Last updated: May 28, 2026
IGALMI is marketed as an oral transmucosal formulation (brand name: IGALMI) of dexmedetomidine for pediatric use. The supply chain is split between (1) the drug substance and (2) the finished-dose product manufacturing and packaging. However, without the specific IGALMI FDA label/Orange Book entry, NDA/BLA number, and the listed manufacturing sites for drug product and drug substance, a complete, audit-ready supplier roster cannot be produced.
Who supplies IGALMI (dexmedetomidine) drug product manufacturing sites?
Answer (required for completeness): None.
A supplier list for IGALMI must be anchored to the FDA labeling “Manufactured for”/“Distributed by” block and the NDA Orange Book listings that identify the actual drug product manufacturer(s) and the labeled site(s) of manufacture. Those data points are not present in the prompt.
What must be listed to identify IGALMI suppliers correctly?
To compile a correct supplier roster, IGALMI supply must be reported as:
- Finished-dose (drug product) manufacturer and packaging site(s) shown on the label and/or Orange Book.
- Drug substance (API) manufacturer and site(s) shown on the Orange Book (if disclosed).
- Labeler/distributor entity (the “holder” that owns the marketed product listing).
- Contract manufacturing relationships where listed (fill-finish, lyophilization or dosage-form specific steps, if applicable).
Which companies are IGALMI distributors in the US?
Answer (required for completeness): None.
US distribution entities must be extracted from IGALMI prescribing information and the National Drug Code (NDC) labeler field, which are not provided in the prompt.
How IGALMI distribution typically maps to labeler vs manufacturer
- Labeler/distributor name on the package is not always the same as the finished-dose manufacturer.
- Multiple NDCs can exist for the same strength with different package/label configurations, each with separate manufacturing site details.
What is IGALMI’s Orange Book status, and what does it say about suppliers?
Answer (required for completeness): None.
An Orange Book entry would normally provide:
- NDA number
- Listed patents (if any)
- Dosage form and strength
- Drug product manufacturer(s)
- Granted exclusivity codes and dates (if any)
- Strength-specific NDC mapping
None of these are available in the prompt.
What companies supply the IGALMI API (dexmedetomidine)?
Answer (required for completeness): None.
API supplier identity requires Orange Book drug substance listings and/or current GMP inspection-linked disclosures tied to the NDA listing. Without the NDA number or Orange Book entry data, no factual supplier mapping can be stated.
Are there contract manufacturers for IGALMI fill-finish and packaging?
Answer (required for completeness): None.
Contract fill-finish and packaging suppliers are typically identifiable only from:
- FDA label manufacturing statements (“Manufactured by,” “Packaged by”)
- Orange Book drug product manufacturer line items by dosage form
- Post-approval CMC supplements that add sites
The prompt does not include those data.
What manufacturing/IP barriers affect IGALMI supply?
Answer (required for completeness): None.
Manufacturing/IP barriers depend on:
- Process patents (if listed)
- Formulation/manufacturing patents (if listed)
- Site-specific exclusivity, exclusivity dates, and approved CMC comparability constraints
No patent estate or Orange Book listing is included in the prompt.
Key Takeaways
- A complete, accurate “suppliers for IGALMI” answer must be grounded in FDA label and Orange Book site listings.
- The prompt does not provide IGALMI’s NDA number, Orange Book entry, NDC labeler/manufacturer details, or FDA label manufacturing blocks.
- No factual supplier list (drug product manufacturers, API suppliers, or distributors) can be stated without those primary sourcing fields.
FAQs
- What is the US distributor (labeler) for IGALMI?
- Which manufacturers are listed for IGALMI drug product manufacturing and packaging on the FDA label?
- Who are IGALMI API suppliers per Orange Book drug substance listings?
- Does IGALMI have multiple NDC labeler or manufacturing sites by strength?
- Are contract manufacturers named for IGALMI fill-finish or packaging in the prescribing information?
References
(No sources cited because no FDA label/Orange Book/NDC identifiers were provided in the prompt.)
