Last updated: June 1, 2026
Wixela Inhub Suppliers: Who Manufactures the Inhaled Fluticasone Propionate + Salmeterol Product and How Is It Sourced?
Wixela Inhub is an inhaled combination product containing fluticasone propionate (an inhaled corticosteroid) and salmeterol xinafoate (a long-acting beta2-agonist). The supply chain centers on: (1) contract manufacturing of the inhaler and metered-dose/actuation components, (2) active pharmaceutical ingredient (API) sourcing for fluticasone and salmeterol salts, and (3) finished-goods release and distribution into the U.S. market under the ANDA/labeler structure reflected in FDA product listings.
What companies supply APIs for WIXELA INHUB (fluticasone propionate and salmeterol xinafoate)?
Direct API supplier identities for Wixela Inhub are not consistently disclosed in public sources. What is publicly determinable is the API and finished-dose manufacturing ecosystem through FDA product label/registration information and standard industry practice around ANDA supply chains. Publicly available “supplier” information typically appears indirectly via:
- ANDA product manufacturing sites (drug product and sometimes intermediate manufacture) tied to FDA establishment registration and labeler data.
- Drug master file (DMF) or supplier relationships that are not required to be publicly enumerated at the company-to-company level for each product.
- Excipients and device components often produced by specialized inhalation device OEMs, with those roles not always mapped to the brand owner in public labeling.
How does FDA labeling map to upstream supply?
For U.S. inhalation combination products, the public chain typically looks like:
- Labeler/Applicant (ANDA holder) controls formulation, specs, and regulatory filing.
- Drug product manufacturer(s) at registered sites manufacture and package.
- Device and components come from contracted OEMs (metering system, canister, valves, actuators), with the device “who builds it” not always disclosed in the label.
Who manufactures the Wixela Inhub finished drug product (and where are the manufacturing sites)?
Wixela Inhub is an ANDA product. Public manufacturing-site mapping comes from FDA’s structured listings (drug establishment registrations and the product’s labeled manufacturer/distributor identifiers). The concrete supplier answer, by company and location, is only complete when the exact FDA listing(s) and establishment registrations are enumerated for the specific strength(s) and dosage form(s) marketed as “Wixela Inhub.”
No complete, verifiable supplier list can be produced from the information provided in the prompt alone. Under strict accuracy constraints, a precise company-and-site supplier table would require pulling the FDA product listing, labeler, and establishment registrations for the exact NDC(s) used for Wixela Inhub.
Which inhaler-device OEMs supply the Wixela Inhub inhaler components?
Wixela Inhub uses a dry-hydrophobic powder formulation delivered via a breath-actuated inhaler platform (commonly in the class of diskus-like multi-dose powder inhalers). Device OEM supply typically involves:
- Dose metering and blistering/foil components
- Metering chamber hardware and dose selector mechanism
- Actuator and mouthpiece assemblies
But the specific device OEM(s) for Wixela Inhub are not reliably stated in public-facing labeling for the brand. Public “device supplier” identification is usually found through detailed contract manufacturing disclosures, regulatory submissions, or specialized device supply documentation that is not included in the prompt.
What contract manufacturers produce Wixela Inhub for the ANDA holder?
The ANDA holder typically outsources:
- Bulk manufacturing of the combination formulation (or separate blends by component then final blend)
- Filling, packaging, and labeling
- QA release under GMP for inhalation product critical quality attributes
A definitive contract manufacturer list requires the product’s NDC-specific FDA establishment registration and labeling data. That chain is not provided in the prompt.
How many suppliers are in the Wixela Inhub supply chain (APIs, drug product, device)?
A typical inhalation combination product supply chain includes:
- API supply for fluticasone propionate
- API supply for salmeterol xinafoate
- Combination formulation manufacturer (drug product)
- Packaging/labeling site
- Inhaler device/OEM hardware supply (canister, valves/actuator components if applicable, or dose-metering device components for the powder platform)
A quantified supplier count for Wixela Inhub cannot be stated accurately without the FDA-registered manufacturing sites and the exact NDC mapping for each Wixela Inhub strength.
What are the key supply-chain risk points for Wixela Inhub (API, inhaler device, GMP release)?
Even without naming suppliers, the supply risks for inhaled fluticasone/salmeterol combinations typically center on:
- API availability constraints for steroid and long-acting beta2 agonist salts
- Inhalation-specific particle engineering and blend uniformity controls
- Device component availability and compatibility with dose metering
- Batch release delays driven by stability and analytical method verification
What is the Orange Book status of Wixela Inhub and does it affect supplier arrangements?
Orange Book status affects patent-based competition, not day-to-day GMP sourcing. For supplier questions, the controlling public artifacts are:
- FDA drug product listings (NDCs, labeler/applicant)
- FDA establishment registrations (GMP manufacturing sites)
- Quality agreements between ANDA holder and contract manufacturers
This prompt does not include the specific Orange Book-listed patents or the application identifiers needed to map supply chain to specific labeled manufacturers.
Which generic or authorized-duplicate products compete with Wixela Inhub and how does that change sourcing?
Competition changes leverage in supply procurement, but supplier identities still depend on the specific ANDA labelers and their registered manufacturing sites. A complete competitive sourcing comparison requires NDC lists and FDA establishment mapping.
No reliable supplier comparison can be produced without the NDC-to-labeler-to-manufacturing-site mapping for Wixela Inhub and its competitors.
Wixela Inhub supplier table (company, role, evidence status)
| Role |
Supplier company |
Location/site |
Evidence level |
Status in provided prompt |
| Fluticasone propionate API |
Not provided |
Not provided |
Not determinable |
Not available |
| Salmeterol xinafoate API |
Not provided |
Not provided |
Not determinable |
Not available |
| Drug product manufacturer (GMP) |
Not provided |
Not provided |
Not determinable |
Not available |
| Packaging/labeling site |
Not provided |
Not provided |
Not determinable |
Not available |
| Inhaler device/OEM |
Not provided |
Not provided |
Not determinable |
Not available |
Key Takeaways
- Wixela Inhub’s supply chain spans API sourcing (fluticasone propionate and salmeterol xinafoate), outsourced inhalation drug product manufacturing, and inhaler-device component procurement.
- Public identification of the exact upstream suppliers by company name is not derivable from the prompt alone without the product’s NDC-specific FDA listing and establishment registration data.
- A decision-ready supplier map must be grounded in FDA-registered manufacturing sites and product labeler identifiers tied to the specific Wixela Inhub NDCs.
FAQs
- How do I identify Wixela Inhub contract manufacturers using FDA establishment registration data?
- Do inhalation device OEM suppliers show up in public FDA listings for Wixela Inhub?
- What public sources can confirm API manufacturers for fluticasone propionate and salmeterol xinafoate used in U.S. inhalation products?
- How can NDC-level mapping be used to distinguish manufacturing sites across Wixela Inhub strengths?
- Does FDA compliance history for inhalation sites predict supply disruption risk for Wixela Inhub?
References
- U.S. Food and Drug Administration. Drugs@FDA product databases and labeling listings (accessed via FDA public resources).
- U.S. Food and Drug Administration. FDA Establishment Registration and Drug Listing resources.
