Drug
Who makes dexmedetomidine?
11 companies list dexmedetomidine as a human prescription drug, including under the names IGALMI. Forms: film; injection; injection, solution; injection, solution, concentrate. Routes: intravenous, sublingual.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing dexmedetomidine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| WG Critical Care, LLC. | injection; injection, solution, concentrate | NDANDA206628 | 4 | 0 |
| ProPharma Distribution, LLC.United States | injection, solution | ANDAANDA202126, ANDA204843 | 2 | 3 |
| Piramal Critical Care IncUnited States | injection, solution | ANDAANDA202126 | 2 | 1 |
| BioXcel Therapeutics, Inc. | film | NDANDA215390 | 2 | 0 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA202126 | 1 | 4 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection, solution | ANDAANDA204023 | 1 | 2 |
| Medical Purchasing Solutions, LLCUnited States | injection, solution | ANDAANDA202126 | 1 | 1 |
| Avenacy, Inc. | injection, solution, concentrate | ANDAANDA209065 | 1 | 0 |
| Eugia US LLC | injection, solution | ANDAANDA205867 | 1 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection, solution | ANDAANDA204843 | 1 | 0 |
| Mylan Institutional Inc. | injection, solution, concentrate | ANDAANDA202881 | 1 | 0 |
Bulk ingredient listings
- Hubei Biocause Heilen Pharmaceutical Co., LtdChina · 1 NDC
Enquiry
Common questions
- Who makes dexmedetomidine?
- 11 companies list dexmedetomidine as a human prescription drug in the openFDA NDC Directory, led by WG Critical Care, LLC., ProPharma Distribution, LLC., Piramal Critical Care Inc, BioXcel Therapeutics, Inc., GLAND PHARMA LIMITED. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic IGALMI?
- 9 companies list dexmedetomidine under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies dexmedetomidine active ingredient?
- 1 company lists dexmedetomidine as a bulk ingredient, including Hubei Biocause Heilen Pharmaceutical Co., Ltd.