Suppliers and packagers for FLOVENT DISKUS 50

FLOVENT DISKUS 50

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833	NDA	A-S Medication Solutions	50090-1245-0	1 INHALER in 1 CARTON (50090-1245-0) / 60 POWDER, METERED in 1 INHALER	2007-05-08
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-7076-0	1 INHALER in 1 CARTON (50090-7076-0) / 60 POWDER, METERED in 1 INHALER	2023-10-30
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-7962-0	1 INHALER in 1 CARTON (50090-7962-0) / 60 POWDER, METERED in 1 INHALER	2023-10-30

Suppliers and packagers for FLOVENT DISKUS 50

Last updated: May 25, 2026

FLOVENT DISKUS 50 Suppliers: Who Makes Fluticasone Propionate, Inhalation Powder, and the Device?

Flovent Diskus 50 (fluticasone propionate inhalation powder) is manufactured as a branded inhalation product under a portfolio that includes the drug substance and the Diskus dry-powder inhaler system. The practical “supplier” map is the set of (1) drug-substance manufacturers of fluticasone propionate, (2) inhalation-product formulators and fill-finish sites for the Diskus powder, and (3) the inhaler device/component and assembly suppliers that produce the Diskus cartridge and device used by FDA-labeled manufacturers.

Who are the manufacturers and suppliers behind FLOVENT DISKUS 50?

Answer (industry view): The FDA-labeled manufacturer of Flovent Diskus products acts as the marketing authorization holder for the product and coordinates supply of fluticasone propionate (drug substance), formulation and fill (drug product), and the Diskus device assembly (container-closure and delivery system). For supplier diligence and vendor qualification, the key entities to identify are the FDA “labeler” (application holder), the listed manufacturing sites in the approved application, and the contract manufacturers handling either (a) powder manufacturing and filling or (b) device component manufacturing and assembly.

Critical diligence targets

• Application labeler (FDA labeler): the entity responsible for the NDA/ANDA label and product release chain for Flovent Diskus.
• Drug-substance suppliers: fluticasone propionate API manufacturers (often multiple sources).
• Drug-product manufacturing sites: sites that manufacture the inhalation powder and perform fill/finish.
• Device suppliers: component and assembly partners for the Diskus inhaler, including dose counter and inhalation mechanics.

What does the FDA labeling imply about FLOVENT DISKUS 50 suppliers?

In the US, the supplier network for an inhaled NDA product is reflected in:

• The FDA “labeler” on the package insert and labeling history.
• The current Good Manufacturing Practice (cGMP) manufacturing sites listed in the approved application.
• Contract manufacturing relationships that show up in inspection records, importation records, and (for commercial investors) supply-chain due diligence summaries.

For Flovent Diskus, the supplier landscape is typically concentrated around a small number of inhalation-experienced contract manufacturers for:

• dry-powder blending and milling,
• dose uniformity and moisture control,
• filling into the Diskus dose compartments or cartridges,
• and device assembly compatible with the labeled performance specifications.

Which companies supply fluticasone propionate API for FLOVENT DISKUS 50?

Answer: Fluticasone propionate API is sourced from established small-molecule steroid API suppliers that support respiratory inhalation programs. The specific API supplier(s) used for a given branded lot can change across time based on sourcing, compliance, and availability.

Supplier diligence checklist for API

• Confirm the API manufacturing site(s) associated with the approved NDA manufacturing plan.
• Cross-check with importer-of-record / entry data (for actual flow).
• Validate DMF status and cross-reference to the NDA where used.
• Track changes to quality agreements and supplier change notifications (annual product reviews).

How many API sources typically exist for inhaled fluticasone products?

Commercial inhaled steroid programs often support multiple qualified API sources to mitigate supply risk. For investors and supply-chain buyers, the count is determined by the NDA’s approved control strategy and the DMF landscape supporting the application.

Who manufactures the FLOVENT DISKUS 50 drug product (powder fill-finish)?

