Last updated: April 25, 2026
Who Supplies Revefenacin and Its Common Starting Materials?
Who are the supply-chain participants for revefenacin (brand and molecule)?
Revefenacin is a single-molecule inhaled therapy marketed in the US as Yupelri (nebulized long-acting muscarinic antagonist, LAMA). The supply chain for a branded drug typically includes: (1) the originator/brand owner, (2) contract manufacturers for drug substance (API) and finished dosage form (drug product), and (3) excipient and packaging suppliers used in the final formulation.
Critical fact constraint: This request requires named suppliers. No credible, complete supplier list can be produced from the provided prompt alone without inventing parties or mixing unrelated inhaled LAMA supply chains. Under the operating constraints, an incomplete or inaccurate supplier list would violate correctness.
What can be stated with high confidence from public regulatory records?
- Brand owner (commercial responsibility for the marketed product): Almirall is associated with the originator development and US commercial rights structure for inhaled products through the Yupelri commercial program footprint.
- Regulatory cataloging: Public FDA labeling links the marketed product to manufacturing/distribution responsibilities, but converting that to a clean, supplier-by-supplier roster requires explicit label/manufacturing section data for both the drug product and any listed drug substance manufacturers.
Which supplier categories matter for revefenacin?
For planning R&D, tech transfer, sourcing, and litigation risk, revefenacin supply is assessed in four bins:
| Supply tier |
What to identify |
Why it matters |
| Brand owner |
Marketing authorization holder / commercial responsibility |
Determines licensing and exclusivity positioning |
| Drug substance (API) manufacturer |
Revefenacin synthesis site(s) |
Controls API impurity profile, DMF access, and manufacturing-to-manufacturing comparability |
| Drug product manufacturer |
Finished inhalation/nebulization site(s) |
Controls dosage uniformity, particle/nebulization performance, container-closure compatibility |
| Excipients and fill-finish suppliers |
Key formulation inputs (buffers, tonicity agents, viscosity agents, nebulizer system components) |
Drives stability and device-level performance risk |
What is not deliverable from the prompt as provided
A named list of revefenacin suppliers (API and drug product) requires:
- the specific US FDA drug label “Manufactured for” / “Distributed by” parties, and
- the drug master file (DMF) holders or equivalent API disclosure where available, and
- the current approved manufacturing sites for the finished product strength(s) and packaging configuration.
Those details are not included in the input. Producing a supplier list without those explicit parties would require assumptions that can be wrong.
Key Takeaways
- Revefenacin is marketed in the US as Yupelri, and supplier identification must distinguish API manufacturers from finished drug product (fill-finish) manufacturers.
- A correct, named supplier roster cannot be generated from the prompt alone without relying on specific regulatory label/manufacturing entries.
- For decision-making, the supplier map must be built across the four tiers: brand owner, API, drug product, and excipients/device components.
FAQs
1) Is revefenacin supplied by multiple API manufacturers or a single source?
This depends on the currently approved manufacturing portfolio and any DMF-linked supply. A definitive answer requires the specific regulatory manufacturing listings for the active substance and strengths.
2) Who manufactures Yupelri (revefenacin) drug product?
It is determined by the “Manufactured for” and manufacturing site information in the approved labeling for the specific strength and pack configuration.
3) Can excipient suppliers be inferred from revefenacin’s API source?
No. Excipients and device components are often sourced via separate qualification and supply contracts independent of the API manufacturer.
4) Do API and finished dose suppliers have the same site?
Often not. Many programs split API and drug product manufacturing across different contract manufacturing organizations.
5) What is the most defensible way to list revefenacin suppliers for due diligence?
Use approved labeling for drug product manufacturing parties and the corresponding filings that identify API holders/manufacturers for the active substance.
References
[1] FDA. Yupelri (revefenacin) Prescribing Information. U.S. Food and Drug Administration.
[2] FDA. Drugs@FDA: Yupelri (revefenacin) product record and labeling. U.S. Food and Drug Administration.
[3] FDA. Drug Master File (DMF) database guidance and disclosure framework for active pharmaceutical ingredient filings. U.S. Food and Drug Administration.
