ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595	NDA	Covis Pharma US, Inc	70515-001-01	1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER	2019-03-29
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595	NDA	Covis Pharma US, Inc	70515-001-03	1 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER	2019-03-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for respiratory therapies has expanded significantly, driven by the prevalence of chronic obstructive pulmonary disease (COPD) and asthma. Two key agents—Aclidinium Bromide and Formoterol Fumarate—serve as vital components in inhalation therapies. Identifying reliable suppliers for these drugs is critical for manufacturers, distributors, and healthcare providers aiming to ensure drug availability, compliance with regulatory standards, and cost-effective procurement. This article provides an in-depth overview of current suppliers for Aclidinium Bromide and Formoterol Fumarate, examining market dynamics, manufacturing sources, and distribution channels.

Overview of Aclidinium Bromide and Formoterol Fumarate

Aclidinium Bromide: A long-acting muscarinic antagonist (LAMA), primarily prescribed for COPD management. It exhibits high selectivity for M3 muscarinic receptors, reducing bronchodilation-related symptoms with a favorable side effect profile. Aclidinium Bromide is marketed under brand names such as Tudorza® Pressair® (by AstraZeneca).

Formoterol Fumarate: A long-acting beta-2 adrenergic agonist (LABA), indicated for both COPD and asthma. Known for rapid onset and sustained bronchodilation, Formoterol Fumarate is supplied under brand names including Foradil® and Perforomist® (by AstraZeneca and other manufacturers).

Primary Manufacturers and Suppliers

1. Active Pharmaceutical Ingredient (API) Manufacturers

a. Global API Producers

Cipla Limited (India): A leading producer of respiratory API, including Aclidinium Bromide and Formoterol Fumarate, with facilities certified by major regulatory agencies (FDA, EMA, PMDA). Cipla supplies both branded and generic APIs globally, with a focus on affordability and quality assurance.
Sun Pharma (India): Offers a broad portfolio of respiratory APIs, including Formoterol Fumarate. Sun Pharma’s manufacturing sites are GMP-compliant, and the company supplies APIs to both domestic and international markets.
Mylan N.V. (USA/Europe): Produces Formoterol Fumarate API, serving global markets with a focus on high-quality standards. Mylan’s integrated supply chain facilitates consistent API availability.
Veb Farma (Turkey): Manufactures Aclidinium Bromide API, with some supply routes directed toward European and Middle Eastern markets.

b. Contract Manufacturing Organizations (CMOs)

Boehringer Ingelheim (Germany): Engaged in contract manufacturing of APIs, including respiratory agents, for select clients under strict quality parameters.
Recipharm (Sweden): Provides API synthesis services, including for Formoterol Fumarate, and supplies to multiple pharmaceutical firms globally.
Piramal Enterprises (India): Offers comprehensive contract manufacturing, including APIs for respiratory drugs, aligning with international quality standards.

2. Finished Dosage Form Manufacturers

AstraZeneca: As the patent owner of various formulations, AstraZeneca manufactures both Aclidinium Bromide (Tudorza®) and Formoterol-based inhalers (Foradil®, Perforomist®). These products are distributed worldwide through its extensive supply chain network.
Teva Pharmaceuticals: Produces generic formulations containing Formoterol Fumarate and markets inhalation products globally, sourcing APIs from third-party manufacturers.
Mylan and Novartis: Offer generic and biosimilar alternatives, sourcing APIs from multiple suppliers and conducting rigorous quality controls.
Other Regional Manufacturers: Several regional pharma companies—particularly in India, China, and Eastern Europe—produce inhaler formulations incorporating APIs sourced from primary API manufacturers.

Distribution Channels and Supplier Networks

The supply chain for these respiratory agents involves multiple tiers—API sourcing, formulation development, manufacturing, quality control, and distribution.

APIs are centrally supplied by Indian, Chinese, European, and US-based API producers. These manufacturers often distribute directly to formulation plants or via authorized regional distributors.
Finished drug products undergo distribution through global pharmaceutical wholesalers, specialty distributors, and directly to healthcare providers.
Third-party logistics providers facilitate the international movement of APIs and finished formulations, adhering to regulatory standards such as GDP (Good Distribution Practice).

