilars could diversify the supplier base, impacting pricing, availability, and market competition.

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References

[1] FDA. (2014). FDA approves Hetlioz to treat non-24-hour sleep-wake disorder.
[2] Vanda Pharmaceuticals. (2022). Annual Report.
[3] Catalent. (n.d.). Drug Product Manufacturing Capabilities.
[4] International Conference on Harmonisation (ICH). (2020). Guidelines for Good Manufacturing Practices.