Ephedrine API Manufacturers & Suppliers
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Ephedrine | CAS No: 299-42-3 | GMP-certified suppliers
A medication that supports management of anesthesia‑related hypotension, allergic respiratory conditions such as bronchial asthma, and nasal congestion across key North American markets.
Therapeutic categories
Adrenergic AgentsAdrenergic AgonistsAdrenergic alpha-AgonistsAdrenergic and Dopaminergic AgentsAdrenergic beta-AgonistsAdrenergics for Systemic Use
Generic name
Ephedrine
Molecule type
small molecule
CAS number
299-42-3
DrugBank ID
DB01364
Approval status
Approved drug
ATC code
S01FB02
Primary indications
- Ephedrine intravenous injections are indicated to treat hypotension under anesthesia,ephedrine injections by multiple routes are indicated to treat allergic conditions such as bronchial asthma,ephedrine nasal spray is and OTC medication used as a decongestant
Product Snapshot
- Ephedrine is a small‑molecule API available in injectable, oral, nasal, topical, and rectal formulations
- It is used for anesthesia‑related hypotension, certain allergic or bronchospastic conditions, and as an OTC nasal decongestant
- It is approved and marketed in the United States and Canada
Clinical Overview
Ephedrine (CAS 299‑42‑3) is a sympathomimetic amine classified within the phenylpropane family. It has long-standing medical use and remains approved in multiple regions. Clinically, ephedrine is employed to treat hypotension occurring under anesthesia, to manage allergic conditions such as bronchial asthma through injectable formulations, and as a nonprescription nasal decongestant in topical preparations.
Ephedrine exhibits both direct and indirect adrenergic activity. It stimulates alpha‑1, beta‑1, and beta‑2 adrenergic receptors, while also promoting the release of norepinephrine from presynaptic neurons and inhibiting its reuptake. These combined actions increase synaptic norepinephrine concentrations, resulting in enhanced sympathetic tone. Alpha‑1 receptor activation contributes to venous constriction and increased vascular resistance. Beta‑1 stimulation augments heart rate and myocardial contractility, and beta‑2 stimulation mediates bronchodilation and peripheral vasodilation.
Pharmacodynamic effects include elevation of blood pressure through increases in cardiac output and variable changes in systemic resistance. Bronchodilation supports its historical use in obstructive airway conditions. Its influence on bladder smooth muscle may increase urinary outflow resistance. A relatively wide therapeutic window is documented, with typical dosing ranges from 5 mg to 50 mg depending on clinical context. Tachyphylaxis can occur, particularly with repeated administration. Prophylactic use for anesthesia‑related hypotension has been associated with a higher incidence of hypertensive episodes compared with reactive dosing.
Ephedrine is absorbed systemically following parenteral and mucosal administration, with distribution to both central and peripheral compartments. It undergoes partial hepatic metabolism and is eliminated renally, primarily as unchanged drug and metabolites. The pharmacokinetic profile supports rapid onset with moderate duration of action.
Safety considerations include pressor responses, tachycardia, CNS stimulation, and the potential for excessive blood pressure elevation. Caution is advised in patients with cardiovascular disease or conditions sensitive to sympathetic stimulation.
For API procurement, sourcing should emphasize verified identity, optical purity, and control of related phenethylamine impurities to ensure compliance with pharmacopeial and regional regulatory standards.
Ephedrine exhibits both direct and indirect adrenergic activity. It stimulates alpha‑1, beta‑1, and beta‑2 adrenergic receptors, while also promoting the release of norepinephrine from presynaptic neurons and inhibiting its reuptake. These combined actions increase synaptic norepinephrine concentrations, resulting in enhanced sympathetic tone. Alpha‑1 receptor activation contributes to venous constriction and increased vascular resistance. Beta‑1 stimulation augments heart rate and myocardial contractility, and beta‑2 stimulation mediates bronchodilation and peripheral vasodilation.
