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Difelikefalin Acetate bulk supplier for pharma manufacturers

Difelikefalin Acetate 0.5 mg/mL , 1 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 0.5 mg/mL , 1 mg/mL

Reference Brands: Korsuva (USA)

Category: Critical Care

Difelikefalin Acetate is a Critical Care product available as Injection in strengths 0.5 mg/mL , 1 mg/mL. It corresponds to the reference brand Korsuva (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

Product Description:

Difelikefalin, marketed under the brand name Korsuva, is a peripherally acting opioid peptide used for the treatment of moderate to severe pruritus (itch) associated with chronic kidney disease in patients undergoing hemodialysis. It is a highly selective agonist of the κ-opioid receptor (KOR) that acts predominantly outside the central nervous system, minimizing typical opioid-related side effects.

The mechanism of action of difelikefalin involves dual pathways. By activating KORs on peripheral nerve terminals, it inhibits ion channels responsible for transmitting pain and itch signals, reducing the perception of discomfort. Additionally, it activates KORs expressed by certain immune cells, leading to decreased release of proinflammatory and nerve-sensitizing mediators such as prostaglandins. This combined action helps alleviate itch while addressing the underlying inflammatory component.

Difelikefalin is administered as an intravenous injection during hemodialysis sessions under specialist supervision. Its peripherally restricted activity, targeted mechanism, and favorable safety profile make it a valuable therapeutic option for improving quality of life in patients with chronic kidney disease-associated pruritus, especially in populations where conventional therapies may be less effective or poorly tolerated.

Difelikefalin Acetate — third party manufacturing & bulk supply

Difelikefalin Acetate 0.5 mg/mL , 1 mg/mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Difelikefalin Acetate listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Difelikefalin acetate is used to treat moderate-to-severe pruritus associated with chronic kidney disease in patients receiving hemodialysis.

Difelikefalin acetate is a synthetically produced peptide formulated as a sterile injectable solution.

The trade name is Korsuva.

Korsuva is marketed by Cara Therapeutics in the USA.

The complete generic name is difelikefalin acetate.

The approved brand name is Korsuva.

Difelikefalin acetate is manufactured in GMP-approved facilities in the USA and other regulated pharmaceutical regions depending on the authorized supplier.

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