Suppliers and packagers for generic pharmaceutical drug: fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482	NDA	GlaxoSmithKline LLC	0173-0887-10	1 TRAY in 1 CARTON (0173-0887-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER	2017-09-18
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482	NDA	GlaxoSmithKline LLC	0173-0887-14	1 TRAY in 1 CARTON (0173-0887-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER	2017-09-18
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482	NDA	GlaxoSmithKline LLC	0173-0887-61	1 TRAY in 1 CARTON (0173-0887-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER	2017-09-18
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482	NDA	GlaxoSmithKline LLC	0173-0893-10	1 TRAY in 1 CARTON (0173-0893-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER	2020-09-09
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482	NDA	GlaxoSmithKline LLC	0173-0893-14	1 TRAY in 1 CARTON (0173-0893-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER	2020-09-09
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482	NDA	GlaxoSmithKline LLC	0173-0893-61	1 TRAY in 1 CARTON (0173-0893-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER	2020-09-09

Suppliers for Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate

Last updated: February 19, 2026

Major manufacturers supply these active pharmaceutical ingredients (APIs) across global markets. Each compound is produced primarily by established pharmaceutical companies, with some sourcing from contract manufacturing organizations (CMOs).

Fluticasone Furoate

Leading Suppliers:

• GlaxoSmithKline (GSK): Patent holder; supplies both branded and generic formulations.
• Macleods Pharmaceuticals: Offers API and finished dosage forms.
• Sun Pharmaceutical Industries: Produces fluticasone furoate APIs for respiratory medications.
• Aurobindo Pharma: Has API manufacturing capacity.
• Cipla: Supplies APIs for inhaler products.

Key Details:

• API produced primarily in India and Europe.
• GSK maintains proprietary control over the branded API.
• Contract manufacturers are used for generic API supply.

Umeclidinium Bromide

Leading Suppliers:

• GlaxoSmithKline: Original developer and supplier.
• Theravance Biopharma: Collaborator in inhaled muscarinic antagonists.
• Glenmark Pharmaceuticals: API manufacturing capabilities.
• MEGGLE: Produces pharmaceutical intermediates.

Key Details:

• API produced mainly in the US and India.
• GSK’s patent protections limit generic entry until expiration.

Vilanterol Trifenatate

Leading Suppliers:

• GSK: Proprietary rights and primary supplier.
• Sun Pharmaceutical Industries: Potential contract manufacturer.
• Cipla: Has capabilities for API and formulations.
• Macleods Pharmaceuticals: Produces APIs for inhalation products.

Key Details:

• API manufacturing concentrated in India.
• The API is often supplied through licensed agreements.

Notes on Market Dynamics

• Most APIs are produced in regulated markets such as India, China, and Europe.
• US FDA and EMA compliance influence manufacturing and supplier choices.
• Patent protections, especially for GSK products, restrict generic competition for several years.
• Contract manufacturing organizations participate heavily in API supply chains for cost efficiency.

Summary Table

Drug	Main Suppliers	Regions of Production	Patent Status
Fluticasone Furoate	GSK, Macleods, Sun Pharma, Aurobindo, Cipla	India, Europe	Patent held (GSK)
Umeclidinium Bromide	GSK, Glenmark, MEGGLE	US, India	Patent held (GSK)
Vilanterol Trifenatate	GSK, Sun Pharma, Cipla, Macleods	India, US	Patent held (GSK)

Key Takeaways

• GSK dominates the supply of these APIs, especially for proprietary products.
• Indian manufacturers like Cipla, Macleods, and Sun Pharma are leading exporters of generic APIs.
• Patent expiration will influence future supplier options, potentially increasing generic API availability.
• Quality standards and regulatory compliance shape supplier selection, especially for markets like the US and Europe.

FAQs

1. Who are the primary manufacturers of fluticasone furoate?
GSK is the original patent holder and primary supplier; several Indian companies produce generic APIs under licensing agreements.

2. When do patent protections for these APIs expire?
Patent timelines vary; generally, GSK holds patents until 2025-2030, after which generic manufacturing is expected to increase.

3. Are contract manufacturing organizations common for these APIs?
Yes. CMOs are widely used, especially for cost-effective production in India and China.

4. How do quality standards influence supplier selection?
Suppliers must comply with cGMP and meet regulatory standards (FDA, EMA), which affects approval and market access.

5. Are there regulatory barriers to switching suppliers?
Yes, especially for APIs used in inhalation devices, requiring validation and compliance with local regulatory agencies.

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References

[1] U.S. Food and Drug Administration. (2022). List of approved drug products.

[2] European Medicines Agency. (2023). Summary of medicinal product characteristics.

[3] MarketWatch. (2023). Global inhaler APIs market analysis.