Pharmacodynamic effects include elevation of blood pressure through increases in cardiac output and variable changes in systemic resistance. Bronchodilation supports its historical use in obstructive airway conditions. Its influence on bladder smooth muscle may increase urinary outflow resistance. A relatively wide therapeutic window is documented, with typical dosing ranges from 5 mg to 50 mg depending on clinical context. Tachyphylaxis can occur, particularly with repeated administration. Prophylactic use for anesthesia‑related hypotension has been associated with a higher incidence of hypertensive episodes compared with reactive dosing.
Ephedrine is absorbed systemically following parenteral and mucosal administration, with distribution to both central and peripheral compartments. It undergoes partial hepatic metabolism and is eliminated renally, primarily as unchanged drug and metabolites. The pharmacokinetic profile supports rapid onset with moderate duration of action.
Safety considerations include pressor responses, tachycardia, CNS stimulation, and the potential for excessive blood pressure elevation. Caution is advised in patients with cardiovascular disease or conditions sensitive to sympathetic stimulation.
For API procurement, sourcing should emphasize verified identity, optical purity, and control of related phenethylamine impurities to ensure compliance with pharmacopeial and regional regulatory standards.
Identification & chemistry
| Generic name | Ephedrine |
|---|---|
| Molecule type | Small molecule |
| CAS | 299-42-3 |
| UNII | GN83C131XS |
| DrugBank ID | DB01364 |
Pharmacology
| Summary | Ephedrine is a mixed direct and indirect sympathomimetic that activates alpha‑ and beta‑adrenergic receptors while also increasing synaptic norepinephrine through reuptake inhibition and enhanced presynaptic release. These combined actions elevate sympathetic tone, producing increased vascular resistance, cardiac stimulation, and bronchodilation. Its primary targets include alpha‑1, beta‑1, beta‑2 adrenergic receptors and the norepinephrine transporter. |
|---|---|
| Mechanism of action | Ephedrine is a direct and indirect sympathomimetic amine.As a direct effect, ephedrine activates alpha-adrenergic and beta-adrenergic receptors. As an indirect effect, it inhibits norepinephrine reuptake and increases the release of norepinephrine from vesicles in nerve cells.These actions combined lead to larger quantities of norepinephrine present in the synapse for more extended periods of time, increasing stimulation of the sympathetic nervous system. Ephedrine acts as an agonist of alpha-1, beta-1 and beta-2-adrenergic receptors. The stimulation of alpha-1-adrenergic receptors causes the constriction of veins and a rise in blood pressure, the stimulation of beta-1-adrenergic receptors increases cardiac chronotropy and inotropy, and the stimulation of beta-2-adrenergic receptors causes vasodilation and bronchodilation. |
| Pharmacodynamics | Ephedrine increases blood pressure by stimulating heart rate and cardiac output and variably increasing peripheral resistance.It causes bronchodilation due to the activation of beta-adrenergic receptors in the lungs. By stimulating alpha-adrenergic receptors in bladder smooth muscle cells, ephedrine also increases the resistance to the outflow of urine.The therapeutic window of ephedrine is wide, as patients can be given doses of 5mg up to 50mg.Patients should be counselled regarding the pressor effects of sympathomimetic amines and the risk of tachyphylaxis.Also, the use of ephedrine for hypotension prophylaxis is associated with a higher risk of hypertension, compared to when ephedrine is used to treat hypotension. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Alpha-1A adrenergic receptor | Humans | agonist |
| Beta-1 adrenergic receptor | Humans | agonist |
| Beta-2 adrenergic receptor | Humans | agonist |
ADME / PK
| Absorption | Oral ephedrine reaches an average C<sub>max</sub> of 79.5ng/mL, with a T<sub>max</sub> of 1.81h, and a bioavailability of 88%. |
|---|---|
| Half-life | Oral ephedrine has a plasma elimination half life of approximately 6 hours, but there is a large degree of inter-patient variability. |
| Protein binding | (-) Ephedrine is 4.9±0.3% bound to human serum albumin and (+) Ephedrine is 6.9±1.4% bound to human serum albumin. |
| Metabolism | Ephedrine is largely unmetabolized in the body.Ephedrine can be N-demethylated to norephedrine, or demethylated and deaminized to benzoic acid conjugates and 1,2-hydroxypropylbenzene. |
| Route of elimination | Ephedrine is mainly eliminated in the urine.Approximately 60% is eliminated as the unmetabolized parent compound, 13% as benzoic acid conjugates, and 1% as 1,2-dihydroxypropylbenzene. |
| Volume of distribution | Oral ephedrine has an average volume of distribution of 215.6L. |
| Clearance | Oral ephedrine has a clearance of 23.3L/h but there is a high degree of inter-patient variability. |
Formulation & handling
- Ephedrine is a small‑molecule, water‑soluble solid suitable for oral, nasal, topical, and parenteral formulations, with straightforward dissolution in aqueous vehicles.
