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Norepinephrine | CAS No: 51-41-2 | GMP-certified suppliers
A medication that treats vasodilatory shock and critical hypotension by restoring blood pressure and improving survival in septic and neurogenic shock patients.
Therapeutic categories
Primary indications
- Mainly used to treat patients in vasodilatory shock states such as septic shock and neurogenic shock and has shown a survival benefit over dopamine
- Also used as a vasopressor medication for patients with critical hypotension
Product Snapshot
- Norepinephrine is available as an injectable solution formulated for intravenous administration
- It is primarily indicated as a vasopressor for managing vasodilatory shock states, including septic and neurogenic shock, and critical hypotension
- This active pharmaceutical ingredient is approved for use in key regulatory markets including the US and Canada
Clinical Overview
Clinically, norepinephrine is primarily indicated for the management of vasodilatory shock states such as septic shock and neurogenic shock. It is also utilized as a vasopressor in critically hypotensive patients, demonstrating a survival benefit compared to dopamine in relevant contexts.
The pharmacodynamic activity of norepinephrine is largely mediated via agonism at alpha-1 and alpha-2 adrenergic receptors, leading to vasoconstriction and an increase in systemic vascular resistance. Its mechanism of action extends to the beta-adrenergic receptors, where it exerts positive inotropic effects on the heart and dilates coronary arteries. These combined receptor interactions contribute to its efficacy in restoring blood pressure and cardiac output under shock conditions.
ADME characteristics of norepinephrine include rapid metabolism by catechol-O-methyltransferase (COMT) and monoamine oxidase (MAO), resulting in a short plasma half-life and necessitating continuous intravenous administration in clinical use. Its peripheral pharmacokinetics are consistent with limited central nervous system penetration due to poor blood-brain barrier permeability.
Safety and toxicity considerations include the potential for excessive vasoconstriction leading to ischemic complications, arrhythmias due to cardiac stimulation, and extravasation risk causing local tissue injury. Close monitoring during administration is critical to mitigate adverse effects.
Notable clinical usage includes branded formulations used in critical care settings globally for vasopressor support.
From an API sourcing perspective, quality control should ensure compliance with pharmacopeial standards regarding identity, purity, and potency. Given norepinephrine’s sensitivity to oxidation and its classification as a catechol, appropriate storage, handling under inert atmospheres, and stability data are essential considerations for procurement and formulation development.
Identification & chemistry
| Generic name | Norepinephrine |
|---|---|
| Molecule type | Small molecule |
| CAS | 51-41-2 |
| UNII | X4W3ENH1CV |
| DrugBank ID | DB00368 |
Pharmacology
| Summary | Norepinephrine acts primarily as a peripheral vasoconstrictor through agonism of alpha-1 and alpha-2 adrenergic receptors, increasing systemic vascular resistance and blood pressure. It also exerts positive inotropic effects and coronary vasodilation via beta-adrenergic receptor activation. This pharmacological profile supports its use in managing vasodilatory shock and critical hypotension by restoring vascular tone and cardiac output. |
|---|---|
| Mechanism of action | Norepinephrine functions as a peripheral vasoconstrictor by acting on alpha-adrenergic receptors. It is also an inotropic stimulator of the heart and dilator of coronary arteries as a result of it's activity at the beta-adrenergic receptors. |
| Pharmacodynamics | Noradrenaline acts on both alpha-1 and alpha-2 adrenergic receptors to cause vasoconstriction. Its effect in-vitro is often limited to the increasing of blood pressure through antagonising alpha-1 and alpha-2 receptors and causing a resultant increase in systemic vascular resistance. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Alpha-1A adrenergic receptor | Humans | agonist |
| Alpha-1B adrenergic receptor | Humans | agonist |
| Alpha-1D adrenergic receptor | Humans | agonist |
Formulation & handling
- Norepinephrine is formulated primarily for intravenous or parenteral administration due to its small molecule catecholamine structure.
- The API exhibits high water solubility and low logP, facilitating formulation as aqueous solutions for injection.
- Handling requires protection from oxidation and light to maintain stability given its catechol moiety.
Regulatory status
| Lifecycle | The API is protected by multiple patents in the United States with expiration dates extending to 2039, indicating a mature lifecycle phase in the US and Canada markets where patent protections remain in effect. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Norepinephrine is primarily originated and manufactured by a single company, Hospira Inc., with multiple packagers involved in its distribution across the US and Canadian markets. Branded products, notably Levophed, are established predominantly in these regions. Patent protection extends through 2038 to 2039 in the United States, indicating limited generic competition in the near term. |
|---|
Safety
| Toxicity | In high dose and especially when it is combined with other vasopressors, it can lead to limb ischemia and limb death. |
|---|
- High doses, particularly in combination with other vasopressors, may cause limb ischemia and necrosis
- Monitor infusion rates closely to minimize risk of peripheral vascular complications
- Avoid concurrent use with multiple vasopressors without strict clinical justification due to increased ischemic risk
Norepinephrine is a type of Adrenergic agents
Adrenergic agents are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that target the adrenergic system in the body. This system is responsible for regulating various physiological responses, including heart rate, blood pressure, and smooth muscle contraction.
Adrenergic agents can be further divided into two main groups: adrenergic agonists and adrenergic antagonists. Adrenergic agonists stimulate the adrenergic receptors, leading to an increase in sympathetic nervous system activity. This can result in effects such as vasoconstriction, bronchodilation, and increased heart rate. Adrenergic agonists are commonly used in the treatment of conditions such as asthma, hypotension, and cardiac arrest.
On the other hand, adrenergic antagonists block the adrenergic receptors, thereby inhibiting the effects of sympathetic nervous system activation. These agents are often employed to lower blood pressure, treat certain heart conditions, and manage symptoms associated with conditions like benign prostatic hyperplasia. Adrenergic antagonists can be further classified into alpha-adrenergic antagonists and beta-adrenergic antagonists, based on their selectivity for different adrenergic receptor subtypes.
Pharmaceutical companies extensively utilize adrenergic agents as key components in the development of various medications. Adrenergic APIs offer targeted effects on the adrenergic system, allowing for precise modulation of physiological responses. The understanding of adrenergic agents and their mechanisms of action is vital for the design and optimization of drugs used in the treatment of numerous medical conditions. Researchers and scientists continue to explore and innovate within this subcategory to develop new adrenergic agents with enhanced efficacy and fewer side effects, ultimately improving patient outcomes.
Norepinephrine (Adrenergic agents), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Norepinephrine API manufacturers & distributors
Compare qualified Norepinephrine API suppliers worldwide. We currently have 6 companies offering Norepinephrine API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Cambrex | Producer | Italy | Unknown | CoA, USDMF | 104 products |
| ChemPacific | Producer | United States | Unknown | CoA, USDMF | 10 products |
| Curia | Producer | United States | United States | CoA, GMP, MSDS, USDMF | 106 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Harman Finochem | Producer | India | India | CoA, USDMF | 34 products |
| Tianjin Pharmacn Medical ... | Producer | China | China | CoA, GMP | 66 products |
When sending a request, specify which Norepinephrine 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 Norepinephrine 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.
