Suppliers and packagers for generic pharmaceutical drug: UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975	NDA	GlaxoSmithKline LLC	0173-0869-06	1 TRAY in 1 CARTON (0173-0869-06) / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER	2014-01-31
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975	NDA	GlaxoSmithKline LLC	0173-0869-10	1 TRAY in 1 CARTON (0173-0869-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER	2014-01-31
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-134-97	1 TRAY in 1 CARTON (66993-134-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER	2025-04-11

Suppliers for the Pharmaceutical Drug: UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Last updated: July 29, 2025

Introduction

The combination of umeclidinium bromide and vilanterol trifentate represents a pivotal therapeutic option primarily for inhalation in treating chronic obstructive pulmonary disease (COPD) and certain asthma cases. As the demand for this fixed-dose combination grows globally, identifying reliable suppliers ensures consistent quality, regulatory compliance, and competitive supply chains. This report provides an in-depth analysis of key suppliers for both active pharmaceutical ingredients (APIs), focusing on manufacturing capabilities, geographic distribution, market share, and strategic positioning.

Understanding the Components

• Umeclidinium Bromide: A long-acting muscarinic antagonist (LAMA) that antagonizes M3 muscarinic receptors, leading to bronchodilation. It is marketed under brand names like Incruse Ellipta.

• Vilanterol Trifenatate: A long-acting beta2-adrenergic agonist (LABA) offering bronchodilation effects, often combined with other agents for the management of respiratory diseases.

The fixed-dose combination (FDC) enhances therapeutic efficacy by providing dual bronchodilation with once-daily dosing, facilitating improved adherence and symptom control.

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Leading Suppliers for Umeclidinium Bromide

Manufacturers and Key Players

1. GlaxoSmithKline (GSK)

   • Market Role: Original developer and proprietary supplier of umeclidinium bromide.
   • Manufacturing Capabilities: GSK operates extensive API manufacturing facilities globally, including sites in the UK, USA, and Asia, adhering to stringent GMP standards.
   • Supply Volume & Distribution: As the originator, GSK supplies the drug primarily for its proprietary inhaler products, with strategic licensing agreements to expand access.

2. Suzhou Golden Bridge Pharmaceutical Co., Ltd. (China)

   • Market Role: Leading Chinese API producer, supplying to both domestic and international markets.
   • Capabilities: Possesses advanced chemical synthesis and large-scale fermentation infrastructure, ensuring high purity and batch consistency.
   • Regulatory Status: Approved by Chinese authorities and increasingly seeking international certifications (e.g., EMA, FDA).

3. Hanmi Pharmaceuticals (South Korea)

   • Market Role: Noted for innovative respiratory APIs and licensed production.
   • Capabilities: Focused on R&D and manufacturing, with global supply agreements for imports into the US and EU.

4. Other Suppliers

   • Several smaller API manufacturers in India (e.g., Laurus Labs, Cipla) are developing or producing production-grade umeclidinium bromide for regional markets under licensing agreements with GSK or via their own formulations.

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Key Suppliers for Vilanterol Trifenatate

Manufacturers and Core Suppliers

1. GSK

   • Principal Supplier: GSK is the original innovator and primary supplier of vilanterol trifentate.
   • Manufacturing Facilities: Located in the UK and the US, with multiple cGMP-compliant plants dedicated to inhalation APIs.
   • Supply and Licensing: Supplies both for proprietary products and licensing arrangements with generic manufacturers targeting global markets.

2. Booth-Meyers Pharmaceuticals (USA)

   • Specialization: Produces specialized inhalation APIs, including long-acting beta2-agonists.
   • Capabilities: Advanced synthesis and purification methods, quality assurance with a focus on inhalation-grade APIs.

3. APIs from Chinese Manufacturers

   • Companies such as Zhejiang Hisun Pharmaceuticals and Shanghai Green Valley Pharmaceuticals are investing in the synthesis of vilanterol-related compounds for local and export markets. They often seek regulatory approvals to widen their distribution scope.

4. Other Operational Players

   • Indian API producers, such as Cipla and Aurobindo Pharma, are working on generic versions or equivalents, often under licensing or collaborative agreements with GSK or other originators.

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Supply Chain Dynamics

The global supply of umeclidinium bromide and vilanterol trifentate hinges on several factors, including manufacturing capacity, regulatory approvals, geopolitical stability, and intellectual property rights.