- Parenteral solutions are typically simple aqueous systems; the API is chemically stable but requires protection from oxidation and control of pH to limit degradation and discoloration.
- Oral formulations generally show reliable absorption with limited food effects, allowing flexible formulation into tablets, capsules, syrups, or elixirs.
Regulatory status
| Lifecycle | The API remains in an early stage of its lifecycle, with multiple U.S. patents expiring in 2040 and current commercialization limited to the United States and Canada. Market maturity is therefore low, with no near‑term loss of exclusivity expected. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Ephedrine is an established active ingredient with no single dominant originator, and the market is supplied largely by multiple manufacturers and repackagers supporting long‑standing therapeutic use. Branded products are present mainly in the US and Canada, with most availability driven by non‑branded or institutional supply channels. Although several US patents extend to 2040, these appear to relate to specific formulations rather than the core molecule, which is already off‑patent and supports ongoing generic competition. |
|---|
Safety
| Toxicity | Patients experiencing an overdose of ephedrine will present with rapidly increasing blood pressure.Manage overdose with blood pressure monitoring, and possibly the administration of parenteral antihypertensives.The LD<sub>50</sub> in mice after oral administration is 785mg/kg, after intraperitoneal administration if 248mg/kg, and after subcutaneous administration is 425mg/kg. |
|---|
High Level Warnings:
- Overexposure can produce marked hypertensive responses
- Monitor for rapid blood‑pressure elevation during handling of concentrated materials
- Acute toxicity varies by route, with reported LD50 values in mice of 785 mg/kg (oral), 248 mg/kg (intraperitoneal), and 425 mg/kg (subcutaneous), indicating higher hazard via parenteral exposure
Ephedrine 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.
Ephedrine (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.
Frequently asked questions about Ephedrine API
Sourcing
What matters most when sourcing GMP-grade Ephedrine?
Key considerations include verifying GMP compliance and ensuring the supplier meets US and Canadian regulatory requirements for controlled substances. Because the molecule is off‑patent and supplied by multiple manufacturers, assessing supply chain reliability and quality consistency is essential. It is also important to confirm that the intended use does not intersect with any formulation‑specific patents active to 2040.
Which documents are typically required when sourcing Ephedrine API?
Request the core API documentation set: CoA (7 companies), GMP (6 companies), MSDS (3 companies), USDMF (3 companies), WC (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Ephedrine API?
Known or reported manufacturers for Ephedrine: Duchefa Farma B.V., Chr. Olesen Group, Hänseler AG, Pharm Rx Chemical Corp. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Ephedrine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Ephedrine manufacturers?
Audit reports may be requested for Ephedrine: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Ephedrine API on Pharmaoffer?
Reported supplier count for Ephedrine: 7 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Ephedrine API?
Production countries reported for Ephedrine: India (5 producers), China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Ephedrine usually hold?
