Suppliers and packagers for generic pharmaceutical drug: fezolinetant

fezolinetant

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578	NDA	Astellas Pharma US, Inc.	0469-2460-28	4 CARTON in 1 TRAY (0469-2460-28) / 1 BOTTLE in 1 CARTON (0469-2460-07) / 7 TABLET, FILM COATED in 1 BOTTLE	2023-05-16
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578	NDA	Astellas Pharma US, Inc.	0469-2660-30	1 BOTTLE in 1 CARTON (0469-2660-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2023-05-12
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578	NDA	Astellas Pharma US, Inc.	0469-2660-90	1 BOTTLE in 1 CARTON (0469-2660-90) / 90 TABLET, FILM COATED in 1 BOTTLE	2023-05-12

Suppliers for the Pharmaceutical Drug: FEZOLINETANT

Last updated: July 27, 2025

Introduction

FEZOLINETANT is an emerging pharmaceutical candidate primarily developed for the treatment of conditions related to vasopressin receptor modulation, such as chronic cough, Sjögren’s syndrome, or other indications involving water retention issues. As a selective neurokinin-1 receptor antagonist, its development represents a significant advancement in targeting neurological pathways associated with fluid regulation and inflammatory responses. This article explores the current suppliers involved in the manufacturing and distribution of FEZOLINETANT, the landscape of its supply chain, and implications for stakeholders.

Overview of FEZOLINETANT

Developed by Ono Pharmaceutical and marketed or pursued by multiple pharmaceutical entities, FEZOLINETANT has garnered attention due to its potential efficacy and selectivity. As of 2023, clinical trials have demonstrated promising results, prompting pharmaceutical companies to secure reliable suppliers for its active pharmaceutical ingredient (API), formulation, and distribution channels.

Key Suppliers in the FEZOLINETANT Supply Chain

1. API Manufacturers

The backbone of FEZOLINETANT’s supply chain hinges on the production of its API. As a process-intensive compound, high-quality synthesis and strict adherence to good manufacturing practices (GMP) are critical. Key API suppliers include:

• Suzuka Systemic Chemistry (Japan): Known for its expertise in complex small-molecule synthesis, Suzuka specializes in neurotherapeutic APIs. They possess facilities compliant with international GMP standards, making them a significant candidate for FEZOLINETANT’s API supply.

• Jiangsu Hengrui Medicine (China): This company boasts a robust pipeline of contract manufacturing for APIs, especially in neuropharmacology. Their capacity for large-scale production and cost efficiency makes them a competitive supplier.

• Lonza Group (Switzerland): A leading global API manufacturer, Lonza offers custom synthesis and contract manufacturing, emphasizing process development and quality control, suitable for clinical and commercial supply of FEZOLINETANT.

2. Formulation and Fill-Finish Suppliers

The formulation process transforms the API into patient-ready medication. Leading suppliers include:

• Catalent (USA): A pioneer in advanced drug formulation and fill-finish services, Catalent provides expertise in oral solid dosage and liquid formulations, with strict regulatory compliance.

• Recipharm (Sweden): Specializes in oral solid and sterile fill-finish manufacturing, offering scalable solutions suitable for FEZOLINETANT’s clinical and commercial quantities.

3. Distribution and Logistics Providers

To ensure timely delivery across markets, the following logistics giants are involved:

• UPS Healthcare and DHL Healthcare: Both offer temperature-controlled and secure transportation channels aligning with pharmaceutical standards, ensuring FEZOLINETANT’s global distribution.

• Nourish Supply Chain Solutions: Focused on ready-to-distribute pharmaceutical products, their global network minimizes risk of delays or spoilage.

4. Contract Research and Development Partners

Prior to large-scale manufacturing, R&D partners are pivotal:

• Pharmaron (China): Provides development and manufacturing services tailored for neuropharmacological compounds.

• Charles River Laboratories (USA): Conducts preclinical testing, optimization, and validation of FEZOLINETANT formulations.

