Central alpha-2 Adrenergic Agonist
Where is Dexmedetomidine made?
25 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 20 factories in India, the United States, China, the United Kingdom and Italy.
India 11United States 5China 2United Kingdom 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. Precedex4 ug per 1 mL, 100 ug per 1 mL · NDC 0409-1638, 0409-1660, 0409-1434 +10 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 | |
| Pfizer Healthcare India Private LimitedMakes it, tests it, packages it and labels it | Anakapalli, India | Problems found, fixed voluntarilyOct 2022 | |
| Terumo BCT LtdMakes it, tests it, packages it and labels it | Larne, United Kingdom | Problems found, fixed voluntarilyFeb 2022 | |
| Amneal Pharmaceuticals LLC4 ug per 1 mL · NDC 70121-1711, 70121-1712, 70121-1388 +1 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Mehsana, India | Not inspected on record | |
| Maiva Pharma Private LimitedMakes it, tests it, packages it and labels it | Hosur, India | Problems found, fixed voluntarilyOct 2022 | |
| Accord Healthcare Inc.100 ug per 1 mL · NDC 16729-432, 16729-239 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Baxter Healthcare Corporation100 ug per 1 mL, 200 ug per 50 mL, 400 ug per 100 mL · NDC 36000-262, 43066-561, 43066-555 +4 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Round Lake, IL, United States | Serious problems, FDA actionApr 2026 |
| Baxter Pharmaceuticals India Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | Serious problems, FDA actionJan 2023 | |
| Civica, Inc.4 ug per 1 mL · NDC 72572-127, 72572-128 | Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Dr. Reddy's Laboratories Inc.4 ug per 1 mL · NDC 43598-976, 43598-975 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Gland Pharma Limited4 ug per 1 mL, 100 ug per 1 mL · NDC 68083-527, 68083-238, 68083-239 +1 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Wilshire Pharmaceuticals Inc.4 ug per 1 mL · NDC 52536-125, 52536-126 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Akorn100 ug per 1 mL · NDC 17478-055 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| AuroMedics Pharma LLC4 ug per 1 mL, 100 ug per 1 mL · NDC 55150-209, 55150-296, 55150-297 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| BioXcel Therapeutics, Inc. Igalmi120 ug, 180 ug · NDC 81092-1120, 81092-1180 | ARx, LLCMakes it | Glen Rock, PA, United States | Problems found, fixed voluntarilyJun 2026 |
| Caraco Pharmaceutical Laboratories, Ltd.100 ug per 1 mL · NDC 57664-596 | Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Fresenius Kabi USA, LLC100 ug per 1 mL · NDC 65219-642 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi, LLC100 ug per 1 mL · NDC 63323-421 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Meitheal Pharmaceuticals Inc.100 ug per 1 mL · NDC 71288-505 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Piramal Critical Care Inc.4 ug per 1 mL, 100 ug per 1 mL, 200 ug per 2 mL · NDC 66794-238, 66794-230, 66794-233 +2 | Gland Pharma LimitedMakes it, makes the active ingredient, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Precision Dose Inc.4 ug per 1 mL · NDC 68094-047, 68094-147, 68094-247 | Corden Pharma SpaMakes it, tests it, packages it and labels it | Caponago, Italy | Problems found, fixed voluntarilyMar 2025 |
| Sandoz Inc.4 ug per 1 mL · NDC 0781-3493, 0781-3494, 0781-3495 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)Makes it | Lianyungang, China | Problems found, fixed voluntarilyAug 2023 |
| Somerset Therapeutics, LLC100 ug per 1 mL · NDC 70069-758, 70069-759 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Avenacy Inc.100 ug per 1 mL · NDC 83634-600 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.4 ug per 1 mL, 100 ug per 1 mL · NDC 42023-146, 42023-186, 42023-187 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.4 ug per 1 mL, 100 ug per 1 mL · NDC 0143-9532, 0143-9526, 0143-9525 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC100 ug per 1 mL, 200 ug per 50 mL, 400 ug per 100 mL · NDC 67457-251, 67457-924, 67457-925 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals4 ug per 1 mL · NDC 25021-615, 25021-617 | The label doesn't name the factory. Plants this company names for other drugs | ||
| WG Critical Care, LLC. Dexmedetomidine in Dextrose4 ug per 1 mL, 100 ug per 1 mL · NDC 44567-600, 44567-601, 44567-602 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dexmedetomidine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Henry Schein, Inc.:
0404-9938 - Medical Purchasing Solutions, LLC.:
71872-7218,71872-7122,71872-7030,71872-7031+1 - ProPharma Distribution:
84549-505,84549-230,84549-493
Recalls
- Aug 6, 2026 · Class II · Baxter Healthcare Corporation
CGMP Deviations
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.