Common certifications for Ephedrine suppliers: CoA (7 companies), GMP (6 companies), MSDS (3 companies), USDMF (3 companies), WC (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Ephedrine (CAS 299-42-3) used for?
Ephedrine is used to treat hypotension during anesthesia, where its mixed adrenergic activity helps raise blood pressure. It is also employed to relieve bronchospasm in conditions such as bronchial asthma and is included in topical preparations as a nasal decongestant. These uses derive from its alpha‑1, beta‑1, and beta‑2 receptor stimulation and its indirect enhancement of norepinephrine levels.
Which therapeutic class does Ephedrine fall into?
Ephedrine belongs to the following therapeutic categories: Adrenergic Agents, Adrenergic Agonists, Adrenergic alpha-Agonists, Adrenergic and Dopaminergic Agents, Adrenergic beta-Agonists. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Ephedrine mainly prescribed for?
The primary indications for Ephedrine: Ephedrine intravenous injections are indicated to treat hypotension under anesthesia,Ephedrine injections by multiple routes are indicated to treat allergic conditions such as bronchial asthma,Ephedrine nasal spray is and OTC medication used as a decongestant. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Ephedrine work?
Ephedrine is a direct and indirect sympathomimetic amine.As a direct effect, Ephedrine activates alpha-adrenergic and beta-adrenergic receptors. As an indirect effect, it inhibits norepinephrine reuptake and increases the release of norepinephrine from vesicles in nerve cells.These actions combined lead to larger quantities of norepinephrine present in the synapse for more extended periods of time, increasing stimulation of the sympathetic nervous system.
Ephedrine acts as an agonist of alpha-1, beta-1 and beta-2-adrenergic receptors. The stimulation of alpha-1-adrenergic receptors causes the constriction of veins and a rise in blood pressure, the stimulation of beta-1-adrenergic receptors increases cardiac chronotropy and inotropy, and the stimulation of beta-2-adrenergic receptors causes vasodilation and bronchodilation.
What should someone know about the safety or toxicity profile of Ephedrine?
Ephedrine can produce marked increases in blood pressure and heart rate due to its adrenergic activity, and individuals with cardiovascular disease may be more sensitive to these effects. CNS stimulation may also occur. Overexposure to concentrated material can cause rapid hypertensive responses, and acute toxicity varies by route, with lower LD50 values reported for parenteral administration. Monitoring for pressor effects is important, particularly with repeated or prophylactic dosing.
What are important formulation and handling considerations for Ephedrine as an API?
Ephedrine is a water‑soluble solid that dissolves readily in aqueous vehicles, allowing straightforward development of oral, nasal, topical, and parenteral dosage forms. Parenteral formulations generally use simple aqueous systems but require protection from oxidation and careful pH control to limit degradation and discoloration. Oral products can be formulated as tablets, capsules, syrups, or elixirs, with reliable absorption and minimal food effects. Proper handling includes maintaining conditions that minimize oxidative stress to preserve chemical stability.
Is Ephedrine a small molecule?
Ephedrine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Ephedrine?
Oral Ephedrine is generally chemically stable, as the API is a water‑soluble solid with straightforward dissolution in aqueous systems. The main stability considerations relate to protection from oxidation and maintaining appropriate pH to limit degradation and discoloration. These requirements are similar to those used for simple aqueous formulations and help preserve product quality during storage.
Regulatory
Where is Ephedrine approved or in use globally?
Ephedrine is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Ephedrine right now?
In the United States and Canada, Ephedrine is regulated as a controlled precursor chemical with strict limits on distribution, recordkeeping, and sales. These controls focus on preventing diversion while allowing permitted medical and industrial uses.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Ephedrine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Ephedrine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Ephedrine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Ephedrine: 2129 verified transactions across 390 suppliers and 128 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Ephedrine?
Market report availability for Ephedrine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
