Suppliers and packagers for generic pharmaceutical drug: UMECLIDINIUM BROMIDE

UMECLIDINIUM BROMIDE

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 England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382	NDA	GlaxoSmithKline LLC	0173-0873-06	1 TRAY in 1 CARTON (0173-0873-06) / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER	2014-04-30
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382	NDA	GlaxoSmithKline LLC	0173-0873-10	1 TRAY in 1 CARTON (0173-0873-10) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER	2014-04-30

Suppliers for the Pharmaceutical Drug: Umeclidinium Bromide

Last updated: July 28, 2025

Introduction

Umeclidinium bromide, a long-acting muscarinic antagonist (LAMA), plays a pivotal role in the management of respiratory diseases, particularly chronic obstructive pulmonary disease (COPD). As demand surges globally, understanding key suppliers of this pharmaceutical compound becomes essential for industry stakeholders, including pharmaceutical manufacturers, healthcare providers, and investors. This report offers a comprehensive overview of prominent suppliers, manufacturing sources, and distribution channels for umeclidinium bromide, emphasizing their roles within the global supply chain.

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Overview of Umeclidinium Bromide

Umeclidinium bromide is marketed primarily under the brand name Incruse Ellipta by GlaxoSmithKline. As an inhalation powder, it aids in bronchodilation by antagonizing muscarinic receptors, relieving airflow obstruction. The molecule's complex synthesis process necessitates specialized chemical manufacturing and stringent quality controls, cementing its position within a niche pharmaceutical segment.

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Major Suppliers and Manufacturers

1. Original Equipment Manufacturers (OEMs) and Contract Manufacturing Organizations (CMOs)

The production of umeclidinium bromide involves both proprietary manufacturing and outsourced options. Several OEMs and CMOs facilitate the supply chain:

• GlaxoSmithKline (GSK): As the patent-holder and primary marketer, GSK maintains in-house manufacturing capabilities for umeclidinium bromide, ensuring quality and supply consistency. Their global manufacturing network encompasses facilities in the UK, the US, and other strategic locations to meet international demand.

• Aspen Pharmacare: Engaged in partnerships for inhalation powders, Aspen has established manufacturing expertise in generic respiratory products, including LAMAs, and may serve as a CMO for certain formulations.

• Recipharm: A prominent contract development and manufacturing organization based in Sweden, Recipharm possesses inhalation product manufacturing capacity. While primarily known for inhaler device production, they also offer active pharmaceutical ingredient (API) synthesis capabilities, including complex molecules like umeclidinium bromide under contract.

• Vaccine and Pharmaceutical CMOs in Asia: Firms such as Shenzhen Third Pharmaceutical Factory (China) and Hikma Pharmaceuticals (Jordan) have been reported to develop or manufacture APIs for respiratory drugs, possibly including umeclidinium bromide, often under licensing agreements.

2. API Synthesizers and Ingredient Suppliers

The active pharmaceutical ingredient (API) supply chain is critical for drug producers worldwide:

• Suzhou Yabang Pharmaceutical Co., Ltd. (China): Known for synthesizing novel and complex APIs, this firm has capabilities that could extend to LAMA compounds like umeclidinium bromide, subject to licensing and international regulatory approval.

• Synthesis Technologies in Europe and India: Companies specializing in complex organic synthesis, such as Divi's Laboratories (India) and Sanofi (France), may produce umeclidinium bromide as part of their respiratory API portfolio or under bespoke manufacturing agreements.

• Synthesis Intermediates Suppliers: Several companies supply intermediates crucial for the synthesis of umeclidinium bromide, including BASF and Evonik.

3. Distributors and Supply Chain Players

Large pharmaceutical distributors, such as McKesson, Sinopharm, and Alibaba Pharma, facilitate the global distribution of inhaled respiratory medication, sourcing from primary manufacturers. These distributors may also serve as intermediaries for raw materials or finished products in specific regional markets.

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Geographical Distribution of Suppliers

The supply landscape for umeclidinium bromide spans several key regions:

• Europe: GSK’s manufacturing units are central to global supply; European biochemical synthesis facilities provide API intermediates.

