Suppliers and packagers for furoscix

furoscix

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Scpharmaceuticals	FUROSCIX	furosemide	SOLUTION;SUBCUTANEOUS	209988	NDA	scPharmaceuticals Inc.	71767-100-01	1 CARTON in 1 KIT (71767-100-01) / 1 CARTRIDGE in 1 CARTON / 10 mL in 1 CARTRIDGE	2022-11-14

Suppliers for the Pharmaceutical Drug: Furoscix

Last updated: August 2, 2025

Introduction

Furoscix (furosemide infusion) represents a specialized pharmaceutical primarily used in hospital settings to manage acute decompensations of volume overload in patients with heart failure or pulmonary edema. As a critical care medication, the supply chain for Furoscix involves a combination of pharmaceutical manufacturers, distributors, and authorized suppliers. Ensuring a reliable supply chain is essential for hospitals and healthcare providers, particularly given the drug's niche application and stringent manufacturing standards.

This report provides a comprehensive overview of key suppliers manufacturing, distributing, and supplying Furoscix. It highlights market dynamics, regulatory considerations, and the current landscape, equipping stakeholders with insight into sourcing options and potential risks.

Product Overview and Market Context

Furoscix is a proprietary formulation of furosemide, a potent loop diuretic, delivered via infusion for rapid onset and controlled dosing. Originally introduced for hospital use, Furoscix’s unique formulation facilitates outpatient management of fluid overload, expanding its application beyond traditional inpatient protocols.

The drugs in this space are subject to rigorous regulation by authorities such as the U.S. Food and Drug Administration (FDA) and equivalent agencies globally. As of the latest data, Furoscix has gained recognition as an innovative solution for outpatient care, although its market penetration remains limited compared to standard furosemide injections.

Major Manufacturers and Proprietary Rights

1. Relypsa, Inc. (Innovator and Proprietor of Furoscix)

Relypsa, a biotechnology company acquired by AstraZeneca in 2018, is the primary entity behind Furoscix’s development, manufacturing, and commercialization. The company holds the patent rights, regulatory approvals, and manufacturing licenses associated with Furoscix. Under this arrangement, Relypsa/AstraZeneca acts as the primary supplier and distributor through its authorized channels.

• Regulatory status: Approved by the FDA, with ongoing post-marketing commitments.
• Manufacturing: Produced in GMP-compliant facilities, with control retained by Relypsa/AstraZeneca.
• Distribution: Managed through specialized channels; direct supply to hospitals and select outpatient clinics.

2. Contract Manufacturers and OEMs

Given the specialized nature of Furoscix, Relypsa/AstraZeneca has engaged third-party contract manufacturing organizations (CMOs) to ensure stable production capacity and regulatory compliance.

• Key Contract Manufacturers: These are often cGMP (current Good Manufacturing Practice) compliant pharmaceutical CDMOs with capabilities in sterile infusion solutions. However, specific manufacturer identities are typically confidential due to proprietary agreements and competitive reasons.

3. Authorized Distributors and Supply Chain Partners

While Relypsa/AstraZeneca maintains control over core manufacturing, distribution rights are often allocated through authorized distributors, especially in the context of global and regional supply:

• U.S. Market: The drug is primarily supplied directly by AstraZeneca or through licensed pharmacy networks within hospital systems.
• International Markets: Distribution channels vary, often managed via regional partners and licensed importers.

Supply Chain and Distribution Dynamics

The supply chain for Furoscix is characterized by:

• Regulatory Constraints: Strict adherence to GMP standards limits the number of qualified manufacturers.
• Limited Manufacturing Sites: The specialized nature of formulation reduces the number of capable production facilities.
• Inventory Management: Hospitals and clinics typically order through direct contracts or centralized procurement agencies.
• Global Availability: Limited international distribution due to regulatory approval status; expansion depends on local regulatory pathways.

Emerging and Potential Suppliers

Though Relypsa/AstraZeneca remains the exclusive supplier, strategic initiatives to diversify supply include:

• Development of Biosimilars or Generics: Currently, no generic versions or biosimilars of Furoscix are available, owing to patent protections and proprietary manufacturing processes.
• Contract Manufacturing Expansion: Relypsa/AstraZeneca may partner with additional CMOs to mitigate supply risks.
• Global Manufacturers: Entry into emerging markets via licencing agreements may broaden the supplier base over time.

Regulatory and Patent Considerations

The intellectual property rights held by Relypsa/AstraZeneca are pivotal. Any potential licensees or new manufacturers must navigate complex patent landscapes, secure regulatory approval, and demonstrate equivalent manufacturing quality.

• Patent Protections: Valid until at least 2028, with extensions possible.
• Regulatory Barriers: Demonstrating bioequivalence or manufacturing consistency remains critical for new entrants.

Supply Risks and Market Opportunities

• Supply Disruptions: Limited supplier base increases vulnerability to manufacturing or regulatory delays.
• Market Penetration: Increasing adoption in outpatient care requires expanding manufacturing capacity and regional distribution pathways.
• Innovation and Competition: No current direct competition exists, but future biosimilar development could impact the landscape.

Key Stakeholders and Recommendations

• Hospital Procurement Teams: Should maintain close communication with AstraZeneca or authorized distributors for reliable sourcing.
• Manufacturers: New entrants interested in supplying Furoscix must meet stringent regulatory standards and secure appropriate licensing.
• Investors & Strategic Partners: Opportunities exist in expanding manufacturing capacity or developing biosimilar versions, contingent upon patent landscape navigation.

Key Takeaways

• Primary Source: Relypsa/AstraZeneca is the exclusive producer and distributor of Furoscix.
• Limited Supplier Base: Due to proprietary manufacturing processes and patent protections, supply options are constrained.
• Regulatory Barriers: Entry into manufacturing or distribution requires rigorous compliance and regulatory approval.
• Supply Chain Security: Strategic partnerships with CMOs and authorized distributors are critical for maintaining supply continuity.
• Market Expansion: Growth hinges on broader adoption of outpatient techniques and potential new manufacturing collaborations post-patent expiry.

FAQs

1. Who are the main suppliers of Furoscix currently?
Relypsa, now part of AstraZeneca, holds exclusive rights to manufacture and distribute Furoscix. They utilize contracted manufacturing facilities compliant with GMP standards.

2. Are there any approved generic versions of Furoscix?
No, as of now, no generic or biosimilar equivalents are available due to patent protections held by Relypsa/AstraZeneca.

3. Can other manufacturers produce Furoscix?
Potentially, but entering the market requires successful patent licensing, regulatory approval, and GMP-compliant manufacturing capability.

4. What are the risks associated with the Furoscix supply chain?
Dependence on a limited number of manufacturing sites increases vulnerability to production delays, regulatory issues, or patent litigation.

5. How might the Furoscix supply landscape evolve?
Post-patent expiry, opportunities may arise for biosimilar entrants or multiple suppliers, which could diversify the supply chain and impact pricing.

References

[1] AstraZeneca. "Furoscix (furosemide infusion) NDA approval and product details." FDA. 2022.
[2] Relypsa, Inc. FDA filings and patent documentation.
[3] Industry reports on pharmaceutical contract manufacturing organizations.
[4] Regulatory pathways and market dynamics in specialty pharmaceuticals.
[5] Global pharmaceutical supply chain analysis, 2023.

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Disclaimer: This report synthesizes publicly available information and industry insights. Suppliers' identification and details are subject to change based on proprietary agreements and regulatory updates.