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Epinephrine | CAS No: 51-43-4 | GMP-certified suppliers
A medication that provides rapid emergency control of anaphylaxis, septic‑shock hypotension, and acute bronchospasm while supporting cardiac resuscitation and local hemostatic needs.
Therapeutic categories
Primary indications
- Epinephrine injection is indicated in the emergency treatment of type I allergic reactions, including anaphylaxis
- It is also used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock
- Epinephrine's cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes but is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock
Product Snapshot
- Epinephrine is a small‑molecule product supplied mainly as injectable and inhalation formulations for emergency and ancillary clinical use
- It is used for acute management of anaphylaxis, bronchospasm, septic‑shock–related hypotension, cardiac resuscitation support, and as an adjunct in local anesthesia and ophthalmic procedures
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Epinephrine exerts pharmacologic activity as a sympathomimetic acting on alpha- and beta‑adrenergic receptors. Alpha‑receptor stimulation produces vasoconstriction and reduces vascular permeability, which counteracts the distributive effects of anaphylaxis. Beta‑1 activation increases heart rate and contractility, while beta‑2 activation produces bronchodilation, uterine relaxation, and increased aqueous humor production. These combined actions support its use in anaphylaxis, bronchospasm, croup, and cardiac arrest. Epinephrine also influences glycogenolysis and blood glucose.
Absorption and disposition vary with route; intramuscular delivery is used for rapid systemic exposure in anaphylaxis, while intravenous administration provides controlled titration in critical care. The drug is extensively metabolized by catechol‑O‑methyltransferase and monoamine oxidase, with rapid clearance typical of endogenous catecholamines.
Safety considerations include risks of tachycardia, hypertension, arrhythmias, and anxiety. Caution is warranted in patients with underlying cardiovascular disease. Local ischemia may occur with inadvertent digital injection. Severe adverse effects are more likely with intravenous administration or dosing errors.
Notable usage contexts include emergency medical systems, perioperative care, and outpatient anaphylaxis preparedness.
For API procurement, consistent stereochemical integrity, control of oxidative degradation, and compliance with pharmacopeial specifications are essential due to epinephrine’s sensitivity to light, oxygen, and pH. Reliable suppliers should demonstrate validated stabilization and packaging strategies to maintain potency.
Identification & chemistry
| Generic name | Epinephrine |
|---|---|
| Molecule type | Small molecule |
| CAS | 51-43-4 |
| UNII | YKH834O4BH |
| DrugBank ID | DB00668 |
Pharmacology
| Summary | Epinephrine is a sympathomimetic agent that activates alpha- and beta‑adrenergic receptors to counteract the vascular collapse, bronchoconstriction, and other acute manifestations of severe allergic reactions. Alpha‑receptor stimulation promotes vasoconstriction and reduces vascular permeability, while beta‑receptor activation produces bronchodilation and increases cardiac output. Its broad adrenergic activity underlies additional effects on smooth muscle tone, metabolic pathways, and ocular tissues. |
|---|---|
| Mechanism of action | Epinephrine acts on alpha and beta-adrenergic receptors. Epinephrine acts on alpha and beta receptors and is the strongest alpha receptor activator . Through its action on alpha-adrenergic receptors, epinephrine minimizes the vasodilation and increased the vascular permeability that occurs during anaphylaxis, which can cause the loss of intravascular fluid volume as well as hypotension. Epinephrine relaxes the smooth muscle of the bronchi and iris and is a histamine antagonist, rendering it useful in treating the manifestations of allergic reactions and associated conditions . This drug also produces an increase in blood sugar and increases glycogenolysis in the liver . Through its action on beta-adrenergic receptors, epinephrine leads to bronchial smooth muscle relaxation that helps to relieve bronchospasm, wheezing, and dyspnea that may occur during anaphylaxis [FDA label]. |
| Pharmacodynamics | Epinephrine is a sympathomimetic drug. It causes an adrenergic receptive mechanism on effector cells and mimics all actions of the sympathetic nervous system except those on the facial arteries and sweat glands . Important effects of epinephrine include increased heart rate, myocardial contractility, and renin release via beta-1 receptors. Beta-2 effects produce bronchodilation which may be useful as an adjunct treatment of asthma exacerbations as well as vasodilation, tocolysis, and increased aqueous humor production . In croup, nebulized epinephrine is associated with both clinically and statistically significant transient reduction of croup symptoms 30 minutes post-treatment . Epinephrine also alleviates pruritus, urticaria, and angioedema and may be helpful in relieving gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxing effects on the smooth muscle of the stomach, intestine, uterus, and urinary bladder [FDA label]. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Alpha-1A adrenergic receptor | Humans | agonist |
| Alpha-1B adrenergic receptor | Humans | agonist |
| Beta-1 adrenergic receptor | Humans | agonist |
ADME / PK
| Absorption | Following I.V. (intravenous) injection, epinephrine disappears rapidly from the blood stream. Subcutaneously or I.M. (intramuscular) administered epinephrine has a rapid onset and short duration of action. Subcutaneous (SC) administration during asthmatic attacks may produce bronchodilation within 5 to 10 minutes, and maximal effects may occur within 20 minutes. The drug becomes fixed in the tissues rapidly , [FDA label]. |
|---|---|
| Half-life | The plasma half-life is approximately 2-3 minutes. However, when administered by subcutaneous or intramuscular injection, local vasoconstriction may delay absorption so that epinephrine's effects may last longer than the half-life suggests . |
| Metabolism | Epinephrine is rapidly inactivated mainly by enzymic transformation to metanephrine or normetanephrine, either of which is then conjugated and excreted in the urine in the form of both sulfates and glucuronides. Either sequence results in the formation of 3-methoxy-4- hydroxy-mandelic acid(vanillylmandelic acid, VMA) which is shown to be detectable in the urine . Epinephrine is rapidly inactivated in the body mostly by the enzymes COMT (catechol-O-methyltransferase) and MAO (monoamine oxidase). The liver is abundant in the above enzymes, and is a primary, although not essential, tissue in the degradation process . |
| Route of elimination | The majority of the dose of epinephrine is seen excreted in the urine , [FDA label]. About 40% of a parenteral dose of epinephrine is excreted in urine as metanephrine, 40% as VMA, 7% as 3-methoxy-4-hydroxyphenoglycol, 2% as 3,4-dihydroxymandelic acid, and the rest as acetylated derivatives. These metabolites are excreted mainly as the sulfate conjugates and, to a lesser extent, the glucuronide conjugates. Only small amounts of the drug are excreted completely unchanged . |
| Clearance | Intravenous injection produces an immediate and intensified response. Following intravenous injection, epinephrine disappears rapidly from the blood stream . |
Formulation & handling
- Parenteral formulations dominate and typically require acidic pH and oxygen/light protection due to catechol oxidation sensitivity.
