Last updated: April 25, 2026
AIRDUO RESPICLICK Suppliers: What the Patent and Labeling Landscape Shows
Which entities supply AIRDUO RESPICLICK ingredients and manufacturing services?
AIRDUO RESPICLICK is a fixed-dose, prescription combination inhaler. The product is marketed in the US by Janssen Biotech, Inc. (a Johnson & Johnson company) as the label holder for AIRDUO RESPICLICK (fluticasone propionate and albuterol sulfate). The label identifies the manufacturing site(s) associated with the drug product, which in turn drive the supply chain for contract manufacturing and packaging.
Because supplier identification for inhalation products is typically split across:
- Active pharmaceutical ingredient (API) manufacturers
- Drug product manufacturers (fill-finish and device integration)
- Package and label distribution network
the most defensible, auditable “supplier” set for AIRDUO RESPICLICK starts with the entities named on the approved US product label (and related FDA drug listings).
What do official label and FDA listing documents identify as the manufacturer/supplier for the drug product?
AIRDUO RESPICLICK’s US prescribing information and FDA product listing identify Janssen Biotech, Inc. as the labeler and state the manufacturer/site responsible for producing and/or distributing the product (label and labeling typically list a manufacturing and packaging facility and the label holder separately).
Label holder: Janssen Biotech, Inc.
Product: AIRDUO RESPICLICK (fluticasone propionate and albuterol sulfate)
What is the upstream ingredient split implied by the combination?
AIRDUO RESPICLICK contains two drug substances:
- Fluticasone propionate (corticosteroid API)
- Albuterol sulfate (short-acting beta-agonist API)
In practice, these APIs come from specialized API manufacturers and are then supplied to the drug product manufacturer for blending, micronization (as needed), and formulation into the inhaler dose system.
A defensible supply-chain map for AIRDUO RESPICLICK therefore has three procurement “nodes”:
- Fluticasone propionate API
- Albuterol sulfate API
- Drug product manufacturing and packaging for the Respimat-style inhaler system (RESPICLICK is a breath-actuated dry powder inhaler device)
What contract-manufacturing model applies to AIRDUO RESPICLICK?
For US inhalation fixed-dose combination products, the typical operational model is:
- One or more firms supply APIs
- A separate drug product manufacturer conducts formulation and fill into the inhaler device
- A packaging/distribution chain then supports commercial release
The supplier answer that is strongest for decision-making is the drug product manufacturer(s) named in the labeling plus the company labeled as responsible for the product’s release and distribution.
Actionable Supplier Set (Labeler and Named Manufacturer Entities)
AIRDUO RESPICLICK’s supplier network can be operationally treated as two categories for sourcing and vendor due diligence:
Category 1: Regulatory label holder (commercial supplier of record)
- Janssen Biotech, Inc. (labeler/holder on the US prescribing information)
Category 2: Drug product manufacturer (site named in label/FDA product documentation)
- Manufacturer and/or packager named in the US prescribing information for AIRDUO RESPICLICK (the prescribing information for the product identifies the responsible manufacturing site(s))
Key Takeaways
- AIRDUO RESPICLICK is marketed under a US label structure where Janssen Biotech, Inc. is the label holder.
- The most reliable “supplier” entities for supply-chain mapping are the manufacturer/packager named in the approved prescribing information and the labeler identified in the FDA labeling record.
- Upstream supply is logically segmented into fluticasone propionate API, albuterol sulfate API, and drug product fill-finish plus device integration.
FAQs
1) Who is the label holder for AIRDUO RESPICLICK?
Janssen Biotech, Inc.
2) What APIs does AIRDUO RESPICLICK contain?
Fluticasone propionate and albuterol sulfate.
3) Are API suppliers the same as the drug product manufacturer?
Often not. API supply is usually separate from drug product fill-finish and inhaler device assembly.
4) What supplier identification is most defensible for operational sourcing?
Entities named in the US prescribing information and FDA product records (labeler plus named manufacturer/packager sites).
5) What part of the supply chain is most critical for AIRDUO RESPICLICK?
The drug product manufacturing and inhaler device integration, because the Respiclick system performance depends on formulation and device-specific processing.
References
[1] U.S. Food and Drug Administration. (n.d.). AIRDUO RESPICLICK product information and labeling (drug approval and listing records). FDA.
[2] Janssen Biotech, Inc. (n.d.). AIRDUO RESPICLICK (fluticasone propionate and albuterol sulfate) prescribing information (US label).
