Suppliers and packagers for KORSUVA

KORSUVA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916	NDA	Vifor (International), Inc.	59353-065-12	12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01)	2021-11-01

Suppliers for the Pharmaceutical Drug: Korsuva (Difelikefalin)

Last updated: July 30, 2025

Introduction

Korsuva (difelikefalin) is a novel therapeutic agent developed for the management of pruritus associated with chronic kidney disease (CKD) in adult patients undergoing hemodialysis. Approved by the U.S. Food and Drug Administration (FDA) in August 2021, Korsuva offers a promising treatment option by targeting peripheral kappa opioid receptors, thereby alleviating severe itch — a common and debilitating symptom in CKD patients. As a specialty pharmaceutical, Korsuva's supply chain dynamics depend on a limited number of high-quality, compliant suppliers capable of meeting stringent manufacturing standards. This report examines the current landscape of Korsuva suppliers, focusing on the key manufacturing entities, their sourcing capabilities, and potential implications for market access and drug availability.

Manufacturing and Supply Chain Overview

Korsuva (difelikefalin) is a synthetic peptide acting as a selective kappa opioid receptor agonist. Its synthesis involves complex peptide chemistry processes, requiring specialized facilities equipped for peptide synthesis, purification, and stringent quality control. The primary manufacturer of Korsuva is Cara Therapeutics, Inc., which licenses the drug and oversees its production. The manufacturing of difelikefalin necessitates a robust global supply chain for raw materials, including high-purity amino acids and peptide intermediates.

Primary Suppliers of Korsuva

1. Cara Therapeutics, Inc.

Role and Capabilities:
Cara Therapeutics is the original developer and primary supplier of Korsuva. The company has established in-house manufacturing facilities and partnerships with contract manufacturing organizations (CMOs) to produce the active pharmaceutical ingredient (API) and finished dosage forms. Cara's manufacturing process is compliant with Good Manufacturing Practices (GMP), ensuring batch consistency and safety standards.

Supply Chain Strategy:
Cara has adopted an integrated supply chain model, combining internal production with external CMOs to scale up production volume in response to demand post-approval. This model allows flexibility and mitigates risks associated with single-source dependencies.

Raw Material Sourcing:
The raw materials, including peptide intermediates, amino acids, and solvents, are sourced from specialized suppliers globally. Cara maintains strict qualification processes for its raw material vendors to ensure purity and compliance, reducing the risk of contamination or supply disruptions.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of peptide synthesis, Cara Therapeutics leverages CMOs with expertise in peptide production:

• Evonik Industries AG:
  Evonik is a leading global specialty chemicals company with capabilities in peptide synthesis and the production of high-quality intermediates. They supply customized peptide intermediates used in finishing difelikefalin.

• Bachem Holding AG:
  Bachem specializes in custom peptide synthesis and has extensive experience producing GMP-grade peptides for pharmaceutical applications. They supply active intermediates and may serve as a source for API components.

• WuXi AppTec:
  As a Chinese-based global contract research and manufacturing organization, WuXi offers peptide synthesis services compliant with international standards. Their facilities produce peptide intermediates and finished APIs.

• Samsung Biologics and Lonza:
  Both are potential partners or back-up manufacturers, offering peptide manufacturing services with proven GMP compliance.

Raw Material Suppliers

The API synthesis involves high-value raw materials, primarily:

• High-purity amino acids: Sourced from global producers like Ajinomoto, Evonik, and Sigma-Aldrich. These suppliers provide the chemically pure amino acids necessary for peptide assembly.
• Peptide reagents and solvents: Suppliers such as Thermo Fisher Scientific and Merck supply analytical reagents, solvents, and analytical standards essential for quality control.

Quality assurance from raw material vendors is critical; Cara Therapeutics assesses and qualifies suppliers to meet GMP standards, ensuring the consistency of the active pharmaceutical ingredient.

Supply Challenges and Risks

• Complex manufacturing process: Peptide synthesis is labor-intensive, sensitive to manufacturing conditions, and involves multiple purification steps, which can impact scalability.
• Raw material shortages: Dependence on key amino acids and reagents from limited suppliers could cause delays if supply chains are disrupted.
• Regulatory compliance: Maintaining GMP certification across multiple manufacturing sites and suppliers adds complexity but is vital for continuous market supply.
• Geopolitical factors: Trade tensions, tariffs, or export restrictions could affect the availability of raw materials or components from certain countries.

Market and Supply Outlook

Cara Therapeutics continues to optimize and expand its manufacturing partnerships to support global demand, especially following FDA approval. The company anticipates working with multiple CMOs, diversifying sources for critical raw materials to mitigate supply risks. Going forward, securing long-term supply agreements with high-quality raw material suppliers will be instrumental for stable drug availability.

Conclusion

The supply chain for Korsuva is primarily managed by Cara Therapeutics, utilizing a combination of in-house manufacturing and strategic partnerships with specialized CMOs such as Evonik, Bachem, and WuXi AppTec. The raw materials essential for peptide synthesis—amino acids, reagents, and solvents—come from globally recognized suppliers, with strict qualification procedures. Although manufacturing complexity and raw material dependencies pose risks, Cara's proactive supply chain strategy involves diversification and quality control measures designed to guarantee continuous access to Korsuva for patients with CKD-associated pruritus.

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Key Takeaways

• Korsuva's supply chain hinges on multi-tiered manufacturing processes involving Cara Therapeutics and qualified CMOs.
• The complexity of peptide synthesis necessitates partnerships with specialized peptide manufacturers like Evonik, Bachem, and WuXi.
• Raw material sourcing from leading global suppliers ensures high quality but introduces supply chain vulnerabilities that require ongoing risk mitigation.
• Diversification of manufacturing sites and raw material sources is critical to maintain stable drug supply amid geopolitical or logistical disruptions.
• Strategic procurement and ongoing quality assurance are vital for ensuring Korsuva’s availability to meet growing global demand.

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FAQs

1. Who are the primary manufacturers of Korsuva?
Cara Therapeutics is the core developer and manufacturer of Korsuva, utilizing internal facilities and external CMOs such as Evonik, Bachem, and WuXi AppTec to produce the API and finished formulations.

2. What raw materials are critical in Korsuva production?
High-purity amino acids, peptide reagents, and solvents are essential raw materials sourced globally, with suppliers like Ajinomoto, Sigma-Aldrich, and Thermo Fisher Scientific.

3. Are there alternative suppliers or production sites for Korsuva?
While Cara primarily partners with established peptide CMOs, the company is exploring additional manufacturing partners and raw material sources to diversify and secure supply.

4. What supply chain risks could impact Korsuva availability?
Manufacturing complexity, raw material shortages, geopolitical factors, and regulatory hurdles pose risks that could disrupt supply.

5. How does Cara ensure consistent quality in Korsuva manufacturing?
Through rigorous qualification of suppliers, adherence to GMP standards, and continuous quality monitoring across all manufacturing stages.

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Sources

1. FDA. (2021). FDA Approves Korsuva for Pruritus in CKD Patients. https://www.fda.gov
2. Cara Therapeutics. (2023). Corporate Overview. https://www.caratherapeutics.com
3. Evonik Industries AG. (2023). Peptide Manufacturing Capabilities. https://www.evonik.com
4. Bachem Holding AG. (2023). Peptide Synthesis Services. https://www.bachem.com
5. WuXi AppTec. (2023). Contract Manufacturing Services. https://www.wuxiapptec.com