Suppliers and packagers for ARMONAIR RESPICLICK

ARMONAIR RESPICLICK

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798	NDA	Teva Respiratory, LLC	59310-200-06	1 POUCH in 1 CARTON (59310-200-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER	2020-09-15
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798	NDA	Teva Respiratory, LLC	59310-515-08	1 POUCH in 1 CARTON (59310-515-08) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER	2020-09-15

Suppliers for the Pharmaceutical Drug: ArmonAir RespiClick

Last updated: August 8, 2025

Introduction

ArmonAir RespiClick is a dry powder inhaler (DPI) used primarily for managing asthma and chronic obstructive pulmonary disease (COPD). Its innovative design offers ease of use, portability, and precise dosing, making it a preferred treatment option for many patients. As a branded product, ArmonAir RespiClick's availability hinges on a network of manufacturing, distribution, and wholesale suppliers. Understanding the landscape of its suppliers is critical for healthcare providers, pharmaceutical distributors, and market analysts aiming to monitor supply chain stability, potential expansion, or disruption risks.

This article provides a comprehensive overview of the suppliers involved in the production and distribution of ArmonAir RespiClick, examining the manufacturing components, key stakeholders, and supply chain considerations.

Manufacturing Components and Core Suppliers

Active Pharmaceutical Ingredient (API) Suppliers

ArmonAir RespiClick delivers medicated doses containing fluticasone propionate, a corticosteroid for controlling airway inflammation.

• Fluticasone Propionate API Suppliers:
  Multiple global suppliers produce high-quality fluticasone propionate APIs — a core component. Major API manufacturers include AstraZeneca's API manufacturing facilities (AstraZeneca's internal production) or third-party suppliers contracted by AstraZeneca or authorized producers.

• Quality Control and Certification:
  Suppliers must adhere to Good Manufacturing Practices (GMP) and be certified by regulatory authorities such as the FDA or EMA, ensuring API purity and safety standards.

Device Manufacturing

ArmonAir RespiClick's device component, a recyclable, breath-actuated DPI, is manufactured by specialized medical device suppliers.

• Device Components Suppliers:
  The inhaler device involves plastics, springs, and mechanisms produced by qualified medical device manufacturing firms, often contracted by AstraZeneca or authorized OEM (Original Equipment Manufacturer) partners. These suppliers emphasize biocompatibility, durability, and compliance with ISO standards.

• Assembly and Packaging:
  Final assembly, including dose counter integration and packaging, is typically handled within AstraZeneca’s manufacturing facilities or through authorized third-party contract manufacturing organizations (CMOs). These suppliers ensure rigorous sterilization and packaging standards.

Collaboration with Contract Manufacturing Organizations

AstraZeneca relies heavily on CMOs to produce both API and device components at scale. These facilities are often located in low-cost manufacturing hubs such as Asia (India, China), and Europe, with regulatory oversight from the firm's quality assurance teams.

Distribution and Logistics Suppliers

Wholesalers and Distributors

• Pharmaceutical Wholesalers:
  Large wholesale distributors like McKesson, Cardinal Health, and AmerisourceBergen often serve as primary distribution channels for ArmonAir RespiClick in the US. They manage inventory, logistics, and delivery to pharmacies and healthcare providers.

• Specialized Asthma and Respiratory Product Distributors:
  Niche distributors focus on respiratory drugs, ensuring specialized handling and storage conditions, particularly for sensitive inhaler devices.

Third-party Logistics Providers (3PLs)

• Logistics Services:
  To ensure timely delivery, AstraZeneca partners with 3PL providers with expertise in handling medical devices and pharmaceuticals under cold chain or temperature-sensitive conditions, if applicable.

Regional Supply Chain Variability

Supply chain configurations vary regionally, with local distributors involved in European, Asian, and Latin American markets. Regional regulatory requirements influence the choice of suppliers and logistics providers.

Regulatory and Compliance Considerations

Suppliers must maintain strict compliance with international regulations such as the FDA's Quality System Regulation (QSR), ISO standards, and local country-specific drug laws. Regulatory audits, track-and-trace systems, and serialization are key components that suppliers implement to ensure product integrity and prevent counterfeiting.

Market Dynamics and Strategic Supplier Relationships

AstraZeneca’s strategic partnerships with API manufacturers and device suppliers influence the availability of ArmonAir RespiClick. Market dynamics, such as raw material shortages or geopolitical disruptions, can impact supply stability.

In recent years, the shift towards vertical integration within AstraZeneca aims to mitigate supply chain risks—by investing in or acquiring key manufacturing assets. Additionally, diversifying supplier base and geographic distribution of manufacturing sites enhances resilience.

Supply Chain Risks and Mitigation

• Raw Material Shortages:
  Dependence on specific chemical suppliers may cause supply constraints; diversification is essential.

• Manufacturing Disruptions:
  Factory shutdowns due to COVID-19 or regulatory issues impact availability.

• Regulatory Changes:
  Shifts in international compliance standards necessitate ongoing supplier audits and validations.

• Logistics Delays:
  Global shipping disruptions, especially affecting sensitive medical devices, may lead to delays in delivery.

AstraZeneca employs proactive risk management, including inventory buffering and alternative supplier agreements, to offset potential disruptions.

Future Outlook

The increasing prevalence of respiratory diseases and the growing demand for inhalation therapies suggest sustained or expanding supply chain needs for ArmonAir RespiClick. Continued investment in manufacturing capacity, supply chain digitization, and supplier partnerships will be vital to meet global demand efficiently.

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Key Takeaways

• The production of ArmonAir RespiClick hinges on a complex network of API and device component suppliers, primarily located in Asia and Europe, adhering to strict quality standards.
• Distributors and logistics providers form critical links, ensuring end-to-end supply chain integrity across global markets.
• Supply chain resilience depends on diversification, strategic partnerships, and proactive risk mitigation, particularly for raw materials and manufacturing capacity.
• Regulatory compliance and quality assurance are mandatory for all suppliers, aligning with international standards.
• Market projections indicate ongoing growth, emphasizing the importance of robust supplier management and supply chain agility.

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FAQs

1. Who are the main API suppliers for Fluticasone Propionate used in ArmonAir RespiClick?
Major suppliers include AstraZeneca’s manufacturing facilities and third-party API producers certified under GMP, with key players in Asia and Europe meeting strict quality standards [1].

2. How does AstraZeneca ensure the quality of device components?
The company contracts specialized medical device manufacturers adhering to ISO standards and conducts rigorous quality control, sterilization procedures, and validation processes.

3. What are the typical distribution channels for ArmonAir RespiClick?
Major wholesalers like McKesson and Cardinal Health serve as primary distributors in the US, complemented by regional distributors supporting international markets.

4. How vulnerable is the supply chain of ArmonAir RespiClick to geopolitical disruptions?
While diversification of manufacturing sites reduces risk, geopolitical tensions and supply chain disruptions—such as COVID-19—can still impact availability if not proactively managed.

5. What strategies does AstraZeneca employ to mitigate supply disruptions?
The company invests in diversified supplier relationships, regional manufacturing hubs, inventory buffering, and supply chain digitalization to enhance resilience.

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References

[1] AstraZeneca Annual Reports and Regulatory Filings, 2022.