Last updated: May 27, 2026
SEREVENT (salmeterol) Suppliers: Which Companies Manufacture, Supply, and Source the Marketed Product?
SEREVENT is a brand of inhaled salmeterol (a long-acting beta2-agonist). In the US, the marketed product is typically supplied by the brand holder and/or their contract manufacturing network; the exact “supplier” depends on (1) strength and dosage form (Diskus vs. AirDuo RespiClick historically), (2) country/market, and (3) which party holds the FDA listing for the specific NDC at the time of sale.
A complete, accurate supplier map requires tying each marketed strength/NDC to the current FDA “Labeler” and the listed manufacturing sites, then cross-matching to upstream API (salmeterol xinafoate) makers and excipient suppliers used in the inhalation formulation. This cannot be produced from the provided input alone.
Which companies supply SEREVENT inhalation product in the US (NDC labeler and manufacturer sites)?
Direct answer (US): Not determinable from the provided information.
What determines the “supplier” for SEREVENT in the supply chain?
- FDA labeler (NDC “Labeler” field): the entity responsible for product listing.
- Dispensing form: Diskus (metered-dose dry powder inhaler) versus other inhaler platforms used in different markets.
- Manufacturing sites: listed under current good manufacturing practice (CGMP) and site identifiers for drug product.
- Packaging sites: sometimes separate from drug product manufacturing.
What companies supply salmeterol xinafoate API used to make SEREVENT?
Direct answer (API suppliers): Not determinable from the provided information.
Why API supplier identification is non-trivial
- SEREVENT drug product is sourced from contract manufacturers whose supply chains change over time.
- API procurement can be multi-sourced across DMFs, each tied to different manufacturing sites.
- Public-facing materials often do not enumerate upstream API suppliers by brand.
How do SEREVENT suppliers differ by dosage form and strength (Diskus vs other inhaler formats)?
Direct answer: Not determinable from the provided information.
Form-factor shifts change the manufacturing ecosystem
- Different inhaler platforms require different formulation processing, powder engineering, and inhaler component sourcing.
- Companies that manufacture the device may differ from those that fill/formulate the powder.
What is the Orange Book status of SEREVENT and how does it affect supplier sourcing?
Direct answer: Not determinable from the provided information.
Exclusivity and listed patents do not identify suppliers
- Orange Book entries list patents and regulatory status, not the full supplier network.
- Supplier identification relies on FDA labeling/CMC and DMF-linked manufacturing sites.
Which generics or authorized products compete with SEREVENT and who supplies them?
Direct answer: Not determinable from the provided information.
Competitive supply chains track NDC-level labeling
- Generic inhalers can have different labelers/manufacturers even with the same active.
- Entry timing affects who is in the market and which manufacturing sites dominate.
What contract manufacturing organizations (CMOs) typically produce SEREVENT-like dry powder inhalers?
Direct answer: Not determinable from the provided information.
Covers the right topic but needs brand-linked evidence
- Dry powder inhaler manufacturing is often done by specialized CMO networks.
- Without NDC-to-manufacturer mapping for SEREVENT, identifying specific CMOs would be speculative.
Key Takeaways
- SEREVENT supplier identification requires NDC- and site-level linkage to current FDA listings for each marketed strength and inhaler format.
- Upstream API supplier mapping requires DMF-to-site evidence for salmeterol xinafoate tied to the SEREVENT manufacturing process.
- The provided input does not contain the jurisdiction, strength/form, or FDA listing identifiers needed to produce a complete supplier table.
FAQs
- Who is the FDA labeler for SEREVENT Diskus in the US?
- Which sites manufacture the SEREVENT drug product for each NDC?
- What DMF manufacturing sites produce salmeterol xinafoate used in SEREVENT?
- Do SEREVENT suppliers change after manufacturing site transfers or relabeling events?
- How can I verify SEREVENT’s manufacturer and packaging sites from FDA data?
References
No sources were provided or cited.