• Asia: China and India host numerous API synthesis firms, with capacities expanding due to low production costs and growing API manufacturing expertise.

• North America: Certain CMOs and API suppliers operate in the US, often partnering with GSK or other multinational firms to produce umeclidinium bromide under licensing agreements.

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Regulatory and Quality Considerations

Suppliers must adhere to stringent regulatory standards such as Good Manufacturing Practice (GMP) certifications issued by agencies like the FDA (US), EMA (Europe), and PMDA (Japan). The complexity of inhalation APIs like umeclidinium bromide elevates the importance of quality controls, traceability, and compliance for suppliers seeking market access.

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Market Dynamics and Supply Chain Challenges

The supply chain for umeclidinium bromide faces specific challenges:

• Complex Synthesis: The molecule’s complex stereochemistry and synthesis pathways limit the number of capable manufacturers.

• Patent and Licensing Agreements: Patent protections and licensing restrict manufacturing rights in certain regions, influencing supplier diversity.

• API Availability and Cost: Fluctuations in raw material prices and geopolitical factors impact the cost and availability.

• Regulatory Barriers: Compliance requirements can delay entry for new suppliers, consolidating market power among established manufacturers.

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Emerging Trends and Future Outlook

The pharmaceutical industry’s pivot toward biosimilar and generic respiratory drugs raises opportunities for new entrants in API production:

• Diversification of Supply: Increasing the number of certified API producers can reduce supply risks and stabilize prices.

• Vertical Integration: Some pharmaceutical firms are investing in upstream manufacturing to secure supply chains for APIs like umeclidinium bromide.

• Innovations in Synthesis: Advances in green chemistry could streamline production, decreasing costs and environmental impact.

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Key Takeaways

• The primary supplier of umeclidinium bromide is GlaxoSmithKline, which maintains control over its manufacturing facilities.

• Several CMOs, especially in Europe and Asia, have the capacity to produce the API under licensing agreements or as part of contract manufacturing.

• The complex synthesis process necessitates specialized facilities, limiting the number of high-quality manufacturers.

• Regulatory compliance and quality standards shape the supplier landscape, favoring established, GMP-certified firms.

• The evolving respiratory drug market and supply chain disruptions highlight opportunities for diversified manufacturing partnerships and innovative synthesis approaches.

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FAQs

Q1: Are there generic manufacturers for umeclidinium bromide?
A1: Yes. While GSK holds primary patents, several generic manufacturers, primarily in India and China, have developed or are developing inhalation products containing umeclidinium bromide, subject to regional patent laws and licensing agreements.

Q2: What are the key regions supplying API for umeclidinium bromide?
A2: China and India are the leading regions for API synthesis due to cost advantages and technological expertise. Europe and North America host core manufacturing facilities for final drug formulations.

Q3: How does the supply chain ensure API quality and regulatory compliance?
A3: Suppliers must adhere to GMP standards, undergo rigorous audits, and comply with regional regulatory authorities like the FDA and EMA. Certification and traceability are essential to meet international quality benchmarks.

Q4: What are the challenges in sourcing umeclidinium bromide?
A4: Challenges include the molecule’s complex synthesis, limited manufacturing capacity, patent restrictions, and regulatory approval hurdles, which can impact supply availability and pricing.

Q5: Are there upcoming suppliers or manufacturers entering the umeclidinium bromide market?
A5: While new entrants are emerging, significant barriers exist due to complex synthesis and regulatory requirements. However, ongoing research into more efficient manufacturing methods could expand the supplier base in the future.

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Sources

[1] Pharmaceutical Technology. "GSK's inhalation product manufacturing." (2022).
[2] GlobalData Reports. "Respiratory Drugs Market and Supply Chain Analysis." (2023).
[3] U.S. FDA Database. "Approved APIs and manufacturing facilities." (2023).
[4] Industry Insider. "Contract manufacturing trends in respiratory drugs." (2022).
[5] European Medicines Agency. "GMP guidelines for inhalation products." (2023).