Last updated: June 7, 2026
FLONASE ALLERGY RELIEF Suppliers: What Companies Manufacture, Formulate, and Distribute the Product
FLONASE ALLERGY RELIEF (fluticasone propionate, intranasal corticosteroid) is marketed in the US by GSK. In the US, the brand is supplied through GSK’s manufacturing and distribution network; the underlying drug substance and finished-dose manufacturing are governed by GSK’s registered facilities and supply chain. For FDA regulatory, supplier identification is anchored in the National Drug Code (NDC) listings, Orange Book references to the approved drug product, and the manufacturing sites listed in FDA records tied to each NDC strength and dosage form.
Scope note for “suppliers”: In practice, pharma “suppliers” for a branded intranasal include (1) finished-dose manufacturer(s) tied to each NDC, (2) drug substance source(s) for fluticasone propionate (often contract-linked but not always disclosed in public-facing sources), and (3) label/distributor entities appearing in FDA-facing product data.
Who manufactures FLONASE ALLERGY RELIEF (fluticasone propionate) and what are the NDC-linked sites?
Primary commercial marketer in the US: GlaxoSmithKline (GSK).
How to identify the actual manufacturer(s): For each FLONASE ALLERGY RELIEF NDC (strength, package size, device), the FDA’s product listings specify the labeler and the manufacturing location(s) tied to that NDC. In US filings, the manufacturer for finished dosage is generally the site(s) that produce and/or package the intranasal spray for that specific NDC.
What product configuration drives the supplier mapping?
FLONASE products vary by:
- Strength: common fluticasone propionate intranasal strengths are 50 mcg per actuation
- Delivery device: nasal spray
- Package: unit count and bottle form factor
- Country-specific labeling (US vs international can change labeler/manufacturer records)
Supplier identification therefore changes by NDC rather than by “brand name” alone.
What companies supply fluticasone propionate drug substance for FLONASE?
Fluticasone propionate is a specialty corticosteroid API. In branded supply chains, API sourcing can involve:
- GSK internal or owned supply
- Contract manufacturing of the API
- Multiple qualified suppliers to support commercial continuity and regulatory compliance
Publicly pinned “supplier of API” is rarely stated in plain language in consumer or brand pages. Supplier confirmation for the API layer typically comes from:
- FDA DMF linkages (Drug Master File) to the approved application components
- Site qualification references within FDA submission history
- Contract-manufacturing disclosures in inspections and regulatory records
For a defensible supplier list, the supplier must be tied to an FDA record or DMF-linked submission component for the specific product/NDC.
What is the Orange Book status of FLONASE ALLERGY RELIEF and why does it matter for supplier research?
Fluticasone propionate intranasal products have an Orange Book record tied to the approved NDA and NDA reference product. Orange Book information matters because:
- It ties the approved drug product to an NDA
- It helps confirm the exact formulation category and approved strengths
- It supports cross-checking NDCs against FDA manufacturing site listings
Practical impact on supplier mapping: Orange Book is not the direct “supplier list,” but it anchors the regulatory identity needed to pull the correct NDC manufacturing entries in the FDA datasets.
How do you identify FLONASE suppliers for each dosage strength and pack size?
Supplier mapping must be NDC-specific. The workflow in regulatory due diligence is:
- Enumerate all FLONASE ALLERGY RELIEF NDCs by strength and package configuration
- For each NDC, extract the FDA listing fields for:
- labeler/holder
- manufacturing/packing sites
- Normalize manufacturer names to parent entities (if plants are contract facilities)
- Cross-check with drug product packaging records and facility lists
Why this matters: A single brand can use multiple contract manufacturing and packaging sites across:
- different package formats
- different lots
- different lifecycle periods (line changes, facility transfers)
Which supplier facilities produce FLONASE intranasal spray in the US?
The only auditable way to list specific facilities is via the FDA’s NDC-linked manufacturing sites for each FLONASE NDC strength/package.
What your due diligence should extract per facility (plant-level):
- facility name and address as listed for the NDC
- manufacturing type (finished dosage vs packaging vs repacking where indicated)
- responsible company entity if the labeler differs from the plant owner
Are there contract manufacturers or third-party packagers for FLONASE?
Most branded intranasals have a split between:
- drug product manufacturing (active + excipients into final sterile/non-sterile intranasal dosage form)
- device assembly and packaging
- secondary packaging and distribution staging
Whether a given FLONASE NDC uses a contract packager depends on the NDC manufacturing site records. The presence of multiple manufacturing sites in FDA listings is a common marker for contract or network manufacturing.
What suppliers support the nasal delivery device and packaging for FLONASE?
For intranasal sprays, supplier layers include:
- pump/actuator assemblies (often from a specialized device vendor)
- bottle/closure components
- spray head manufacturing and assembly
- carton and insert printing suppliers
These suppliers are usually not listed by name in public brand materials. They are inferred through:
- FDA manufacturing and packaging site records
- component supply chain disclosures in quality agreements (not public)
- facility and inspection documentation
Actionable supplier identification for litigation or sourcing requires pulling the FDA manufacturing site and labeler for each NDC and then mapping to the physical operations at those sites.
How does distribution work for FLONASE ALLERGY RELIEF: who are the wholesalers and logistics suppliers?
Distribution in the US is handled through:
- GSK distribution channels and 3PL networks (varies by geography and contract)
- national wholesalers and specialty distributors depending on channel
Wholesaler/logistics company names typically do not appear as “suppliers” in FDA drug product listings. They show up in commercial operations, purchase orders, and EDI transaction networks.
What generics and authorized alternatives of fluticasone propionate can tell you about supplier footprints?
If generic fluticasone propionate intranasal products use the same plant network or similar formulation/device specifications, they can reveal:
- competing plants that qualify for the same dosage form
- similar packaging device lines
- overlapping contract manufacturers
However, supplier overlap is not guaranteed. Many generics use different manufacturing sites and may rely on different device supplier ecosystems.
Key Takeaways
- FLONASE ALLERGY RELIEF is marketed in the US by GSK, and the legally actionable supplier mapping is NDC-specific.
- The auditable supplier list for “who manufactures” is derived from FDA NDC-linked manufacturing/packing sites tied to each FLONASE NDC.
- API supplier identity (fluticasone propionate drug substance) is typically established via FDA DMF and NDA linkages, not by consumer-facing product pages.
- For device, packaging, and distribution “supplier” names, the public record is incomplete; the supplier footprint must be reconstructed from FDA manufacturing/packaging sites and regulatory records.
FAQs
1) How many manufacturing sites does FLONASE have in the FDA NDC database?
Depends on the number of FLONASE NDCs and whether each NDC uses the same or multiple manufacturing/packing facilities in FDA listings.
2) Are FLONASE manufacturers different by pack size or bottle format?
Yes. Supplier identity frequently changes by NDC due to different packaging lines and contract packaging.
3) Does GSK manufacture fluticasone propionate API for FLONASE?
It can, but API sourcing is often multi-sourced via internal and/or contract manufacture, typically validated through FDA DMF and NDA composition linkages.
4) Can I identify the exact plant producing FLONASE from the label?
The safest route is to match the NDC on the label to FDA NDC listing fields that name the manufacturing and packing sites.
5) Do FLONASE generics use the same suppliers?
Sometimes plants overlap, but not as a rule. You must compare NDC-linked manufacturing sites for each product and strength.
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- U.S. Food and Drug Administration. National Drug Code (NDC) Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
- U.S. Food and Drug Administration. Drug Master Files (DMF). https://www.fda.gov/drugs/drug-master-files-dmfs
