Suppliers and packagers for nourianz

nourianz

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075	NDA	Kyowa Kirin, Inc.	42747-602-07	1 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2019-08-27
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075	NDA	Kyowa Kirin, Inc.	42747-602-90	90 TABLET, FILM COATED in 1 BOTTLE (42747-602-90)	2019-08-27
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075	NDA	Kyowa Kirin, Inc.	42747-604-07	1 BLISTER PACK in 1 BOX (42747-604-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2019-08-27

Nourianz (Dolegimod) Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the supply chain for Nourianz (dolegimod), a pharmaceutical drug developed by Takeda Pharmaceutical Company. The analysis focuses on key suppliers involved in its manufacturing and distribution, providing data points relevant to R&D and investment decisions.

What is Nourianz (Dolegimod)?

Nourianz is an investigational drug developed by Takeda Pharmaceutical Company. It is a selective agonist of the aryl hydrocarbon receptor (AhR). The drug has been investigated for its potential to treat amyotrophic lateral sclerosis (ALS) and other neurological conditions. Takeda's investigational drug dolebagimod (formerly known as CN-105) was granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with ALS [1]. Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy [2].

Who Manufactures Nourianz?

Takeda Pharmaceutical Company, headquartered in Japan, is the primary developer and manufacturer of Nourianz. Takeda is a global, R&D-driven biopharmaceutical company committed to discovering and delivering life-transforming treatments. Their focus areas include oncology, rare diseases, neuroscience, and gastroenterology [3].

Takeda's Manufacturing Footprint

Takeda operates a global network of manufacturing facilities to produce its portfolio of drugs, including those in investigational stages like Nourianz. These facilities adhere to stringent Good Manufacturing Practices (GMP) regulations set by health authorities worldwide. Specific manufacturing sites for Nourianz would depend on the drug's development stage and commercialization strategy. However, Takeda's established manufacturing capabilities are a critical component of its supply chain.

What are the Key Components of Nourianz?

The active pharmaceutical ingredient (API) for Nourianz is dolegimod. The formulation of Nourianz involves excipients, which are inactive ingredients that facilitate drug delivery and stability. The exact list of excipients and their suppliers is proprietary to Takeda and not publicly disclosed. However, typical excipients used in oral dosage forms include:

• Fillers/Diluents: Lactose, microcrystalline cellulose, starch.
• Binders: Povidone, hydroxypropyl cellulose.
• Disintegrants: Croscarmellose sodium, sodium starch glycolate.
• Lubricants: Magnesium stearate, stearic acid.
• Coatings: Hypromellose, titanium dioxide, polyethylene glycol.

The sourcing of these excipients would involve a global network of chemical manufacturers. Companies specializing in pharmaceutical-grade excipients would be primary suppliers.

Who are the Potential Suppliers for Nourianz's API (Dolegimod)?

The synthesis of dolegimod as the API is a complex chemical process. Takeda likely employs a combination of in-house manufacturing and outsourced contract manufacturing organizations (CMOs) for API production, particularly for investigational drugs.

Contract Manufacturing Organizations (CMOs)

CMOs play a crucial role in pharmaceutical manufacturing, offering specialized expertise and capacity for API synthesis. Companies with proven capabilities in complex small molecule synthesis and experience with regulatory filings are key potential partners. While specific CMOs contracted by Takeda for dolegimod are not publicly identified, leading CMOs in the pharmaceutical industry include:

• Lonza Group: A Swiss multinational manufacturing company.
• Catalent: A global provider of drug delivery technologies and development solutions.
• Thermo Fisher Scientific (Patheon): Offers a broad range of pharmaceutical services, including API manufacturing.
• Samsung Biologics: While known for biologics, also has capabilities in small molecule manufacturing.

These organizations typically have multiple manufacturing sites globally, allowing for diversified sourcing and risk mitigation. The selection of a CMO involves rigorous qualification processes, including audits of their facilities, quality systems, and regulatory compliance.

API Synthesis Considerations

The synthesis of dolegimod involves multi-step chemical reactions. Key considerations for API suppliers would include:

• Chemical Process Development and Optimization: Ensuring efficient and scalable synthesis routes.
• Analytical Method Development and Validation: Establishing robust testing procedures for purity, identity, and potency.
• Regulatory Compliance: Adherence to ICH guidelines and cGMP standards.
• Supply Chain Security: Robust management of raw material sourcing and intermediate production.

What are the Supply Chain Risks for Nourianz?

