Suppliers and packagers for FLONASE ALLERGY RELIEF

FLONASE ALLERGY RELIEF

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Haleon Us Holdings	FLONASE ALLERGY RELIEF	fluticasone propionate	SPRAY, METERED;NASAL	205434	NDA	Haleon US Holdings LLC	0135-0576-01	1 BOTTLE in 1 CARTON (0135-0576-01) / 30 SPRAY, METERED in 1 BOTTLE	2014-12-04
Haleon Us Holdings	FLONASE ALLERGY RELIEF	fluticasone propionate	SPRAY, METERED;NASAL	205434	NDA	Haleon US Holdings LLC	0135-0576-02	1 BOTTLE in 1 PACKAGE (0135-0576-02) / 60 SPRAY, METERED in 1 BOTTLE	2014-12-04
Haleon Us Holdings	FLONASE ALLERGY RELIEF	fluticasone propionate	SPRAY, METERED;NASAL	205434	NDA	Haleon US Holdings LLC	0135-0576-03	1 BOTTLE in 1 PACKAGE (0135-0576-03) / 120 SPRAY, METERED in 1 BOTTLE	2014-12-04

Suppliers for the Pharmaceutical Drug: Flonase Allergy Relief

Last updated: August 4, 2025

Introduction

Flonase Allergy Relief, the over-the-counter (OTC) formulation of fluticasone propionate nasal spray, is a widely used treatment for allergic rhinitis and nasal congestion. Its market dominance and consumer trust hinge on a complex network of suppliers spanning active pharmaceutical ingredients (API), finished formulations, packaging, and distribution channels. Understanding the supply landscape is critical for stakeholders involved in procurement, manufacturing, regulatory compliance, and market strategy.

This report delineates the primary suppliers and manufacturing sources associated with Flonase Allergy Relief, elaborating on the pharmaceutical supply chain, regulatory considerations, and market dynamics influencing its procurement.

Manufacturers and Brand Ownership

GlaxoSmithKline (GSK) holds patent rights and global marketing responsibilities for Flonase (also known as Flixonase outside the United States). Since acquiring the rights, GSK manages the formulation, production, and distribution channels for Flonase Allergy Relief, leveraging extensive manufacturing facilities and supply chain capabilities.

While GSK acts as the brand owner, the actual manufacturing and supplying involve multiple third-party suppliers and contract manufacturing organizations (CMOs).

Active Pharmaceutical Ingredient (API) Suppliers

Fluticasone propionate, the active molecule in Flonase, requires high-quality API sourcing. Leading API suppliers for fluticasone include:

• Xianju State Pharmaceutical Factory (China): Noted for large-scale production of corticosteroid APIs, including fluticasone. Their APIs comply with international standards after extensive validation and are often used by brand-name and generic manufacturers.

• Novartis (Switzerland): Novartis supplies certain corticosteroid APIs and intermediates, with some formulations used in generic nasal sprays and inhalers.

• European API producers: Companies such as Recipharm (Sweden) and Evonik Industries (Germany) have developed high-purity corticosteroid APIs, including fluticasone.

The API supply chain is characterized by a complex web of origin points, with many APIs sourcing from Chinese and Indian manufacturing hubs, subject to rigorous quality assurance and certification processes to meet U.S. FDA regulations and EMA standards.

Contract Manufacturing Organizations (CMOs)

GSK, like many pharmaceutical companies, employs CMOs to produce Flonase formulations. Key CMO players include:

• Hovione (Portugal): Known for spray formulations, Hovione provides development and manufacturing support for nasal sprays, including Flonase.

• Catalent (USA): Provides formulation development, fill-finish, and packaging services for OTC nasal spray products.

• Recipharm (Sweden): Offers contract manufacturing for nasal spray devices, ensuring compliance with regulatory standards.

These CMOs handle formulation, filling, assembly, and packaging, with robust quality control protocols to ensure product consistency and regulatory compliance.

Packaging and Delivery Systems Suppliers

The integrity of Flonase nasal spray hinges on specialized delivery devices and packaging. Suppliers include:

• Baxter International: Supplies aerosol delivery systems suitable for nasal sprays, with customizable valving and spray mechanisms.

• Philips (now part of Terumo): Provides nasal spray bottle components, including the container, actuator, and nozzle.

