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Nicotine | CAS No: 54-11-5 | GMP-certified suppliers
A medication that relieves nicotine withdrawal symptoms and supports smoking cessation efforts for patients managing dependence in key markets such as the US and Canada.
Therapeutic categories
Primary indications
- For the relief of nicotine withdrawal symptoms and as an aid to smoking cessation
Product Snapshot
- Nicotine is supplied as multiple non-sterile oral, buccal, transdermal, and inhalation formulations including patches, gums, lozenges, sprays, solutions, powders, and inhalants
- It is used as a pharmacologic aid to manage nicotine withdrawal symptoms and support smoking cessation programs
- These products are approved and commercially available in the US and Canada
Clinical Overview
Nicotine acts as a stereoselective agonist at ionotropic nicotinic acetylcholine receptors located in autonomic ganglia, the adrenal medulla, neuromuscular junctions, and multiple brain regions. Receptor activation enables sodium and calcium influx, leading to neuronal depolarization. In dopaminergic pathways, this triggers calcium‑dependent vesicular release of dopamine, contributing to reinforcement and dependence. In the adrenal medulla, receptor activation induces epinephrine release, producing peripheral vasoconstriction, increased heart rate, and elevated blood pressure.
Pharmacodynamically, nicotine exhibits stimulant and rewarding effects mediated through the locus coeruleus and limbic structures. Intravenous or rapidly absorbed nicotine can increase the release of acetylcholine, norepinephrine, dopamine, serotonin, vasopressin, beta‑endorphin, and ACTH. These broad neuroendocrine effects underpin both its addictive potential and its autonomic actions.
Absorption, distribution, metabolism, and excretion characteristics vary with route of administration. Nicotine undergoes extensive hepatic metabolism, predominantly via CYP2A6, with contributions from multiple other cytochrome P450 pathways. It is also an inducer or inhibitor of several CYP enzymes, creating potential for metabolic interactions. Metabolites are primarily eliminated renally. Rapid absorption through pulmonary or mucosal routes contrasts with slower transdermal uptake, influencing pharmacokinetic profiles across dosage forms.
Safety considerations include dose‑dependent cardiovascular stimulation, risk of toxicity with accidental ingestion or excessive exposure, and potential drug interactions due to enzyme modulation. Nicotine remains contraindicated where acute cardiovascular instability is present.
For API procurement, suppliers should provide material meeting recognized pharmacopeial specifications, with strict controls on residual solvents, enantiomeric purity, and stabilization practices due to the compound’s volatility and toxicity.
Identification & chemistry
| Generic name | Nicotine |
|---|---|
| Molecule type | Small molecule |
| CAS | 54-11-5 |
| UNII | 6M3C89ZY6R |
| DrugBank ID | DB00184 |
Pharmacology
| Summary | Nicotine is an agonist at nicotinic acetylcholine receptors, where it activates ligand‑gated ion channels composed of various alpha and beta subunits to enhance cation influx and neuronal depolarization. This signaling increases neurotransmitter release, including dopamine in reward pathways and catecholamines from the adrenal medulla, contributing to its stimulant and dependence‑forming properties. In cessation therapies, its controlled delivery mitigates withdrawal by partially substituting for endogenous receptor stimulation. |
|---|---|
| Mechanism of action | Nicotine is a stimulant drug that acts as an agonist at nicotinic acetylcholine receptors. These are ionotropic receptors composed up of five homomeric or heteromeric subunits. In the brain, nicotine binds to nicotinic acetylcholine receptors on dopaminergic neurons in the cortico-limbic pathways. This causes the channel to open and allow conductance of multiple cations including sodium, calcium, and potassium. This leads to depolarization, which activates voltage-gated calcium channels and allows more calcium to enter the axon terminal. Calcium stimulates vesicle trafficking towards the plasma membrane and the release of dopamine into the synapse. Dopamine binding to its receptors is responsible the euphoric and addictive properties of nicotine. Nicotine also binds to nicotinic acetylcholine receptors on the chromaffin cells in the adrenal medulla. Binding opens the ion channel allowing influx of sodium, causing depolarization of the cell, which activates voltage-gated calcium channels. Calcium triggers the release of epinephrine from intracellular vesicles into the bloodstream, which causes vasoconstriction, increased blood pressure, increased heart rate, and increased blood sugar. |
