Suppliers and packagers for ADVAIR HFA

ADVAIR HFA Suppliers: What Companies Provide Inhaler Components, Propellants, and Contract Manufacturing

Adva​​ir HFA (fluticasone propionate and albuterol sulfate) is a branded pressurized metered-dose inhaler (pMDI) supplied through a vertically integrated network spanning FDA-registered drug product manufacturing, inhaler device and subassembly supply, and specialty inputs including the pMDI propellant and inhaler components. Specific “supplier” assignments vary by lot, market, and contract roles, and are not consistently published as a single consolidated vendor list.

What companies supply ADVAIR HFA inhaler hardware and subassemblies?

Public-facing supplier information for ADVAIR HFA typically appears in two places: (1) inhaler device component supply used in pMDI ecosystems (actuator, valve, canister, stem, mouthpiece) and (2) contract manufacturing of drug product and packaging. For pMDI systems, the market standard supplier set tends to include large device makers and specialized propellant handling and filling partners.

Key device and pMDI-system supplier types (typical for ADVAIR HFA-style pMDIs):

• Metered-dose valve and actuator systems (global inhaler device OEM ecosystem)
• Canisters and corrosion-resistant metal components compatible with HFA
• Mouthpiece/actuator assemblies for drug-device integration
• QA release and inspection supporting combination drug-device products
• Filling, crimping/sealing, and leak-testing tooling

Actionable implication for procurement and diligence: supplier identity must be traced by drug product lot and manufacturing site (labeler/manufacturer on the carton and FDA listing), then mapped back to device and fill subcontracts.

Which contract manufacturers make ADVAIR HFA drug product and final packaged units?

ADVAIR HFA is manufactured and released by an FDA-registered drug product manufacturer (labeler and/or manufacturer of record on FDA labeling/packaging). For pMDI, the manufacturing chain usually includes:

• Bulk drug substance handling (fluticasone propionate and albuterol sulfate)
• Drug product formulation and mixing
• pMDI formulation fill into canisters using HFA propellant
• Assembly with metering valve, actuator, and mouthpiece
• Canister sealing, crimping, and system integrity testing
• Packaging and distribution

Actionable diligence path: use FDA product listings and labeling to identify the “manufactured for” or “manufactured by” parties for each strength (50/250 mcg and 50/500 mcg) and package size.

What companies supply HFA propellant used in ADVAIR HFA?

ADVAIR HFA uses HFA propellant for pMDI delivery. In the market, HFA (typically 1,1,1,2-tetrafluoroethane, HFC-134a) procurement is handled through specialty chemical suppliers and distributors under pharmaceutical-grade supply chains with inhalation-use traceability.

Procurement implication: propellant supply is typically sourced from large chemical manufacturers or approved pharmaceutical distributors with:

• Pharmaceutical-grade specifications
• Documented extractables/leachables compatibility for inhaler contact materials
• Controlled moisture and impurity profiles
• Lot traceability supporting inhaler performance and regulatory documentation

How do you identify the actual ADVAIR HFA vendor for a specific batch or strength?

For high-stakes sourcing, the reliable method is to map:

1. NDC and label manufacturer (from package labeling)
2. FDA listing “manufactured for” and “manufactured by” fields
3. Drug product facility (site name on labeling)
4. Device integration chain (pMDI valve/actuator can be traced to the device OEM ecosystem used by the drug product site)

This approach is operationally stronger than searching for a single “supplier of ADVAIR HFA” because branded inhalers frequently change contract partners across years and geographies.

What does the ADVAIR HFA supply chain look like end-to-end?

A practical end-to-end map for a pMDI combination product:

• Active ingredients: fluticasone propionate and albuterol sulfate obtained via API supply chain
• Drug product formulation: blending with excipients suitable for suspension/solution in HFA-compatible formulation
• Propellant: pharmaceutical-grade HFA procurement
• Canister and valve-actuator system: device components sourced from inhaler component OEM network
• Filling and assembly: contract filling and assembly operations under GMP at the manufacturing site
• Final packaging: carton and label configuration per NDC and market

Which upstream vendors typically supply the APIs for fluticasone and albuterol?

API sourcing for fluticasone propionate and albuterol sulfate commonly involves:

• Primary API manufacturers with DMF/CEP-supported supply
• Secondary contract manufacturers for specific intermediates or polymorph control
• Multi-source qualified suppliers under the brand’s regulatory filings

For ADVAIR HFA specifically, API supplier identity is not a single public vendor list; it is governed by regulatory filing access (DMFs) and confidentiality around commercial supply agreements.

What regulatory touchpoints constrain ADVAIR HFA supplier changes?

Supplier substitution in a pMDI combination drug is constrained by:

• CMC requirements for formulation and device compatibility
• Device component interchangeability (actuator/valve tolerances, metering precision)
• Propellant grade and impurity profile acceptance
• Stability, aerosol performance, and extractables/leachables documentation
• Regulatory notification and comparability exercises for site changes

Where does supplier information show up for due diligence?

The most decision-grade supplier data for branded inhalers generally comes from:

• FDA product labeling fields (manufacturer of record, packaged for, distributed by)
• FDA listing for NDC and firm names
• Inspection and facility information tied to the manufacturing sites
• DMF-based or CMC-based disclosures (limited in public sources)
• Quality agreements required by GMP that identify approved vendors

Key Takeaways

• ADVAIR HFA is a pMDI whose “supplier” footprint spans drug product manufacturing, pMDI device components, and HFA propellant chemical sourcing.
• A single consolidated supplier list is rarely public; vendor identification must be done through NDC-level manufacturer of record and mapping back to drug product sites and pMDI device integration chains.
• Regulatory and CMC constraints make supplier swaps non-trivial for formulation, device interchangeability, and propellant grade.

FAQs

1. How do I find the manufacturer of record for a specific ADVAIR HFA NDC?
   Use the NDC-level labeling and FDA listing “manufactured for/manufactured by” fields.

2. Do ADVAIR HFA device components come from the same company that fills the inhaler?
   Often device component OEMs and drug-product filling/assembly sites are different entities in pMDI supply chains.

3. What evidence matters for switching HFA propellant suppliers for an inhaler?
   Pharmaceutical-grade specs, impurity profile, and compatibility testing for aerosol performance and contact materials.

4. Are API suppliers for fluticasone and albuterol publicly named for ADVAIR HFA?
   Usually not as a single vendor roster; API supplier identity is typically managed through regulatory filings and commercial contracts.

5. How do paragraph IV and generic strategy affect ADVAIR HFA sourcing?
   They do not directly change sourcing by themselves, but they can shift manufacturing capacity and contract partner choices during supply rebalancing.

References (APA)

1. FDA. (n.d.). Drug databases and product labeling resources (NDC, labeling manufacturer fields). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files
2. U.S. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. FDA. (n.d.). Device and drug combination product regulatory information. https://www.fda.gov/medical-devices/combination-products