Bulk Pharmaceutical API Sources for HETLIOZ LQ

Bulk Pharmaceutical API Sources for HETLIOZ LQ

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-6143
ChemMol		30112311
ChemMol		49404654
ACT Chemical		ACT06729

Bulk Active Pharmaceutical Ingredient (API) Sources for: HETLIOZ LQ

Last updated: July 30, 2025

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Introduction

HETLIOZ LQ (tasimelteon) is a targeted therapeutic agent approved by the U.S. Food and Drug Administration (FDA) primarily to treat non-24-hour sleep-wake disorder, especially in blind individuals. As a critical compound in the pharmacological management of circadian rhythm disorders, the procurement of high-quality bulk Active Pharmaceutical Ingredient (API) is fundamental to ensuring product efficacy, safety, and regulatory compliance. This analysis provides a comprehensive overview of the leading sources for bulk tasimelteon APIs, addressing quality standards, global manufacturing capacities, and key suppliers.

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Overview of Tasimelteon API Manufacturing

Tasimelteon is a selective melatonin receptor agonist acting on MT1 and MT2 receptors, with unique synthetic pathways involving complex chemical synthesis and rigorous quality controls. The API's production process demands strict adherence to Good Manufacturing Practices (GMP), with suppliers primarily operating in regions with advanced pharmaceutical manufacturing infrastructure, such as North America, Europe, and Asia.

The sourcing of tasimelteon API is influenced by factors including regulatory compliance, supply chain stability, manufacturing capacity, and cost considerations. While brand-name manufacturing sources may be limited due to proprietary processes, multiple generic and contract manufacturing organizations (CMOs) now provide APIs that meet stringent quality standards.

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Key API Suppliers for HETLIOZ LQ

1. Vanda Pharmaceuticals and its Licensed Manufacturers

Vanda Pharmaceuticals, the originator of HETLIOZ (tasimelteon), controls the proprietary API synthesis and initial manufacturing processes. They collaborate with select GMP-certified contract manufacturers to ensure an uninterrupted supply chain for commercial or clinical use.

• Vanda's Role: They maintain strict oversight of the API synthesis, ensuring compliance with FDA regulations and establishing parameters for bulk API sourcing.
• Availability: Often, Vanda directly supplies bulk API to qualified CMO partners for formulation and distribution, particularly for clinical trials.

2. Contract Manufacturing Organizations (CMOs)

Several globally recognized CMOs are accredited suppliers of tasimelteon API, offering high-quality, GMP-compliant products:

• LGM Pharma: A prominent API distributor with extensive catalog offerings, including tasimelteon. They source APIs from multiple approved manufacturers, conducting rigorous testing to verify quality parameters aligned with USP, BP, or EP standards.

• Aurora Pharmaceuticals: An established CMO specializing in the manufacture of complex APIs, including circadian rhythm disorder drugs. They possess the necessary infrastructure for large-scale synthesis of tana-treated compounds such as tasimelteon.

• Fisher BioReagents: Known for delivering high-purity APIs, including unique or custom-synthesized compounds, with certifications ensuring GMP compliance and batch traceability.

• Cambrex Corporation: A global leader in small molecule APIs, with extensive capacity for complex compounds like tasimelteon, adhering to stringent quality standards suitable for clinical and commercial applications.

3. Regional API Suppliers

North American Suppliers:

• Patheon (Part of Thermo Fisher Scientific): Offers GMP manufacturing for APIs, potentially including tasimelteon, sourced from in-house or approved external manufacturers.

European Suppliers:

• Lonza: Well-established in custom API synthesis for CNS-active compounds, capable of producing tasimelteon at various scales per client specifications.

• Stelis Biopharma: India-based CDMO with manufacturing capabilities aligned with international regulatory standards, increasingly supplying high-cost APIs like tasimelteon.

Asian Suppliers:

• WuXi AppTec: Provides integrated API synthesis and manufacturing services in China, with GMP facilities that adhere to global standards. They have experience producing complex APIs, including CNS drugs.

• Hangzhou Huaao Pharmaceutical: An emerging manufacturer with capabilities in synthesizing melatonin analogs and related compounds.

