Last Updated: June 25, 2026

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 and packagers for BREZTRI AEROSPHERE

Last updated: April 25, 2026

Who Supplies BREZTRI AEROSPHERE’s Components and Manufacturing Inputs?

BREZTRI AEROSPHERE is an AstraZeneca respiratory inhalation product. The product’s supply chain is anchored by AstraZeneca’s global manufacturing network and by component suppliers tied to inhalation device hardware and inhalation formulation supply.

Product identity

  • Brand: BREZTRI AEROSPHERE
  • Active ingredients (MDD): budesonide, glycopyrrolate, formoterol fumarate (delivered via metered-dose pressurized inhalation device)
  • Marketing authorization holder (EU/UK practice; commonly AstraZeneca): AstraZeneca

What entities supply BREZTRI’s drug substance and finished product?

Drug substance and formulation supply

BREZTRI is manufactured as a combination product (ICS + LAMA + LABA) with fixed-dose inhalation formulation supplied into a pressurized metered-dose system. In practice, supply is handled through AstraZeneca’s sites and commercial manufacturing partners (CMOs) where AstraZeneca assigns formulation scale-up, fill-finish, and device integration.

AstraZeneca’s inhaled-therapy portfolio uses:

  • In-house and contract fill-finish for pressurized metered-dose inhalers
  • Vendor-supplied device parts (canisters, valves, actuators, seals) integrated into finished units by the fill-finish site

Device hardware supply

Pressurized inhalation products require dedicated hardware suppliers for:

  • Canisters (drug container)
  • Valves and metering components
  • Actuators/nozzles
  • Seals, springs, and related elastomeric hardware
  • Packaging and secondary cartons

For AstraZeneca inhaler programs, valve and metering systems are typically sourced from specialist inhaler-component manufacturers used across multiple respiratory products, with final assembly at the designated fill-finish/manufacturing location.

Which suppliers are tied to BREZTRI’s inhaler device ecosystem?

BREZTRI is built on standard pressurized metered-dose inhaler component classes. Suppliers fall into two buckets: (1) device component OEMs (valves, actuators, canisters) and (2) fill-finish/packaging manufacturers that assemble the system into marketed units.

AstraZeneca’s inhaler device supply chain commonly uses the same global suppliers across programs for:

  • Metering valves and valve assemblies
  • Actuator/nozzle systems
  • Canister manufacturing
  • Cartridge or canister integration components

Where is BREZTRI manufactured (and who runs the fill-finish)?

For business decisions, the key operational reality is that:

  • The finished dosage form (filled pressurized containers integrated with actuator/valve) is manufactured at the site(s) that AstraZeneca assigns for fill-finish and assembly.
  • The component suppliers feed those sites with valve, canister, actuator, and packaging inputs.

Supply risk mapping for BREZTRI

  • Valve and metering components drive schedule risk in supply chain interruptions because they are precision components and have long lead times.
  • Canisters drive schedule risk due to corrosion, coating, and dimensional control requirements.
  • Formulation supply drives risk because drug substance batch availability controls fill campaign timing.

How to identify the actual named suppliers for BREZTRI (device + drug product)?

The supplier names that matter for contracting, diligence, and contingency planning are the ones that appear in:

  • regulatory product manufacturing disclosure (where the Marketing Authorization dossier lists manufacturing sites)
  • labeler/manufacturer sections on approved labeling
  • cGMP manufacturing site listings associated with BREZTRI’s marketing authorization
  • device supplier traceability records held by the fill-finish site (often reflected in batch record structure, component control documentation, and can be inferred from the assembly site’s vendor base)

Key Takeaways

  • BREZTRI’s supply chain is split between AstraZeneca-controlled drug formulation/fill-finish integration and specialist OEM suppliers of pressurized inhaler hardware (valves, canisters, actuators, seals).
  • The most operationally material supplier classes are metering valves and precision canisters feeding the fill-finish/manufacturing sites.
  • For definitive supplier naming (who supplies valves, canisters, actuators, and which CMO assembles), the only actionable source is the regulatory disclosure tied to BREZTRI’s manufacturing sites and labeling, plus the fill-finish site’s component OEM roster.

FAQs

  1. Who is the primary manufacturer of BREZTRI AEROSPHERE?
    AstraZeneca is the marketing authorization holder and program integrator; finished product manufacturing and fill-finish occur at assigned AstraZeneca and/or contract manufacturing sites.

  2. Are there separate suppliers for the drug and the inhaler device?
    Yes. Drug formulation supply and pressurized inhaler device hardware supply typically come from different supplier categories and then integrate at the fill-finish site.

  3. What components are most sensitive to supply disruption for BREZTRI?
    Metering valves, canisters, and actuator/nozzle assemblies are the highest lead-time, highest precision components.

  4. How are BREZTRI’s hardware suppliers typically used?
    Valve, canister, and actuator OEMs supply parts to the fill-finish/assembly manufacturer, which then produces the packaged, labeled inhalers.

  5. Where can supply chain decision-makers confirm named suppliers?
    In BREZTRI’s regulatory manufacturing disclosures and the manufacturing-site listings tied to its marketing authorization, supplemented by labeling-manufacturer references and the fill-finish site’s component procurement records.


References (APA)

[1] AstraZeneca. (n.d.). BREZTRI AEROSPHERE product information and prescribing information. AstraZeneca.
[2] U.S. FDA. (n.d.). Bre z tr i AEROSPHERE (budesonide, glycopyrrolate, formoterol fumarate) inhalation aerosol: label and prescribing information. U.S. Food and Drug Administration.
[3] European Medicines Agency. (n.d.). BREZTRI AEROSPHERE EPAR: manufacturing sites and product information. European Medicines Agency.

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