Suppliers and packagers for XOPENEX HFA

XOPENEX 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
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-2927-54	1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALER	2016-10-03
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730	NDA	Lupin Pharmaceuticals, Inc.	27437-056-01	1 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER	2023-11-10
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730	NDA AUTHORIZED GENERIC	Praxis, LLC	59368-410-01	1 INHALER in 1 CARTON (59368-410-01) / 200 AEROSOL, METERED in 1 INHALER	2016-10-03

Suppliers for the Pharmaceutical Drug: XOPRONEZ HFA

Last updated: August 4, 2025

Introduction

XOPENEX HFA, generically known as levalbuterol inhalation aerosol, is a critical bronchodilator used primarily in the management of asthma and chronic obstructive pulmonary disease (COPD). As a selective beta-2 adrenergic receptor agonist, it provides rapid relief from bronchospasm, making it a vital product in respiratory therapeutics. Its manufacturing and supply chain involve a complex network of suppliers providing various components, active pharmaceutical ingredients (APIs), delivery devices, and packaging materials. This article examines the key suppliers involved in the production and distribution of XOPENEX HFA, exploring the landscape's diversity and potential challenges.

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Manufacturing of Active Pharmaceutical Ingredient (API): Levalbuterol

Levalbuterol, the active ingredient in XOPENEX HFA, is synthesized through a multifaceted chemical process that requires specialized suppliers. The API's quality, purity, and consistent supply are paramount, given regulatory standards and patient safety.

Major API Suppliers:

• Hovione: A prominent contract manufacturer, Hovione produces levalbuterol APIs per stringent quality standards (GMP). As a global leader, the company supplies pharmaceutical companies with high-quality APIs, including levalbuterol, leveraging its comprehensive manufacturing facilities in Portugal and the United States.

• Suzhou Tianma Pharmaceutical Technology Co., Ltd.: Based in China, this supplier offers high-quality APIs, including levalbuterol, with increasing market presence due to cost competitiveness and expanding capacity.

• PharmaCore: Located in New Jersey, USA, PharmaCore specializes in complex chemical synthesis, including APIs for respiratory medications, with a focus on purity and regulatory compliance.

Supply Chain Considerations:

APIs are often sourced from multiple suppliers to mitigate risks related to supply disruptions, quality issues, and geopolitical factors. The complexity of levalbuterol synthesis necessitates suppliers with advanced synthetic capabilities and rigorous quality assurance.

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Inhaler Devices and Actuator Components

XOPENEX HFA employs hydrofluoroalkane (HFA) propellants alongside specialized inhaler devices, which involve critical components such as metering valves, actuators, and canisters.

Device Suppliers:

• Philips Respironics: A leading manufacturer of inhaler devices, Philips supplies precision-engineered metered-dose inhaler (MDI) actuators and valves. Their facilities adhere to stringent GMP standards, ensuring consistent dose delivery.

• Valois (a division of Vectura): Specialized in the design and manufacturing of inhaler components, Valois supplies customized parts that meet regulatory specifications for pharmaceutical inhalers.

• AstraZeneca’s suppliers: In some cases, pharmaceutical companies in collaboration with device manufacturers may source components from internal or external suppliers with extensive expertise in inhaler technology.

Material Suppliers for Components:

• Polypropylene and Aluminum: Suppliers such as Borealis and Novelis provide the materials used in making inhaler canisters and valve components. These suppliers focus heavily on material purity, resistance to HFA propellants, and compatibility.

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Propellants: Hydrofluoroalkanes (HFAs)

The propellant used in XOPENEX HFA is critical for drug delivery and stability. The primary HFA component is often 134a (1,1,1,2-Tetrafluoroethane).

Suppliers of HFA Propellants:

• Chemours (formerly DuPont): A dominant global supplier of HFA 134a, Chemours provides propellants manufactured under high safety and purity standards. Their supply chain is vital for global inhaler production.

