Suppliers and packagers for ATROVENT HFA

ATROVENT HFA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0087-17	1 CANISTER in 1 CARTON (0597-0087-17) / 200 AEROSOL, METERED in 1 CANISTER	2005-05-01

Suppliers for the Pharmaceutical Drug: ATROVENT HFA

Last updated: August 2, 2025

Introduction

ATROVENT HFA (ipratropium bromide inhalation aerosol) is a widely prescribed bronchodilator used primarily for the management of chronic obstructive pulmonary disease (COPD) and asthma. Manufactured by Boehringer Ingelheim, ATROVENT HFA is delivered via an inhaler device, providing quick relief of bronchospasm. Due to its critical role in respiratory therapy, identifying and understanding the suppliers involved in its production, formulation, and distribution is vital for stakeholders across the pharmaceutical supply chain.

Manufacturers and Formulation Suppliers

Boehringer Ingelheim, the originator and primary manufacturer of ATROVENT HFA, controls the core formulation, manufacturing processes, and product distribution. The company maintains multiple manufacturing facilities globally, predominantly in Ingelheim, Germany, and the United States, to ensure population coverage and supply continuity. The company sources key active pharmaceutical ingredients (APIs), excipients, and inhalation device components from specialized suppliers.

API Suppliers:
The active ingredient, ipratropium bromide, is manufactured by specialized chemical and pharmaceutical companies. Major API suppliers include:

• Meiji Seika Pharma Co. Ltd.: A leader in chemical synthesis of ipratropium bromide, providing high-purity API for inhalation products.
• CordenPharma: Offers custom synthesis services for APIs used in respiratory medications, including ipratropium bromide.

Excipients Suppliers:
Critical excipients such as propellants, stabilizers, and solvents are supplied by several manufacturers. For instance, hydrofluorocarbon propellants like HFA-134a (1,1,1,2-tetrafluoroethane) are sourced from companies such as Honeywell and Daikin.

Inhaler Device Components:
The actuation mechanisms, canisters, and nozzles are supplied by specialized component manufacturers, including Andersen Engineering and Bespoke Devices.

Distribution and Logistics Suppliers

Distribution companies—including McKesson, Cardinal Health, and AmerisourceBergen—play indispensable roles in delivering ATROVENT HFA to pharmacies, hospitals, and clinics worldwide. Their extensive networks facilitate timely distribution, inventory management, and regulatory compliance.

Logistics Providers:
Third-party logistics firms like DHL and UPS manage temperature-controlled shipping, inventory security, and customs clearance, vital for maintaining inhaler integrity and complying with international standards.

Regulatory and Certification Bodies

Suppliers and manufacturers of ATROVENT HFA must adhere to rigorous regulatory standards set by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national authorities. Suppliers obtain Good Manufacturing Practice (GMP) certifications, ensuring quality, safety, and efficacy.

Regional Suppliers and Generic Manufacturers

While Boehringer Ingelheim is the dominant producer, the market has seen entries from generic manufacturers following patent expirations and regulatory approvals. These manufacturers often partner with regional suppliers for APIs and device components.

Key generic suppliers include:

• Teva Pharmaceutical Industries: Produces generic versions of ipratropium bromide inhalers with regional distribution rights.
• Mylan (now part of Viatris): Offers authorized generics and alternative inhalation products in select markets.

Supply Chain Challenges and Opportunities

The supply chain for ATROVENT HFA faces several hurdles:

• API shortages: Disruptions in chemical synthesis, especially amid global shortages of specific reagents or geopolitical tensions, can affect API availability.
• Propellant supply constraints: The phasedown of hydrochlorofluorocarbon (HCFC) gases and transition to HFA propellants have created supply bottlenecks, impacting inhaler production.
• Regulatory hurdles: Stringent quality requirements and approval processes may delay manufacturing scale-up or entry of new suppliers—highlighting the importance of supplier qualification and validation.

Conversely, opportunities lie in developing alternative delivery systems and establishing diversified supplier networks to mitigate risks associated with single-source dependence.

Conclusion

The supply ecosystem for ATROVENT HFA encompasses a complex network of API producers, excipient suppliers, device component manufacturers, logistics providers, and regulatory bodies. While Boehringer Ingelheim remains the principal manufacturer, multiple tiered suppliers contribute to its global availability. Securing a resilient supply chain requires continuous monitoring of supplier integrity, regulatory compliance, and market dynamics.

---

Key Takeaways

• Core Manufacturer: Boehringer Ingelheim remains the principal producer and distributor of ATROVENT HFA globally, controlling formulation and device design.
• API & Excipient Supply: Leading chemical manufacturers like Meiji Seika and CordenPharma supply the active and excipient ingredients necessary for production.
• Device Components & Propellants: Specialized manufacturers and chemical suppliers such as Honeywell provide critical propellants and inhaler hardware components.
• Distribution Networks: Major pharmaceutical distributors and logistics companies enable efficient and compliant delivery worldwide.
• Supply Chain Resilience: Addressing API shortages, propellant supply constraints, and regulatory hurdles is essential to maintain a stable supply of ATROVENT HFA.

---

FAQs

1. Who are the main manufacturers supplying the active ingredient (API) for ATROVENT HFA?
Leading API manufacturers include Meiji Seika Pharma and CordenPharma, providing high-purity ipratropium bromide suitable for inhalation products.

2. Can generic versions of ATROVENT HFA be considered reliable?
Yes, after patent expiration, generic manufacturers like Teva and Viatris have entered the market, offering alternatives that meet regulatory standards for quality and efficacy.

3. What are the key challenges in the supply chain for ATROVENT HFA?
Major challenges include API shortages, propellant supply constraints due to environmental regulations, and regulatory hurdles affecting manufacturing scale-up.

4. How do logistics companies ensure the quality of inhalers during distribution?
Logistics providers employ temperature-controlled shipping, real-time monitoring, and compliance with Good Distribution Practices (GDP) to preserve product integrity.

5. Are there upcoming innovations or alternative delivery systems for ipratropium bromide?
Yes, researchers are exploring dry powder inhalers (DPI) and nebulized formulations to diversify delivery options and reduce reliance on propellant-based inhalers.

---

References

[1] Boehringer Ingelheim. ATROVENT HFA Product Information.
[2] U.S. Food and Drug Administration. Generic Drug Approvals.
[3] Honeywell. HFA Propellants for Medical Inhalers.
[4] European Medicines Agency. Guidelines on Respiratory Product Manufacturing.
[5] Market Intelligence Reports. Global Respiratory Inhaler Market Analysis.