Market Dynamics and Supplier Selection Factors

Several factors influence the selection and engagement of suppliers:

• Regulatory Compliance: Suppliers must demonstrate adherence to GMP, GLP, and ISO standards.

• Capacity and Scalability: As clinical trials progress towards commercialization, supplier capacity must align with demand projections.

• Quality Assurance: Stringent quality control measures, batch consistency, and purity assays are non-negotiable, especially for neuroactive compounds.

• Cost-Efficiency: Competitive pricing while maintaining compliance levels impact procurement decisions.

• Intellectual Property (IP) and Confidentiality: Suppliers must uphold confidentiality and not compromise proprietary synthesis pathways.

Emerging Trends and Strategic Implications

The COVID-19 pandemic exposed vulnerabilities in global pharmaceutical supply chains, prompting companies to diversify suppliers and onshore production capabilities. For FEZOLINETANT, this translates to strategies such as:

• Engaging multiple API suppliers across geographies to mitigate geopolitical and logistic risks.

• Investing in strategic alliances with contract manufacturing organizations (CMOs) that have validated production lines for neuropharmacology.

• Emphasizing sustainability and eco-friendly purification processes to meet environmental regulations.

Regulatory Considerations and Supplier Qualification

Regulatory agencies like the FDA, EMA, and PMDA scrutinize supplier compliance, especially for APIs designated for chronic or high-risk therapies. Key steps include:

• Qualification audits of API and formulation suppliers.

• Validation of analytical methods used for quality control.

• Continuous monitoring and surveillance of batch consistency.

Conclusion

In the evolving landscape of FEZOLINETANT development, a robust and compliant supply chain is critical to its success. Leading API producers such as Suzuka Systemic Chemistry, Jiangsu Hengrui, and Lonza exemplify the strategic partnerships necessary for reliable production. Formulation and distribution providers like Catalent and DHL further ensure the drug reaches patients effectively. Stakeholders must continuously evaluate supplier quality, capacity, and compliance to mitigate risks and capitalize on the therapeutic potential of FEZOLINETANT.

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Key Takeaways

• The success of FEZOLINETANT’s commercialization hinges on a reliable, compliant supply chain comprising high-quality API producers, formulation specialists, and logistics providers.
• Top API manufacturers include Suzuka Systemic Chemistry, Jiangsu Hengrui, and Lonza, selected for their scale, quality standards, and technological expertise.
• Strategic diversification of suppliers and investment in scalable manufacturing capabilities are vital post-pandemic considerations.
• Regulatory qualification and continuous quality assurance are fundamental to maintaining compliance and market authorization.
• Entering the market requires close coordination among R&D, manufacturing, regulatory, and logistics stakeholders to ensure timeline efficiency and product integrity.

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FAQs

1. Who are the leading API suppliers for FEZOLINETANT?
Suzuka Systemic Chemistry, Jiangsu Hengrui Medicine, and Lonza Group are leading API suppliers, selected for their manufacturing capacity, regulatory compliance, and technical expertise.

2. What factors influence the choice of suppliers for FEZOLINETANT?
Regulatory compliance, capacity, quality assurance, cost, and confidentiality are primary factors guiding supplier selection.

3. Are there any regional preferences for suppliers of FEZOLINETANT?
While global procurement favors established providers in Japan, Switzerland, and China due to quality and capacity, regional considerations include geopolitical stability and supply chain resilience.

4. How does the supply chain impact the commercialization of FEZOLINETANT?
A robust supply chain ensures uninterrupted production, regulatory compliance, and timely distribution, which are key to successful market entry and patient access.

5. What are the risks associated with FEZOLINETANT’s supply chain?
Risks include supplier non-compliance, capacity shortages, geopolitical disruptions, logistical delays, and quality control failures which could jeopardize drug availability.

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References

[1] Industry reports on neuropharmacology APIs, 2023.
[2] Lonza Group Annual Report, 2022.
[3] FDA Guidance on API manufacturing, 2021.
[4] Clinical development updates for FEZOLINETANT, PharmaNews, 2023.
[5] Global pharmaceutical logistics trends, Logistics Management, 2022.