Last updated: June 14, 2026
ADVAIR DISKUS 500/50 Suppliers: What companies manufacture, supply, and contract-build fluticasone propionate and salmeterol
ADVAIR DISKUS 500/50 (fluticasone propionate 500 mcg + salmeterol xinafoate 50 mcg) is supplied in the US by the GlaxoSmithKline (GSK) commercial organization. The underlying drug substance and finished-dose supply chain is a mix of company-owned manufacturing and contract manufacturing for inhaler components (device plus packaging) and active pharmaceutical ingredient (API) manufacture, with final drug product typically produced for GSK and distributed under GSK’s label.
Who supplies ADVAIR DISKUS 500/50 in the US market?
GSK is the marketing authorization holder and label manufacturer for ADVAIR DISKUS in the US. Finished product distribution is tied to GSK’s branded inhalation supply network.
Who is the manufacturer of record (label holder) for ADVAIR DISKUS 500/50?
- GSK (brand and label)
- GSK distribution network for the US retail channel
What roles do upstream suppliers play (API vs finished inhaler)?
ADVAIR DISKUS 500/50 supply generally splits into:
- Drug substances: fluticasone propionate (steroid) and salmeterol xinafoate (LABA)
- Inhaler/device system: Diskus blistered/strip-based DPI mechanism and housing
- Finished-dose assembly: filling dose into the device, packaging, and lot release
Which companies manufacture fluticasone propionate for ADVAIR DISKUS 500/50?
ADVAIR DISKUS uses fluticasone propionate as one API. The market supply for fluticasone propionate for branded products typically involves multiple API sources over time, but the specific active-manufacturing supplier for ADVAIR DISKUS 500/50 is not consistently published in a way that ties a single supplier to a specific NDC strength and year.
What is the API sourcing pattern for branded inhaled steroids?
- Multi-source API production across GSK and qualified contract manufacturers
- Periodic manufacturing site changes tied to capacity, lifecycle, and regulatory filings
Which companies manufacture salmeterol xinafoate for ADVAIR DISKUS 500/50?
ADVAIR DISKUS 500/50 uses salmeterol xinafoate as the LABA API. As with fluticasone propionate, salmeterol xinafoate is typically produced by either GSK manufacturing sites or qualified API contract manufacturers, with supply site shifts over time.
What does “supply” mean for salmeterol APIs in branded DPIs?
- API manufacturing
- API purification and salt formation control
- Batch release under GSK’s quality system for downstream filling
What companies supply the Diskus dry powder inhaler device for ADVAIR DISKUS 500/50?
The “Diskus” device is a critical component supplier category for ADVAIR DISKUS. Device supply typically includes:
- The plastic/metal inhaler body
- The dose counter and metering system
- The blister/strip components used to deliver measured doses of DPI powders
How does device procurement typically work for GSK DPIs?
- Device components sourced from qualified suppliers
- Assembly and final filling occur under controlled contract manufacturing or at GSK sites
- Packaging and distribution are GSK-controlled for the NDC label
How can you map ADVAIR DISKUS 500/50 suppliers to NDC, lot, and label information?
In US branded products, the most direct supplier mapping comes from:
- The package labeling for “Manufactured for” / “Distributed by”
- NDC labeler fields on FDA labeling databases
- FDA manufacturing site listings for the product (when present)
- Drug Master File (DMF) or site-specific API details when disclosed in filings, which often do not enumerate a single named “supplier” for each strength on a public dashboard
Where the supply chain is usually visible to buyers
- FDA label data (labeler and sometimes manufacturing site)
- COA references on individual lots (if shared in procurement workflows)
- Vendor qualification dossiers in controlled procurement settings
Is ADVAIR DISKUS 500/50 produced by GSK only, or is there contract manufacturing?
ADVAIR DISKUS is produced in a branded inhalation manufacturing network that commonly uses:
- GSK manufacturing sites for drug product release
- Contract manufacturing for device-related components and some finished dose production steps, depending on capacity and site strategy
What steps are most often contract-manufactured for DPIs?
- Device component fabrication
- Blister strip manufacturing
- Assembly and packaging under GMP contracts
What supplier risks exist for ADVAIR DISKUS 500/50 (API, device, and device component shortages)?
Supplier risks are usually concentrated in three areas:
- API availability (fluticasone and salmeterol sourcing)
- DPI device supply (metering components, blister/strip materials)
- Regulatory lot release capacity (GMP release timing and quality controls)
Common supply constraints in inhaled DPIs
- Steroid and LABA API crystallization and particle attributes that must match specs
- Device component lead times (metering parts and blister/strip films)
- Packaging line capacity and regional pack-out requirements
Key Takeaways
- GSK is the label manufacturer and primary supplier-facing entity for ADVAIR DISKUS 500/50 in the US market.
- Upstream supply is split by category: fluticasone propionate API, salmeterol xinafoate API, and Diskus DPI device components.
- Public data often does not name a single “supplier company” per NDC strength for each API and device component; procurement mapping is typically done via labeler/manufacturer-of-record data plus internal lot COAs and vendor qualification records.
- Device and API availability are the principal operational risks for continuity of supply of branded DPIs.
FAQs
What companies make ADVAIR DISKUS 500/50 in the US?
GSK is the label and distributor. Specific named manufacturers for each process step (API and device components) are not consistently tied to a single strength publicly.
Who are common suppliers for Diskus DPI devices used in ADVAIR?
Diskus device supply is sourced through qualified inhaler device component vendors and contract assembly partners, with vendor names varying over time.
Does ADVAIR DISKUS 500/50 rely on contract manufacturing?
Branded inhaler programs commonly use contract manufacturing for device-related steps and may also use contract drug product capacity depending on site loading and lifecycle strategy.
Where can I find the manufacturing site for a specific ADVAIR DISKUS 500/50 lot?
Use the carton/label “manufactured for/distributed by” and lot information, then map to FDA labeler/manufacturer fields and lot COAs used in procurement.
What parts of the supply chain are most likely to cause shortages for ADVAIR?
API batch release constraints for fluticasone propionate and salmeterol xinafoate, plus device component lead times for Diskus metering/blister systems.
References
- FDA. Drug Label Information for ADVAIR DISKUS (fluticasone propionate and salmeterol xinafoate). US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- GSK. Prescribing Information for ADVAIR DISKUS (fluticasone propionate and salmeterol xinafoate). GlaxoSmithKline. https://www.accessdata.fda.gov/scripts/cder/daf/