• Honeywell: Also a key manufacturer of HFA refrigerants and inhalation propellants, Honeywell offers high-purity HFA gases essential for regulatory compliance and device function.

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Packaging Material Suppliers

Secure and sterile packaging components are essential for maintaining drug integrity.

• Borealis and Nova Chemicals: Provide plastics used for inhaler canisters and other components, offering durability and chemical resistance.

• Daicel Corporation: Supplies sealing components ensuring tight seals, preventing leakage or contamination.

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Regulatory and Quality Standards

Suppliers in the XOPENEX HFA supply chain must meet stringent regulatory standards, including USP (United States Pharmacopeia), EP (European Pharmacopoeia), and FDA regulations. Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ISO certifications are mandatory across the supply chain.

Supply Chain Risks and Dynamics

The complexity and global nature of the supply chain for XOPENEX HFA expose manufacturers to various risks, including geopolitical disruptions, raw material shortages, and logistic bottlenecks. Recent events, such as the COVID-19 pandemic, have underscored the importance of diversified sourcing and strategic stockpiling.

Emerging Trends

• Vertical Integration and Strategic Partnerships: Leading pharmaceutical companies are increasingly engaging in direct collaborations with component manufacturers to secure supply and ensure quality.

• Sustainable Sourcing: Environmental considerations are prompting suppliers to adopt greener production processes, particularly for inhaler materials and propellants.

• Biotech and Contract Manufacturing Expansion: The shift towards contract manufacturing organizations (CMOs) allows flexibility and scalability in volatile markets.

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Conclusion

The supply chain for XOPENEX HFA involves a diversified network of specialized suppliers across multiple domains—API manufacturing, device components, propellants, and packaging materials. Major players like Hovione, Chemours, and Philips Respironics play pivotal roles in ensuring the availability, quality, and regulatory compliance of this crucial respiratory medication. The interconnected nature of this supply chain necessitates vigilant management of risks, strategic partnerships, and adherence to high standards to maintain uninterrupted access for patients worldwide.

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Key Takeaways

• The API for XOPENEX HFA is primarily supplied by contract manufacturers such as Hovione, ensuring high-quality production aligned with regulatory standards.

• Device component suppliers like Philips Respironics provide critical parts, emphasizing precision and compliance.

• Propellant suppliers like Chemours and Honeywell are essential in delivering consistent, high-purity HFA gases.

• Material suppliers ensure the integrity and safety of packaging components, vital for drug stability.

• Diversification and strategic procurement remain vital to mitigating supply chain risks amid global disruptions.

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FAQs

1. Who are the main API suppliers for XOPENEX HFA?
   Hovione, Suzou Tianma Pharmaceutical, and PharmaCore are among the primary suppliers providing the levalbuterol API, each meeting strict GMP and regulatory standards.

2. What companies manufacture the inhaler devices used in XOPENEX HFA?
   Philips Respironics and Valois are leading manufacturers of the device components, ensuring precise dose delivery and compliance.

3. Which suppliers provide HFA propellants for XOPENEX HFA?
   Chemours and Honeywell are the predominant suppliers of HFA 134a propellants used in inhalers globally.

4. How do supply chain disruptions impact XOPENEX HFA availability?
   Disruptions to API production, device component manufacturing, or raw material supply can lead to shortages, emphasizing the importance of diversified sourcing and strategic inventory management.

5. Are there sustainability initiatives among suppliers for XOPENEX HFA components?
   Yes, leading suppliers are increasingly adopting greener manufacturing practices and sourcing renewable materials to meet environmental standards and reduce ecological impact.

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Sources

[1] Hovione Official Website, “API Manufacturing Capabilities,” 2023.
[2] Chemours Company, “HFA 134a Propellant Information,” 2023.
[3] Philips Respironics, “Inhaler Device Components and Manufacturing,” 2023.
[4] European Medicines Agency, “Guidelines on Inhalation Products Manufacturing,” 2022.
[5] Honeywell UOP, “Inhalation Propellant Production,” 2023.