ADVAIR DISKUS 100/50: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077	NDA	GlaxoSmithKline LLC	0173-0695-00	1 INHALER in 1 CARTON (0173-0695-00) / 60 POWDER in 1 INHALER	2001-02-28
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077	NDA	GlaxoSmithKline LLC	0173-0696-00	1 INHALER in 1 CARTON (0173-0696-00) / 60 POWDER in 1 INHALER	2001-02-05
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077	NDA	GlaxoSmithKline LLC	0173-0697-00	1 INHALER in 1 CARTON (0173-0697-00) / 60 POWDER in 1 INHALER	2001-03-05
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 31, 2026

Executive summary

Brand product: ADVAIR DISKUS 100/50 (fluticasone propionate 100 mcg + salmeterol 50 mcg per inhalation).
US supply chain in practice: The product is marketed by GSK and supplied through a combination of GSK manufacturing sites and GSK-controlled contract manufacturing for device-ready inhalation product (Diskus) and packaging, with finished-goods distribution handled by GSK affiliates and logistics partners.
Key supplier nodes typically include: (1) API and intermediate supply (fluticasone propionate and salmeterol xinafoate), (2) inhalation blend and canister/dry powder processing, (3) Diskus device assembly, (4) finished-goods fill-pack, and (5) NDC-level distribution.
Actionable next step for sourcing, diligence, or litigation readiness is to map each supplier to the correct node and confirm it against Drug Master File (DMF) holders, Orange Book/labeling/manufacturing section entries, and GMP inspection records tied to the specific dosage strength.

Who manufactures ADVAIR DISKUS 100/50 (fluticasone/salmeterol) in the US?

ADVAIR DISKUS is a GSK inhalation combination product. For “suppliers,” the most decision-relevant answer is the set of entities listed as manufacturers/packagers for the finished dosage form on the US product labeling and in regulatory databases tied to the specific NDC strength.

What entities typically appear as ADVAIR DISKUS manufacturers on labeling

For US respiratory inhalation products like ADVAIR DISKUS, the label’s “Manufactured for” / “Distributed by” sections typically identify:

Marketing authorization holder / labeler (GSK)
Finished-goods manufacturer(s) (GMP site(s) for drug product)
Packager(s) (where packaging is performed, which can differ from bulk manufacturing)
Parallel roles: separate entities can handle blending, fill into Diskus cartridges, device assembly, and final packaging.

Supply chain mapping you can use for procurement due diligence

Use a node-based supplier map so you can qualify vendors for the exact step you need:

API supplier node
- Fluticasone propionate API
- Salmeterol xinafoate API
Drug substance processing node
- API crystallization, milling, particle-size control, polymorph control
Dry powder blend node
- Mixing with excipient (commonly lactose monohydrate in DPI formulations)
Inhaler fill and device node
- Powder filling into device blister structure/cartridge components
- Diskus device assembly (hinge and dose counter components)
Final packaging and distribution node
- Carton labeling, lot control, GTIN and pharmacy distribution

Which suppliers provide fluticasone propionate for ADVAIR DISKUS 100/50?

For ADVAIR DISKUS, fluticasone propionate is the corticosteroid API. Supplier diligence should focus on:

DMF holders and approved manufacturing sites for fluticasone propionate
Evidence of polymorph and particle-size control for DPI performance
Whether the supplier provides API only or also supplies drug substance intermediates and milled material

What to verify for DPI fluticasone propionate supply

Polymorphic form consistency (DPI inhalation performance is sensitive to solid-state properties)
Particle size distribution and surface area control
Residual solvent and impurity profile aligned to GSK specifications

Which suppliers provide salmeterol xinafoate for ADVAIR DISKUS 100/50?

Salmeterol xinafoate is the long-acting beta2-agonist (LABA) API in ADVAIR DISKUS. Supplier diligence should focus on:

DMF holders and approved manufacturing sites
Salt form consistency (xinafoate) and impurity thresholds
Compatibility with DPI blending and excipient system

What to verify for DPI salmeterol xinafoate supply

Salt form identity and stability
Impurity control for trace related substances
Physical form and flow properties suitable for uniform dosing in dry powder blends

How is ADVAIR DISKUS 100/50 manufactured: drug product, Diskus device, and packaging suppliers?

ADVAIR DISKUS is a metered dose dry powder inhaler (DPI) delivered via the Diskus mechanism. Supplier responsibilities are often split between:

Drug product manufacturing (blend and fill)
Device assembly (Diskus components)
Packaging and distribution

Typical manufacturing step supplier roles

Blend rooms: controlled humidity mixing to manage powder cohesion
Filling lines: dose uniformity validation by lot release testing
Device assembly and dose counter calibration
Final cartons and NDC-level packaging

Qualification gate criteria suppliers must meet

GMP for inhalation dosage forms
Process validation for dose uniformity and aerodynamic performance
Stability testing aligned to label shelf-life and storage conditions

What companies supply the Diskus inhaler device components for ADVAIR DISKUS 100/50?

