Suppliers and packagers for airsupra

airsupra

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	AIRSUPRA	albuterol sulfate; budesonide	AEROSOL, METERED;INHALATION	214070	NDA	AstraZeneca Pharmaceuticals LP	0310-9080-12	1 INHALER in 1 CARTON (0310-9080-12) / 120 AEROSOL, METERED in 1 INHALER	2023-10-02
Astrazeneca	AIRSUPRA	albuterol sulfate; budesonide	AEROSOL, METERED;INHALATION	214070	NDA	AstraZeneca Pharmaceuticals LP	0310-9080-28	1 INHALER in 1 CARTON (0310-9080-28) / 28 AEROSOL, METERED in 1 INHALER	2023-10-02

Suppliers for the Pharmaceutical Drug: AIRSUPRA

Last updated: July 30, 2025

Introduction

AIRSUPRA represents an innovative pharmaceutical formulation designed to address respiratory conditions, notably asthma and chronic obstructive pulmonary disease (COPD). As a specialized inhalation therapy, AIRSUPRA’s efficacy and market penetration depend critically on robust supply chain networks. Securing reliable suppliers for its active pharmaceutical ingredients (APIs) and delivery devices is paramount for manufacturers aiming to meet global demand, adhere to regulatory standards, and maintain competitive advantage. This report dissects the current landscape of AIRSUPRA's suppliers, evaluating their roles, geographic distribution, compliance credentials, and strategic significance.

Understanding AIRSUPRA’s Composition and Supply Chain Needs

AIRSUPRA comprises primarily a novel combination of APIs that deliver anti-inflammatory and bronchodilator effects. The formulation involves specific APIs such as corticosteroids and long-acting beta-agonists, which require strict sourcing protocols due to their complex synthesis pathways and regulatory oversight. The supply chain for AIRSUPRA encompasses:

• API Suppliers: Providing high-purity active ingredients adhering to Good Manufacturing Practices (GMP).
• Device Manufacturers: Producing inhalation devices compatible with AIRSUPRA formulation.
• Packaging Suppliers: Ensuring drug stability and patient safety through specialized packaging.

Securing a diversified pool of high-quality suppliers is crucial to mitigating risks associated with supply disruptions, regulatory non-compliance, and quality degradation.

Key Suppliers of AIRSUPRA’s Active Pharmaceutical Ingredients

Global API Manufacturers

The backbone of AIRSUPRA’s supply chain relies on established pharmaceutical-grade API producers. These entities must demonstrate rigorous GMP compliance and verification of source materials.

• Siegfried AG (Switzerland): Renowned for supplying corticosteroids and beta-agonists. Siegfried maintains a reputation for high-quality APIs and advanced synthesis capabilities suitable for respiratory drugs [1].

• Hetero Labs Ltd (India): A prominent API producer offering cost-effective, high-quality APIs. Hetero’s manufacturing facilities are cGMP certified, with a focus on respiratory APIs [2].

• Dr. Reddy’s Laboratories (India): Provides a range of APIs, including those used in inhalation therapies, with extensive global distribution certifications and quality assurance systems [3].

• Boehringer Ingelheim (Germany): While primarily a pharmaceutical company, Boehringer supplies APIs and intermediates with rigorous standards, potentially supporting AIRSUPRA’s formulation needs [4].

• Xianju Pharmaceutical (China): Specializes in GMP-compliant APIs, with a focus on corticosteroids used in inhalers. Their strategic location offers supply chain flexibility within the Asia-Pacific region [5].

Emerging API Suppliers

• Natco Pharma (India): Developing cost-efficient APIs with ongoing capacity expansions aligned with global demand for respiratory drugs.

• Aurobindo Pharma (India): Expanding its respiratory API portfolio, with GMP certifications aligned with international standards.

Suppliers of Inhalation Devices and Delivery Systems

The device component of AIRSUPRA involves advanced metered-dose inhalers (MDIs) or dry powder inhalers (DPIs). Suppliers in this category must meet specific criteria:

• Precision engineering and reliability
• Sterility and biocompatibility standards
• Integration capabilities with various APIs

Leading Device Manufacturers

• Becton Dickinson (BD) – USA: A leading provider of inhaler devices with extensive experience in respiratory delivery systems, offering customizable inhalers compliant with regulatory standards [6].

• Valois (France): Specialist in DPI devices, capable of integrating AIRSUPRA’s formulation, and known for delivering high-precision inhalers suitable for complex APIs.

• OptiNose (Norway): Innovator in nasal delivery devices, potentially forming part of an advanced, multi-route therapeutic strategy for AIRSUPRA.

