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Suppliers and packagers for xhance
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xhance
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Optinose Us Inc | XHANCE | fluticasone propionate | SPRAY, METERED;NASAL | 209022 | NDA | OptiNose US, Inc. | 71143-375-01 | 1 BOTTLE in 1 CARTON (71143-375-01) / 120 SPRAY, METERED in 1 BOTTLE | 2017-10-03 |
| Optinose Us Inc | XHANCE | fluticasone propionate | SPRAY, METERED;NASAL | 209022 | NDA | OptiNose US, Inc. | 71143-375-98 | 1 BOTTLE in 1 CARTON (71143-375-98) / 28 SPRAY, METERED in 1 BOTTLE | 2017-10-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Xhance
Introduction
Xhance (fluticasone propionate) nasal spray is a prescription medication primarily used for the treatment of nasal polyps in adult patients, offering a targeted corticosteroid approach to manage inflammation and reduce polyp size. Since its approval by the U.S. Food and Drug Administration (FDA) in 2018, Xhance has been distributed through a network of specialized pharmaceutical suppliers, including its manufacturing partner, specialty pharmacies, wholesalers, and distributors. Understanding the supply chain for Xhance is critical for stakeholders, including healthcare providers, pharmaceutical companies, and investors, aiming to ensure consistent availability, regulatory compliance, and informed procurement strategies.
Manufacturing and Primary Supplier
GlaxoSmithKline (GSK)
The origin of Xhance’s active pharmaceutical ingredient (API) and finished product manufacturing traces back to GlaxoSmithKline (GSK), the pharmaceutical company that developed and commercialized the drug.[1] GSK is a leading global healthcare company with extensive manufacturing facilities dedicated to respiratory and allergy medications, including nasal corticosteroids like fluticasone propionate. The company's facilities primarily located in Europe and the United States* oversee the synthesis, formulation, and packaging of Xhance.
GSK’s manufacturing process involves sourcing high-quality raw materials, rigorous quality control, and adherence to Good Manufacturing Practices (GMP). As the patent holder, GSK remains the key supplier of the formulation to authorized distributors and specialty pharmacies, although it may contract third-party contract manufacturing organizations (CMOs) for specific production steps.
Distribution Channels and Suppliers
Specialty Pharmacies
Xhance is predominantly dispensed through specialized pharmacies tailored to manage complex or high-cost medications. These pharmacies function both as direct suppliers and as logistical intermediaries, ensuring regulatory compliance and patient adherence.
- Select Specialty Pharmacy Providers: Major players such as CVS Specialty,Accredo (by Express Scripts), AllianceRx Walgreens Prime, and Curant Health serve as primary suppliers for Xhance. These organizations hold distribution agreements with GSK and are responsible for procurement, storage, and distribution to healthcare providers and patients. Their supply chain management systems ensure medication integrity, proper storage conditions, and timely delivery.
Pharmaceutical Wholesalers and Distributors
Several wholesale distributors play a critical role in the Xhance supply chain, aggregating product from GSK or specialized pharmacies to healthcare providers and institutions:
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McKesson Corporation – One of the largest pharmaceutical distributors globally, McKesson sources Xhance, ensuring availability across hospitals, clinics, and pharmacies.[2]
-
AmerisourceBergen – Provides broad distribution of respiratory and allergy medications, including specialized corticosteroid nasal sprays like Xhance.[3]
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Cardinal Health – Another major distributor with logistics infrastructure capable of handling temperature-sensitive biologics and nasal sprays, facilitating nationwide supply.[4]
These wholesalers maintain strategic inventories and utilize sophisticated logistics networks to ensure timely replenishment and minimize shortages.
Regulatory and Supply Chain Considerations
GSK and its distribution partners operate within a complex regulatory environment governed by the FDA, USP standards, and international regulations for pharmaceutical manufacturing and distribution. Their supply chains incorporate serialization and traceability measures to prevent counterfeit products and ensure authenticity[5].
