Medicine
Igalmi 180 mcg sublingual film
Igalmi 180 mcg sublingual film is a prescription medicine containing Dexmedetomidine for sublingual use, marketed by BioXcel Therapeutics, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Storage as on the product label
Key facts
- Active ingredient (INN)
- Dexmedetomidine
- Brand
- Igalmi
- Strength
- 180 mcg
- Dosage form
- Sublingual film
- Route
- Sublingual
- Packs
- 10 pouches, 30 pouches
- Marketing authorisation holder
- BioXcel Therapeutics
- Manufacturer
- BioXcel Therapeutics
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05CM18 Dexmedetomidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 July 2022
- Identifiers
- NDC 81092-1180Application NDA215390
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 pouch in 1 carton / 1 film in 1 pouch | 81092-1180-1 | BioXcel Therapeutics | 1 July 2022 |
| 30 pouch in 1 carton / 1 film in 1 pouch | 81092-1180-3 | BioXcel Therapeutics | 1 July 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Dexmedetomidine
Clinical summary
Dexmedetomidine is a central alpha-2 adrenergic agonist indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting, among other approved uses. MedsAcross supplies Dexmedetomidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DexmedetomidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- US FDA NDC directory · Checked 12 November 2026
- Precedex prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
- Dexdor: European public assessment report (EPAR) · European Medicines Agency
Need Igalmi 180 mcg sublingual film for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.