Last updated: May 31, 2026
FUROSCIX (furosemide) is a prescription diuretic delivered as an on-body system. Supplier and contract-manufacturing visibility for the active product (furosemide), the on-body delivery device components, and the final finished dosage form depends on Orange Book linkages (listed firms), FDA device/drug application manufacturing sections, and public inspections. With the data provided in this request, a complete, accurate supplier map cannot be produced.
What companies supply FUROSCIX active ingredient furosemide and key drug-substance intermediates?
Public supplier lists for FUROSCIX at the API (furosemide) and intermediate level are not included in the prompt. Without Orange Book firm names, FDA manufacturing sites, or disclosed vendor documents, it is not possible to enumerate specific API suppliers or confirm whether furosemide is sourced through a single supplier or multiple qualified routes.
Which contract manufacturers produce FUROSCIX finished drug product and packaged on-body systems?
FUROSCIX is a combination of a drug product and an on-body delivery system. Supplier roles typically split across (1) drug product manufacturing (bulk solution, filling, sterilization or aseptic processing where applicable), (2) device assembly (reservoir, cannula/needle, pump/actuation module, adhesive or housing), and (3) secondary packaging and labeling. The prompt does not provide the FUROSCIX manufacturer of record, NDA/BLA manufacturing sites, or Orange Book listed firms, so specific contract manufacturers cannot be identified.
What suppliers make the on-body delivery system components used in FUROSCIX?
On-body system components commonly include housing, adhesives, reservoirs, valve/pump mechanisms, needles or cannulas, tubing, and sensors for delivery verification. Public component-level supplier identification requires disclosure from the FDA product application manufacturing sections, device master records, or listed contractors in regulatory submissions. Those data are not present in the prompt.
What does the Orange Book list for FUROSCIX manufacturing firms and where can vendors be traced?
The Orange Book listing can identify drug-product manufacturers associated with listed patents and application numbers. The prompt does not include FUROSCIX Orange Book entry details (application number, NDA holder, listed firm names), so no firm-level supplier mapping can be generated.
How can FUROSCIX suppliers be validated for cGMP compliance and supply continuity?
A defensible vendor diligence checklist typically covers:
- Regulatory manufacturing site identity (site-by-site confirmation against FDA inspection history and application manufacturing tables).
- Quality system readiness (sterile/aseptic controls if applicable, extractables/leachables for device-contacting components, particulates, delivery-rate verification).
- Supply continuity (component dual sourcing for critical device parts like actuation module, reservoir seals, cannula assemblies).
- Change-control history (device deltas and their impact on drug delivery performance).
- Technical transfer scope (analytical method transfer, device assembly requalification, and delivery performance comparability).
Specific supplier conclusions cannot be made without the underlying site and vendor identities.
What IP or formulation constraints affect FUROSCIX outsourcing and alternative sourcing?
FUROSCIX’s delivery mechanism can impose constraints on substitution of device components, packaging configuration, and manufacturing process parameters tied to stability and delivery performance. Vendor strategy depends on the exact patent and regulatory history for the on-body system and drug product. The prompt provides no patent estate or application dossier facts, so supplier substitution and barrier analysis cannot be completed.
Key Takeaways
- A supplier list for FUROSCIX cannot be produced from the information provided.
- Building a correct FUROSCIX supplier map requires firm-level disclosures (Orange Book listed firms and FDA manufacturing site tables) for drug substance, drug product, and device system components.
- Without those identifiers, any naming of suppliers would be speculative and not actionable for procurement, licensing, or regulatory submissions.
FAQs
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Who is the manufacturer of record for FUROSCIX?
Not provided in the request.
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Does FUROSCIX use a specific contract manufacturer for aseptic filling or device assembly?
Not provided in the request.
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Are on-body device components sourced from a single vendor or multiple suppliers?
Not provided in the request.
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Where can FUROSCIX supplier identities be confirmed for regulatory submissions?
Typically via Orange Book listed firms and NDA manufacturing tables; not included in the request.
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What documentation should be requested from FUROSCIX vendors for regulatory readiness?
Typically site-by-site cGMP evidence, change-control history, and comparability packages tied to device-contacting components; vendor identities not provided in the request.
References
(References not provided because no sources were cited in the request.)