Answer: The drug product is manufactured by the NDA holder or its contract manufacturing partners at one or more cGMP sites that specialize in dry-powder inhalation technology.

What operations are performed by FLOVENT DISKUS 50 suppliers?

Drug-product suppliers for inhalation powders typically cover:

• API micronization / particle engineering support (where applicable),
• blending with inhalation excipients to meet dispersibility,
• moisture conditioning and environmental controls,
• powder fill into Diskus compartments at controlled dose uniformity,
• primary packaging and labeling,
• and product release testing for aerosol performance and stability.

What companies supply the Diskus inhaler device used for FLOVENT DISKUS 50?

Answer: The Diskus system involves a dedicated device platform with mechanical dose loading, dose metering, and inhalation air path geometry. Device supply usually comes from a device platform manufacturer or an inhaler assembly network that the NDA holder qualifies and audits.

How does device sourcing affect supplier qualification and IP risk?

Device supply impacts:

• extractable/leachable studies and compatibility with the powder,
• mechanical performance specs (dose counter correctness, actuation force, and airflow resistance),
• and component-level change control that can trigger comparability assessments.

What supply chain constraints matter most for FLOVENT DISKUS 50?

Answer: For Flovent Diskus 50, the highest-risk bottlenecks are typically:

1. Dry-powder inhalation manufacturing capacity (blending, milling control, and high-precision filling),
2. device component availability (plastic components, springs, seals, and counter mechanisms),
3. quality system stability (deviations, batch failures, and inspection readiness).

What drives supplier switching for branded inhalation products?

• regulatory requirements and inspection outcomes,
• supply continuity for APIs and device components,
• cost reduction and capacity rebalancing,
• and change-control feasibility for device and formulation parameters.

Can generics source from the same suppliers as FLOVENT DISKUS 50?

Answer: Generic entrants commonly rely on different manufacturing partners for device packaging and powder fill-finish while using qualified inhalation device designs that must match labeled performance. Even when generic companies use the same contract manufacturer as the brand, the approved manufacturing process and device compatibility must support their own regulatory submission.

How to map “suppliers” into a deal-ready diligence package for FLOVENT DISKUS 50

For licensing, acquisition, or investment diligence, the actionable supplier map is built around:

1) Labeler and NDA-related manufacturing responsibilities

• Identify the FDA application holder (the marketing labeler).
• Pull the approved manufacturing site list tied to product release.

2) Drug-substance supply

• Identify API DMF(s) and cross-references linked to the NDA.
• Confirm API release testing requirements and impurity specs for the branded product.

3) Drug-product fill-finish and release

• Identify the fill/finish sites and their validated powder process steps.
• Confirm stability program ownership and release specifications for inhalation performance.

4) Device supply and assembly

• Identify device component vendors and assembly locations.
• Validate change-control governance for device components that impact dosing delivery.

Key Takeaways

• “Suppliers” for Flovent Diskus 50 should be mapped to three categories: API, dry-powder drug-product manufacturing and fill-finish, and Diskus device/component assembly.
• The only vendor set that is reliably deal-relevant is the one tied to the FDA-labeled manufacturer’s approved manufacturing plan and its qualified contract manufacturers.
• Supplier risk concentrates in inhalation powder manufacturing capacity, device component availability, and change-control stability across powder-device integration.

FAQs

1. What information should I pull from FDA labeling to identify FLOVENT DISKUS 50 manufacturing sites?
2. How can I determine the fluticasone propionate API source for a specific branded lot of FLOVENT DISKUS 50?
3. Do device suppliers for Diskus change over time, and how is that reflected in regulatory submissions?
4. What cGMP capabilities are required to manufacture dry-powder inhalation products like FLOVENT DISKUS 50?
5. When generic inhalators differ in device supply, what matters most for regulatory and performance comparability?

References

(No sources were cited because no supplier list or labeler/manufacturing-site detail was provided in the prompt.)