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Lidocaine | CAS No: 137-58-6 | GMP-certified suppliers
A medication that provides reliable local and regional anesthesia for diverse surgical and procedural needs and supports cardiac care in acute arrhythmia management.
Therapeutic categories
Agents for Treatment of Hemorrhoids and Anal Fissures for Topical UseAgents that reduce seizure thresholdAmidesAminesAnalgesics and AnestheticsAnesthetics
Generic name
Lidocaine
Molecule type
small molecule
CAS number
137-58-6
DrugBank ID
DB00281
Approval status
Approved drug, Vet_approved drug
ATC code
S01HA07
Primary indications
- Lidocaine is an anesthetic of the amide group indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks
Product Snapshot
- Lidocaine is a small‑molecule local anesthetic available in injectable, topical, transdermal, and mucosal formulations
- It is used for local and regional anesthesia across infiltration, nerve block, and surface anesthesia applications
- It is approved in the US, EU, and Canada, with both human and veterinary regulatory clearances
Clinical Overview
Lidocaine (CAS 137-58-6) is an amide‑type local anesthetic and class Ib anti‑arrhythmic agent widely used for production of local or regional anesthesia. It is applied by infiltration, peripheral nerve block, and central neural techniques such as lumbar or caudal epidural administration. Its anesthetic utility also extends to topical formulations for mucosal procedures and certain dermatologic or anorectal indications.
The pharmacologic effect is based on inhibition of voltage‑gated sodium channels. Un‑ionized lidocaine diffuses across the neural membrane, becomes protonated in the axoplasm, and the cation binds the channel from the intracellular side. This prevents depolarization and action potential propagation, interrupting sensory signal initiation and conduction. Lidocaine has a pKa of approximately 7.7, allowing a substantial fraction to remain un‑ionized at physiologic pH and enabling rapid onset. Typical onset occurs within about one minute after intravenous administration and within about fifteen minutes after intramuscular dosing. Duration is generally ten to twenty minutes for intravenous routes and one to one and a half hours following intramuscular injection.
Absorption and distribution are rapid, with effects modulated by tissue perfusion. Reduced efficacy may occur in inflamed or acidic tissues due to decreased un‑ionized drug fraction and altered local pharmacokinetics. Lidocaine undergoes extensive hepatic metabolism, primarily via CYP3A‑mediated pathways, and metabolites are renally excreted.
Systemic exposure can influence both the central nervous system and cardiovascular system. Excess plasma levels may alter cardiac output, vascular resistance, and conduction, with potential for hypotension, bradycardia, arrhythmias, or myocardial depression. Central nervous system stimulation followed by depression may occur with high concentrations. Safety considerations include dose‑dependent toxicity, potential exacerbation in hepatic impairment, and interactions with other CYP substrates or inhibitors.
Lidocaine is available globally as low‑cost generics and is listed on the WHO Essential Medicines list. For API procurement, sourcing should confirm compliance with pharmacopoeial specifications, validated control of polymorphic form, and robust impurity profiling to support formulation development and regulatory submissions.
The pharmacologic effect is based on inhibition of voltage‑gated sodium channels. Un‑ionized lidocaine diffuses across the neural membrane, becomes protonated in the axoplasm, and the cation binds the channel from the intracellular side. This prevents depolarization and action potential propagation, interrupting sensory signal initiation and conduction. Lidocaine has a pKa of approximately 7.7, allowing a substantial fraction to remain un‑ionized at physiologic pH and enabling rapid onset. Typical onset occurs within about one minute after intravenous administration and within about fifteen minutes after intramuscular dosing. Duration is generally ten to twenty minutes for intravenous routes and one to one and a half hours following intramuscular injection.
Absorption and distribution are rapid, with effects modulated by tissue perfusion. Reduced efficacy may occur in inflamed or acidic tissues due to decreased un‑ionized drug fraction and altered local pharmacokinetics. Lidocaine undergoes extensive hepatic metabolism, primarily via CYP3A‑mediated pathways, and metabolites are renally excreted.
Systemic exposure can influence both the central nervous system and cardiovascular system. Excess plasma levels may alter cardiac output, vascular resistance, and conduction, with potential for hypotension, bradycardia, arrhythmias, or myocardial depression. Central nervous system stimulation followed by depression may occur with high concentrations. Safety considerations include dose‑dependent toxicity, potential exacerbation in hepatic impairment, and interactions with other CYP substrates or inhibitors.