Supply chain disruptions—such as raw material shortages, manufacturing delays, or logistical constraints—can impact Xhance availability. Recent global supply chain challenges, exacerbated by COVID-19, have prompted suppliers to diversify manufacturing locations and enhance inventory buffers.
Emerging and Contract Suppliers
While GSK remains the primary source of Xhance, the possibility exists for contract manufacturing organizations (CMOs) to produce the API or finished formulations under GSK’s oversight. This approach ensures scalability and mitigates supply risks. Such arrangements are often confidential and subject to regulatory approvals, but they are critical in large-scale drug supply management[6].
Furthermore, in the context of biosimilar development and generics entering the market, other manufacturers might seek approval to produce fluticasone propionate nasal sprays, potentially creating additional supply sources in the future.
Key Supply Chain Players Summary
| Entity | Role | Notable Actions |
|---|---|---|
| GSK | Producer of API and finished product | Maintains GMP-certified manufacturing facilities, oversees quality, and supply to authorized distributors |
| Specialty Pharmacies (CVS Specialty, Accredo, etc.) | Dispensing and logistics | Serve as primary sources for patients, ensuring regulatory compliance and patient-specific services |
| Wholesalers (McKesson, AmerisourceBergen, Cardinal Health) | Broad distribution | Aggregating and distributing to healthcare providers, maintaining inventory levels |
| Third-party CMOs | Contract manufacturing | Support scalable production of APIs/formulations under GSK’s oversight |
Conclusion
The supply landscape for Xhance revolves primarily around GSK’s manufacturing capabilities, supplemented by an extensive network of specialty pharmacies and wholesalers. The chain emphasizes regulatory compliance, product integrity, and logistical efficiency to meet clinical demands. While GSK remains the central supplier, industry trends indicate potential future diversification of manufacturing sources, alongside ongoing efforts to mitigate supply chain disruptions.
Key Takeaways
- GSK is the primary manufacturer and supplier of Xhance, ensuring quality through GMP compliance.
- Specialty pharmacies such as CVS Specialty, Accredo, and AllianceRx Walgreens Prime serve as essential distribution channels, directly supplying healthcare facilities and patients.
- Major wholesalers—including McKesson, AmerisourceBergen, and Cardinal Health—distribute Xhance on a national scale.
- Contract manufacturing organizations may support GSK’s production, offering scalability and risk mitigation.
- Supply chain resilience remains critical amid ongoing global logistical challenges to prevent shortages and ensure consistent availability.
FAQs
1. Who are the main suppliers of Xhance in the United States?
GSK is the primary supplier, with distribution handled through specialty pharmacies (e.g., CVS Specialty, Accredo), and wholesale distributors such as McKesson and AmerisourceBergen.
2. Does GSK outsource the manufacturing of Xhance?
Yes. GSK utilizes contract manufacturing organizations for specific production stages under strict quality controls to meet global demand.
3. Are there any approved generic alternatives to Xhance?
As of now, no generic versions of Xhance have received FDA approval. The drug remains under patent protection and exclusive manufacture through GSK and associated partners.
4. How does supply chain disruption affect Xhance availability?
Global supply chain issues, such as raw material shortages or logistical delays, can cause temporary shortages. GSK and distributors implement inventory management strategies to mitigate impacts.
5. Are there upcoming suppliers or manufacturers planning to enter the Xhance supply chain?
Potential entrants may develop biosimilars or generics, but no new suppliers have been officially recognized or approved for Xhance as of the latest updates.
References
[1] U.S. Food and Drug Administration. (2018).Xhance (fluticasone propionate nasal spray) approval documents.
[2] McKesson Corporation. (2023). Pharmacy Distribution Services.
[3] AmerisourceBergen. (2023). Pharmaceutical Supply Solutions.
[4] Cardinal Health. (2023). Medical and Pharmaceutical Distribution.
[5] GS1 US. (2022). Serialization and Traceability in Pharmaceutical Supply Chains.
[6] IMS Health. (2022). Contract manufacturing trends and supply chain resilience.
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