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Dexmedetomidine | CAS No: 113775-47-6 | GMP-certified suppliers
A medication that supports ICU and procedural sedation and provides control of acute agitation associated with schizophrenia or bipolar disorders for diverse clinical settings.
Therapeutic categories
Primary indications
- Administered intravenously, dexmedetomidine is indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in intensive care settings, and for the sedation of non-intubated patients prior to and/or during surgery and other procedures
- It is also available as a buccally- or sublingually-administered dissolvable film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder
Product Snapshot
- Dexmedetomidine is an injectable small‑molecule sedative available primarily as intravenous solutions and concentrates, with additional sublingual or buccal film formulations
- It is used for procedural and ICU sedation as well as acute agitation management in psychiatric settings
- The product is approved in major markets including the US, EU, and Canada, with both human and veterinary authorizations
Clinical Overview
Dexmedetomidine produces dose‑dependent sedation, anxiolysis, and modest analgesia through selective activation of central and peripheral alpha‑2 adrenoceptors. Pharmacodynamic effects include suppression of sympathetic outflow with attenuation of hemodynamic and neuroendocrine responses to surgical stress. The reduction in norepinephrine release from presynaptic terminals contributes to inhibition of pain signal propagation, while postsynaptic receptor activation decreases heart rate and blood pressure.
Mechanistically, its action is mediated via high affinity for alpha‑2 adrenoceptors, producing a state of cooperative sedation often described as mimicking natural sleep. It does not cause significant respiratory depression at therapeutic concentrations, which differentiates it from many sedative‑hypnotic agents.
Reported ADME characteristics indicate rapid distribution and metabolism primarily through hepatic pathways, with renal excretion of metabolites. Specific quantitative parameters, such as clearance or half‑life, vary across studies and are formulation‑dependent.
Safety considerations include bradycardia, hypotension, and transient hypertension during loading doses due to peripheral vasoconstriction. Caution is warranted in patients with compromised cardiac function or altered autonomic tone. Abrupt discontinuation after prolonged infusions may lead to withdrawal‑like symptoms.
Notable brand contexts include parenteral ICU sedatives and transmucosal films for psychiatric agitation. For API procurement, sourcing should ensure enantiomeric purity, control of benzene‑derived impurities, and compliance with pharmacopoeial or regional regulatory specifications to support sterile and non‑sterile formulation development.
Identification & chemistry
| Generic name | Dexmedetomidine |
|---|---|
| Molecule type | Small molecule |
| CAS | 113775-47-6 |
| UNII | 67VB76HONO |
| DrugBank ID | DB00633 |
Pharmacology
| Summary | Dexmedetomidine is a selective alpha‑2A adrenergic receptor agonist that reduces presynaptic norepinephrine release and suppresses sympathetic activity. This action produces sedation, analgesia, and attenuation of neuroendocrine and hemodynamic responses during procedures and critical care. Its pharmacologic effects also decrease anesthetic and opioid requirements through central sympatholytic mechanisms. |
|---|---|
| Mechanism of action | Dexmedetomidine is a specific and selective alpha-2 adrenoceptor agonist. By binding to the presynaptic alpha-2 adrenoceptors, it inhibits the release if norepinephrine, therefore, terminate the propagation of pain signals. Activation of the postsynaptic alpha-2 adrenoceptors inhibits the sympathetic activity decreases blood pressure and heart rate. |
| Pharmacodynamics | Dexmedetomidine activates 2-adrenoceptors, and causes the decrease of sympathetic tone, with attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery; it reduces anesthetic and opioid requirements; and causes sedation and analgesia. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Alpha-2A adrenergic receptor | Humans | agonist |
ADME / PK
| Half-life | 2 hours |
|---|---|
| Protein binding | 94% |
| Metabolism | Hepatic |
| Route of elimination | A mass balance study demonstrated that after nine days an average of 95% of the radioactivity, following intravenous administration of radiolabeled dexmedetomidine, was recovered in the urine and 4% in the feces. Fractionation of the radioactivity excreted in urine demonstrated that products of N-glucuronidation accounted for approximately 34% of the cumulative urinary excretion. The majority of metabolites are excreted in the urine. |
| Volume of distribution | * 118 L |
| Clearance | * 39 L/h [Healthy volunteers receiving IV infusion (0.2-0.7 mcg/kg/hr)] |
Formulation & handling
- Dexmedetomidine is a small‑molecule API primarily formulated as aqueous IV solutions or concentrates, with moderate lipophilicity and low water solubility requiring solubilizers and pH control.