• Gerresheimer (Germany): Manufactures glass and plastic containers for nasal spray formulations complying with pharmaceutical standards.

Supply chain disruptions or innovations in delivery devices can impact availability, efficacy, and user experience.

Distribution and Wholesale Suppliers

Major pharmaceutical distributors and wholesalers involved in Flonase distribution include:

• McKesson Corporation: Distributes OTC medications, including Flonase, across North America.

• Cardinal Health: Key distributor for OTC and prescription pharmaceuticals, ensuring global reach and timely supply.

• AMRI Pharmaceuticals: Specializes in high-volume distribution with comprehensive logistics for OTC nasal sprays.

Distribution channels are highly regulated and subject to inventory management policies to prevent shortages and ensure product stability.

Market Dynamics and Supply Chain Challenges

The supply chain for Flonase Allergy Relief faces several challenges:

• Global API Supply Dependency: Heavy reliance on Chinese and Indian API manufacturers introduces risks related to geopolitical tensions, tariffs, and quality standard fluctuations.

• Regulatory Oversight: Compliance with FDA, EMA, and other regulatory bodies necessitates rigorous quality assurance and batch testing throughout the supply chain.

• Manufacturing Capacity Constraints: Sudden demand surges, such as during allergy seasons or pandemic-related supply chain disruptions, strain manufacturing capacities.

• Innovation and Reformulation: Introduction of new formulations or delivery systems by GSK or competitors can shift supplier partnerships and favor different supplier profiles.

Regulatory and Quality Assurance Considerations

To maintain regulatory compliance, suppliers must adhere to Good Manufacturing Practices (GMP). GSK conducts extensive supplier qualification processes, including audits and certifications, before qualifying raw material or component suppliers. The global nature of the supply chain amplifies the importance of traceability, batch consistency, and documentation.

Conclusion

The supply ecosystem for Flonase Allergy Relief is intricate, involving multiple tiers—from high-quality API manufacturers, specialized CMOs, packaging providers, to broad distribution networks. GSK’s strategic partnerships with global suppliers underpin product consistency and availability. Stakeholders must monitor geopolitical, regulatory, and manufacturing factors that could influence supply stability and quality.

Key Takeaways

• Diverse API sourcing primarily from China, India, and European producers ensures supply resilience but introduces geopolitical and quality considerations.
• Contract manufacturing organizations such as Hovione and Catalent are pivotal in formulating and packaging Flonase, emphasizing the importance of robust quality management.
• Packaging and delivery system suppliers like Gerresheimer and Terumo are essential for ensuring product stability and user safety.
• Global distribution networks via companies like McKesson and Cardinal Health facilitate wide market access, but supply chain disruptions can impact product availability.
• Regulatory compliance and quality assurance are critical throughout the supply chain, requiring ongoing audits and certification processes to meet international standards.

Understanding the supply landscape for Flonase Allergy Relief equips stakeholders with insights necessary for strategic procurement, risk management, and market planning.

FAQs

1. Who are the primary API suppliers for fluticasone in Flonase?
   Major API producers include Chinese companies like Xianju State Pharmaceutical Factory and European firms such as Recipharm, all adhering to stringent quality standards.

2. Does GSK manufacture Flonase entirely in-house?
   No. GSK employs contract manufacturing organizations, including Hovione and Catalent, for formulation and packaging, ensuring flexible and scalable production.

3. What are the main risks in the Flonase supply chain?
   Risks include dependency on overseas API suppliers, geopolitical tensions, regulatory compliance issues, capacity constraints, and raw material shortages.

4. Can supply chain disruptions affect Flonase availability?
   Yes. Disruptions in API supply, manufacturing delays, or distribution issues can lead to shortages or delays in market availability.

5. Are there alternative suppliers for Flonase formulations?
   While GSK maintains strict supplier qualification, alternative or generic nasal sprays may be sourced from different API producers and contract manufacturers, contingent upon regulatory approval and quality assurance.

References

[1] GSK Official Website. (2023). Flonase Product Information.
[2] FDA Database. (2023). Approved API Suppliers.
[3] IQVIA. (2022). OTC Medication Market and Supply Chain Overview.
[4] European Medicines Agency. (2023). API Quality Standards.
[5] Industry Reports. (2022). Pharmaceutical Contract Manufacturing Trends.