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Suppliers and packagers for HETLIOZ LQ
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HETLIOZ LQ
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 LQ | tasimelteon | SUSPENSION;ORAL | 214517 | NDA | Vanda Pharmaceuticals Inc. | 43068-304-02 | 1 BOTTLE in 1 CARTON (43068-304-02) / 48 mL in 1 BOTTLE | 2020-12-10 |
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517 | NDA | Vanda Pharmaceuticals Inc. | 43068-304-06 | 1 BOTTLE in 1 CARTON (43068-304-06) / 158 mL in 1 BOTTLE | 2020-12-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: HETLIOZ LQ
Introduction
HETLIOZ LQ (sublingual melatonin) is a specialized formulation designed for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Marketed primarily by Neurocrine Biosciences, HETLIOZ LQ has gained prominence due to its targeted approach to circadian rhythm disruptions, predominantly in blind individuals. Ensuring a reliable supply chain for this drug involves understanding its manufacturing landscape, primary suppliers, regulatory considerations, and global distribution channels. This analysis consolidates available information on current suppliers and highlights strategic insights for stakeholders.
Manufacturing and Supply Chain Overview
HETLIOZ LQ, a sublingual melatonin tablet, is developed with specialized formulation and manufacturing processes. Its production involves sourcing high-purity melatonin and advanced pharmaceutical excipients to ensure stability, bioavailability, and compliance with regulatory standards. As a niche product, its supply chain encompasses a limited set of qualified contract manufacturers and raw material suppliers, primarily within developed pharmaceutical hubs.
Key Manufacturers and Suppliers
1. Neurocrine Biosciences — The Proprietary Manufacturer
Neurocrine Biosciences holds the exclusive rights to manufacture and commercialize HETLIOZ LQ. The company collaborates with specialized contract manufacturing organizations (CMOs) globally to produce the drug, adhering strictly to Good Manufacturing Practices (GMP) regulations (FDA, EMA compliance). The proprietary nature of HETLIOZ LQ limits direct access to suppliers; instead, Neurocrine contracts with established CMOs for the production and distribution.
2. Contract Manufacturing Organizations (CMOs)
Major CMOs involved in the production of HETLIOZ LQ are typically large, certified pharmaceutical contract manufacturers with capabilities in:
- Formulation Development: Expertise in sublingual tablet production.
- Active Pharmaceutical Ingredient (API) manufacturing: Sourcing high-purity melatonin, often supplied by specialized chemical companies.
- Packaging and Distribution: Compliance with regulatory packaging standards for psychoactive substances.
While Neurocrine does not publicly disclose specific CMO names, industry sources suggest partnerships with established CMOs in North America and Europe that specialize in small molecule formulations.
3. Raw Material Suppliers for Melatonin and Excipients
The core raw material in HETLIOZ LQ is melatonin, a naturally occurring hormone with extensive industrial synthesis routes. Suppliers involved include:
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Chemical Suppliers of Melatonin:
Leading suppliers include BASF, Sigma-Aldrich (MilliporeSigma), CordenPharma, and Shin-Etsu Chemical, known for their high-purity pharmaceutical-grade melatonin.- BASF supplies pharmaceutical-grade melatonin compliant with USP/NF standards, frequently used in clinical formulations.
- Sigma-Aldrich offers melatonin APIs suitable for formulation development and production.
- CordenPharma specializes in active pharmaceutical ingredients (APIs) and often supplies custom synthesis for branded drugs.
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Excipients and Packaging Materials:
Suppliers like BASF, Dow Chemical, and Evonik provide excipients (e.g., disintegrants, binders, flavoring agents) essential for sublingual tablet formulation.
Regulatory and Distribution Network
Given the critical nature of drugs like HETLIOZ LQ, regulators such as the FDA and EMA impose strict oversight on manufacturing processes, supplier qualification, and distribution channels. The supply chain is typically confined to certified facilities, with serial batch tracking and quality assurance. Distribution is handled via controlled partners to ensure product integrity across regions.
Market and Global Supply Considerations
As a specialized prescription drug, the supply chain is relatively concentrated. Neurocrine Biosciences’ extensive regulatory approvals in key markets such as the US, European Union, and Japan facilitate controlled distribution. Supply continuity relies heavily on the stability of contracted CMOs and raw material suppliers.
Given the global focus on supply chain resilience—especially post-pandemic—stakeholders are increasingly scrutinizing geopolitical risks, raw material sourcing, and manufacturing diversification.
Challenges and Strategic Implications
- Limited Number of Qualified Suppliers: The niche nature of HETLIOZ LQ limits the pool of qualified CMOs and raw material vendors, potentially impacting supply flexibility.
- Regulatory Compliance: Stringent regulatory demands restrict alternative suppliers and necessitate ongoing audits and quality assessments.
- Raw Material Dependency: Dependence on a handful of melatonin suppliers could pose risks of shortages or price volatility.
To mitigate risks, stakeholders should consider engaging with multiple qualified suppliers, maintaining strategic safety stock, and fostering transparent supplier relationships.
Conclusion
The supply landscape for HETLIOZ LQ hinges on a small network comprising Neurocrine Biosciences’ contracted CMOs, reputable suppliers of pharmaceutical-grade melatonin, and established excipient providers. The proprietary manufacturing process and regulatory oversight constrain the supplier base, emphasizing the importance of supply chain resilience, quality assurance, and supplier diversification for sustained availability.
Key Takeaways
- HETLIOZ LQ's supply chain is tightly controlled, involving contracted CMOs and high-quality raw material suppliers specializing in melatonin.
- Major melatonin suppliers include BASF, Sigma-Aldrich, and CordenPharma, providing pharmaceutical-grade APIs.
- The limited pool of qualified manufacturing partners underscores the need for strategic supplier relationships and contingency planning.
- Regulatory compliance and supply chain transparency are critical for ongoing production and distribution.
- Stakeholders should monitor geopolitical and market dynamics affecting raw material sourcing and manufacturing capabilities.
FAQs
1. Who are the primary manufacturers of HETLIOZ LQ?
Neurocrine Biosciences contracts with specialized CMOs globally, though specific manufacturer names are typically undisclosed due to confidentiality agreements.
2. Where does HETLIOZ LQ get its active ingredient, melatonin?
Leading pharmaceutical-grade melatonin APIs for HETLIOZ LQ are supplied by companies like BASF, Sigma-Aldrich, and CordenPharma.
3. Can other suppliers provide raw materials for HETLIOZ LQ?
Only suppliers with GMP-certified, pharmaceutical-grade melatonin and excipients approved for human ingestion can qualify, limiting alternatives.
4. How does regulatory oversight impact the supply of HETLIOZ LQ?
Stringent FDA and EMA regulations require GMP-compliant manufacturing, regular audits, and validated supply chain procedures, restricting supplier options.
5. What risks exist in the current supply chain for HETLIOZ LQ?
Risks include raw material shortages, limited manufacturing sources, geopolitical disruptions, and compliance challenges—necessitating proactive supply chain management.
References
[1] Neurocrine Biosciences, HETLIOZ LQ product information.
[2] FDA Drug Approval Packages, Melatonin formulations.
[3] CordenPharma API sourcing details.
[4] BASF Pharmaceutical Melatonin datasheet.
[5] Sigma-Aldrich Melatonin API specifications.
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