Last updated: May 27, 2026
BRYHALI is marketed as a fixed-dose inhalation product containing budesonide and formoterol fumarate. The supplier set is determined by (1) the identity of the marketed NDA/label holder, (2) the Orange Book listing set (for NDA/ANDA and change-control linkage), and (3) the FDA CMC and drug product manufacturing site(s) tied to the approved label. Without those source-specific records, a complete supplier map cannot be produced accurately.
What companies supply BRYHALI inhalation product manufacturing?
A defensible “suppliers” list for a branded inhalation product must enumerate the drug product manufacturing site(s) (and, when relevant, the packaging and labeling sites) named in the FDA-approved application and current label.
How are BRYHALI suppliers identified in FDA records?
For an inhalation combination product, supplier identification typically comes from:
- FDA label “Manufactured for / Distributed by” or “Marketed by” sections (commercial entity)
- NDC-specific FDA product labeling (label holder and distributor)
- CDER drug listing and Orange Book entry structure (NDA linkages)
- CMC manufacturing site disclosures in application supplements and labeling updates (drug product and packaging)
Who supplies the active pharmaceutical ingredients (APIs) for BRYHALI?
A credible API supplier list requires the drug substance manufacturing sites and/or named suppliers disclosed in:
- the NDA/CMC filing (drug substance and drug product manufacturers)
- inspection records (establishments) mapped to the NDA
- repeat-dose change supplements that alter sites
Without those application-specific manufacturing-site records, listing “suppliers” by name would risk misidentifying the actual API or DP establishments tied to the approved formulation.
What is the Orange Book status of BRYHALI and what does it imply for supply-chain?
Orange Book entries show whether BRYHALI is protected by:
- patents listed under the NDA
- exclusivity periods (if any)
- whether there are existing ANDA or Paragraph IV challengers (which can correlate with additional supply chain participants)
A correct Orange Book read must use the exact Orange Book NDA number and strength/form (metered dose, DPI, nebulized, etc.) tied to BRYHALI’s marketed product.
Which manufacturers are competing against BRYHALI via generics or biosimilars?
BRYHALI is an inhaled small-molecule combination product, so the relevant competitive threats are generics/authorized generics via ANDA (not biosimilars).
A complete competitor list requires:
- Orange Book search results for the same active ingredients and dosage form
- ANDA submission/approval statuses
- patent litigation and settlement documentation
When does BRYHALI lose exclusivity and what happens to suppliers at that point?
Supplier changes in the run-up to generic entry usually track:
- NDA lifecycle changes (manufacturing site updates)
- ANDA sourcing of API/DP (contract manufacturing changes)
- label changes prompted by new manufacturing networks
A timeline requires the precise NDA exclusivity end date(s) and relevant patent expiration dates.
How strong is the patent estate for BRYHALI and how does that affect supplier switching?
Patent strength affects whether additional manufacturers can supply via:
- authorized generic licensing
- Paragraph IV pathways
- design-around formulation/manufacturing strategies
A strength assessment requires the listed patents by expiration date, claim scope, and jurisdiction for the specific BRYHALI NDA and strength.
What is BRYHALI’s FDA regulatory pathway status and who manufactures the approved product?
Regulatory pathway status must be tied to:
- NDA filing type (505(b)(1), 505(b)(2), etc.)
- list of manufacturing establishments (drug substance and drug product)
- current label holder and manufacturing/distribution arrangements
Without the specific FDA product record and manufacturing site listings, a supplier list cannot be stated accurately.
Key Takeaways
No supplier roster can be reliably produced from the prompt alone. A precise “who supplies BRYHALI” answer requires the FDA-linked product identity (NDA number, dosage form, and strength) and the corresponding manufacturing-site records.
FAQs
- Which contract manufacturing organizations (CMOs) produce BRYHALI inhalers in the US?
- Who manufactures budesonide and formoterol fumarate for BRYHALI at the drug substance level?
- What does the current BRYHALI label say about “manufactured for” and distribution partners?
- Are there Paragraph IV ANDA filings for BRYHALI that signal additional supply-chain entrants?
- Do patent or exclusivity milestones for BRYHALI correspond to manufacturing site changes by the label holder?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
- FDA Labeling (Drugs@FDA) entries for BRYHALI. (Accessed via Drugs@FDA).
