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 and packagers for airsupra

Last updated: May 27, 2026

Airsupra suppliers: Who manufactures and supplies the ingredients, inhaler device, and finished product for AstraZeneca’s albuterol-budesonide

Airsupra (albuterol sulfate inhalation aerosol combined with budesonide inhalation aerosol) is supplied in the US by AstraZeneca’s commercial organization through contract manufacturing and packaging partners across drug substance, drug product fill-finish, and device supply chains. The supplier map depends on the specific strength and packaging configuration released by the manufacturer-of-record on the FDA label and on batch-level CGMP supply contracts.

Who are the contract manufacturers supplying Airsupra (albuterol-budesonide) to the US market?

Featured snippet:

• Manufacturer-of-record and NDA-related labeling supply chain: check the “Manufactured for” and “Distributed by” sections on the current Airsupra FDA label; those entities are the commercial “supplier” of the finished drug product for distribution in the US (including packaging and release testing responsibility).
• Device and fill-finish: inhalation aerosols typically use specialized CMO fill-finish and valve/canister supply for pressurized metered-dose inhalers.

Airsupra inhalation aerosol supply chain segments

1. Drug substance (API)
   • Albuterol sulfate (short-acting beta2-agonist)
   • Budesonide (inhaled corticosteroid)
2. Drug product (pressurized metered-dose inhaler)
   • Formulation manufacture and canister filling
   • Valve installation, crimping, and aerosolizing system assembly
   • Inhaler packaging components (actuator, blister cartons, instruction inserts)
3. Quality and release
   • Batch disposition and QC release under NDA controls
   • Stability program and shelf-life release

Which companies supply the Airsupra inhaler device (actuator, canister, valve system)?

Featured snippet:

• The device suppliers for metered-dose inhalers are typically distinct from the NDA holder’s finished-goods release party. The actionable supplier names show up on:
  • the device component supply chain described in CMO disclosures (less public), and
  • the label’s manufacturer-of-record and “Manufactured for” entity.

What to look for on labels and regulatory filings

• “Manufactured for”: the entity responsible for final drug product manufacture and labeling
• “Distributed by”: the commercial distributor, not the device maker
• NDA/CMC listing in FDA review disclosures: fill-finish and intermediate manufacturing sites

Who supplies albuterol and budesonide APIs used in Airsupra?

Featured snippet:

• API suppliers for combination inhalation products are generally handled through AstraZeneca’s global API sourcing and are reflected in CMC documents rather than public-facing supplier lists.

API sourcing is usually split

• Albuterol sulfate supply: multiple global API sources are common for inhalation generics, but for a branded product the NDA holder typically qualifies one or a limited set of suppliers under change control.
• Budesonide supply: budesonide is a specialized corticosteroid API with a tighter qualified supplier set.

How do finished-goods suppliers differ by strength and package size for Airsupra?

Featured snippet:

• For aerosols, finished goods may differ by:
  • canister size and number of actuations
  • actuator variant or packaging format
  • distribution channel (retail vs institutional) Supplier-of-record can shift per production site and per packaging run.

Common execution pattern in inhalation products

• One drug product site produces multiple SKUs.
• Another site may handle secondary packaging.
• A third may supply the canister and valve assembly if the NDA holder outsources device hardware procurement.

What is Airsupra’s supplier status for US inventory: who makes and releases batches?

Featured snippet:

• Batch release is performed by the manufacturer-of-record named on the US label. Inventory continuity depends on:
  • validated manufacturing lines
  • qualified valve/canister supply
  • packaging component lead times (cartons, leaflets, labels)

Procurement and supply risk points

• Pressurized aerosol supply chains are sensitive to:
  • valve/crimp system availability
  • canister lot consistency (surface treatment, tolerances)
  • propellant procurement and fill-finish scheduling

Are there alternative suppliers (second-source CMOs) for Airsupra if capacity is constrained?

Featured snippet:

• Branded inhalers often maintain alternate qualified manufacturing sites to support continuity, but the names are not always publicly listed beyond labeling and specific CMC submissions.

What “alternate supplier” typically means in practice

• Alternate fill-finish site for canister filling and aerosol assembly
• Alternate secondary packaging site
• Alternate API supplier under approved CMC changes

What patent and regulatory constraints shape who can supply Airsupra’s formulation or process?

Featured snippet:

• Airsupra’s supplier landscape is constrained by:
  • AstraZeneca-owned formulation and manufacturing process know-how
  • the NDA’s approved manufacturing processes and validated acceptance criteria
  • IP barriers for generics and biosimilar-like pathways are less relevant because Airsupra is a small-molecule inhalation aerosol product, not a biologic.

Regulatory gating factors

• CMC comparability requirements if a supplier changes
• Analytical method transfer and validation across sites
• Stability and container-closure integrity data for canister and valve systems

How can you identify the Airsupra supplier list for a specific lot or shipment?

Featured snippet:

• Use the package label “Manufactured for” entity for finished product supplier identification for retail distribution.
• Lot-specific identification is typically available via:
  • lot number traceability in purchasing and pharmacovigilance systems
  • supply chain documentation held by wholesalers and manufacturers

Best operational indicators

• Wholesaler/dispensing-side documentation that maps NDC to manufacturer-of-record
• Contract manufacturing site disclosure when present in public FDA summaries (limited)

Key Takeaways

• “Suppliers for Airsupra” breaks into drug substance sourcing, inhaler device component sourcing, and finished-goods manufacturing and packaging.
• The most actionable public supplier identity is the manufacturer-of-record named on the current US prescribing information label; this is the entity responsible for final manufacture, labeling, and batch release.
• Device and component suppliers for aerosol metering systems are usually not fully enumerated publicly; in practice they are tracked via NDA CMC manufacturing sites, valve/canister qualification, and procurement contracts.
• Capacity continuity in pressurized aerosols depends on qualified fill-finish lines and valve/canister procurement lead times, so alternate qualified sites are common but not always publicly enumerated.

FAQs

1. How do I find the manufacturer-of-record for Airsupra for a specific NDC?
   Check the current US prescribing information label sections “Manufactured for” and the NDC-labeled product packaging.

2. Who performs batch release for Airsupra in the US?
   The entity listed as the finished product manufacturer on the label is the practical batch-release/disposition party.

3. Are there different suppliers for Airsupra’s device versus the finished drug product?
   Yes. Device hardware (canister/valve/actuator) is commonly sourced separately from the NDA holder’s finished-goods fill-finish and packaging.

4. Can a new contract manufacturer supply Airsupra without re-approvals?
   Changes require CMC work under the NDA to maintain validated process, analytical methods, and stability for the approved container-closure system.

5. Does Airsupra use a single API supplier for albuterol and budesonide?
   NDA holders commonly qualify a limited set of API suppliers; the exact names are reflected in CMC documentation rather than consumer-facing materials.

References

1. AstraZeneca. Airsupra (albuterol sulfate and budesonide) prescribing information. (Latest US label).