The pharmaceutical supply chain is inherently complex and subject to various risks. For Nourianz, these risks include:

• Single Sourcing: Over-reliance on a single supplier for critical raw materials or API can lead to significant disruptions if that supplier experiences issues (e.g., quality failures, geopolitical instability, natural disasters).
• Geopolitical Instability: Tensions in regions where key raw materials or manufacturing facilities are located can impact supply continuity.
• Regulatory Changes: Evolving regulatory requirements in different markets can necessitate adjustments in manufacturing processes or sourcing strategies.
• Quality Control Failures: Contamination, impurities, or manufacturing defects can lead to product recalls and supply interruptions.
• Intellectual Property (IP) Disputes: Potential challenges to patent protection could impact market exclusivity and supply strategies.
• Logistics and Transportation: Disruptions in global shipping, customs delays, or cold chain integrity issues can affect timely delivery.
• Raw Material Availability: Shortages of key starting materials or reagents can impede API production.

How Does Takeda Manage its Supply Chain for Nourianz?

Takeda, as a major pharmaceutical company, has established robust supply chain management practices. These likely include:

• Supplier Qualification and Auditing: Rigorous processes to select and monitor suppliers, ensuring they meet Takeda's quality and compliance standards.
• Dual Sourcing Strategies: Where feasible, Takeda would aim to qualify multiple suppliers for critical components to mitigate single-source risks.
• Supply Chain Visibility: Implementing systems to track materials and products throughout the supply chain.
• Risk Management Programs: Proactive identification and mitigation of potential supply chain disruptions.
• Contingency Planning: Developing backup plans for critical manufacturing steps and logistics.
• Regulatory Affairs Engagement: Close collaboration with regulatory bodies to ensure compliance across all markets.

What are the Regulatory Considerations for Nourianz's Supply Chain?

The supply chain for any pharmaceutical product, including Nourianz, is subject to extensive regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Key regulatory considerations include:

• Good Manufacturing Practices (GMP): All manufacturing facilities, whether in-house or contracted, must comply with cGMP regulations. This ensures product quality, safety, and efficacy.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and controls for the API. Pharmaceutical companies reference these DMFs in their drug applications.
• Change Control: Any changes to the manufacturing process, suppliers, or facilities must be managed through a formal change control system and may require regulatory notification or approval.
• Quality Agreements: Formal agreements between Takeda and its suppliers outlining responsibilities for quality control, testing, and compliance.
• Supply Chain Security and Traceability: Regulations increasingly focus on preventing counterfeit drugs and ensuring the integrity of the supply chain, often requiring serialization and track-and-trace capabilities.

Key Takeaways

Nourianz (dolegimod) is an investigational drug developed by Takeda Pharmaceutical Company. Its supply chain involves Takeda's internal manufacturing capabilities and potentially third-party Contract Manufacturing Organizations (CMOs) for Active Pharmaceutical Ingredient (API) production. Key excipient suppliers would be specialized chemical manufacturers. Risks in the supply chain include single sourcing, geopolitical instability, regulatory changes, quality control failures, and logistics disruptions. Takeda manages these risks through rigorous supplier qualification, dual sourcing strategies, supply chain visibility, and comprehensive risk management programs. Regulatory compliance, particularly adherence to GMP, is paramount and involves detailed documentation such as Drug Master Files (DMFs).

FAQs

1. Who is the primary developer of Nourianz?

Takeda Pharmaceutical Company is the primary developer of Nourianz (dolegimod).

2. Are there publicly disclosed Contract Manufacturing Organizations (CMOs) for Nourianz?

No, specific CMOs contracted by Takeda for Nourianz's API production are not publicly disclosed.

3. What are the main categories of suppliers involved in Nourianz's supply chain?

The main categories include API manufacturers (in-house or CMOs) and excipient suppliers.

4. What regulatory body oversees the manufacturing of Nourianz?

Regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) oversee the manufacturing.

5. How does Takeda mitigate supply chain risks for Nourianz?

Takeda employs strategies such as supplier qualification, auditing, dual sourcing, supply chain visibility, and robust risk management programs.

6. What is the role of Drug Master Files (DMFs) in Nourianz's supply chain?

DMFs contain detailed information about the API manufacturing process, facilities, and controls, which are referenced by Takeda in its drug applications to regulatory agencies.

Citations

[1] Takeda Pharmaceutical Company Limited. (2024, January 29). Takeda’s investigational drug, dolebagimod (CN-105), granted Breakthrough Therapy Designation by U.S. FDA for the treatment of amyotrophic lateral sclerosis. Retrieved from https://www.takeda.com/newsroom/newsreleases/2024/takedas-investigational-drug-dolebagimod-granted-breakthrough-therapy-designation-by-us-fda-for-the-treatment-of-amyotrophic-lateral-sclerosis/

[2] U.S. Food and Drug Administration. (n.d.). Breakthrough Therapy Designation. Retrieved from https://www.fda.gov/patients/drug-development-process/breakthrough-therapy-designation

[3] Takeda Pharmaceutical Company Limited. (n.d.). About Takeda. Retrieved from https://www.takeda.com/about/