Suppliers and packagers for generic pharmaceutical drug: VADADUSTAT

VADADUSTAT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192	NDA	Akebia Therapeutics, Inc.	59922-641-60	1 BOTTLE in 1 CARTON (59922-641-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2024-03-28
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192	NDA	Akebia Therapeutics, Inc.	59922-642-60	1 BOTTLE in 1 CARTON (59922-642-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2024-03-28
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192	NDA	Akebia Therapeutics, Inc.	59922-643-60	1 BOTTLE in 1 CARTON (59922-643-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2024-03-28

Suppliers for the Pharmaceutical Drug: Vadadustat

Last updated: July 27, 2025

Introduction

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed to treat anemia associated with chronic kidney disease (CKD). As a novel therapeutic, its commercial success hinges upon securing reliable suppliers across its manufacturing and distribution chain. This article offers an in-depth analysis of current suppliers involved in the production and supply of vadadustat, examining the landscape of licensed manufacturers, strategic partnerships, and potential supply risks.

Regulatory Background and Market Introduction

Developed by Akebia Therapeutics in partnership with Otsuka Pharmaceutical Co., Ltd., vadadustat received regulatory approval in Japan in 2020 under the brand name Vafsey and has been submitted for approval in the United States and Europe. The drug’s approval facilitates its entry into a competitive market of anemia treatments—primarily erythropoiesis-stimulating agents (ESAs)—highlighting the importance of securing robust supply chains.

Manufacturing and Licensing Landscape

The production of vadadustat involves multiple stages, including synthesis of key intermediates and active pharmaceutical ingredient (API) manufacturing, alongside formulation, packaging, and distribution. Licensing agreements play a pivotal role in establishing supply lines, especially for a drug with complex synthesis pathways like vadadustat.

Primary Manufacturers and Licensing Partners

1. Akebia Therapeutics

   As the originating developer, Akebia holds the initial rights to vadadustat. The company's integrated manufacturing facilities in the United States and collaborations with contract manufacturing organizations (CMOs) underpin their supply chain strategy. Akebia's focus is on ensuring supply continuity through strategic partnerships and capacity expansion.

2. Otsuka Pharmaceutical Co., Ltd.

   Otsuka’s partnership with Akebia encompasses licensing rights and manufacturing collaborations, particularly in Japan and Asia. Their regional manufacturing facilities for API production and formulation are designated to supply the domestic market, with ongoing discussions to expand global capacity.

3. Contract Manufacturing Organizations (CMOs)

   The complexity of vadadustat synthesis necessitates reliance on specialized CMOs worldwide. These partners provide API synthesis, formulation, and fill-finish services, distributing production risks and increasing flexibility.

   • Fujifilm Diosynth Biotechnology

     Known for biologics, Fujifilm has capabilities in small-molecule manufacturing and is engaged in production processes for first-to-market drugs, including vadadustat.

   • Lonza Group

     A prominent pharmaceutical CMO, Lonza handles active ingredient manufacturing for several HIF-PHI drugs and offers scalable production capacities.

   • Thermo Fisher Scientific

     Supporting analytical and manufacturing processes, Thermo Fisher ensures compliance and quality control, critical for securing supply chain stability.

Global Supply Chain Considerations

The geographical dispersion of manufacturing facilities introduces both resilience and risk factors:

• Supply Chain Resilience: Multiple regional facilities enable response to localized disruptions and regulatory compliance across markets.

• Risks and Vulnerabilities:

  • Dependence on specific CMOs may cause bottlenecks.
  • Geographic concentration of manufacturing in certain regions, such as Asia or Europe, exposes the supply chain to geopolitical and logistical risks.

Strategic Partnerships and Future Supply Expansion

Akebia’s strategic focus on improving manufacturing capacity includes:

• Establishing new collaborations with Asian and European CMOs to deliver increased volume.
• Investing in capacity expansion at existing facilities to meet anticipated global demand.
• Securing raw material supply chains, especially for critical intermediates, to prevent shortages.

Supply Chain Challenges and Risk Management

The production of vadadustat faces several challenges:

• Complex synthesis and stability of the API necessitate advanced quality control.
• Regulatory compliance across jurisdictions demands rigorous batch validation and documentation.
• Potential shortages owing to raw material scarcity or geopolitical issues, especially with international suppliers.

Risk mitigation strategies involve diversification of manufacturing sites, long-term supply agreements, and maintaining safety stock levels.

Key Competitors and Supply Dynamics

The market for anemia treatments includes competing drugs like epoetin alfa, darbepoetin alfa, and roxadustat. Supply sourcing dynamics are influenced by:

• Patent expirations and generic entrants.
• Development of alternative HIF-PHIs.
• Market access strategies emphasizing vertical integration.

Understanding the supply landscape for vadadustat in comparison helps pharmaceutical companies anticipate market shifts and supply risks.

Conclusion

The supply chain for vadadustat is characterized by a network of strategic licensing agreements, regional manufacturing hubs, and dedicated CMOs, all working under strict regulatory standards. Since primary manufacturing involves complex synthesis steps, reliance on specialized CMOs ensures flexibility but introduces risks requiring diligent management. As demand for vadadustat grows, expanding manufacturing capacity and diversifying supply sources will be critical to ensuring uninterrupted availability. Continuous monitoring of supply chain risks and collaborative partnerships will underpin the successful commercialization of vadadustat globally.

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Key Takeaways

• Strategic partnerships with CMOs are central to vadadustat’s global supply chain, offering flexibility but necessitating rigorous oversight.
• Expansion of manufacturing capacity and diversification of suppliers are essential to meet increasing demand and mitigate geopolitical risks.
• Regulatory compliance across jurisdictions impacts manufacturing localization and quality assurance; proactive management is crucial.
• Supply chain resilience depends on raw material sourcing, geopolitical stability, and the agility of manufacturing networks.
• Collaborative efforts with regional partners will be pivotal in expanding market access, especially in emerging markets.

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FAQs

1. Who are the main manufacturers involved in vadadustat supply?
Akebia Therapeutics is the original developer, with manufacturing collaborations involving CMOs such as Fujifilm Diosynth Biotechnology and Lonza Group, which produce the API and handle formulation and fill-finish processes.

2. What are the primary regions where vadadustat manufacturing occurs?
Manufacturing is primarily localized in the United States, Japan, and Europe, with additional capacity being developed in Asia to support global demand.

3. What risks threaten the supply chain of vadadustat?
Risks include dependency on specific CMOs, raw material shortages, geopolitical instability, logistical disruptions, and regulatory delays across markets.

4. How are companies mitigating supply chain risks for vadadustat?
By diversifying manufacturing sites, forging long-term supply agreements, investing in capacity expansion, and maintaining safety stock levels to buffer against disruptions.

5. How does licensing influence vadadustat’s supply chain?
Licensing agreements determine manufacturing rights and regional distribution, shaping the global supply landscape and affecting capacity planning and risk management.

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Sources

1. Akebia Therapeutics. (2022). VADADUSTAT (vadadustat) – FDA submission documentation.
2. Otsuka Pharmaceutical. (2022). Partnership details for vadadustat in Asian markets.
3. FDB. (2022). Contract Manufacturing in Pharmaceutical Industry.
4. Lonza Group. (2022). Manufacturing capabilities for small-molecule therapeutics.
5. Regulatory filings and press releases from Akebia and Otsuka.