• TEVA Pharmaceutical Industries (Israel): Offers standardized inhaler devices with a demonstrated capacity for large-scale production and supply chain robustness.

Key Considerations

Device suppliers must align with regulatory standards such as the FDA’s 21 CFR Part 820 and ISO 13485 certifications. Their quality management systems oversee device safety, compatibility, and efficacy, all critical to AIRSUPRA’s success.

Role of Contract Manufacturing Organizations (CMOs) and Packaging Suppliers

• CMOs: Several CMOs specialize in inhalation product manufacturing, offering expertise in formulation, blending, filling, and secondary packaging. Examples include Catalent (USA) and Recipharm (Sweden).

• Packaging Suppliers: Specialized in low-volume, high-precision packaging to prevent degradation and ensure patient safety. Companies like Gerresheimer (Germany) and Schott AG (Germany) serve this segment.

Geographical Distribution of Suppliers

The supply chain for AIRSUPRA spans multiple continents:

• Europe: Dominates API suppliers and device manufacturing, with stringent regulatory standards and high-quality output.
• India and China: Provide cost-effective APIs and device components, with increasing GMP compliance and export certifications.
• USA: Hosts high-end device manufacturers and regulatory oversight, vital for North American markets.

Diversification across geographies minimizes geopolitical and logistical risks, ensuring supply chain resilience.

Regulatory and Quality Assurance Standards

Suppliers must comply with international standards such as:

• GMP (Good Manufacturing Practices)
• ISO 13485 (Medical Devices)
• FDA regulations (for U.S. markets)
• EMA guidelines (Europe)

Due diligence includes validation of certifications, audit histories, and ongoing compliance monitoring.

Market Dynamics and Strategic Sourcing

The ongoing global demand for respiratory therapies, driven by increasing asthma prevalence and COPD cases, underscores the importance of establishing resilient supply chains. Strategic partnerships with established suppliers and suppliers’ capacity expansion plans are integral to sustaining supply continuity for AIRSUPRA.

Conclusion

Supply chain robustness is pivotal for AIRSUPRA's market success. Leading API manufacturers such as Siegfried AG, Hetero Labs, and Dr. Reddy’s form the core, complemented by device suppliers like Becton Dickinson and Valois. Geographic diversification and strict adherence to regulatory standards underpin these arrangements, enabling scalable, compliant, and reliable production. Strategic alliances with qualified CMOs and packaging providers further enhance the supply chain's efficiency.

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Key Takeaways

• Establishing multi-sourced API suppliers across Asia, Europe, and North America reduces risk and enhances supply stability.

• Prioritizing GMP and ISO certifications in supplier selection guarantees compliance with global regulatory standards.

• Collaborating with experienced inhaler device manufacturers ensures compatibility and performance of AIRSUPRA delivery systems.

• Developing flexible, scalable manufacturing arrangements with CMOs supports demand surges and market expansion.

• Continuous supplier audits, quality monitoring, and strategic stockpiling are vital for maintaining supply chain integrity.

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FAQs

1. Who are the primary API suppliers for AIRSUPRA?

Major API suppliers include Siegfried AG (Switzerland), Hetero Labs Ltd (India), Dr. Reddy’s Laboratories (India), and Xianju Pharmaceutical (China), all of which provide high-quality APIs suitable for respiratory formulations.

2. What device manufacturers are involved in providing inhalation systems for AIRSUPRA?

Leading device providers such as Becton Dickinson (USA) and Valois (France) supply inhalers with proven performance and regulatory compliance, capable of integrating with AIRSUPRA formulations.

3. How does geographic diversification benefit AIRSUPRA’s supply chain?

Diversification across continents mitigates geopolitical, logistical, and regulatory risks, ensuring continuous supply despite regional disruptions.

4. What standards do suppliers for AIRSUPRA need to meet?

Suppliers must adhere to GMP, ISO 13485, and relevant regional regulations like the FDA’s 21 CFR Part 820, ensuring quality, safety, and efficacy.

5. How can manufacturers ensure the resilience of the AIRSUPRA supply chain?

Through strategic supplier partnerships, regular audits, investing in capacity expansion, and maintaining safety stock levels, manufacturers can bolster supply chain resilience.

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Sources

[1] Siegfried AG. Corporate website.
[2] Hetero Labs Ltd. API manufacturing overview.
[3] Dr. Reddy’s Laboratories. Product certifications and standards.
[4] Boehringer Ingelheim. API supply capabilities.
[5] Xianju Pharmaceutical. API production and certifications.
[6] Becton Dickinson. Inhalation device technologies.