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Quality and Regulatory Considerations

Sourcing APIs for HETLIOZ LQ demands rigorous quality assurance. Good Manufacturing Practices (GMP) certification ensures batch-to-batch consistency, purity, and compliance with pharmacopeial standards. Buyers should scrutinize:

• Certificate of Analysis (CoA): Confirm potency, purity (typically >99%), residual solvents, heavy metals, and endotoxin levels.
• Regulatory Approvals: Suppliers should possess transparent documentation for international certifications like FDA Drug Master Files (DMF), EMA, or other relevant authorities.
• Traceability: Ability of suppliers to provide detailed batch records, chemical characterization, and adherence to quality management systems.

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Supply Chain Dynamics

The global demand for CNS-active APIs like tasimelteon is growing, but supply chains face challenges including:

• Manufacturing Congestion: The complex synthetic pathways limit the number of authorized suppliers.
• Regulatory Barriers: Procurement often involves ongoing compliance checks with agencies like the FDA, EMA, or PMDA.
• Geopolitical Factors: Trade restrictions and tariffs can impact supplier accessibility and costs.

Mitigating these risks involves engaging multiple qualified sources, establishing long-term agreements, and regularly auditing manufacturing sites.

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Emerging Trends in API Sourcing

• Shift to Contract Manufacturing: Increased reliance on CMOs, particularly in India and China, has led to expanded capacities for complex APIs like tasimelteon.
• Quality Harmonization: Adoption of international standards (ICH Q7, Q9, and Q10) ensures consistent quality across suppliers.
• Supply Chain Transparency: Enhanced traceability through blockchain or digital tracking is increasingly employed to improve confidence in API sourcing.

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Conclusion

Securing high-quality bulk tasimelteon API necessary for HETLIOZ LQ involves a multi-faceted approach centered on regulatory compliance, manufacturing capacity, and supply chain robustness. Leading suppliers include the original manufacturer, Vanda Pharmaceuticals, alongside reputable CMOs such as LGM Pharma, Aurora Pharmaceuticals, and global CDMOs like Lonza and WuXi AppTec. Prospective buyers should emphasize due diligence, including verifying GMP certification, conducting chemical and microbiological testing, and establishing long-term partnerships to ensure consistent API supply for pharmaceutical needs.

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Key Takeaways

• Primary API sourcing for HETLIOZ LQ revolves around Vanda Pharmaceuticals’ licensed manufacturers and premier CMOs with GMP accreditation.
• Quality assurance hinges on rigorous CoA verification, adherence to international standards, and supplier transparency.
• Sourcing strategies must account for supply chain stability amid global manufacturing trends and regulatory landscapes.
• Emerging markets and CMOs are increasingly capable of producing complex APIs, including tasimelteon, at scale.
• Long-term vendor qualification, periodic auditing, and compliance monitoring are critical to maintaining reliable API supply for clinical and commercial production.

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FAQs

Q1. What are the main regions producing tasimelteon APIs?
A1. North America, Europe, and Asia (particularly India and China) are the primary regions with GMP-capable manufacturers producing tasimelteon APIs due to their advanced chemical synthesis capabilities and regulatory compliance infrastructure.

Q2. How can buyers verify the quality of tasimelteon API from suppliers?
A2. Buyers should review Certificates of Analysis, ensure GMP certification, request detailed batch records, and conduct independent testing for purity, potency, and residual impurities before procurement.

Q3. Are there multiple sources for tasimelteon API?
A3. Currently, the number of reliable sources is limited due to the complexity of synthesis and regulatory standards. Major suppliers include Vanda Pharmaceuticals’ licensed manufacturers and select CMOs with proven track records.

Q4. What challenges exist in sourcing tasimelteon API globally?
A4. Challenges include manufacturing capacity constraints, regulatory approvals, supply chain disruptions, geopolitical trade issues, and ensuring consistent quality across batches.

Q5. Is there potential for new suppliers to enter the market?
A5. Yes. As demand grows and manufacturing technologies advance, new qualified suppliers, especially in emerging markets with GMP facilities, are increasingly entering the market, enhancing supply diversity.

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Sources

[1] FDA Drug Approval Package for HETLIOZ, 2014.
[2] Vanda Pharmaceuticals Official Website.
[3] Contract Manufacturing Organization Capabilities in API Production, industry reports.
[4] International Pharmacopoeias (USP, EP, BP).
[5] Regulatory frameworks for API manufacturing standards (ICH Q7).