Market Dynamics and Procurement Considerations

Regulatory Compliance: Suppliers must possess approvals from agencies like the FDA, EMA, and respective national authorities, ensuring high-quality standards.
Price Sensitivity and Market Competition: Indian manufacturers dominate due to lower production costs, driving competitive pricing especially for generics.
Supply Chain Security: COVID-19 pandemic exposed vulnerabilities in drug supply chains, emphasizing the importance of diversified supplier bases and regional manufacturing capacities.
Intellectual Property and Patent Landscape: While AstraZeneca holds patents for certain formulations, APIs like Formoterol Fumarate are often supplied as generics, expanding the supplier base.

Emerging Trends and Challenges

Localization and Regulatory Changes: Countries are incentivizing local API production to reduce dependence on imports, which could alter supplier dynamics.
Quality Assurance and Standardization: Increasing scrutiny on API purity, process validation, and bioequivalence necessitates rigorous supplier qualification.
Sustainability and Environmental Impact: Suppliers are under pressure to adopt greener manufacturing processes, influencing vendor selections.

Conclusion

The supply landscape for Aclidinium Bromide and Formoterol Fumarate is characterized by a diverse network of suppliers—ranging from established multinational pharmaceutical companies to robust regional API producers. Indian and Chinese manufacturers dominate the API market in terms of volume and cost-efficiency, while global pharma giants like AstraZeneca control key formulation production and distribution channels. Healthcare providers and pharmaceutical companies must evaluate suppliers based on regulatory compliance, quality standards, supply stability, and cost-effectiveness to ensure uninterrupted access.

Key Takeaways

The global supply of Aclidinium Bromide and Formoterol Fumarate APIs is primarily driven by Indian and Chinese manufacturers, with regional variations enhancing supply resilience.
Major pharmaceutical firms leverage both in-house manufacturing and third-party APIs, underscoring the importance of supplier qualification and quality assurance.
Increasing regional manufacturing initiatives and regulatory shifts are shaping future supplier strategies.
Maintaining diversified supplier relationships and adhering to strict quality protocols mitigate supply risks and ensure regulatory compliance.
Strategic procurement informed by market intelligence and supplier assessments enhances stability and cost-efficiency for respiratory pharmaceutical products.

FAQs

1. Who are the leading API manufacturers for Aclidinium Bromide and Formoterol Fumarate globally?
Leading API producers include Cipla and Veb Farma for Aclidinium Bromide, and Sun Pharma and Mylan for Formoterol Fumarate. Numerous regional and contract manufacturers also supply these APIs, particularly from India, China, and Turkey.

2. What regulatory standards should suppliers meet for respiratory APIs?
Suppliers must comply with Good Manufacturing Practice (GMP) standards set by authorities such as the FDA, EMA, or equivalent regulatory agencies to ensure quality, safety, and efficacy.

3. How has the COVID-19 pandemic affected the supply chain for respiratory drugs?
The pandemic exposed vulnerabilities, prompting a shift towards regional manufacturing and diversified supplier bases to ensure supply continuity amid global disruptions.

4. Are there regional differences in sourcing APIs for these drugs?
Yes. While India and China dominate API manufacturing due to cost advantages, Europe and North America emphasize regulatory compliance and quality, often sourcing from established multinational suppliers.

5. How can pharmaceutical companies ensure supply stability for these drugs?
By cultivating multiple supplier relationships, verifying supplier compliance through audits, maintaining inventory buffers, and staying informed of regulatory and market developments.

References

[1] AstraZeneca Corporate Website. Tudorza® Pressair® overview.
[2] Mylan Official Website. API sourcing and manufacturing.
[3] Cipla Ltd. Products and API manufacturing capabilities.
[4] European Medicines Agency. Regulatory standards and approved API manufacturers.
[5] Industry Reports. Global Respiratory API Market Analysis, 2022.

Suppliers and packagers for generic pharmaceutical drug: ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE