BREO ELLIPTA: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275	NDA	GlaxoSmithKline LLC	0173-0859-10	1 TRAY in 1 CARTON (0173-0859-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER	2013-08-26
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275	NDA	GlaxoSmithKline LLC	0173-0859-14	1 TRAY in 1 CARTON (0173-0859-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER	2013-08-26
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275	NDA	GlaxoSmithKline LLC	0173-0882-10	1 TRAY in 1 CARTON (0173-0882-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER	2015-04-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 25, 2026

BREO ELLIPTA suppliers: Who manufactures, supplies, and sources the inhalation medicines and devices

Breo Ellipta (fluticasone furoate + vilanterol) is supplied through a vertically integrated branded supply chain led by GlaxoSmithKline (GSK) for the finished drug product and global packaging logistics. Primary sourcing is divided into (i) active pharmaceutical ingredient (API) and critical intermediates, (ii) inhaler device components and subassemblies, and (iii) primary packaging and distribution. The market-facing “supplier” footprint is typically expressed via GSK’s contract manufacturing network for finished dosage forms and via specialized device and packaging providers used for Ellipta platform production.

What the market needs to know at deal and risk level: Breo Ellipta’s supplier landscape is dominated by GSK-controlled manufacturing and controlled-quality logistics, with “supplier lists” used for procurement and regulatory traceability rather than an open, easily auditable public roster of API vendors. As a result, practical supplier due diligence in licensing, generic entry, or supply disruption planning typically focuses on finished dose manufacturers for Ellipta, site approvals for the specific NDA/BLA and strengths, and device/packaging components used in the Ellipta platform.

Who supplies BREO ELLIPTA finished drug product and inhaler systems?

Answer (market structure): Finished Breo Ellipta is manufactured under GSK’s branded supply chain, using contract manufacturing and GSK manufacturing sites for the Ellipta inhaler platform and the filled dosage. Suppliers are usually identified by manufacturing site on the label and by FDA facility listings tied to the drug’s application and product configuration.

What to look up in regulatory filings for supplier identification

For “who supplies,” the most actionable proxy is:

Finished dosage form manufacturing facility listed in FDA labeling/CMC sections
Batch release and packaging sites listed on carton/label and in FDA databases
Device component manufacture and assembly tied to the Ellipta platform packaging lines

How supplier traceability is handled for Ellipta

Ellipta production is a “system” of:

Drug formulation and powder filling
Metering and dose control components inside the device
The tray and mouthpiece assembly
Retail packaging (carton, blister equivalent where applicable, labels, leaflets)
Cold chain is not typically required for dry powder; controls focus on moisture, particulate, and dose uniformity

Which companies manufacture the Ellipta inhaler device used for BREO ELLIPTA?

Answer (platform reality): The Ellipta device is manufactured by specialized inhaler device suppliers and assembled through a device supply chain aligned with GSK’s production sites. Breo Ellipta uses the same Ellipta inhaler architecture as other GSK dry powder inhalers in the class.

What device-supplier categories exist

Metering and dose counter components (mechanical subassemblies)
Mouthpiece and shutter mechanism components
Drug containment elements integrated into the device platform
Primary packaging and device-lot assembly into the commercial kit

Why “device suppliers” are harder to pin down publicly

Device suppliers are often listed in:

Component procurement and device master records (company-internal)
NDA device description sections, sometimes without a public vendor name
Supplier qualification documentation held by the applicant (GSK) and reflected indirectly through manufacturing site approvals

In practice, supplier mapping for litigation or licensing depends on site-level approvals rather than vendor names.

What suppliers provide fluticasone furoate and vilanterol APIs for BREO ELLIPTA?

Answer (sourcing model): API suppliers are typically qualified manufacturers of fluticasone furoate and vilanterol and their intermediates under controlled procurement. Breo Ellipta’s APIs are supplied through GSK’s API supply chain and/or qualified third-party manufacturers.

API supply chain categories

Fluticasone furoate API producers and intermediate chemistry suppliers
Vilanterol API producers and key intermediate suppliers
Finished blend and particle engineering steps (where performed by a qualified supplier)
Powder processing and blending suppliers for dose uniformity

Why API vendor names are not consistently public

NDA/CMC disclosures often provide:

Drug substance specifications and manufacturing description
In some cases, named sites rather than named commercial vendors
Confidential manufacturing details not mapped to externally marketed “supplier” rosters

For an acquisition or generic challenge, teams typically use facility approvals and controlled documentation pathways to identify the actual supplier.

How many suppliers support BREO ELLIPTA across API, device, packaging, and release?

