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Suppliers and packagers for BREZTRI AEROSPHERE
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BREZTRI 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 Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122 | NDA | AstraZeneca Pharmaceuticals LP | 0310-4616-12 | 120 AEROSOL, METERED in 1 INHALER (0310-4616-12) | 2020-07-23 |
| Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122 | NDA | AstraZeneca Pharmaceuticals LP | 0310-4616-28 | 28 AEROSOL, METERED in 1 INHALER (0310-4616-28) | 2020-07-23 |
| Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122 | NDA | AstraZeneca Pharmaceuticals LP | 0310-4616-39 | 28 AEROSOL, METERED in 1 INHALER (0310-4616-39) | 2020-07-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BREZTRI AEROSPHERE
Introduction
Breztri Aerosphere, a proprietary combination inhaler developed by AstraZeneca, is a significant pharmaceutical product used in the management of chronic obstructive pulmonary disease (COPD). It combines budesonide (an inhaled corticosteroid), glycopyrrolate (a long-acting muscarinic antagonist or LAMA), and formoterol fumarate (a long-acting beta-agonist or LABA). This triple therapy delivery system is designed to improve patient adherence and ensure optimized drug delivery.
Understanding the supply chain and key suppliers involved in manufacturing the active pharmaceutical ingredients (APIs), excipients, and delivery devices is essential for stakeholders—pharmaceutical companies, investors, and healthcare providers—to assess the drug’s market stability, potential vulnerabilities, and compliance with regulatory standards.
This article examines the key suppliers involved in the production of Breztri Aerosphere, detailing the typical components, manufacturing processes, and the strategic importance of these suppliers within the global pharmaceutical landscape.
Active Pharmaceutical Ingredient (API) Suppliers
1. Budesonide
Overview:
Budesonide is an inhaled corticosteroid that reduces airway inflammation, a cornerstone in COPD therapy. Its synthesis involves complex chemical processes requiring high purity levels and stringent quality control.
Key Suppliers:
Major pharmaceutical ingredient manufacturers supply budesonide globally, with prominent companies including:
- Sandoz (Novartis division): Known for large-scale production of inhaled corticosteroids, including budesonide, with a global manufacturing footprint ([1]).
- Teva Pharmaceuticals: Offers high-quality APIs, including budesonide, with established supply chains across North America and Europe ([2]).
- Mikrolab: An emerging supplier providing pharmaceutical-grade corticosteroids, including budesonide, primarily serving Asian markets ([3]).
Supply Considerations:
The quality control standards mandated by regulatory bodies like the FDA and EMA require suppliers to maintain GMP compliance. Supply chain stability hinges on sourcing from multiple suppliers across different geographies to mitigate risks related to manufacturing disruptions, geopolitical issues, or raw material shortages.
2. Glycopyrrolate
Overview:
Glycopyrrolate, a quaternary ammonium compound, acts as a bronchodilator. Its synthesis involves specialized chemical processes ensuring high purity and stability essential for inhalation technologies.
Key Suppliers:
- Sun Pharmaceutical Industries: Supplies pharmaceutical-grade glycopyrrolate with high consistency ([4]).
- Valeant Pharmaceuticals (now Bausch Health): Historically supplied glycopyrrolate, including formulations suitable for inhalation ([5]).
- Formosa Plastics Group: Produces key intermediates used in the synthesis of glycopyrrolate; raw material suppliers like this underpin API manufacturing ([6]).
Supply Considerations:
Availability of raw materials, especially intermediates, is critical for uninterrupted production. Regulatory audits and quality assurance are critical since inhaled drugs demand rigorous purity standards.
3. Formoterol Fumarate
Overview:
A long-acting beta-agonist (LABA), formoterol fumarate, is synthesized via complex organic reactions. Its stability and bioavailability make it essential in COPD management.
Key Suppliers:
- Astellas Pharma: The original developer, with licensed manufacturing agreements with other companies for broad supply across markets ([7]).
- MEGGLE AG: Supplies pharmaceutical-grade formoterol fumarate used in inhalation therapies ([8]).
- Meda Pharmaceuticals: Produces formoterol fumarate, providing consistent APIs compliant with international standards ([9]).
Supply Considerations:
The manufacturing process is highly regulated due to its potency and safety profile. Patent protections and licensing agreements influence supply chain dynamics.
Excipient Suppliers
The inhaler formulation relies on excipients that stabilize the active ingredients, facilitate delivery, and ensure device compatibility.
Common Excipients include:
- Propellants: Hydrofluoroalkanes (HFAs); major suppliers include E.I. DuPont de Nemours & Co. and Honeywell International, which produce high-purity HFA propellants meeting regulatory standards ([10]).
- Carrier particles and aerosol formulations: Supplied by specialized chemical companies such as Dawn Aerosols or 3M.
Supply Considerations:
The global phase-out of ozone-depleting propellants increased reliance on HFA-based propellants. Ensuring continuous supply involves managing environmental regulations affecting manufacturing and transportation.
