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

Difelikefalin Acetate Suppliers: Who Manufactures Difelikefalin for US & Global Markets?

Last updated: May 26, 2026

Executive summary: Difelikefalin acetate commercial supply for the US is tied to Kopa Pharmaceuticals (marketed as PHN-PAIN indication set) and the FDA-approved product labeling for difelikefalin injection, for intravenous use. Public information on the specific contract manufacturing organizations (CMOs) making difelikefalin acetate drug substance (API) and drug product (injection) is typically restricted in distributor-facing disclosures and may not be fully captured in FDA labels.

What this means for sourcing: A credible supplier map for difelikefalin acetate typically resolves into (1) the marketing authorization holder / drug sponsor, (2) the contract manufacturer(s) named in regulatory submissions and labeling manufacturing sections, and (3) downstream US distributors that route product to hospitals and wholesalers. Only the first layer is consistently verifiable from public-facing sources.

Who are the commercial suppliers for difelikefalin acetate in the US?

Direct answer: The commercial supplier chain starts with the FDA-approved sponsor/holder of record for difelikefalin acetate injection and then flows to authorized wholesalers/distributors.

What entity is listed as the drug’s sponsor/holder in FDA product information?

The difelikefalin acetate product is marketed under the FDA-approved trade name difelikefalin (injection) for the approved indication set (as reflected in FDA labeling). The company associated with the product’s US commercialization is the point of contact for confirmed supply allocation and contract manufacturing details.

Which downstream distributors supply difelikefalin acetate to hospitals?

In practice, difelikefalin acetate is supplied through standard US pharmaceutical distribution channels (wholesale distributors and hospital group purchasing). However, distributor names are not uniformly published in a single consolidated source for difelikefalin acetate comparable to small-molecule oral drugs with full public distribution tables.

Supply chain due diligence checklist (for procurement teams)

• Confirm NDC-level manufacturer/labeler on finished-goods packaging.
• Request from the seller: GMP manufacturing site address, CoA, specs, traceability, and lot-by-lot release documentation.
• Verify chain-of-custody across wholesaler to hospital procurement.

Which companies manufacture difelikefalin acetate drug substance (API)?

Direct answer: Public-facing sources do not consistently expose the API CMO for difelikefalin acetate in a way that supports a complete, litigation-ready supplier list. API manufacturing is often handled by a specialized API manufacturer under contract, with details maintained in confidential submissions.

How procurement teams typically validate API suppliers

• Match API manufacturer identity by requesting DMF-linked disclosure (where available through regulatory documentation) and lot-level CoA statements.
• Use commercially supplied reference standards and independent testing vendors to verify impurity profile consistency by lot, then backsolve likely manufacturing sites.

Which companies make difelikefalin acetate drug product (injection)?

Direct answer: The finished dosage form supplier is usually the labeler/marketing authorization holder plus one or more GMP manufacturing sites for the injection, as reflected in the FDA label’s manufacturing section and lot release pathway.

Drug product manufacturing details procurement teams should request

• Filling and finishing plant(s)
• Sterile manufacturing approach (aseptic processing and sterilization method, where stated)
• Container-closure system and fill volume per vial
• Stability program and shelf-life by lot

How to identify the exact difelikefalin acetate supplier by NDC?

Direct answer: The most reliable public identifier for manufacturer attribution is the NDC and the labeler/manufacturer information on the outer carton and package insert.

Practical identification steps (procurement workflow)

• Extract NDC from the hospital procurement system or receiving paperwork.
• Cross-check the NDC labeler and manufacturer in the product’s prescribing information.
• Align with CoA lot manufacturer name provided by the supplier.

What supply risks exist for difelikefalin acetate sourcing?

Direct answer: The main risk areas for difelikefalin acetate are sterile injectable capacity constraints, single-site or limited multi-site manufacturing, and regulatory quality events that can trigger allocation.

Risk factors that drive allocation

• Sterile fill-finish capacity (aseptic isolators, LAF/cleanroom throughput)
• Batch size limits and long lead-time for sterile components
• Drug product release delays caused by OOS/OOT investigations

Commercial impact patterns seen in sterile injectables

• Near-term allocation if primary facility faces deviation or regulatory findings
• Lot-to-lot variability mitigation costs for distributors and IDNs

How does difelikefalin acetate supplier landscape compare with other kappa-opioid receptor agonists?

Direct answer: Like many sterile injectables in niche pain categories, difelikefalin acetate typically has fewer public supplier disclosures than large-market oral drugs. The supply chain is more dependent on contract sterile filling and sterile release testing capacity than on generic-style scale procurement.

Competitive sourcing context

• Other kappa-opioid pathway drugs (where applicable) often show a similar pattern: sponsor-led commercialization with contract manufacturing for drug product.

What generic or biosimilar-style supply disruptions could affect difelikefalin acetate?

Direct answer: Difelikefalin acetate is a small-molecule injection, so supply disruption risk is more analogous to generic competitive entry than biologics. However, the likelihood and timing of generic entry depends on US patent and exclusivity status, which is not included in the present sourcing-focused view.

Buyer action points

• Lock multi-source supply only after confirming NDC-level manufacturing site equivalence
• Require lot-release and validation packages for any alternative seller

Key Takeaways

• The difelikefalin acetate supply chain is anchored by the FDA-approved marketing sponsor/labeler, with finished injection manufacturing at one or more GMP sterile sites tied to the labeled product.
• Public sources often do not provide a complete list of API CMOs for difelikefalin acetate; the most defensible supplier attribution is NDC- and labeler-linked.
• Procurement should identify the supplier precisely using NDC + labeled manufacturer + lot CoA and require full GMP and chain-of-custody documentation.
• For sourcing resilience, focus diligence on sterile fill-finish capacity and batch release processes, which drive allocation and supply risk.

FAQs

1) What is the easiest way to confirm the difelikefalin acetate supplier for a hospital purchase order?

Use the NDC to match the labeler/manufacturer in the package insert and confirm with the lot CoA.

2) Are difelikefalin acetate API and drug product always made by the same supplier?

Not necessarily. Sterile injectables often use separate API and drug product manufacturing sites; the only reliable confirmation is lot-level documentation.

3) Can distributors repackage difelikefalin acetate from a different manufacturer?

Authorized redistribution can occur through wholesalers, but repackaging across manufacturers typically changes labeling and is controlled by regulatory labeling and supply chain controls. Confirm by NDC and CoA.

4) What documentation should a difelikefalin acetate buyer require from a supplier?

At minimum: CoA, specs, GMP manufacturing site, sterility-related release documentation where applicable, and traceability/lot history.

5) What factors most often cause difelikefalin acetate allocation?

Sterile injectable manufacturing constraints, quality investigations, and batch release delays tied to sterility/assay/OOS processes.

References

1. U.S. Food and Drug Administration. Prescribing information for difelikefalin acetate injection (product labeling and NDC/manufacturing sections).