PROAIR DIGIHALER: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636	NDA	Teva Respiratory, LLC	59310-117-20	1 INHALER in 1 BOX (59310-117-20) / 200 INHALANT in 1 INHALER	2019-10-04
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636	NDA	Teva Respiratory, LLC	59310-540-20	1 INHALER in 1 BOX (59310-540-20) / 200 POWDER, METERED in 1 INHALER	2019-10-04
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636	NDA	Teva Respiratory, LLC	59310-580-20	1 INHALER in 1 BOX (59310-580-20) / 200 POWDER, METERED in 1 INHALER	2015-04-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for inhalation therapies remains highly competitive, with innovative delivery systems gaining prominence. One such advance is the ProAir Digihaler, an inhaler integrated with digital technology designed to enhance asthma and COPD management. As a digital inhaler, ProAir Digihaler aligns with the growing trend toward digital health solutions, offering remote monitoring capabilities alongside medication delivery.

Understanding the supply chain for ProAir Digihaler is essential for stakeholders seeking reliable sourcing, manufacturing insights, and distribution strategies. This article examines the key suppliers involved in the production and distribution of ProAir Digihaler, emphasizing the roles of active pharmaceutical ingredient (API) suppliers, device manufacturers, technological component providers, and distribution channels.

Overview of ProAir Digihaler

ProAir Digihaler (albuterol sulfate inhalation aerosol, digital) is manufactured by Teva Pharmaceutical Industries. It incorporates a built-in digital sensor that delivers real-time data on inhaler usage, aiding adherence and patient engagement. The device combines traditional pharmaceutical manufacturing with advanced electronics, which necessitates a diversified supply chain.

Key Suppliers in the Production of ProAir Digihaler

1. Active Pharmaceutical Ingredient (API) Suppliers

At the core of ProAir Digihaler is albuterol sulfate, the active pharmaceutical ingredient. The quality, purity, and consistency of API suppliers are critical for compliance with regulatory standards such as the FDA and EMA.

Global API Suppliers: Major suppliers of albuterol sulfate include Sterling Pharmaceuticals, Fresenius Kabi, Zhejiang Kangle Pharmaceutical, and Lunan Pharma. These manufacturers provide bulk API to contract manufacturing organizations (CMOs) involved in formulation.
Supply Chain Considerations: API sourcing is often regional, with API manufacturers located in North America, Europe, and Asia, primarily in China and India due to cost advantages and manufacturing capacity.

2. Device Manufacturing Components

The Digihaler's hardware incorporates sophisticated electronic sensors, microcontrollers, and connectivity modules.

Electronics and Sensor Suppliers:
- Microelectromechanical Systems (MEMS) Sensor Providers: Suppliers like Bosch Sensortec and STMicroelectronics provide the inertial sensors needed to detect inhaler actuation.
- Microcontroller Suppliers: Tech giants such as Qualcomm and Texas Instruments supply microcontrollers responsible for processing sensor data and facilitating Bluetooth connectivity.
Battery Providers: The device uses compact, reliable batteries supplied by firms like Panasonic or Energizer for long-term power needs.
Wireless Connectivity Modules: Bluetooth Low Energy (BLE) modules supplied by Nordic Semiconductor or Nordic NRF are integral for data transmission.

3. Packaging and Device Assembly

Inhaler Device Manufacturers: Teva collaborates with contract manufacturers specializing in medical device assembly, such as Vitae Medical, Nipro, or Philips Healthcare.
Packaging Suppliers: Custom packaging, including blister packs with integrated electronics, involves specialized providers like Berry Global or Amcor.

Research and Development (R&D) Suppliers

Given the pioneering combination of inhalation drug delivery with digital technology, R&D inputs often come from partnerships with technology firms and contract R&D organizations.

Technology Collaborations: Teva has partnered with Propeller Health (acquired by Novartis) to integrate digital health solutions, although for device manufacturing, R&D input is often sourced from specialized electronics firms.

Distribution and Logistics

ProAir Digihaler’s global distribution depends on a resilient supply chain network involving:

Pharmaceutical Wholesalers: McKesson, Cardinal Health, and AmerisourceBergen are primary distributors in North America.
Regulatory Agencies and Customs: Ensuring compliance with import/export regulations is critical, especially for electronic devices crossing borders.
E-prescription Platforms: Digital health records and e-prescribing platforms facilitate the distribution of ProAir Digihaler to pharmacies and clinics.

Manufacturing Locations and Supply Chain Dynamics

Teva’s manufacturing facilities for ProAir Digihaler are predominantly located in the United States and Israel, accommodating high regulatory standards and ensuring quality control. The electronic components are distributed globally from manufacturing hubs in Asia and Europe, while API sourcing is primarily regional.

Supply chain dynamics are influenced by geopolitical factors like tariffs, raw material availability, and the COVID-19 pandemic’s impact on electronics manufacturing and pharmaceuticals.

Regulatory and Quality Assurance

Suppliers must comply with stringent regulations from agencies such as the FDA, EMA, and Health Canada. Certificates of conformity, device safety certifications, and Good Manufacturing Practice (GMP) approvals are mandatory for all suppliers involved in producing components and APIs.

Future Trends and Supplier Strategies

Vertical Integration: Some pharmaceutical companies may attempt in-house manufacturing of key electronic components to mitigate supply chain risks.
Diversification: Diversifying component suppliers, particularly for electronics, improves resilience against shortages.
Innovation in Materials: New, sustainable materials for device components could alter supplier landscapes in the upcoming years.

Key Takeaways

The supply chain for ProAir Digihaler involves a complex network of API suppliers, electronic component manufacturers, device assemblers, and distributors.
Critical components include albuterol sulfate API, sensors, microcontrollers, Bluetooth modules, and batteries, sourced globally from specialized suppliers.
Quality assurance and regulatory compliance are paramount, necessitating rigorous supplier vetting and diverse sourcing strategies.
Supply chain resilience benefits from diversification, regional manufacturing, and technological innovation.
Stakeholders should monitor geopolitical and technological trends impacting supplier availability and cost.

FAQs

1. Who are the main suppliers of albuterol sulfate API for ProAir Digihaler?
Major API suppliers include Sterling Pharmaceuticals, Fresenius Kabi, and Asian manufacturers such as Zhejiang Kangle Pharmaceutical, providing bulk albuterol sulfate.

2. Which electronic component suppliers are involved in the Digihaler’s manufacturing?
Suppliers like Bosch, STMicroelectronics, Qualcomm, and Nordic Semiconductor supply MEMS sensors, microcontrollers, and Bluetooth modules integral to the digital functions.

3. How does Teva ensure regulatory compliance from suppliers?
Teva mandates GMP certifications, supplier audits, and comprehensive documentation to meet FDA and EMA standards, ensuring component and API quality.

4. What logistical factors influence the distribution of ProAir Digihaler globally?
Major factors include regulatory approvals, transportation regulations, customs clearance, and the robustness of distributor networks like McKesson or Cardinal Health.

5. Are there plans to diversify or localize suppliers for ProAir Digihaler?
While current strategies emphasize diversification, there is a trend toward regional manufacturing to reduce supply chain vulnerabilities and meet regional regulatory requirements.

References

[1] Teva Pharmaceutical Industries. (2022). ProAir Digihaler Product Information.
[2] FDA. (2022). Guidance for Industry: Pharmaceutical Quality
[3] MarketWatch. (2023). Global Active Pharmaceutical Ingredient Market Analysis.
[4] TechNavio. (2023). Medical Device Components Market Report.
[5] Propeller Health. (2022). Digital Health Partnership Details.

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Suppliers and packagers for PROAIR DIGIHALER