Last updated: May 25, 2026
ULSPIRA Drug Suppliers: Which Companies Manufacture, Source, and Fill the Product?
Executive summary
No complete, citation-backed supplier dataset can be produced from the information provided. An accurate supplier mapping for ULSPIRA requires verifiable identifiers (active ingredient(s), dosage form/strength, and FDA product identifier, or Orange Book NDA/BLA number). Without those, any list of “suppliers” (API makers, contract manufacturers, fill-finish sites, or labeler/distributors) would risk being incorrect.
What is ULSPIRA and who manufactures it commercially?
Featured snippet answer: No supplier answer can be generated without ULSPIRA’s FDA product identity (NDC/labeler and NDA/BLA), active ingredient(s), and dosage form/strength.
Which “suppliers” count in pharma sourcing?
Typical supplier tiers include:
- API manufacturers (active pharmaceutical ingredient supply)
- Drug product manufacturers (tablet/capsule/liquid manufacture)
- Fill-finish sites (bottling, sterile filling, lyophilization where applicable)
- Labelers/distributors (commercial packaging and distribution)
- Key raw-material and excipient suppliers (only where disclosed via filings or quality agreements)
What are the Orange Book and FDA listings for ULSPIRA?
Featured snippet answer: No Orange Book status or listed companies can be identified without the NDA/BLA number and product identifier.
Orange Book fields used for supplier intelligence
- NDA/BLA holder
- Listed patent/expiration dates
- Applicant/manufacturer details in Orange Book and FDA labeling
- Application type and approval history (which affects transfer and manufacturing responsibilities)
Which companies supply the API for ULSPIRA?
Featured snippet answer: No API supplier can be named without the active ingredient and confirmed ULSPIRA product identity.
API sourcing intelligence sources (what must be matched)
- FDA drug substance manufacturing information (when present in summaries and labeling)
- CMC sections and amendments (supplier names and sites)
- Contract manufacturer disclosures in FDA inspection databases (site-level)
- Import/manufacturing site references in NDA labeling and regulatory filings
Who does ULSPIRA contract manufacturing and fill-finish?
Featured snippet answer: No CDMO/manufacturing site can be identified without ULSPIRA’s drug product specification and FDA product identity.
What “fill-finish” suppliers would look like
- Non-sterile: tablet compression, capsule filling, bottling/packaging
- Sterile: aseptic fill-finish, sterile filtration, terminal sterilization, sterile warehousing
- Blow-fill-seal or prefilled syringe systems (if applicable)
When does ULSPIRA lose exclusivity and how does that affect supplier switching?
Featured snippet answer: No exclusivity timeline can be computed without ULSPIRA’s FDA approval and patent/exclusivity listing.
Exclusivity timeline inputs needed
- Patent expiration for each listed drug substance and formulation patent
- Regulatory exclusivity:
- NCE/NSO
- 3-year/5-year new clinical investigation exclusivity
- Pediatric exclusivity extensions
- Launch/transfer patterns that indicate manufacturing transitions
What patent litigation impacts ULSPIRA manufacturing capacity and supplier choices?
Featured snippet answer: No litigation can be linked to ULSPIRA supplier constraints without the NDA/BLA and case identifiers.
Paragraph IV and manufacturing risk pathways
- Litigation can delay generic entry, preserving incumbent manufacturing utilization
- Settlement agreements can impose design-around requirements that affect CDMO qualification
How does ULSPIRA compare with other products in the same therapeutic class for supply chain patterns?
Featured snippet answer: No comparative supplier patterning can be performed without knowing ULSPIRA’s therapeutic ingredient and dosage form.
Comparison criteria
- Same active ingredient class (e.g., same MoA families)
- Similar dosage form (tablet vs injectable vs inhalation)
- Similar approval year and manufacturing complexity
What commercial suppliers distribute ULSPIRA under the label?
Featured snippet answer: No distributor/labeler list can be produced without NDC/labeler confirmation.
What labeler data typically reveals
- Who owns the NDA label
- Who holds wholesaler/distribution contracts
- Who may be the “commercial manufacturer” vs “marketing authorization holder”
Key Takeaways
- No supplier roster for ULSPIRA can be produced from the provided input.
- Supplier identification requires a verifiable ULSPIRA product identity (NDA/BLA and dosage form/strength) to pull Orange Book/FDA listing, labeling manufacturer fields, and patent-linked manufacturing responsibilities.
FAQs
- What suppliers are listed for ULSPIRA in FDA labeling?
- Which company is the Orange Book applicant for ULSPIRA?
- Who makes the ULSPIRA API and where are the drug substance sites located?
- Which CDMOs perform ULSPIRA fill-finish and packaging?
- Do ULSPIRA patents or exclusivity create manufacturing constraints for generics?
References
None.
