bronchitol: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pharmaxis Europe	BRONCHITOL	mannitol	POWDER;INHALATION	202049	NDA	Arna Pharma Pty Ltd	84639-212-04	1 BLISTER PACK in 1 CARTON (84639-212-04) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)	2024-10-02
Pharmaxis Europe	BRONCHITOL	mannitol	POWDER;INHALATION	202049	NDA	Arna Pharma Pty Ltd	84639-212-14	14 BLISTER PACK in 1 CARTON (84639-212-14) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)	2024-10-02
Pharmaxis Europe	BRONCHITOL	mannitol	POWDER;INHALATION	202049	NDA	Arna Pharma Pty Ltd	84639-212-56	4 CARTON in 1 BOX (84639-212-56) / 14 BLISTER PACK in 1 CARTON (84639-212-14) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)	2024-10-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Bronchitol, a prescription medication primarily used to treat cystic fibrosis (CF), is an inhaled dry powder formulation of mannitol. It facilitates mucus clearance in the lungs, improving respiratory function. As an essential therapeutic option for CF patients, Bronchitol's supply chain is crucial for ensuring consistent access to treatment worldwide.

This detailed overview examines the key suppliers involved in the manufacturing and distribution of Bronchitol, analyzing their roles within the pharmaceutical ecosystem, strategic partnerships, manufacturing capacities, and the competitive landscape.

Manufacturers of Bronchitol

1. Pharmaxis Ltd. – The Original Developer and Primary Supplier

Pharmaxis Ltd., an Australian biotechnology firm, pioneered Bronchitol’s development, obtaining regulatory approvals and overseeing initial manufacturing phases. The company’s core competency encompasses the production of mannitol-based inhalation therapies, with Bronchitol as its flagship product.

Manufacturing Capabilities:
Pharmaxis operates a Good Manufacturing Practice (GMP)-certified facility in Australia, capable of producing commercial-grade inhalation powders. Its manufacturing process includes precise milling, blending, and packaging to ensure consistent particle size and dose accuracy, critical for pulmonary delivery.

Supply Strategy:
Pharmaxis supplies Bronchitol directly to various markets, including Australia, Europe, and select other regions, often engaging in licensing agreements or partnerships for international distribution.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of pharmaceutical manufacturing, Pharmaxis partners with specialized CMOs to boost production capacity, especially in response to increasing global demand.

Key CMOs include:

Vita Pharmaceutical Services:
Provides inhalation powder manufacturing, offering scale-up capabilities for Bronchitol production, ensuring quality compliance with international standards like FDA and EMA regulations.
Recipharm:
A global CMO with extensive experience in dry powder inhaler (DPI) manufacturing, Recipharm supports Pharmaxis for volume expansion in Europe and other markets.

Role and Impact:
Utilizing CMOs allows Pharmaxis to mitigate manufacturing risks, enhance supply flexibility, and meet growing demand without significant capital investment in internal facilities.

Distribution and Supply Chain Partners

1. Distributors and Wholesalers

Bronchitol’s distribution relies on regional and local distributors who coordinate with hospitals, pharmacies, and specialty clinics. These entities ensure timely delivery, inventory management, and compliance with varying healthcare regulations.

Examples include:

Alliance Healthcare (Via Pharma):
Distributes Bronchitol across Europe and Australia, leveraging existing pharmaceutical logistics networks.
McKesson Corporation:
Handles the distribution in North America, ensuring regulatory adherence and cold chain integrity where necessary.

2. Logistics Providers

Third-party logistics (3PL) providers play a vital role, especially for sensitive inhalation powders requiring controlled environments. These providers offer temperature-controlled storage, real-time tracking, and expedited shipping services.

Strategic Partnerships and Licensing Agreements

Pharmaxis has engaged in various strategic collaborations to enhance Bronchitol’s global reach:

Chiesi Farmaceutici:
An Italian pharmaceutical company, Chiesi entered into licensing and distribution agreements with Pharmaxis for European and other markets. Chiesi manages local manufacturing, registration, and distribution, expanding Bronchitol’s availability.
Other Regional Collaborators:
Licensing agreements already established in markets like the Middle East and Asia-Pacific facilitate local manufacturing and distribution, optimized to regional regulatory landscapes.

Competitive Landscape of Suppliers

Bronchitol’s supply chain features a combination of proprietary manufacturing and strategic partnerships with CMOs. Its reliance on licensed manufacturing enables flexibility but also introduces dependencies with potential risks related to supply chain disruptions, regulatory hurdles, and capacity constraints.

Compared to other CF therapies, Bronchitol's unique inhaled dry powder formulation—a niche requiring specialized manufacturing—limits broad supplier options. The primary reliance remains on Pharmaxis’s internal facilities and selected CMOs, emphasizing the importance of robust quality control systems.

Regulatory Considerations

Manufacturers and suppliers face rigorous quality standards, including GMP compliance, validated manufacturing processes, and adherence to regional regulations (FDA, EMA, PMDA). Supply interruptions can arise from regulatory delays, batch rejections, or capacity issues, underscoring the need for diversified supplier relationships.

Conclusion

Bronchitol's supply chain is characterized by Pharmaxis’s direct manufacturing complemented by partnerships with CMOs to enhance production capacity. Distribution relies on regional partners and logistics providers aligned with regional regulatory needs. The strategic licensing agreements with companies such as Chiesi extend Bronchitol’s reach into multiple markets, securing broader patient access.

Ensuring uninterrupted supply requires continual optimization of manufacturing capacities, strategic diversification of sourcing, and robust logistical arrangements, especially given the therapy's specialized inhalation delivery form.

Key Takeaways

Pharmaxis Ltd. remains the primary manufacturer, supported by strategic partnerships with CMOs like Recipharm to scale production.
Licensing agreements, particularly with Chiesi in Europe and other regions, are critical for global distribution.
Distribution channels involve regional wholesalers and specialized logistics providers ensuring compliance and delivery quality.
Supplier dependencies can pose risks; diversification and capacity expansion are vital for supply continuity.
Rigorous regulatory compliance in manufacturing and distribution underpins Bronchitol’s supply chain integrity.

FAQs

1. Who are the main manufacturing partners for Bronchitol?
Pharmaxis develops Bronchitol internally and partners with CMOs such as Recipharm and Vita Pharmaceutical Services for large-scale production.

2. How does Bronchitol’s supply chain ensure quality and regulatory compliance?
Manufacturers adhere to GMP standards, with validated processes and regulatory audits to meet FDA, EMA, and other regional standards.

3. What role do licensing partners play in Bronchitol’s distribution?
Licensing partners like Chiesi foster regional manufacturing, regulatory approvals, and distribution, expanding Bronchitol’s availability globally.

4. Are there risks associated with Bronchitol’s supply chain?
Yes, including manufacturing capacity limits, regulatory delays, and reliance on third-party CMOs; strategic partnerships and capacity planning mitigate these risks.

5. How can supply chain disruptions for Bronchitol be minimized?
Diversifying manufacturing sources, establishing buffer inventories, and strengthening logistics partnerships are key strategies.

Sources

[1] Pharmaxis – Company Website. (2023). Manufacturing and Supply Chain Details.
[2] European Medicines Agency. (2022). Bronchitol (mannitol) Summary of Product Characteristics.
[3] Chiesi Farmaceutici. (2023). Partnership Announcements.
[4] Recipharm. (2023). Contract Manufacturing Capabilities for Inhalation Products.

Suppliers and packagers for bronchitol

bronchitol

Suppliers for the Pharmaceutical Drug: BRONCHITOL