DARIDOREXANT HYDROCHLORIDE bulk active fine chemical suppliers

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ChemShuttle	⤷ Get Started Free	(S)-(2-(5-chloro-4-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone hydrochloride	⤷ Get Started Free
Starshine Chemical	⤷ Get Started Free	2023-05-5H07946	⤷ Get Started Free
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Last updated: July 27, 2025

Introduction

Daridorexant hydrochloride (HYDROCHLORIDE) stands as a novel orexin receptor antagonist utilized primarily in the treatment of insomnia. With the pharmacological campaign focused on enhancing pharmacokinetic profiles and minimizing side effects, companies seek reliable, high-quality bulk API sources to support manufacturing, commercialization, and regulatory compliance. This article examines the global supply landscape, key manufacturers, sourcing considerations, and emerging trends related to daridorexant hydrochloride.

Overview of Daridorexant Hydrochloride

Daridorexant, marketed under the brand name QUVIVIQ by Idorsia Pharmaceuticals, was approved by the FDA in 2022 as a treatment for insomnia characterized by difficulty in sleep onset and maintenance [1]. Its mechanism involves selectively antagonizing orexin 1 and 2 receptors, central to promoting sleep. The API's synthesis involves intricate chemical pathways, demanding high-purity raw materials and rigorous manufacturing controls.

Global API Manufacturing Landscape

The sourcing of daridorexant hydrochloride API predominantly involves a select group of global pharmaceutical chemical manufacturers specializing in complex small-molecule APIs. The supply chain for daridorexant is characterized by a restricted roster of APIs manufacturers due to the compound's synthetic complexity, regulatory hurdles, and quality standards.

Key Manufacturers

Idorsia Pharmaceuticals: As the originator of daridorexant, Idorsia oversees the development and initial supply chain. It maintains strategic partnerships with API manufacturers to secure quality and supply continuity.
Contract Manufacturing Organizations (CMOs): Several CMOs globally, including WuXi STA, Jubilant Life Sciences, and Hikal Ltd., are known for their capabilities in complex API synthesis, potentially serving as sources for daridorexant hydrochloride.
Specialist API Suppliers: Niche chemical suppliers such as Carbosynth and Alfa Aesar may offer advanced intermediates and custom synthesis services to support or supplement supply chains.

Commodity vs. Specialized API Sources

Given the novelty and specificity of daridorexant hydrochloride, most sources are specialized, with production often limited to manufacturing facilities compliant with Good Manufacturing Practices (GMP) and possessing essential regulatory certifications.

Sourcing Criteria for Daridorexant Hydrochloride API

1. Regulatory Compliance:
Suppliers must have current GMP certification and be registered with regulatory authorities such as the FDA, EMA, or PMDA [2].

2. Quality Assurance:
High purity (>99%), low residual solvents, and rigorous batch-to-batch consistency are non-negotiable parameters.

3. Capacity & Supply Stability:
Long-term supply commitments are vital considering manufacturing scale-up and market demand.

4. Proven Synthesis & Intellectual Property (IP):
Manufacturers with transparent synthesis pathways and clear IP rights mitigate compliance risks.

5. Price & Lead Time:
A balance between competitive pricing and reliable delivery timelines influences sourcing decisions significantly.

Emerging Trends and Challenges

Supply Chain Consolidation:
In light of recent global disruptions, pharma companies prioritize diversified supply chains. However, the limited number of high-quality API producers for daridorexant hydrochloride constrains this approach.

Synthetic Process Optimization:
Innovations in synthetic routes aim to reduce costs and improve yield, potentially expanding the global manufacturing base.

Regulatory Harmonization:
As regulatory agencies develop more specific standards for complex APIs, suppliers investing in robust quality systems will increasingly dominate the market.

Environmental and Sustainability Considerations:
Suppliers adopting green chemistry principles are gaining favor, aligning with broader pharma sustainability initiatives.

Sourcing Strategies for Stakeholders

Manufacturers: Establish long-term relationships with trusted API producers equipped with GMP facilities and regulatory credibility.
Pharmaceutical Developers: Conduct thorough due diligence, including audits and validation studies, before onboarding new suppliers.
Distributors & Importers: Verify supplier certifications, assess supply chain transparency, and ensure compliance with regional regulatory standards.

Future Outlook

The API sourcing landscape for daridorexant hydrochloride will evolve as demand increases post-market approval and commercialization. Equities in supply pipelines hinge upon collaborations with CMOs and possibly new entrants leveraging process innovation. Additionally, regulatory pathways advocating for generic inclusion may stimulate the emergence of additional sources.

Key Considerations for Effective API Sourcing

Validate supplier GMP compliance.
Prioritize suppliers with proven analytical and QA capabilities.
Assess supply chain resilience and capacity.
Negotiate flexible terms accommodating regulatory changes.
Monitor ongoing developments in synthetic methodologies.

Conclusion

The supply chain for daridorexant hydrochloride API remains relatively consolidated, with leading manufacturers primarily based in North America, Europe, and Asia. Stakeholders must evaluate quality, regulatory compliance, and capacity to ensure uninterrupted supply of this high-value API. As the market matures, increasing competition might foster expanded sources, but current sourcing strategies should emphasize supplier qualification, risk mitigation, and adherence to evolving regulatory standards.

Key Takeaways

Daridorexant hydrochloride API is produced by a limited number of specialized manufacturers due to its synthetic complexity.
Ensuring regulatory compliance, high quality, and supply stability is vital when sourcing the API.
Strategic partnerships with reliable CMOs are crucial for mitigating supply chain risks.
Innovations in synthesis and manufacturing processes will influence future availability and competition.
Due diligence and rigorous supplier qualification underpin effective sourcing strategies.

FAQs

What are the primary regions manufacturing daridorexant hydrochloride API?
Major manufacturing hubs include North America, Europe, and Asia, notably China and India, which house several GMP-certified API producers.
How does the synthesis complexity impact API sourcing?
The intricate synthetic pathways and purity requirements restrict the pool of capable manufacturers, often leading to reliance on a few specialized suppliers.
Are there alternatives to traditional API suppliers for daridorexant?
Yes, emerging suppliers employing process innovations or custom synthesis services may offer alternative sources, provided they meet stringent quality and regulatory standards.
What regulatory considerations influence API sourcing?
Suppliers must possess current GMP certification, and APIs must adhere to pharmacopoeial standards, with comprehensive documentation for regulatory submissions.
How might market demand influence future API sourcing options?
Growing demand and regulatory approvals could prompt new entrants into the market, expanding available sources and fostering competition.

References

[1] FDA. (2022). FDA approves QUVIVIQ (daridorexant) for insomnia.
[2] European Medicines Agency. (2022). Guidelines on active substance manufacturing.

Bulk Pharmaceutical API Sources for daridorexant hydrochloride