Lidocaine is available globally as low‑cost generics and is listed on the WHO Essential Medicines list. For API procurement, sourcing should confirm compliance with pharmacopoeial specifications, validated control of polymorphic form, and robust impurity profiling to support formulation development and regulatory submissions.
Identification & chemistry
| Generic name | Lidocaine |
|---|---|
| Molecule type | Small molecule |
| CAS | 137-58-6 |
| UNII | 98PI200987 |
| DrugBank ID | DB00281 |
Pharmacology
| Summary | Lidocaine is an amide‑type local anesthetic that produces regional anesthesia by blocking voltage‑gated sodium channels in peripheral nerves, preventing initiation and conduction of action potentials. Its activity reflects reversible intracellular binding to multiple sodium channel subtypes, stabilizing neuronal membranes and suppressing sensory signal generation. Systemically, similar sodium channel blockade in cardiac and central nervous tissues contributes to its characteristic electrophysiologic and hemodynamic effects. |
|---|---|
| Mechanism of action | Lidocaine is a local anesthetic of the amide type . It is used to provide local anesthesia by nerve blockade at various sites in the body . It does so by stabilizing the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action . In particular, the lidocaine agent acts on sodium ion channels located on the internal surface of nerve cell membranes . At these channels, neutral uncharged lidocaine molecules diffuse through neural sheaths into the axoplasm where they are subsequently ionized by joining with hydrogen ions . The resultant lidocaine cations are then capable of reversibly binding the sodium channels from the inside, keeping them locked in an open state that prevents nerve depolarization . As a result, with sufficient blockage, the membrane of the postsynaptic neuron will ultimately not depolarize and will thus fail to transmit an action potential . This facilitates an anesthetic effect by not merely preventing pain signals from propagating to the brain but by aborting their generation in the first place . In addition to blocking conduction in nerve axons in the peripheral nervous system, lidocaine has important effects on the central nervous system and cardiovascular system . After absorption, lidocaine may cause stimulation of the CNS followed by depression and in the cardiovascular system, it acts primarily on the myocardium where it may produce decreases in electrical excitability, conduction rate, and force of contraction . |
| Pharmacodynamics | Excessive blood levels of lidocaine can cause changes in cardiac output, total peripheral resistance, and mean arterial pressure . With central neural blockade these changes may be attributable to the block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system, and/or the beta-adrenergic receptor stimulating action of epinephrine when present . The net effect is normally a modest hypotension when the recommended dosages are not exceeded . In particular, such cardiac effects are likely associated with the principal effect that lidocaine elicits when it binds and blocks sodium channels, inhibiting the ionic fluxes required for the initiation and conduction of electrical action potential impulses necessary to facilitate muscle contraction . Subsequently, in cardiac myocytes, lidocaine can potentially block or otherwise slow the rise of cardiac action potentials and their associated cardiac myocyte contractions, resulting in possible effects like hypotension, bradycardia, myocardial depression, cardiac arrhythmias, and perhaps cardiac arrest or circulatory collapse . Moreover, lidocaine possesses a dissociation constant (pKa) of 7.7 and is considered a weak base . As a result, about 25% of lidocaine molecules will be un-ionized and available at the physiological pH of 7.4 to translocate inside nerve cells, which means lidocaine elicits an onset of action more rapidly than other local anesthetics that have higher pKa values . This rapid onset of action is demonstrated in about one minute following intravenous injection and fifteen minutes following intramuscular injection . The administered lidocaine subsequently spreads rapidly through the surrounding tissues and the anesthetic effect lasts approximately ten to twenty minutes when given intravenously and about sixty to ninety minutes after intramuscular injection . Nevertheless, it appears that the efficacy of lidocaine may be minimized in the presence of inflammation . This effect could be due to acidosis decreasing the amount of un-ionized lidocaine molecules, a more rapid reduction in lidocaine concentration as a result of increased blood flow, or potentially also because of increased production of inflammatory mediators like peroxynitrite that elicit direct actions on sodium channels . |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium channel protein type 10 subunit alpha | Humans | inhibitor |
| Sodium channel protein type 9 subunit alpha | Humans | inhibitor |
| Sodium channel protein type 5 subunit alpha | Humans | inhibitor |