| Pharmacodynamics | Nicotine, the primary alkaloid in tobacco products binds stereo-selectively to nicotinic-cholinergic receptors on autonomic ganglia, the adrenal medulla, neuromuscular junctions and in the brain. Nicotine exerts two effects, a stimulant effect exerted at the locus ceruleus and a reward effect in the limbic system. Itranvenous administration of nicotine causes release of acetylcholine, norepinephrine, dopamine, serotonine, vasopressin, beta-endorphin and ACTH. Nicotine is a highly addictive substance. Nicotine also induces peripheral vasoconstriction, tachycardia and elevated blood pressure. Nicotine inhalers and patches are used to treat smoking withdrawl syndrome. Nicotine is classified as a stimulant of autonomic ganglia. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Neuronal acetylcholine receptor subunit alpha-4 | Humans | agonist |
| Neuronal acetylcholine receptor subunit alpha-7 | Humans | agonist |
| Neuronal acetylcholine receptor subunit beta-2 | Humans | agonist |
ADME / PK
| Absorption | Absorption of nicotine through the buccal mucosa is relatively slow and the high and rapid rise followed by the decline in nicotine arterial plasma concentrations seen with cigarette smoking are not achieved with the inhaler. About 10% of absorbed nicotine is excreted unchanged in urine. |
|---|---|
| Half-life | Cotinine has a half life of 15-20 hours, while nicotine has a half life of 1-3 hours |
| Protein binding | Less than 5% |
| Metabolism | Primarily hepatic, cotinine is the primary metabolite. |
| Route of elimination | About 10% of the nicotine absorbed is excreted unchanged in the urine. |
| Volume of distribution | * 2 to 3 L/kg |
| Clearance | * 1.2 L/min [healthy adult smoker] |
Formulation & handling
- High aqueous solubility and liquid state support flexible oral, buccal, transmucosal, and inhalation formulations, with rapid mucosal absorption driving the need for controlled‑release matrices in transdermal systems.
- Oral and buccal products require consideration of food‑related interference with mucosal uptake, warranting formulations that minimize pH‑dependent precipitation or reduced permeability.
- Volatile, hygroscopic, and oxidizable nature of nicotine necessitates tight control of storage conditions, antioxidant use, and compatible packaging to limit degradation and evaporation during processing and shelf life.
Regulatory status
| Lifecycle | Most US and Canadian patent protections for the API have lapsed, enabling a mature market with established generic presence, while a remaining US patent expiring in 2028 provides limited ongoing exclusivity for specific protected aspects. Overall, the product is in a late‑lifecycle phase with residual protection only in the United States. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Nicotine products are supplied by multiple originator and legacy brand manufacturers, with production supported by a broad network of packagers involved in transdermal and consumer‑health formats. Branded and private‑label products are established in the US and Canadian markets, where nicotine replacement therapies are widely available. Most listed patents have expired, and only one extends to 2028, indicating a mature landscape with existing generic competition and limited remaining exclusivity. |
|---|
Safety
| Toxicity | Symptoms of overdose include nausea, abdominal pain, vomiting, diarrhea, diaphoresis, flushing, dizziness, disturbed hearing and vision, confusion, weakness, palpitations, altered respiration and hypotension. LD<sub>50</sub>= 24 mg/kg (orally in mice). |
|---|
- Overdose exposure may produce pronounced gastrointestinal distress, autonomic activation, sensory disturbances, and cardiovascular depression
- Monitor for hypotension and altered respiration in high‑dose scenarios
- LD50 of 24 mg/kg (oral, mouse) indicates moderate acute toxicity
Nicotine is a type of Drugs for nicotine addiction
Pharmaceutical APIs (Active Pharmaceutical Ingredients) are crucial components in the development of drugs to combat nicotine addiction. Nicotine addiction is a significant health concern affecting a large population worldwide. To address this issue, pharmaceutical companies focus on developing effective drugs targeting nicotine addiction, utilizing specialized APIs.