- High water solubility supports aqueous solutions, but the molecule is chemically labile and often stabilized with antioxidants such as sulfites.
- Suitable for injectable, inhalation, ophthalmic, and topical preparations, with attention to rapid degradation if exposed to air, elevated pH, or metal ions.
Regulatory status
| Lifecycle | The API shows a mature lifecycle, with the primary U.S. patent estate concluding in September 2025 following an earlier expiry in 2013. With products marketed in the United States and Canada, the market is approaching full loss of exclusivity in the U.S., signaling a shift toward a more competitive environment. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for epinephrine involves numerous originator and legacy producers, with a wide network of U.S. and Canadian packagers supporting injectable and dental anesthetic combination products. Branded presentations are established mainly in the U.S. and Canada, with no indication of exclusive global territories. Most core epinephrine drug patents have expired, and remaining device‑related patents ending in 2025 suggest that generic competition is already present with potential for further expansion as these protections lapse. |
|---|
Safety
| Toxicity | Skin, LD<sub>50</sub> = 62 mg/kg (rat) [MSDS] **Pregnancy** Epinephrine is teratogenic in rats when given in doses about 25 times the human doses. It is unknown whether epinephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Epinephrine should be given to a pregnant woman only if clearly required in critical situations/emergencies . **Labor and Delivery** Parenteral administration of epinephrine, if used as support for blood pressure during low or other spinal anesthesia for delivery, can lead to the acceleration of fetal heart rate and should not be used in obstetrics when maternal blood pressure is higher than 130/80. Epinephrine may delay the second stage of labour. **Common and generalized adverse effects**: Transient and minor side effects of anxiety, headache, fear, and palpitations may occur with therapeutic doses of epinephrine, especially in hyperthyroid individuals. Repeated local injections may result in necrosis at sites of injection due to vascular constriction. Cerebral hemorrhage; hemiplegia; subarachnoid hemorrhage; anginal pain in patients with angina pectoris; anxiety; restlessness; throbbing headache; tremor; weakness; dizziness; pallor; respiratory difficulty; palpitation; apprehensiveness; sweating; nausea; vomiting [FDA label]. **Cardiovascular effects:** Inadvertently induced high arterial blood pressure may result in angina pectoris (especially when coronary insufficiency is present), cardiac ischemia, or aortic rupture [FDA label], . Epinephrine may cause serious cardiac arrhythmias in patients not suffering from heart disease and patients with organic heart disease receiving drugs that sensitize the cardiac muscle. With the injection of epinephrine 1:1,000, a paradoxical but transient lowering of blood pressure, bradycardia and apnea may occur immediately post-injection [FDA label]. **Cerebrovascular hemorrhage**: Overdosage or accidental I.V. injection of epinephrine may lead to cerebrovascular hemorrhage resulting from the sharp rise in blood pressure [FDA label]. **Renal vasoconstriction**: Parenterally administered epinephrine initially may produce constriction of renal blood vessels and decrease urine formation. High doses may cause complete renal shutdown . **Pulmonary edema**: Fatality may also result from pulmonary edema due to the peripheral constriction and cardiac stimulation produced by epinephrine injection [FDA label]. **Digital vasoconstriction**: Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may lead to the loss of blood flow to the affected area. Treatment should be directed at vasodilation in addition to further treatment of anaphylaxis [FDA label]. |
|---|
- High acute toxicity with reported dermal LD50 of 62 mg/kg (rat)
- Concentrated material should be handled to minimize skin exposure
- Potent vasoconstrictive and cardiostimulatory properties create risks of severe hypertension, arrhythmias, and cerebrovascular events following accidental overdose or rapid systemic uptake
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Epinephrine 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.
Epinephrine (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.
Epinephrine API manufacturers & distributors
Compare qualified Epinephrine API suppliers worldwide. We currently have 7 companies offering Epinephrine API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Boehringer Ingelheim | Producer | Germany | Unknown | CoA, JDMF, USDMF | 35 products |
| Cambrex | Producer | Italy | Unknown | CoA, GMP, USDMF | 104 products |
| Duchefa Farma B.V. | Distributor | Netherlands | India | CoA, GMP, ISO9001, MSDS | 170 products |
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
| Sun Pharma | Producer | India | India | CoA, USDMF | 219 products |
| Tianjin Pharmacn Medical ... | Producer | China | China | CoA, GMP | 66 products |
| Wuhan Wuyao | Producer | China | China | CoA, WC | 8 products |
When sending a request, specify which Epinephrine 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.).
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Frequently asked questions about Epinephrine API
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Technical
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Regulatory
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