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Difelikefalin Acetate bulk supplier for pharma manufacturers

Difelikefalin Acetate 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 available in Injection and strengths such as 0.5 mg/mL , 1 mg/mL. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Difelikefalin Acetate is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Difelikefalin Acetate can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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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.

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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.

Yes, Difelikefalin Acetate is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Difelikefalin Acetate is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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