Last updated: May 25, 2026
Trudhesa is a branded dihydroergotamine (DHE) nasal solution. Supplier coverage depends on (1) the FDA-listed manufacturer of record for Trudhesa and (2) the firms supplying drug substance, key excipients, and device/packaging components. Only supplier answers that are directly supported by citable sources can be provided; no supplier list is produced below without sufficient verifiable, publication-grade information.
What companies supply Trudhesa (dihydroergotamine) to the U.S. market?
Featured answer: Supplier identification for Trudhesa requires the FDA drug product labeling “Manufactured for / Distributed by” chain and the FDA Orange Book “Applicant/Holder” listings for the specific NDA strength and dosage form. Without those citable listings for Trudhesa, a complete supplier list cannot be stated.
Which supply-chain roles matter for Trudhesa
The Trudhesa supply chain breaks into:
- Drug product manufacturer of record (finished nasal solution, fill-finish, labeling, release)
- Drug substance supplier for the DHE active ingredient
- Excipients (solvent system, tonicity agents, preservatives, pH adjusters)
- Primary packaging (nasal spray bottle, closure, actuator components)
- Secondary packaging (cartons, leaflets)
- Quality agreement manufacturers (analytical testing sites, sterile or non-sterile release testing as applicable)
What is the Orange Book status of Trudhesa and who is the patent holder/applicant?
Featured answer: The Orange Book provides the NDA holder/applicant for Trudhesa and any listed patents. Supplier identification should be aligned to the NDA holder and the drug product manufacturer on file. A supplier list cannot be produced without the Orange Book record for Trudhesa.
How Orange Book listings map to suppliers
- Orange Book “Applicant/Holder” indicates the regulatory owner tied to the manufacturing authorization strategy.
- Patent assignees often align to the NDA holder but are not always the same legal entity that performs fill-finish.
Who manufactures Trudhesa nasal solution (fill-finish and packaging)?
Featured answer: The manufacturer of record is named in Trudhesa prescribing information under “Manufactured for…” and “Distributed by…” lines. Without citable Trudhesa labeling, no manufacturer names can be asserted.
What to look for in Trudhesa labeling
- “Manufactured for [company]” plus the manufacturing site address
- “Packaged by” or “Manufactured by” lines
- National Drug Code (NDC) labeler and packaging configuration
- The device subcomponents if the nasal spray actuator is sourced from a specialized supplier
Who supplies the dihydroergotamine drug substance used in Trudhesa?
Featured answer: DHE drug substance suppliers are not consistently listed publicly for branded nasal products unless named in:
- Trudhesa drug substance documentation (rare outside filings)
- FDA Drug Master Files (DMFs)
- Public supplier or contract manufacturing disclosures
Without citable Trudhesa-specific DMF or regulatory documentation naming drug substance vendors, no supplier claims can be made.
What suppliers make Trudhesa’s excipients and nasal spray components?
Featured answer: Excipients and nasal device components are typically supplied via contract manufacturing and component sourcing. Trudhesa labeling and regulatory documents may not disclose the underlying vendor names.
Without citable component sourcing disclosures, no supplier list can be provided.
How can a Trudhesa buyer verify the correct suppliers fast (NDC and label chain)?
Featured answer: The fastest verification path is to use Trudhesa’s NDC to identify:
- Labeler (company name tied to NDC)
- Registration/manufacturing sites (FDA establishment registrations)
- Corresponding NDA manufacturer of record in label text
No step-by-step execution can be provided without the specific Trudhesa NDC(s) and FDA product registration entries.
Key Takeaways
- Trudhesa supplier identification requires citable Trudhesa labeling and FDA Orange Book/NDC registration records.
- Without those citable records, a supplier list would be incomplete or incorrect.
- Build the supplier map by linking NDA holder/applicant, manufacturer of record, and NDC labeler, then trace fill-finish, packaging, and excipient/device sourcing through disclosed manufacturing sites and registrations.
FAQs
- Which company is the NDA holder for Trudhesa in the FDA Orange Book?
- What is the manufacturer of record listed on Trudhesa prescribing information for nasal solution?
- Does Trudhesa use a third-party fill-finish site, and how is it shown on FDA registrations?
- Are dihydroergotamine drug substance suppliers disclosed for Trudhesa in public filings or DMFs?
- How do I map Trudhesa NDC labeler names to manufacturing sites and contract suppliers?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration.
- FDA National Drug Code (NDC) Directory. U.S. Food and Drug Administration.
- Trudhesa prescribing information (FDA label). U.S. Food and Drug Administration.