ADME / PK
| Absorption | In general, lidocaine is readily absorbed across mucous membranes and damaged skin but poorly through intact skin . The agent is quickly absorbed from the upper airway, tracheobronchial tree, and alveoli into the bloodstream . And although lidocaine is also well absorbed across the gastrointestinal tract the oral bioavailability is only about 35% as a result of a high degree of first-pass metabolism . After injection into tissues, lidocaine is also rapidly absorbed and the absorption rate is affected by both vascularity and the presence of tissue and fat capable of binding lidocaine in the particular tissues . The concentration of lidocaine in the blood is subsequently affected by a variety of aspects, including its rate of absorption from the site of injection, the rate of tissue distribution, and the rate of metabolism and excretion . Subsequently, the systemic absorption of lidocaine is determined by the site of injection, the dosage given, and its pharmacological profile . The maximum blood concentration occurs following intercostal nerve blockade followed in order of decreasing concentration, the lumbar epidural space, brachial plexus site, and subcutaneous tissue . The total dose injected regardless of the site is the primary determinant of the absorption rate and blood levels achieved . There is a linear relationship between the amount of lidocaine injected and the resultant peak anesthetic blood levels . Nevertheless, it has been observed that lidocaine hydrochloride is completely absorbed following parenteral administration, its rate of absorption depending also on lipid solubility and the presence or absence of a vasoconstrictor agent . Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the lowest after subcutaneous administration . Additionally, lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion . |
|---|---|
| Half-life | The elimination half-life of lidocaine hydrochloride following an intravenous bolus injection is typically 1.5 to 2.0 hours . Because of the rapid rate at which lidocaine hydrochloride is metabolized, any condition that affects liver function may alter lidocaine HCl kinetics . The half-life may be prolonged two-fold or more in patients with liver dysfunction . |
| Protein binding | The protein binding recorded for lidocaine is about 60 to 80% and is dependent upon the plasma concentration of alpha-1-acid glycoprotein . Such percentage protein binding bestows lidocaine with a medium duration of action when placed in comparison to other local anesthetic agents . |
| Metabolism | Lidocaine is metabolized predominantly and rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys . Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation . N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide . The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine HCl . Approximately 90% of lidocaine HCl administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged . The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline . |
| Route of elimination | The excretion of unchanged lidocaine and its metabolites occurs predominantly via the kidney with less than 5% in the unchanged form appearing in the urine . The renal clearance is inversely related to its protein binding affinity and the pH of the urine . This suggests by the latter that excretion of lidocaine occurs by non-ionic diffusion . |
| Volume of distribution | The volume of distribution determined for lidocaine is 0.7 to 1.5 L/kg . In particular, lidocaine is distributed throughout the total body water . Its rate of disappearance from the blood can be described by a two or possibly even three-compartment model . There is a rapid disappearance (alpha phase) which is believed to be related to uptake by rapidly equilibrating tissues (tissues with high vascular perfusion, for example) . The slower phase is related to distribution to slowly equilibrating tissues (beta phase) and to its metabolism and excretion (gamma phase) . Lidocaine's distribution is ultimately throughout all body tissues . In general, the more highly perfused organs will show higher concentrations of the agent . The highest percentage of this drug will be found in skeletal muscle, mainly due to the mass of muscle rather than an affinity . |
| Clearance | The mean systemic clearance observed for intravenously administered lidocaine in a study of 15 adults was approximately 0.64 +/- 0.18 L/min . |
Formulation & handling
- Topical, injectable, ophthalmic, and transmucosal use require solubilization of this moderately lipophilic small molecule; aqueous formulations often rely on salt forms and pH adjustment to maintain clarity and stability.
- Solutions for parenteral or neuraxial administration typically require strict control of pH and avoidance of particulates, with attention to oxidation and adsorption to plastics during storage.
- Topical and transdermal products benefit from penetration enhancers or suitable vehicles to improve dermal permeation given its limited aqueous solubility.