These APIs for nicotine addiction drugs play a pivotal role in the formulation of medications that aid in smoking cessation. They act on specific receptors in the brain, modulating the effects of nicotine and reducing cravings. By targeting these receptors, the APIs facilitate the release of neurotransmitters, such as dopamine, which helps to alleviate withdrawal symptoms and reduce the rewarding effects of smoking.
The development of APIs for nicotine addiction drugs requires meticulous research and stringent quality control measures to ensure safety and efficacy. Pharmaceutical companies employ advanced techniques, such as synthetic chemistry and biotechnology, to synthesize these APIs. Rigorous testing and validation are conducted to meet regulatory standards and ensure consistent drug performance.
APIs used in drugs for nicotine addiction are designed to provide a comprehensive approach to smoking cessation. They may be available in various forms, including oral medications, transdermal patches, or inhalers, allowing individuals to choose the most suitable method for their needs.
In conclusion, pharmaceutical APIs for drugs targeting nicotine addiction play a critical role in combating this widespread health issue. By leveraging advanced synthesis techniques and adhering to stringent quality control measures, these APIs form the foundation for effective medications that help individuals overcome nicotine addiction, contributing to improved public health and well-being.
Nicotine (Drugs for nicotine addiction), classified under Anti-addiction agents
Anti-addiction agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment and management of various forms of addiction. These agents target the neurochemical pathways in the brain that are involved in addiction and dependence, offering therapeutic interventions to individuals struggling with substance abuse disorders.
One prominent group of anti-addiction agents includes opioid receptor antagonists, such as naltrexone and naloxone. These APIs bind to opioid receptors in the brain, blocking the euphoric effects of opioids and reducing cravings. By doing so, they help individuals overcome opioid addiction and prevent relapse.
Another essential class of anti-addiction agents are nicotine receptor agonists, like varenicline. These APIs target nicotine receptors in the brain, reducing the pleasurable sensations associated with smoking and alleviating nicotine withdrawal symptoms. This aids in smoking cessation efforts and enhances long-term abstinence rates.
Furthermore, anti-addiction agents may also encompass APIs used in the treatment of alcohol addiction, such as disulfiram and acamprosate. Disulfiram inhibits the breakdown of alcohol in the body, leading to unpleasant reactions when alcohol is consumed, thus discouraging its use. Acamprosate, on the other hand, helps normalize brain activity disrupted by chronic alcohol use, reducing cravings and promoting abstinence.
In conclusion, anti-addiction agents are a critical category of pharmaceutical APIs used to combat addiction and substance abuse disorders. By targeting specific neurochemical pathways, these agents provide valuable support in overcoming addiction, preventing relapse, and improving the overall well-being of individuals affected by substance abuse.
Nicotine API manufacturers & distributors
Compare qualified Nicotine API suppliers worldwide. We currently have 4 companies offering Nicotine 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 |
|---|---|---|---|---|---|
| BGP Healthcare | Producer | India | India | CEP, CoA, FDA, USDMF, WC | 2 products |
| Nicobrand | Producer | United Kingdom | United Kingdom | CEP, CoA, GMP | 1 products |
| Porton Fine Chem. | Producer | China | China | CEP, CoA, GMP, USDMF | 4 products |
| Valence Labs | Producer | India | India | CoA, GMP | 32 products |
When sending a request, specify which Nicotine 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 Nicotine 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 Nicotine API
Sourcing
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Technical
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Regulatory
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Pharmaoffer
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