Answer (operating range): For a branded, global dry powder inhaler platform like Ellipta, the supplier map usually spans multiple qualified sites:

At least one (often more) for drug substance
At least one for finished dose powder filling and device integration
At least one for packaging and distribution release
Multiple device component suppliers feeding device assembly

The count varies by geography, discontinuation risks, capacity, and supply continuity planning.

What “supplier count” means in practical due diligence

The number of FDA-listed manufacturing sites is the reliable metric
The number of commercial vendors for components can be higher, but not always exposed publicly

Where are BREO ELLIPTA manufacturing sites located and how does that affect supplier risk?

Answer: Supplier risk is primarily driven by:

Whether the site is dedicated to Ellipta platform products or shared lines
Whether regulatory inspection history supports sustained approvals
Whether device assembly and powder filling occur in a single line or multiple steps across sites

Key supply-risk dimensions

Single-site dependence for a strength (100% of a market’s demand concentrated)
Device component availability during mechanical parts shortages
Powder filling capacity and moisture-control failures
Quality deviations and batch release timing (not vendor name alone)

What generic entry risks exist for BREO ELLIPTA from supplier leverage or substitution?

Answer: Generic risk hinges less on “supplier identity” and more on:

Ability to replicate the dose delivery system and inhalation performance
Access to compatible excipient/powder processing know-how
Manufacturing capability at an FDA-inspected, validated site
Device similarity and ability to meet performance specs

Supplier-related barriers for competitors

Limited vendor capacity for inhaler subassemblies
Proprietary device calibration and dose counter mechanics requirements
Powder blend process know-how and particle-size distribution control

What patents or exclusivity do suppliers’ manufacturing schedules depend on for BREO ELLIPTA?

Answer: Supplier timelines are constrained by:

Patent-protected composition and delivery performance
Process and method patents affecting manufacturing and testing
Regulatory exclusivity tied to the original approvals and subsequent line extensions

This shapes which manufacturers can take on work and when competitors can ramp.

How does BREO ELLIPTA supply compare with other GSK Ellipta products (Trelegy, Anoro, etc.)?

Answer: BREO Ellipta and other GSK Ellipta products share a platform but differ in:

API identity and formulation parameters
Strengths and dose uniformity specs
Device calibration (depending on dosing strength and formulation properties)

This means device suppliers may overlap while API suppliers do not.

What does the Orange Book status imply for supplier transition and licensing?

Answer: The Orange Book status (listed patents and exclusivity) determines:

When generic manufacturers can enter with Paragraph IV challenges
When contract manufacturers can take on third-party production without infringing risk
When process changes might trigger “new” patent exposure

Licensing and supply chain leverage

A licensed generic entry often requires synchronized regulatory strategy and manufacturing readiness.
Supplier contracts are commonly conditional on legal and regulatory clearance.

Key Takeaways

Breo Ellipta’s supplier landscape is primarily GSK-led, with supplier roles best mapped by FDA-listed manufacturing and packaging sites rather than public “vendor lists.”
The “supplier problem” splits into API supply, finished dose manufacture and powder filling, and Ellipta device components and assembly.
Supplier risk in the commercial supply chain is driven by site dependence, regulatory inspection outcomes, and platform manufacturing capacity, not by publicly advertised vendor identities.
For licensing and generic entry planning, the most actionable supplier due diligence centers on site capability and regulatory approval status aligned to the specific Breo strengths and configurations.

FAQs

How do I identify the actual manufacturer of BREO ELLIPTA on the label and in FDA data?
Use the product’s FDA labeling/manufacturing section to find the finished dosage form manufacturer, packager, and distributor release sites for the specific strength.
Do BREO ELLIPTA’s API suppliers overlap with those of other fluticasone furoate products?
Overlap can occur at the level of qualified API intermediates and drug substance manufacturing sites, but it is not guaranteed across strengths and jurisdictions.
Are Ellipta device suppliers public for BREO ELLIPTA?
Device component vendor names are often not directly disclosed; supplier identification is typically done via device manufacturing/assembly sites and regulatory descriptions.
What supply constraints most often threaten BREO ELLIPTA availability?
The main constraints are powder filling/processing capacity, device component availability, and batch release timing tied to quality events at manufacturing sites.
How does Paragraph IV generic strategy change supplier contracting for inhalers like BREO ELLIPTA?
It typically shifts from broad contingency contracting to legally cleared, site-approved manufacturing, aligned with launch timelines and patent-expiration risk.

References (APA)

U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (search: Breo Ellipta).
U.S. FDA. Drugs@FDA (search: Breo Ellipta).
U.S. FDA. Inhalation Drug Products: CDER facility and labeling information resources.
GSK. Breo Ellipta prescribing information (current U.S. label).

Suppliers and packagers for BREO ELLIPTA

BREO ELLIPTA