Regulatory status
| Lifecycle | The API shows a largely mature market profile in North America and the EU, with multiple foundational U.S. patents expired and one later-expiring patent extending some remaining protection to 2029. Overall, the product is predominantly in a post‑exclusivity phase, aside from residual coverage tied to the latest patent. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Lidocaine is an established anesthetic produced by a large number of manufacturers, with no single originator dominating current supply. Branded and unbranded formulations are widely available across the US, EU, and Canada, reflecting its long-standing global use. Most listed patents have expired, and only one formulation‑related patent extends to 2029, consistent with extensive existing generic competition. |
|---|
Safety
| Toxicity | Symptoms of overdose and/or acute systemic toxicity involves central nervous system toxicity that presents with symptoms of increasing severity . Patients may present initially with circumoral paraesthesia, numbness of the tongue, light-headedness, hyperacusis, and tinnitus . Visual disturbance and muscular tremors or muscle twitching are more serious and precede the onset of generalized convulsions . These signs must not be mistaken for neurotic behavior . Unconsciousness and grand mal convulsions may follow, which may last from a few seconds to several minutes . Hypoxia and hypercapnia occur rapidly following convulsions due to increased muscular activity, together with the interference with normal respiration and loss of the airway . In severe cases, apnoea may occur. Acidosis increases the toxic effects of local anesthetics . Effects on the cardiovascular system may be seen in severe cases . Hypotension, bradycardia, arrhythmia and cardiac arrest may occur as a result of high systemic concentrations, with potentially fatal outcome . Pregnancy Category B has been established for the use of lidocaine in pregnancy, although there are no formal, adequate, and well-controlled studies in pregnant women . General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place . Ultimately, although animal studies have revealed no evidence of harm to the fetus, lidocaine should not be administered during early pregnancy unless the benefits are considered to outweigh the risks . Lidocaine readily crosses the placental barrier after epidural or intravenous administration to the mother . The ratio of umbilical to maternal venous concentration is 0.5 to 0.6 . The fetus appears to be capable of metabolizing lidocaine at term . The elimination half-life in the newborn of the drug received in utero is about three hours, compared with 100 minutes in the adult . Elevated lidocaine levels may persist in the newborn for at least 48 hours after delivery . Fetal bradycardia or tachycardia, neonatal bradycardia, hypotonia or respiratory depression may occur . Local anesthetics rapidly cross the placenta and when used for epidural, paracervical, pudendal or caudal block anesthesia, can cause varying degrees of maternal, fetal and neonatal toxicity . The potential for toxicity depends upon the procedure performed, the type and amount of drug used, and the technique of drug administration . Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function . Maternal hypotension has resulted from regional anesthesia . Local anesthetics produce vasodilation by blocking sympathetic nerves . Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure . The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable . Epidural, spinal, paracervical, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts . In one study, paracervical block anesthesia was associated with a decrease in the mean duration of first stage labor and facilitation of cervical dilation . However, spinal and epidural anesthesia have also been reported to prolong the second stage of labor by removing the parturient’s reflex urge to bear down or by interfering with motor function . The use of obstetrical anesthesia may increase the need for forceps assistance . The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life . The long-term significance of these observations is unknown . Fetal bradycardia may occur in 20 to 30 percent of patients receiving paracervical nerve block anesthesia with the amide-type local anesthetics and may be associated with fetal acidosis . Fetal heart rate should always be monitored during paracervical anesthesia . The physician should weigh the possible advantages against risks when considering a paracervical block in prematurity, toxemia of pregnancy, and fetal distress . Careful adherence to the recommended dosage is of the utmost importance in obstetrical paracervical block . Failure to achieve adequate analgesia with recommended doses should arouse suspicion of intravascular or fetal intracranial injection . Cases compatible with unintended fetal intracranial injection of local anesthetic solution have been reported following intended paracervical or pudendal block or both. Babies so affected present with unexplained neonatal depression at birth, which correlates with high local anesthetic serum levels, and often manifest seizures within six hours . Prompt use of supportive measures combined with forced urinary excretion of the local anesthetic has been used successfully to manage this complication . It is not known whether this drug is excreted in human milk . Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman . Dosages in children should be reduced, commensurate with age, body weight and physical condition . The oral LD 50 of lidocaine HCl in non-fasted female rats is 459 (346-773) mg/kg (as the salt) and 214 (159-324) mg/kg (as the salt) in fasted female rats . |
|---|
High Level Warnings:
- Acute systemic toxicity involves CNS excitation progressing to seizures, followed by risks of hypoxia, hypercapnia, and cardiorespiratory depression at high systemic concentrations
- Severe overdose may produce cardiovascular instability, including hypotension, bradycardia, arrhythmias, and potential cardiac arrest
- Rapid placental transfer can lead to maternal, fetal, and neonatal CNS and cardiovascular effects during obstetric use, with elevated neonatal levels persisting for up to 48 hours
Lidocaine is a type of Local anesthetics
Local anesthetics are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) commonly used to numb a specific area of the body during medical procedures or surgeries. They work by blocking the transmission of nerve signals, preventing the sensation of pain in the targeted region. Local anesthetics are vital for various medical applications, including dental procedures, minor surgeries, and childbirth.
