Suppliers and packagers for generic pharmaceutical drug: difelikefalin acetate

difelikefalin acetate

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: Difelikefalin Acetate

Last updated: July 29, 2025

Introduction

Difelikefalin acetate, known commercially as CR845, is a highly selective kappa opioid receptor agonist designed to manage chronic kidney disease-associated pruritus (CKD-aP). Unlike traditional opioids, it exhibits minimal central nervous system penetration, reducing the risk of adverse effects such as dysphoria or hallucinations. Its innovative mechanism of action has positioned it as a promising agent in the treatment of pruritus related to renal failure.

The market for difelikefalin acetate hinges on a well-established supply chain comprising active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distribution entities. Given its recent approval in several jurisdictions, securing a reliable supplier is critical for pharmaceutical companies, compounding pharmacies, healthcare providers, and regional distributors seeking to incorporate this novel therapy into their offerings.

This comprehensive overview identifies and evaluates leading suppliers of difelikefalin acetate, focusing on their manufacturing capabilities, regulatory standing, and strategic partnerships to facilitate procurement and ensure supply chain integrity.

Overview of Difelikefalin Acetate Production

Difelikefalin acetate is synthesized via a multi-step chemical process emphasizing strict control over stereochemistry and purity due to its biological specificity. The API manufacturing process requires advanced chemical synthesis facilities compliant with Good Manufacturing Practices (GMP) and rigorous quality controls.

Due to the drug's recent approval—initially in the United States by the FDA in 2021 and later in other markets—the supply chain infrastructure has expanded, with several specialized contract manufacturing organizations (CMOs) entering the market.

Key Suppliers and Manufacturers

1. Karus Therapeutics and cold-chain manufacturers

Although Karus Therapeutics primarily focuses on kinase inhibitors, they are no known producers of difelikefalin acetate. Instead, the supply chain for the API is more pluralistic, involving contract manufacturers with proven expertise in peptide-like or kappa receptor agonist synthesis.

2. Eine Pharma and China-based Contract Manufacturers

Several Chinese-based pharmaceutical CDMOs, such as Sichuan Huachen Pharmaceutical, have announced capabilities for peptide synthesis and small-molecule APIs suitable for complex opioids, including difelikefalin acetate. Chinese manufacturers benefit from established chemical synthesis infrastructure and cost efficiencies.

• Sichuan Huachen Pharmaceutical: Reportedly possesses GMP-certified facilities capable of producing peptide APIs, with export licenses that enable supply to North America and Europe.

3. Evonik Industries (Germany)

Evonik is a global leader in specialty chemicals and APIs, with capabilities in peptide synthesis and biocompatible intermediates. Their GMP-certified facilities have produced peptide-based APIs, and they have announced their interest in expanding pharmacological pipeline supply, including kappa opioid receptor agonists.

4. Contract Manufacturing Organizations (CMOs)

Numerous CMOs with specialized expertise in peptide and small-molecule active ingredients are key to the supply of difelikefalin acetate:

• Bachem AG (Switzerland): Recognized for peptide synthesis, Bachem offers GMP manufacturing of complex peptides and peptide-like molecules. Their facilities adhere to stringent regulatory standards, making them a prominent supplier candidate.

• CordenPharma (United States & Europe): Specializes in active pharmaceutical ingredients for peptides; offers scalable GMP production lines fit for difelikefalin acetate.

• Samsung Biologics (South Korea): Though primarily a biologics manufacturer, they have expanded into chemistry manufacturing capabilities suitable for complex APIs.

5. Contract Research and Development Partners

While primarily R&D oriented, these organizations are increasingly offering manufacturing services:

• Peptide International (United States): Provides custom peptide synthesis at scale, with GMP-certified facilities.

• Polypeptides (France): Emerging as a strategic partner in peptide APIs, including potential for kappa opioid receptor agonists.

Regulatory and Certification Status

Most reliable API suppliers for difelikefalin acetate are now partnering with or certified by major health authorities such as the FDA, EMA, and PMDA (Japan). Verification of GMP compliance, batch release testing, and stability data is essential to avoid regulatory risks. Suppliers like CordenPharma and Bachem regularly publish Certificates of Analysis (CoA) aligning with European and U.S. standards.

Supply Chain Challenges

Despite growth, supply chain risks include:

• Limited number of specialized API manufacturers due to the complexity of synthesis.
• Geopolitical considerations, particularly with Chinese suppliers facing regulatory scrutiny in Western markets.
• Scale-up limitations as demand increases for difelikefalin acetate following approvals.

Strategic partnerships with multiple suppliers and inventory management remain crucial to ensure uninterrupted supply.

Conclusion

Securing a reliable supplier for difelikefalin acetate involves evaluating capabilities across multiple dimensions: manufacturing expertise in peptide synthesis, GMP compliance, regulatory standing, and geographic considerations. Prominent global players such as Bachem, CordenPharma, and select Chinese CDMOs stand out as the most credible sources. Forward-looking supply strategies should involve establishing relationships early, diversifying sources, and closely monitoring regulatory developments to mitigate supply disruptions.

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Key Takeaways

• Difelikefalin acetate is produced by specialized peptide synthesis CDMOs, with key suppliers including Bachem, CordenPharma, and select Chinese manufacturers.
• Ensuring GMP compliance and regulatory approval status are critical in supplier selection.
• The supply chain remains limited due to manufacturing complexity but is expanding with increased market demand.
• Strategic partnerships and diversify sourcing are essential to mitigate potential supply disruptions.
• Close monitoring of regulatory and geopolitical developments will optimize procurement and market entry strategies.

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FAQs

Q1: Who are the leading global suppliers of difelikefalin acetate?
A: The leading suppliers include Bachem AG, CordenPharma, and select Chinese contract manufacturers such as Sichuan Huachen Pharmaceutical, all recognized for their GMP-certified peptide synthesis capabilities.

Q2: What are the key quality considerations when selecting a supplier?
A: Suppliers must demonstrate GMP compliance, provide Certificates of Analysis (CoA), and have a consistent quality track record, particularly concerning purity, stability, and batch reproducibility.

Q3: Are there regional restrictions on sourcing difelikefalin acetate?
A: Yes. Some regions require localized manufacturing or import licenses, especially given the complex synthesis process. Suppliers with export licenses and local regulatory approval can better serve regional demand.

Q4: How does supply chain complexity impact pricing?
A: The specialized synthesis process and limited number of qualified manufacturers lead to higher costs. Supply chain disruptions can further elevate prices or delay product availability.

Q5: What future developments could influence suppliers for difelikefalin acetate?
A: Increased demand, new formulations, and emerging biosimilar competitors may prompt capacity expansion among current suppliers or entry of new manufacturing entities, influencing supply dynamics and pricing.

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Sources

[1] U.S. Food and Drug Administration (FDA). (2021). Difelikefalin (CR845) Approval Announcements.
[2] European Medicines Agency (EMA). (2022). Difelikefalin Regulatory Status Updates.
[3] CordenPharma. (2023). GMP Peptide API Manufacturing Capabilities.
[4] Bachem AG. (2023). Peptide Manufacturing Services and Quality Standards.
[5] Sichuan Huachen Pharmaceutical. (2022). API Production Capabilities for Peptides.