The Diskus device contains multiple components (plastic housing, mouthpiece, dose counter mechanism). In many DPI programs:

Some component manufacturing is outsourced to specialized device component suppliers
Final device assembly is handled by a GMP device assembly site linked to the finished product manufacturer

Which supplier category is most relevant for procurement

GMP device assembly supplier (not only component fabrication)
Confirmed via finished product labeling/manufacturing section and inspection history

What is the Orange Book status of ADVAIR DISKUS 100/50 and how does it affect supplier access?

ADVAIR DISKUS is a branded combination DPI. Supplier access is constrained by:

Patent estate affecting generic ANDA filing strategies
Exclusivity and associated regulatory barriers for immediate generic entry
Controlled supply and formulation/device IP constraints that can limit third-party participation

Where Orange Book information matters

For suppliers, Orange Book mappings affect:

Whether generic contracts can be sourced for authorized supply chains
Licensing needs if you want to replicate specific product configurations

When do generic and biosimilar risks translate into supplier changes for ADVAIR DISKUS 100/50?

ADVAIR DISKUS is not a biologic, so “biosimilar” does not apply. Generic risk drivers matter for:

Contracting new suppliers for APIs or drug product manufacturing
Potential shifts in sourcing once generics enter or once patents expire

What to monitor

Paragraph IV filings that target the combination product
Patent expirations that unlock new supplier relationships for generic manufacturers
Market share shifts that can force brand supply reoptimization

Patent and litigation: do they affect who can supply ADVAIR DISKUS 100/50?

Yes, through the product ecosystem:

Brand supply for the branded product remains with the authorized manufacturer ecosystem regardless of litigation
Litigation more directly impacts new entrants that want to supply generics, authorized generics, or component equivalents

Supplier diligence lens

If you are evaluating a new supplier for inhalation DPI supply:

demand clarity on whether the supplier’s work is aimed at branded supply, authorized generic, or independent generic
ensure the supplier’s manufacturing scope is compatible with your intended market and regulatory posture

Commercial sourcing: what are the practical supplier targets for ADVAIR DISKUS 100/50?

For procurement and partner selection, the most practical “supplier list” is organized by function:

Finished drug product manufacturer
Diskus device assembly manufacturer
Contract packaging and labeling entity
API suppliers for fluticasone propionate and salmeterol xinafoate
Logistics/distribution partner handling NDC-level shipments

Minimum diligence documents

GMP certificates for inhalation manufacturing and device assembly
CoA and lot release test package alignment with label specifications
Regulatory alignment: DMF references or site approvals that correspond to the APIs used

Key Takeaways

ADVAIR DISKUS 100/50 is supplied through a GSK-controlled manufacturing and distribution ecosystem with supplier responsibilities split across API, dry powder blend/fill, Diskus device assembly, and finished-goods packaging.
For actionable supplier identification, the most reliable source is the finished product label/manufacturing section tied to the exact NDC strength, supplemented by DMF holders for fluticasone propionate and salmeterol xinafoate.
Patent and regulatory status mainly affects third-party generic supply entry, not the brand’s immediate supplier responsibilities.

FAQs

1) Who is the labeler or marketing authorization holder for ADVAIR DISKUS 100/50 in the US?
GSK is the marketing authorization holder/labeler for ADVAIR DISKUS products in the US.

2) Are ADVAIR DISKUS 100/50 suppliers different for API vs finished drug product?
Yes. API is commonly sourced from API manufacturing networks, while the finished DPI involves drug product processing plus Diskus device assembly and final packaging.

3) What supplier function matters most for inhaler performance in ADVAIR DISKUS 100/50?
Dry powder blending, fill uniformity, and device-dose delivery calibration are the highest-impact supplier functions for DPI performance.

4) Do generic launch timelines change who supplies ADVAIR DISKUS branded product?
Usually not. Generic timelines affect new entrant supply, while branded product sourcing typically stays within the brand’s approved manufacturing system.

5) Does ADVAIR DISKUS have biosimilar competition risks?
No. ADVAIR DISKUS is a small-molecule DPI combination, so “biosimilar” does not apply.

References

FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
US Prescribing Information and product labeling for ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder), including “Manufactured for/Distributed by” sections.

Suppliers and packagers for ADVAIR DISKUS 100/50