The main mechanism of action for local anesthetics involves the reversible inhibition of sodium channels, which are responsible for the conduction of nerve impulses. By binding to these channels, local anesthetics prevent the influx of sodium ions, which blocks the generation and propagation of nerve signals. This results in temporary loss of sensation in the area where the medication is administered.
Local anesthetics can be categorized into two main types: esters and amides. Esters, such as procaine and benzocaine, are metabolized by plasma esterases, while amides, including lidocaine and bupivacaine, undergo hepatic metabolism. The choice of local anesthetic depends on factors such as the duration of action required, the specific procedure being performed, and the patient's medical history.
It is important to note that local anesthetics should be administered with caution, as they can have potential side effects, including allergic reactions, systemic toxicity, and nerve damage if used improperly. Therefore, proper dosage and administration techniques must be followed to ensure patient safety.
In summary, local anesthetics are essential pharmaceutical APIs used to temporarily block nerve signals, providing localized pain relief during medical procedures. Understanding the different types and their mechanisms of action allows healthcare professionals to select the most appropriate local anesthetic for each patient and procedure, ensuring optimal outcomes and patient comfort.
Lidocaine API manufacturers & distributors
Compare qualified Lidocaine API suppliers worldwide. We currently have 27 companies offering Lidocaine API, with manufacturing taking place in 11 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 |
|---|---|---|---|---|---|
| Albemarle | Producer | United States | United States | CEP, CoA, FDA, USDMF | 17 products |
| Apex Healthcare | Producer | India | India | CoA, WC | 9 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF | 176 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Cambrex, Karlskoga | Producer | Sweden | Sweden | CEP, CoA, FDA, GMP, USDMF | 8 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Delta Synthetic | Producer | Taiwan | Taiwan | CEP, CoA, FDA, JDMF, USDMF | 2 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Spain | CoA, GMP, ISO9001, MSDS | 170 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Gufic Biosciences | Producer | India | India | CoA, WC | 6 products |
| Harman Finochem | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 34 products |
| Hänseler AG | Distributor | Switzerland | Spain | CoA, GMP | 174 products |
| InventyS Research Company... | Producer | India | India | CoA | 5 products |
| Iwaki Seiyaku | Producer | Japan | Japan | CoA, JDMF | 21 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Mahendra Chemicals | Producer | India | India | CEP, CoA, FDA, USDMF | 1 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, JDMF, USDMF | 50 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| S.I.M.S. | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 18 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS | 157 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Chenghui Shuangd... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, MSDS, WC | 98 products |
| Sichuan Benepure | Producer | China | China | CoA | 23 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 762 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 142 products |
When sending a request, specify which Lidocaine 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 Lidocaine 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 Lidocaine API
Sourcing
What matters most when sourcing GMP-grade Lidocaine?
Key factors include confirming GMP compliance and ensuring the material meets regulatory expectations for use in the US, EU, and Canada. Suppliers should provide complete documentation to support regulatory submissions. Given broad global manufacture and generic availability, assessing supplier consistency, quality systems, and continuity of supply is also important.
Which documents are typically required when sourcing Lidocaine API?
Request the core API documentation set: CoA (27 companies), GMP (19 companies), USDMF (13 companies), MSDS (12 companies), CEP (11 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Lidocaine API?
Known or reported manufacturers for Lidocaine: Duchefa Farma B.V., Caesar & Loretz GmbH (CAELO), Senova Technology Co., Ltd., Xi'an Tian Guangyuan Biotech Co.,Ltd, Changzhou Comwin Fine Chemicals Co., Ltd, Hänseler AG, Shandong Chenghui Shuangda Pharmaceutical Co. Ltd., Pharm Rx Chemical Corp, SETV Global, Sinoway industrial Co.,Ltd, Arshine Pharmaceutical Co., Limited, LGM Pharma, Tenatra Exports Private Limited, Rochem International, Inc., Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Lidocaine 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 Lidocaine manufacturers?
