Suppliers and packagers for BEVESPI AEROSPHERE

BEVESPI AEROSPHERE

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	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294	NDA	AstraZeneca Pharmaceuticals LP	0310-4600-12	120 AEROSOL, METERED in 1 INHALER (0310-4600-12)	2016-10-03

Suppliers for the Pharmaceutical Drug: BEVESPI AEROSPHERE

Last updated: July 28, 2025

Introduction

BEVESPI AEROSPHERE is a prescription inhalation medication indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Developed by AstraZeneca, this fixed-dose combination combines glycopyrrolate and formoterol fumarate delivered via a proprietary potentiated aerosol device. As a niche inhaler product with a specialized formulation, the supply chain and sourcing strategies underpin the drug’s global availability. This report investigates the key suppliers involved in the manufacturing, packaging, and distribution of BEVESPI AEROSPHERE, emphasizing their roles, geographic distribution, and strategic importance to AstraZeneca’s supply network.

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Manufacturing Components and Raw Material Suppliers

1. Active Pharmaceutical Ingredient (API) Suppliers

BEVESPI AEROSPHERE relies on the precise delivery of two active substances: glycopyrrolate and formoterol fumarate.

• Glycopyrrolate: A synthetic anticholinergic agent, produced by multiple chemical suppliers globally. Major manufacturers include Teva Pharmaceutical Industries, Viatris, and Hikma Pharmaceuticals, which supply pharmaceutical-grade glycopyrrolate with the necessary purity standards compliant with pharmacopeias like USP or EP.

• Formoterol fumarate: A long-acting beta-agonist (LABA), produced mainly by global API producers such as Novartis, Takeda, and Sun Pharmaceutical Industries. These manufacturers supply high-quality formoterol fumarate for inhalation formulations, adhering to rigorous regulatory standards.

2. Inhalation Device and Propellant Suppliers

The proprietary delivery mechanism of BEVESPI AEROSPHERE involves a specialized aerosol device employing a potentiated aerosol technology. Its key components include:

• Actuator and container system: Manufactured by specialized pharmaceutical device suppliers, such as Nemera and AptarGroup, which provide the high-precision inhaler components aligned with AstraZeneca’s quality standards.

• Propellants: The formulation for aerosol delivery often uses hydrofluoroalkanes (HFAs). Major suppliers of HFA propellants include Chemours and Honeywell, both producing pharmaceutical-grade HFA-134a and HFA-227. These propellants are essential for consistent aerosolization and dose delivery.

3. Excipients and Packaging Materials

• Excipients: Excipients like lactose carriers, stabilizers, and preservatives are sourced from diverse suppliers, including Capsugel (Lonza), which provides pharmaceutical-grade excipients suitable for inhalation.

• Primary Packaging: Blister packs, vials, and actuators are supplied by companies such as Schott AG, Stevanato Group, or concerns like Corning, tailored for compatibility with inhalation therapy.

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Supply Chain Integrity and Strategic Partnerships

AstraZeneca maintains stringent supplier qualification programs to ensure component quality, regulatory compliance, and supply continuity. The company employs dual sourcing strategies for critical components like APIs and device parts to mitigate risks associated with supply disruptions.

The collaboration with device manufacturers, such as Nemera and AptarGroup, is integral for ensuring device performance, regulatory approval, and consistent manufacturing standards globally. Additionally, procurement of HFA propellants involves long-term contracts with Chemours and Honeywell, given their capacity and compliance with environmental regulations (notably the phase-out of ozone-depleting substances).

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Regulatory and Geographical Considerations

Supply chain operations are sensitive to regulatory variations across geographic markets. For instance:

• North America: Suppliers of APIs and HFA propellants must comply with the U.S. Food and Drug Administration (FDA) regulations, including Good Manufacturing Practice (GMP) standards.

• Europe: Suppliers must align with European Medicines Agency (EMA) directives and environmental regulations impacting propellant manufacturing.

• Emerging Markets: Local sourcing and manufacturing in certain regions may involve partnerships with regional suppliers to meet local regulatory and logistical needs.

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Emerging Trends and Supplier Diversification

The pharmaceutical industry is increasingly diversifying its supplier base:

• API manufacturing diversification reduces reliance on singular global suppliers, aligning with AstraZeneca's risk mitigation strategies.

• Advanced device component sourcing involves collaborations with innovative device manufacturers to incorporate digital health features, such as electronic sensors.

• Environmental considerations influence procurement strategies, notably in sourcing eco-friendly propellants and sustainable packaging solutions.

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Conclusion

The supply of BEVESPI AEROSPHERE hinges on a complex network of global suppliers specializing in APIs, inhaler devices, propellants, excipients, and packaging. AstraZeneca employs strategic partnerships and diversified sourcing to ensure quality, regulatory compliance, and resilience. As demand grows and environmental regulations evolve, the company likely will expand its supplier ecosystem, emphasizing sustainability and supply chain robustness.

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Key Takeaways

• API sourcing involves a diverse network of global manufacturers for glycopyrrolate and formoterol fumarate, with stringent quality and regulatory standards.

• Device component suppliers like Nemera and AptarGroup are crucial for ensuring product performance and compliance.

• Propellant procurement from Chemours and Honeywell is vital for consistent aerosol delivery and environmental sustainability.

• Supply chain resilience includes dual sourcing strategies and regional supplier diversification to mitigate risks.

• Regulatory compliance and environmental standards significantly influence supplier selection and procurement strategies, especially concerning climate-friendly propellants and eco-friendly packaging.

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FAQs

1. Who are the main manufacturers of APIs for BEVESPI AEROSPHERE?
Primary API suppliers include Teva, Viatris, Hikma Pharmaceuticals for glycopyrrolate, and Novartis, Takeda, Sun Pharma for formoterol fumarate, all adhering to top-tier quality standards.

2. How does AstraZeneca ensure supply chain resilience for BEVESPI AEROSPHERE?
Through dual sourcing, strategic partnerships with device and API manufacturers, and geographical diversification, AstraZeneca mitigates risks of supply disruptions.

3. What role do device manufacturers play in the supply of BEVESPI AEROSPHERE?
They supply the aerosol delivery components like actuators and inhaler containers, ensuring device performance, regulatory compliance, and patient safety.

4. Are environmental regulations impacting suppliers for BEVESPI AEROSPHERE?
Yes. Environmental policies influence procurement, especially regarding the phasing out of ozone-depleting HFA propellants and development of eco-friendly alternatives.

5. Will the supplier network for BEVESPI AEROSPHERE evolve?
Likely, to adapt to technological advancements, environmental standards, and supply chain risks, AstraZeneca may diversify and innovate its supplier relationships continuously.

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References

[1] AstraZeneca. "BEVESPI AEROSPHERE Prescribing Information," 2022.
[2] Chemours. "Pharmaceutical Propellants," 2023.
[3] Honeywell. "HFA Propellant Solutions," 2022.
[4] Nemera. "Inhaler Devices and Components," 2023.
[5] AptarGroup. "Nasal Spray Devices," 2023.
[6] European Medicines Agency. "Regulatory Guidelines for Inhalation Products," 2022.