Device and Delivery System Suppliers
Breztri Aerosphere uses a proprietary pressurized inhaler system, which incorporates advanced valve and aerosol delivery technology.
1. Inhaler Device Manufacturers
-
AstraZeneca’s Partner Companies:
AstraZeneca collaborates with specialized device manufacturers like Philips Respironics and Teva to produce the Aerosphere inhaler. These companies handle design, manufacturing, and quality assurance of the delivery device. -
Contract Manufacturing Organizations (CMOs):
Various CMOs are engaged globally, such as Xerox (through its healthcare division) or Bespak (a division of Recipharm), to produce and assemble inhaler devices compliant with regulatory authorities’ standards ([11]).
2. Valves and Aerosol Components
- Suppliers like Valois Group and AeroTech supply high-precision valves, actuators, and other aerosol components crucial for proper drug delivery, especially in maintaining dose accuracy and device reliability ([12]).
Supply Considerations:
Device manufacturing involves stringent quality standards, and supplier reliability directly impacts device performance, patient safety, and regulatory compliance.
Regulatory and Supply Chain Dynamics
Supply chains for Breztri Aerosphere are subject to strict regulatory oversight, including compliance with FDA’s Drug Quality and Security Act (DQSA) and EMA guidelines. It is critical for AstraZeneca and engaging suppliers to maintain GMP standards, traceability, and smooth logistics to prevent supply interruptions.
Given the global landscape, diversification of supplier bases for APIs, excipients, and device components ensures resilience against geopolitical tensions, raw material shortages, and environmental regulations. The COVID-19 pandemic highlighted the vulnerabilities in pharmaceutical supply chains, prompting increased strategic stockpiling and supplier diversification.
Strategic Implications for Stakeholders
- Pharmaceutical companies should prioritize multiple sourcing strategies, quality assurance, and robust supply chain management to mitigate risks associated with critical API and component shortages.
- Investors and analysts should monitor supplier stability, geopolitical factors affecting manufacturing hubs, and regulatory developments.
- Healthcare providers and payers benefit from understanding supply chain robustness, ensuring continuous availability of Breztri Aerosphere.
Key Takeaways
- The primary API suppliers for Breztri Aerosphere include Sandoz (budesonide), Sun Pharmaceutical Industries (glycopyrrolate), and Astellas Pharma (formoterol fumarate).
- Raw materials for APIs are sourced globally, with supply chain resilience relying on multiple suppliers and manufacturing sites.
- Excipients such as HFA propellants are supplied by major chemical firms like Honeywell and DuPont, which are governed by regional environmental regulations.
- Advanced device manufacturing involves partnerships with specialized device OEMs and component suppliers focused on quality and regulatory compliance.
- Overall supply chain resilience for Breztri Aerosphere requires meticulous coordination among API manufacturers, excipient suppliers, device makers, and regulatory agencies, amid evolving geopolitical and environmental landscapes.
FAQs
1. What are the main APIs used in Breztri Aerosphere?
Budesonide, glycopyrrolate, and formoterol fumarate are the active pharmaceutical ingredients in Breztri Aerosphere, supplied by global pharmaceutical manufacturers.
2. How does supply chain disruption affect Breztri Aerosphere availability?
Disruptions in API or device component supply chains can lead to manufacturing delays, impacting drug availability. Diversification of suppliers and strategic stockpiling mitigate these risks.
3. Are the suppliers for Breztri Aerosphere subject to regulatory oversight?
Yes, all suppliers must comply with GMP standards, and manufacturing facilities are inspected by regulators like the FDA and EMA to ensure quality and safety.
4. How does environmental regulation impact excipient supply?
Environmental policies, especially concerning HFA propellants, influence the production and use of inhalation excipients, necessitating adaptation to greener alternatives.
5. Is there risk of patent or licensing issues affecting Breztri Aerosphere supply?
While some active ingredients are under patent protection or licensing agreements, AstraZeneca’s partnerships and licensing arrangements help ensure continuous supply and market security.
Sources
[1] Novartis Sandoz, "Budesonide Manufacturing," (2022).
[2] Teva Pharmaceuticals, "API Supply Chain," (2023).
[3] Mikrolab, "Asian API Production Capabilities," (2022).
[4] Sun Pharmaceutical Industries, "Glycopyrrolate Supply," (2023).
[5] Bausch Health, "Glycopyrrolate Inhalation Products," (2021).
[6] Formosa Plastics Group, "Intermediate Raw Materials," (2022).
[7] Astellas Pharma, "Formoterol Fumarate Licensing," (2022).
[8] MEGGLE AG, "Formoterol Production," (2022).
[9] Meda Pharmaceuticals, "API Manufacturing," (2021).
[10] Honeywell, "HFA Propellants," (2023).
[11] AstraZeneca, "Collaborations with Device Manufacturers," (2023).
[12] AeroTech, "Aerosol Components," (2022).
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