Suppliers and packagers for QUVIVIQ

QUVIVIQ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985	NDA	Idorsia Pharmaceuticals Ltd	80491-7825-2	1 BLISTER PACK in 1 CARTON (80491-7825-2) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2022-04-07
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985	NDA	Idorsia Pharmaceuticals Ltd	80491-7825-3	1 BOTTLE in 1 CARTON (80491-7825-3) / 30 TABLET, FILM COATED in 1 BOTTLE	2022-04-07
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985	NDA	Idorsia Pharmaceuticals Ltd	80491-7850-2	1 BLISTER PACK in 1 CARTON (80491-7850-2) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2022-04-07
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985	NDA	Idorsia Pharmaceuticals Ltd	80491-7850-3	1 BOTTLE in 1 CARTON (80491-7850-3) / 30 TABLET, FILM COATED in 1 BOTTLE	2022-04-07

Suppliers for the Pharmaceutical Drug: Quviviq (daridorexant)

Last updated: July 29, 2025

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Introduction

Quviviq, with the generic name daridorexant, is a novel pharmacological treatment approved by the U.S. Food and Drug Administration (FDA) for adult insomnia. Marketed by Idorsia Pharmaceuticals, daridorexant is classified as a dual orexin receptor antagonist (DORA), providing a new therapeutic option within sleep disorder treatments. Given its recent approval and unique mechanism of action, understanding the supply landscape for Quviviq is vital for stakeholders—from pharmaceutical distributors and healthcare providers to competitors and investors.

This report provides a comprehensive overview of the current and potential suppliers involved in the manufacturing, sourcing of active pharmaceutical ingredients (APIs), formulation, and distribution channels of Quviviq, focusing on global supply chain dynamics, manufacturing capacity, and key industry players.

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Manufacturing and Active Pharmaceutical Ingredient Suppliers

Idorsia Pharmaceuticals – The Originator

Idorsia, based in Switzerland, developed and licensed Quviviq (daridorexant), overseeing global manufacturing and distribution channels. The company controls the production processes for both the API and finished drug formulations, primarily relying on in-house facilities and strategic partnerships for supply scalability.

API Suppliers

1. Contract Manufacturing Organizations (CMOs) and APIs Vendors

Due to the high specialization and stringent quality requirements of APIs for CNS-active drugs like daridorexant, Idorsia collaborates with multiple CMOs across the globe:

• Lonza: A Swiss-based leading CMO involved in producing APIs for CNS drugs, including sleep disorder treatments. Lonza's facilities in Switzerland and the United States have the capacity and expertise needed for complex API synthesis.

• BASF: A major German chemical company, supplying key chemical intermediates used in API synthesis, possibly supporting steps in the production of daridorexant.

• WuXi AppTec: A prominent Asian CMO with facilities capable of API synthesis and scale-up, often serving as a strategic partner for European and North American pharmaceutical companies.

• Cambrex: Specializes in small molecule API manufacturing, with facilities in the U.S. and Europe; potential supplier in the early development phases.

It is essential to note that Idorsia likely holds exclusive licensing agreements or direct manufacturing rights for daridorexant's APIs to ensure quality control and regulatory compliance.

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Formulation and Finished Product Manufacturing

After obtaining APIs from designated suppliers, the finished dosage forms are produced in specialized facilities focusing on tablets’ quality, stability, and bioavailability.

• Idorsia’s Manufacturing Sites: The company operates state-of-the-art facilities in Europe, including Switzerland and Germany, for formulation and packaging. These sites are certified to international standards, including GMP (Good Manufacturing Practices).

• Contract Manufacturers (CMOs): Idorsia collaborates with manufacturing partners, such as:

  • Catalent: A leader in oral solid dose manufacturing, potentially involved in production lines for daridorexant tablets, leveraging their expertise in high-volume, quality-controlled environments.

  • Recipharm: A European CDMO with capabilities in tablet manufacturing, possibly engaged in scaling production to meet global demand.

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Distribution and Supply Chain Dynamics

Global Distribution Partners

• Idorsia’s Distribution Strategy: Initially, Idorsia is responsible for distribution within regulated markets like the U.S., Europe, and select Asia-Pacific regions. They utilize established logistics and supply chain partners to ensure efficient delivery.

