Active ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Registration activity, product holders, and manufacturers linked to this active ingredient in the AIPHARM dataset.
Registered products
10
Top manufacturer
Not available
Top holder
FRESENIUS KABI MALAYSIA SDN. BHD
Updated
22 May 2026
Overview
Product registrations over time
Latest visible period: 2025
Analysis
Companies connected to this ingredient
Analysis
Product Manufacturer
| Manufacturer name | Product count |
|---|---|
| No data available | |
No data available
Analysis
Product Holder
| Product holder name | Product count |
|---|---|
| 2 | |
| 1 | |
| 1 | |
| 1 | |
| 1 |
Product count2
Product count1
Product count1
Product count1
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Listing
Registered Product
| Product name | Product Reg. no | Type | Product Holder | Manufacturer | Importer | Registration Status |
|---|---|---|---|---|---|---|
| PRECEDEX | MAL20014305ACRZ | NEW CHEMICAL ENTITY | PFIZER (MALAYSIA) SDN. BHD. | HOSPIRA INC. | PFIZER (MALAYSIA) SDN. BHD. | PRODUCT APPROVED |
| Dexmedetomidine Kabi 0.1mg/mL Concentrate for Infusion | MAL17065012ACRZ | PRESCRIPTION | FRESENIUS KABI MALAYSIA SDN. BHD | Gland Pharma Limited | FRESENIUS KABI MALAYSIA SDN. BHD | PRODUCT APPROVED |
| Dexmedetomidine EVER Pharma 200 µg/2ml Concentrate for solution for infusion | MAL24036033AZ | PRESCRIPTION | TERAJU PHARMA SDN BHD | EVER Pharma Jena GmbH | TERAJU PHARMA SDN BHD | PRODUCT APPROVED |
| Dexdor 100 micrograms/ml concentrate for solution for infusion | MAL24056001AZ | NEW CHEMICAL ENTITY | ORION PHARMA (MY) SDN. BHD. | ORION CORPORATION, ORION PHARMA | ORION PHARMA (MY) SDN. BHD. | PRODUCT APPROVED |
| UNIDEX Dexmedetomidine Injection USP Concentrate for Infusion 100 mcg/ml | MAL24086031AZ | PRESCRIPTION | UNIMED SDN. BHD. | Gland Pharma Limited | UNIMED SDN. BHD. | PRODUCT APPROVED |
| ICUNES 100mcg/ml Concentrate for Solution for Infusion | MAL19106012AZ | PRESCRIPTION | AVERROES PHARMACEUTICALS SDN. BHD. | PT NOVELL PHARMACEUTICAL LABORATORIES. | AVERROES PHARMACEUTICALS SDN. BHD. | PRODUCT APPROVED |
| HYDEX (Dexmedetomidine Concentrate For Infusion 100mcg/ml, 2 ml vial) | MAL19116033AZ | PRESCRIPTION | ACCORD HEALTHCARE SDN.BHD. | INTAS PHARMACEUTICALS LIMITED | ACCORD HEALTHCARE SDN.BHD. | PRODUCT APPROVED |
| Dexmedetomidine Fresenius 100 mcg/ml Concentrate for Solution for Infusion | MAL25046026AZ | PRESCRIPTION | FRESENIUS KABI MALAYSIA SDN. BHD | FRESENIUS KABI AUSTRIA GMBH | FRESENIUS KABI MALAYSIA SDN. BHD | PRODUCT APPROVED |
PRECEDEX
Product Reg. noMAL20014305ACRZ
TypeNEW CHEMICAL ENTITY
Product HolderPFIZER (MALAYSIA) SDN. BHD.
ManufacturerHOSPIRA INC.
ImporterPFIZER (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
Dexmedetomidine Kabi 0.1mg/mL Concentrate for Infusion
Product Reg. noMAL17065012ACRZ
TypePRESCRIPTION
Product HolderFRESENIUS KABI MALAYSIA SDN. BHD
ManufacturerGland Pharma Limited
ImporterFRESENIUS KABI MALAYSIA SDN. BHD
Registration StatusPRODUCT APPROVED
Dexmedetomidine EVER Pharma 200 µg/2ml Concentrate for solution for infusion
Product Reg. noMAL24036033AZ
TypePRESCRIPTION
Product HolderTERAJU PHARMA SDN BHD
ManufacturerEVER Pharma Jena GmbH
ImporterTERAJU PHARMA SDN BHD
Registration StatusPRODUCT APPROVED
Dexdor 100 micrograms/ml concentrate for solution for infusion
Product Reg. noMAL24056001AZ
TypeNEW CHEMICAL ENTITY
Product HolderORION PHARMA (MY) SDN. BHD.
ManufacturerORION CORPORATION, ORION PHARMA
ImporterORION PHARMA (MY) SDN. BHD.
Registration StatusPRODUCT APPROVED
UNIDEX Dexmedetomidine Injection USP Concentrate for Infusion 100 mcg/ml
Product Reg. noMAL24086031AZ
TypePRESCRIPTION
Product HolderUNIMED SDN. BHD.
ManufacturerGland Pharma Limited
ImporterUNIMED SDN. BHD.
Registration StatusPRODUCT APPROVED
ICUNES 100mcg/ml Concentrate for Solution for Infusion
Product Reg. noMAL19106012AZ
TypePRESCRIPTION
Product HolderAVERROES PHARMACEUTICALS SDN. BHD.
ManufacturerPT NOVELL PHARMACEUTICAL LABORATORIES.
ImporterAVERROES PHARMACEUTICALS SDN. BHD.
Registration StatusPRODUCT APPROVED
HYDEX (Dexmedetomidine Concentrate For Infusion 100mcg/ml, 2 ml vial)
Product Reg. noMAL19116033AZ
TypePRESCRIPTION
Product HolderACCORD HEALTHCARE SDN.BHD.
ManufacturerINTAS PHARMACEUTICALS LIMITED
ImporterACCORD HEALTHCARE SDN.BHD.
Registration StatusPRODUCT APPROVED
Dexmedetomidine Fresenius 100 mcg/ml Concentrate for Solution for Infusion
Product Reg. noMAL25046026AZ
TypePRESCRIPTION
Product HolderFRESENIUS KABI MALAYSIA SDN. BHD
ManufacturerFRESENIUS KABI AUSTRIA GMBH
ImporterFRESENIUS KABI MALAYSIA SDN. BHD
Registration StatusPRODUCT APPROVED
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