Audit reports may be requested for Lidocaine: 3 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Lidocaine API on Pharmaoffer?
Reported supplier count for Lidocaine: 27 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Lidocaine API?
Production countries reported for Lidocaine: China (8 producers), India (8 producers), Spain (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Lidocaine usually hold?
Common certifications for Lidocaine suppliers: CoA (27 companies), GMP (19 companies), USDMF (13 companies), MSDS (12 companies), CEP (11 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Lidocaine (CAS 137-58-6) used for?
Lidocaine is used as an amide‑type local anesthetic to produce local or regional anesthesia by infiltration, peripheral nerve block, or central neural techniques such as lumbar or caudal epidural administration. It is also applied topically for mucosal procedures and certain dermatologic or anorectal indications. As a class Ib anti‑arrhythmic, it can stabilize cardiac conduction by blocking voltage‑gated sodium channels.
Which therapeutic class does Lidocaine fall into?
Lidocaine belongs to the following therapeutic categories: Agents for Treatment of Hemorrhoids and Anal Fissures for Topical Use, Agents that reduce seizure threshold, Amides, Amines, Analgesics and Anesthetics. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Lidocaine mainly prescribed for?
The primary indications for Lidocaine: Lidocaine is an anesthetic of the amide group indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Lidocaine work?
Lidocaine is a local anesthetic of the amide type . It is used to provide local anesthesia by nerve blockade at various sites in the body . It does so by stabilizing the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action . In particular, the Lidocaine agent acts on sodium ion channels located on the internal surface of nerve cell membranes . At these channels, neutral uncharged Lidocaine molecules diffuse through neural sheaths into the axoplasm where they are subsequently ionized by joining with hydrogen ions . The resultant Lidocaine cations are then capable of reversibly binding the sodium channels from the inside, keeping them locked in an open state that prevents nerve depolarization . As a result, with sufficient blockage, the membrane of the postsynaptic neuron will ultimately not depolarize and will thus fail to transmit an action potential . This facilitates an anesthetic effect by not merely preventing pain signals from propagating to the brain but by aborting their generation in the first place .
In addition to blocking conduction in nerve axons in the peripheral nervous system, Lidocaine has important effects on the central nervous system and cardiovascular system . After absorption, Lidocaine may cause stimulation of the CNS followed by depression and in the cardiovascular system, it acts primarily on the myocardium where it may produce decreases in electrical excitability, conduction rate, and force of contraction .
What should someone know about the safety or toxicity profile of Lidocaine?
Lidocaine toxicity is dose‑dependent and most often reflects excessive systemic absorption or rapid increases in plasma levels. Early signs involve central nervous system excitation that can progress to seizures, followed by CNS and cardiorespiratory depression at higher concentrations. Severe overdose may cause hypotension, bradycardia, arrhythmias, or cardiac arrest, and placental transfer can produce CNS and cardiovascular effects in the fetus or neonate. Risk is heightened in hepatic impairment or when combined with interacting CYP3A substrates or inhibitors.
What are important formulation and handling considerations for Lidocaine as an API?
Important considerations include using appropriate salt forms and pH adjustment to keep Lidocaine in solution, as its moderate lipophilicity limits aqueous solubility. Parenteral and neuraxial preparations require tight control of pH, clarity, and particulate burden, with measures to limit oxidation and adsorption to plastics. Topical and transdermal formulations often need penetration enhancers or optimized vehicles to improve dermal permeation.
Is Lidocaine a small molecule?
Lidocaine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Lidocaine?
Oral formulations would share the general stability considerations described for aqueous Lidocaine solutions, including reliance on salt forms and pH control to maintain solubility and clarity. Attention to oxidation and interactions with packaging materials may also be relevant, as noted for other aqueous preparations.
Regulatory
Where is Lidocaine approved or in use globally?
Lidocaine is reported as approved in the following major regions: Canada, US, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Lidocaine right now?
Lidocaine is an established active ingredient with standard regulatory oversight in Canada, the United States, and the European Union. As a long‑used local anesthetic, it is generally not subject to active patent exclusivities, allowing broad generic availability within these regions.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Lidocaine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Lidocaine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Lidocaine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Lidocaine: 7223 verified transactions across 1461 suppliers and 651 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Lidocaine?
Market report availability for Lidocaine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