• Patents and Licensing: GSK holds key patents that influence licensing and generic entry strategies. When patents expire or are licensed, generic suppliers concentrate on producing the APIs under regulatory approvals.

• Regional Variations: While North America and Europe predominantly rely on original API suppliers (e.g., GSK), emerging markets like China, India, and South Korea host robust generic API manufacturing capabilities.

• Regulatory Compliance: Suppliers must meet stringent GMP standards for inhalation APIs, which influences market access and international trade.

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Market Challenges and Opportunities

Challenges

• Intellectual Property Constraints: Patent exclusivities can delay generic manufacturing.
• Manufacturing Complexity: High purity standards for inhalation APIs demand advanced, costly manufacturing processes.
• Regulatory Hurdles: Navigating diverse regional regulations can hinder timely market entry for small and medium-sized suppliers.
• Supply Chain Disruptions: Global logistics, geopolitical tensions, and raw material shortages can impact supply chains.

Opportunities

• Expanding Manufacturing Bases: Countries like India and China are scaling up API production capabilities.
• Strategic Licensing: Collaborations with GSK and licensors expand manufacturing rights and market access.
• Alternative Manufacturing Processes: Innovations in green chemistry and continuous manufacturing reduce costs and enhance scalability.

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Regulatory and Quality Considerations

Suppliers must obtain regulatory approvals from agencies such as the FDA, EMA, and Chinese NMPA, ensuring APIs meet required pharmacopoeial standards. Quality assurance measures include rigorous batch testing, impurity profiling, and stability assessments. Suppliers with proven compliance have competitive advantages in bid processes, especially for regulated markets.

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Future Trends and Strategic Outlook

The ongoing development of biosimilars and generics indicates a shift toward more competitive sourcing options. Advances in synthesis technology may reduce production costs and improve API purity. Suppliers investing in R&D and regulatory compliance are positioned to capitalize on increasing demand for combination therapies in respiratory diseases.

Partnerships and Licensing

Manufacturers often create strategic alliances to expand their API portfolios. Licensing agreements with GSK and other originators facilitate technology transfer and market entry for regional producers, ensuring supply continuity.

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Key Takeaways

• GSK remains the leading supplier and innovator for both umeclidinium bromide and vilanterol trifentate, controlling primary manufacturing and licensing.
• Asian companies, notably in China and South Korea, are rapidly scaling production capabilities, filling regional gaps and entering the international scene.
• The complexity of inhalation APIs necessitates stringent manufacturing and quality assurance, limiting the number of reliable suppliers.
• Regional regulatory frameworks significantly influence supplier choices, with originator APIs favored in highly regulated markets.
• Strategic licensing agreements and technological innovations are critical for expanding supply sources and reducing costs.

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FAQs

1. Who are the main global suppliers of umeclidinium bromide?
GSK is the primary original supplier, with several Asian generic manufacturers, especially in China and South Korea, producing high-quality APIs under licensing agreements or proprietary manufacturing setups.

2. Can generic manufacturers produce vilanterol trifentate?
Yes, once patent protections expire or through licensing agreements, generic firms in India, China, and other regions have begun producing vilanterol trifentate, typically meeting regulatory standards for inhalation APIs.

3. What factors influence the choice of API suppliers for pharmaceutical companies?
Quality standards, regulatory compliance, manufacturing capacity, cost, lead times, and strategic partnerships primarily influence supplier selection.

4. How does patent exclusivity affect API supply for umeclidinium bromide and vilanterol trifentate?
Patents held by GSK restrict generic manufacturing until expiration or licensing, thereby limiting supply options during patent-protected periods and incentivizing licensing agreements.

5. Are there ongoing developments to improve API supply chains for these drugs?
Yes, investments in manufacturing technology, regional API production expansion, and strategic licensing are ongoing to enhance supply stability and reduce costs.

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References

1. GlaxoSmithKline. Incruse Ellipta. Pharmacovigilance Data 2022.
2. GlobalData. Respiratory API Market Analysis. 2022.
3. U.S. FDA Drugs Database. API Manufacturers and Approvals. 2022.
4. Chinese Pharmacopoeia. Regulatory Guidelines for Inhalation APIs, 2021.
5. Industry Reports on API Manufacturing in Asia. Pharmaceutical Technology, 2023.