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Last Updated: December 16, 2025

Suppliers and packagers for FLONASE SENSIMIST ALLERGY RELIEF


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FLONASE SENSIMIST 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 SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051 NDA Haleon US Holdings LLC 0135-0615-01 1 BOTTLE in 1 CARTON (0135-0615-01) / 30 SPRAY, METERED in 1 BOTTLE 2017-02-01
Haleon Us Holdings FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051 NDA Haleon US Holdings LLC 0135-0615-02 1 BOTTLE in 1 PACKAGE (0135-0615-02) / 60 SPRAY, METERED in 1 BOTTLE 2017-02-01
Haleon Us Holdings FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051 NDA Haleon US Holdings LLC 0135-0615-03 1 BOTTLE in 1 PACKAGE (0135-0615-03) / 120 SPRAY, METERED in 1 BOTTLE 2017-02-01
Haleon Us Holdings FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051 NDA Haleon US Holdings LLC 0135-0615-04 3 BOTTLE in 1 PACKAGE (0135-0615-04) / 120 SPRAY, METERED in 1 BOTTLE 2017-02-01
Haleon Us Holdings FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051 NDA Haleon US Holdings LLC 0135-0615-05 2 BOTTLE in 1 PACKAGE (0135-0615-05) / 120 SPRAY, METERED in 1 BOTTLE 2017-02-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: FLONASE SENSIMIST ALLERGY RELIEF

Introduction
FLONASE SENSIMIST ALLERGY RELIEF is a prominent OTC nasal spray utilized for seasonal and perennial allergic rhinitis. As an aerosolized intranasal corticosteroid, it leverages an active ingredient designed to suppress inflammation and allergy symptoms. Understanding the landscape of suppliers involved in the manufacturing, distribution, and supply chain of FLONASE SENSIMIST is critical for stakeholders managing procurement, regulatory compliance, and market strategy. This report examines primary suppliers, manufacturing partnerships, and key distribution channels underpinning the availability of FLONASE SENSIMIST.


Manufacturers of FLONASE SENSIMIST

1. GlaxoSmithKline (GSK)
GSK is the exclusive manufacturer of FLONASE SENSIMIST, with a globally integrated supply chain that encompasses active pharmaceutical ingredient (API) production, formulation, packaging, and distribution. Their extensive investment in R&D and manufacturing facilities ensures high-quality standards compliant with global regulatory requirements, such as FDA, EMA, and other health authorities.

2. API Suppliers
The efficacy of FLONASE SENSIMIST hinges on the supply of fluticasone propionate, the active corticosteroid component. Multiple API producers supply fluticasone—primarily large multinational pharmaceutical ingredient manufacturers with stringent quality controls. These suppliers include firms with expertise in sterile manufacturing and inhalation-grade APIs, such as Apotex, Siegfried, and Mylan.

3. Packaging and Aerosol Devices Suppliers
The aerosol delivery system requires specialized pharmaceutical-grade pumps and spray mechanisms. Suppliers like AptarGroup and Bespak are key providers of nasal spray devices. These vendors produce precision-engineered nasal valve or pump components that meet GSK’s specifications, contributing significantly to the final product quality.


Distribution Channels and Supply Chain Partners

4. Wholesalers and Distributors
FLONASE SENSIMIST products are distributed globally through a network of authorized wholesale distributors. Major global pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health handle large-volume distribution within North America. These distributors supply retail outlets, pharmacies, hospitals, and healthcare providers.

5. Regional Distributors and Importers
In international markets, GSK often partners with regional distributors tailored to specific country regulations. This includes entities like Al Nahdi Medical Company in the Middle East and Nippon Kayaku in Japan, which facilitate good distribution practices, customs clearance, and regional compliance.


Supply Chain Challenges and Contingencies

Global supply chains face disruptions from manufacturing delays, raw material shortages, or regulatory shifts. GSK employs dual sourcing strategies for critical components like fluticasone API and spray devices, enabling resilience. Additionally, strategic inventory management and distributed manufacturing hubs mitigate risk, ensuring consistent supply of FLONASE SENSIMIST.


Legal and Regulatory Considerations

Suppliers must adhere to pharmaceutical Good Manufacturing Practices (GMP). GSK’s compliance with international standards ensures that all suppliers and manufacturing processes are regularly audited. Regulatory approvals, including FDA NDA approvals, impose strict quality controls on all components and distribution channels.


Future Supply Chain Developments

GSK continues to invest in manufacturing capacity, including expanding API production lines and regional manufacturing hubs, to meet increasing demand. Partnerships with innovative device suppliers are also underway to enhance spray efficacy and user experience, thus broadening supply chain robustness.


Key Players Summary

  • GSK (GlaxoSmithKline): Sole manufacturer and marketer of FLONASE SENSIMIST.
  • API Suppliers: Apotex, Siegfried, Mylan (fluticasone propionate).
  • Aerosol Device Producers: AptarGroup, Bespak.
  • Distributors & Wholesale Partners: McKesson, AmerisourceBergen, Cardinal Health.
  • Regional Distributors: Local entities tailored for various markets.

Key Takeaways

  • GSK remains the exclusive manufacturer, controlling the supply chain tightly.
  • Critical components include the fluticasone API and specialized nasal spray devices, supplied by multiple global vendors.
  • A resilient global distribution network sustains product availability across markets.
  • Supply chain risks are mitigated through dual sourcing and regional manufacturing hubs.
  • Regulatory compliance is integral for maintaining supply continuity and quality standards.

FAQs

1. Who are the main API suppliers for FLONASE SENSIMIST?
Major suppliers include companies like Apotex, Siegfried, and Mylan, providing pharmaceutical-grade fluticasone propionate to GSK.

2. Does GSK rely on third-party manufacturers for any component of FLONASE SENSIMIST?
Yes, GSK sources nasal spray device components from specialized suppliers such as AptarGroup and Bespak, while API production is likely managed through high-quality third-party manufacturers or internal facilities.

3. How does GSK ensure supply chain resilience for FLONASE SENSIMIST?
Through dual sourcing strategies, regional manufacturing hubs, and rigorous quality assurance programs, GSK maintains a stable supply despite global disruptions.

4. Are there regional differences in suppliers or distribution channels for FLONASE SENSIMIST?
Yes; regional distributors are tailored to local regulatory environments, with partnerships with local firms to facilitate distribution and compliance.

5. What role do packaging and aerosol device suppliers play in the supply chain?
They provide essential components that ensure the product’s efficacy and user safety, with quality and compatibility verified through strict quality controls mandated by GSK.


References
[1] GlaxoSmithKline official website. "FLONASE SENSIMIST product details."
[2] U.S. Food and Drug Administration (FDA). "ANDA approvals and manufacturing guidelines."
[3] Industry reports on pharmaceutical supply chains.
[4] AptarGroup and Bespak corporate disclosures on aerosol device manufacturing.
[5] Global pharmaceutical distribution network analyses.

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