- Solution stability considerations include protection from adsorption to plastics at low concentrations and maintaining compatibility with common diluents for parenteral infusion.
- Sublingual film formulations leverage its adequate mucosal permeability, while avoiding oral GI routes due to limited solubility and first‑pass metabolism.
Regulatory status
| Lifecycle | Most core patent protections for the API have expired in the US and Canada, with one later‑expiring US patent extending potential exclusivity into 2032. Across the EU, US, and Canada, the market appears largely mature with remaining protection limited to the scope of the still‑active US patent. |
|---|
| Markets | EU, US, Canada |
|---|
Supply Chain
| Supply chain summary | Dexmedetomidine is supplied primarily by a single originator manufacturer, with packaging handled by both the originator and an additional company for distribution. Branded products are established across the US, EU, and Canada, indicating broad market availability. Several core patents have already expired in major markets, while one later‑expiring US patent remains in force, suggesting that generic competition is already possible in some regions with potential constraints in others. |
|---|
Dexmedetomidine is a type of Alpha-2 adrenergic agonist
Alpha-2 adrenergic agonists are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) commonly used in the field of medicine. These compounds specifically target and activate alpha-2 adrenergic receptors in the body, which are found primarily in the central nervous system.
Alpha-2 adrenergic agonists exhibit a wide range of pharmacological effects due to their interaction with these receptors. One of their main applications is in the management of hypertension (high blood pressure). By stimulating the alpha-2 adrenergic receptors in the brain, these agonists inhibit the release of norepinephrine, a neurotransmitter that constricts blood vessels. This action leads to vasodilation, resulting in a decrease in blood pressure.
Furthermore, alpha-2 adrenergic agonists are also utilized in ophthalmology to treat conditions such as glaucoma. By reducing the production of aqueous humor, the fluid responsible for intraocular pressure, these compounds help alleviate the symptoms of this eye disorder.
In addition to their cardiovascular and ophthalmological applications, alpha-2 adrenergic agonists have been investigated for their potential role in pain management, sedation, and even in the treatment of attention deficit hyperactivity disorder (ADHD). Research into these areas is ongoing, highlighting the versatility and potential of this API subcategory.
Overall, alpha-2 adrenergic agonists are valuable pharmaceutical compounds that play a crucial role in the treatment of hypertension, glaucoma, and other related disorders. Through their selective interaction with alpha-2 adrenergic receptors, these APIs offer a targeted approach to achieving desired therapeutic outcomes.
Dexmedetomidine (Alpha-2 adrenergic agonist), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Dexmedetomidine API manufacturers & distributors
Compare qualified Dexmedetomidine API suppliers worldwide. We currently have 14 companies offering Dexmedetomidine API, with manufacturing taking place in 9 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ALCAMI | Producer | United States | United States | CoA, USDMF | 5 products |
| Asymchem | Producer | China | China | CoA, USDMF, WC | 10 products |
| Edmond Pharma (Recipharm) | Producer | Italy | Italy | CoA, JDMF, USDMF | 20 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Fermion | Producer | Finland | Finland | CoA, USDMF | 29 products |
| J.S.C. Grindeks | Producer | Latvia | Latvia | CoA, JDMF | 6 products |
| Lifecare Laboratories | Producer | India | India | BSE/TSE, CoA, GMP, MSDS, USDMF | 50 products |
| Moehs | Producer | Spain | Spain | CoA, GMP, USDMF | 50 products |
| Norchim | Producer | France | France | CoA, FDA | 5 products |
| Reliable Biopharm | Producer | United States | United States | CoA, USDMF | 11 products |
| Sichuan Benepure | Producer | China | China | CoA | 23 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Tianjin Pharmacn Medical ... | Producer | China | China | CoA, GMP | 66 products |
| Triquim | Producer | Argentina | Argentina | CoA, GMP, ISO9001 | 16 products |
When sending a request, specify which Dexmedetomidine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Dexmedetomidine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Dexmedetomidine API
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