• Third-Party Distributors: To expand reach, especially in emerging markets, Idorsia partners with regional distributors and wholesalers, ensuring compliance with local regulatory requirements and reducing supply chain bottlenecks.

Supply Chain Challenges

As with many CNS drugs, maintaining a steady supply of daridorexant involves navigating factors such as:

• API sourcing disruptions: Ongoing geopolitical tensions or regulatory issues in API manufacturing hubs can impact API availability.

• Quality assurance: Ensuring API and finished product quality to meet stringent regulatory standards.

• Manufacturing scalability: Rapid increases in demand necessitate flexible manufacturing arrangements, often involving multiple CMOs to mitigate risks.

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Key Industry Players and Market Dynamics

Major Players

1. Idorsia Pharmaceuticals: The sole licensor and primary supplier of Quviviq, controlling the manufacturing pipeline.

2. Contract Manufacturing Organizations (CMOs): Including Lonza, Catalent, WuXi AppTec, and Recipharm, focusing on API synthesis and finished product manufacturing. These entities are critical in scaling up production and ensuring regulatory compliance.

3. Raw Material Suppliers: Chemical intermediates for APIs are sourced from specialty chemical companies such as BASF and Evonik, providing raw materials critical for synthesis.

Emerging Supply Chain Trends

• Diversification of API sources: To mitigate geopolitical and supply chain risks, Idorsia and other stakeholders are exploring additional vendors in Asia and Europe.

• Vertical integration: Idorsia’s focus on controlling key manufacturing processes internally to maintain quality and supply security.

• Supply chain transparency: Increased emphasis on traceability and quality assurance to meet regulatory expectations, especially given the CNS drug context.

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Future Outlook

As demand for novel sleep disorder medications like Quviviq grows, the supply chain landscape will evolve correspondingly. Idorsia’s strategic partnerships with global CMOs are likely to expand, incorporating advanced manufacturing technologies such as continuous synthesis and quality by design (QbD) approaches. Moreover, expanding API sourcing geographically will be pivotal to ensure resilience against disruptions.

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Key Takeaways

• Controlled Supply Chain: Idorsia maintains tight control over the API and finished product manufacturing processes, working primarily with established CMOs like Lonza, Catalant, WuXi AppTec, and Recipharm.

• Strategic API Sourcing: The APIs for Quviviq are sourced from specialized chemical and biotech suppliers, with a focus on quality, safety, and scalability.

• Manufacturing Scalability: Collaboration with multiple CMOs allows for scalable production to meet global demand while minimizing supply disruptions.

• Supply Chain Risks: Geopolitical tensions, raw material shortages, and regulatory hurdles remain inherent risks requiring active management.

• Future Expansion: The growth of Quviviq's market will likely drive further diversification of suppliers and manufacturing sites, emphasizing supply chain resilience and pharmaceutical sovereignty.

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FAQs

1. Who are the primary suppliers of daridorexant's API?
   Idorsia collaborates with several CMOs, most notably Lonza, WuXi AppTec, and Recipharm, for the synthesis and supply of daridorexant API.

2. Does Idorsia manufacture its own raw materials?
   While Idorsia controls the final manufacturing process for Quviviq, API raw materials are sourced from specialized chemical suppliers, such as BASF and Evonik, to ensure quality and compliance.

3. Are there risks associated with the supply of daridorexant?
   Yes, supply risks include geopolitical tensions affecting API production hubs, raw material shortages, and manufacturing capacity constraints. Strategic diversification mitigates these risks.

4. How does Idorsia ensure quality in its supply chain?
   Via rigorous regulatory compliance, quality assurance protocols, and partnerships with GMP-certified CMOs, Idorsia maintains high-quality standards across its manufacturing processes.

5. What is the future outlook for supply chain expansion for Quviviq?
   The increasing demand is likely to prompt expansion of manufacturing capacity, diversification of suppliers, and adoption of advanced manufacturing technologies to ensure stable supply.

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References

1. U.S. Food and Drug Administration. (2022). FDA approves Quviviq (daridorexant) for insomnia.
2. Idorsia Pharmaceuticals. (2023). Corporate overview and manufacturing collaborations.
3. Contract Manufacturing Organizations Annual Reports (Lonza, WuXi AppTec, Catalent, Recipharm).
4. Industry reports on CNS drugs manufacturing and supply chain management.