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Mepivacaine | CAS No: 96-88-8 | GMP-certified suppliers
A medication that supports reliable local and regional analgesia and anesthesia for infiltration, peripheral nerve blocks, and central neuraxial procedures in clinical settings.
Therapeutic categories
AmidesAnestheticsAnesthetics, LocalCentral Nervous System AgentsCentral Nervous System DepressantsDrugs that are Mainly Renally Excreted
Generic name
Mepivacaine
Molecule type
small molecule
CAS number
96-88-8
DrugBank ID
DB00961
Approval status
Approved drug, Vet_approved drug
ATC code
N01BB53
Primary indications
- For production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks
Product Snapshot
- Mepivacaine is an injectable small‑molecule local anesthetic supplied primarily as liquid and solution formulations for parenteral administration
- It is used for local and regional anesthesia applications including infiltration, peripheral nerve block, and central neuraxial techniques
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Mepivacaine (CAS 96-88-8) is an amide‑type local anesthetic used for local or regional analgesia and anesthesia. It is indicated for infiltration techniques, peripheral nerve blocks, and central neuraxial procedures including epidural and caudal administration. It exhibits limited topical effectiveness and is not recommended for routine topical use. Chemically, it is a piperidinecarboxamide structurally related to bupivacaine and pharmacologically aligned with lidocaine.
Mepivacaine produces anesthesia through reversible blockade of voltage‑gated sodium channels in neuronal membranes. This action increases the threshold for electrical excitation, slows impulse propagation, and reduces the rate of rise of the action potential. Clinical block progression typically follows a predictable sequence with loss of pain perception first, followed by temperature, touch, proprioception, and skeletal muscle tone.
Pharmacodynamically, mepivacaine has a reasonably rapid onset and a medium duration of action. Systemic absorption can lead to central nervous system and cardiovascular effects, although therapeutic concentrations usually result in minimal changes in cardiac conduction and contractility. Proprietary formulations have been marketed under names such as Carbocaine and Polocaine.
Absorption is influenced by vascularity of the injection site and dose. Distribution occurs into highly perfused tissues with protein binding typical of amide anesthetics. Metabolism primarily involves hepatic biotransformation, and renal elimination is the major route for metabolites and unchanged drug. Reduced hepatic function may slow clearance, increasing systemic exposure.
Safety considerations include the risk of CNS excitation or depression and cardiovascular depression at elevated plasma levels. As with other amide anesthetics, excessive dosing or rapid intravascular absorption increases the likelihood of systemic toxicity. Mepivacaine is also associated with methemoglobinemia, although this is uncommon.
For API procurement, sourcing should prioritize verified identity, impurity control consistent with pharmacopeial or regulatory specifications, and reliable assessment of residual solvents and particle characteristics to support formulation and manufacturing suitability.
Mepivacaine produces anesthesia through reversible blockade of voltage‑gated sodium channels in neuronal membranes. This action increases the threshold for electrical excitation, slows impulse propagation, and reduces the rate of rise of the action potential. Clinical block progression typically follows a predictable sequence with loss of pain perception first, followed by temperature, touch, proprioception, and skeletal muscle tone.
Pharmacodynamically, mepivacaine has a reasonably rapid onset and a medium duration of action. Systemic absorption can lead to central nervous system and cardiovascular effects, although therapeutic concentrations usually result in minimal changes in cardiac conduction and contractility. Proprietary formulations have been marketed under names such as Carbocaine and Polocaine.
Absorption is influenced by vascularity of the injection site and dose. Distribution occurs into highly perfused tissues with protein binding typical of amide anesthetics. Metabolism primarily involves hepatic biotransformation, and renal elimination is the major route for metabolites and unchanged drug. Reduced hepatic function may slow clearance, increasing systemic exposure.
Safety considerations include the risk of CNS excitation or depression and cardiovascular depression at elevated plasma levels. As with other amide anesthetics, excessive dosing or rapid intravascular absorption increases the likelihood of systemic toxicity. Mepivacaine is also associated with methemoglobinemia, although this is uncommon.
For API procurement, sourcing should prioritize verified identity, impurity control consistent with pharmacopeial or regulatory specifications, and reliable assessment of residual solvents and particle characteristics to support formulation and manufacturing suitability.
Identification & chemistry
| Generic name | Mepivacaine |
|---|---|
| Molecule type | Small molecule |
| CAS | 96-88-8 |
| UNII | B6E06QE59J |
| DrugBank ID | DB00961 |
Pharmacology
| Summary | Mepivacaine is an amide local anesthetic that blocks voltage‑gated sodium channels, increasing the excitation threshold and slowing impulse propagation to prevent nerve signal conduction. Its anesthetic effects follow the typical functional loss pattern for local anesthetics and provide a rapid-onset, medium-duration nerve blockade. Systemic exposure can influence cardiovascular and central nervous system function, though therapeutic concentrations generally produce minimal conduction or contractility changes. |
|---|---|
| Mechanism of action | Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: pain, temperature, touch, proprioception, and skeletal muscle tone. |
| Pharmacodynamics | Mepivicaine is an amide local anesthetic. Mepivicaine as a reasonably rapid onset and medium duration and is known by the proprietary names as Carbocaine and Polocaine. Mepivicaine is used in local infiltration and regional anesthesia. Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous systems. At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium channel protein type 10 subunit alpha | Humans | inhibitor |
ADME / PK
| Absorption | Absorbed locally. The rate of systemic absorption of local anesthetics is dependent upon the total dose and concentration of drug administered, the route of administration, the vascularity of the administration site, and the presence or absence of epinephrine in the anesthetic solution. |
|---|---|
| Half-life | The half-life of mepivacaine in adults is 1.9 to 3.2 hours and in neonates 8.7 to 9 hours. |
| Protein binding | Mepivacaine is approximately 75% bound to plasma proteins. Generally, the lower the plasma concentration of drug, the higher the percentage of drug bound to plasma. |
| Metabolism | Rapidly metabolized, with only a small percentage of the anesthetic (5 percent to 10 percent) being excreted unchanged in the urine. The liver is the principal site of metabolism, with over 50% of the administered dose being excreted into the bile as metabolites. |
| Route of elimination | It is rapidly metabolized, with only a small percentage of the anesthetic (5 percent to 10 percent) being excreted unchanged in the urine.The liver is the principal site of metabolism, with over 50% of the administered dose being excreted into the bile as metabolites. |
Formulation & handling
- Parenteral-only local anesthetic requiring aqueous injectable formulations; moderate lipophilicity and low water solubility may necessitate pH adjustment or co-solvents for solubilization.
- Chemically stable small molecule amide anesthetic; solutions are typically buffered to maintain potency and minimize precipitation during storage.
- Widely used for infiltration, epidural, and dental administration, so formulation must ensure low particulate load and compatibility with common infusion and regional anesthesia delivery materials.
Regulatory status
| Lifecycle | Patent protection in the US and Canada is either expired or nearing expiry, indicating a mature stage of the product’s lifecycle. Market presence in both regions suggests established availability with limited remaining exclusivity. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Mepivacaine is produced by multiple established manufacturers, with originator firms supported by a broad network of secondary suppliers and dental-focused packagers. Branded formulations such as Polocaine and Carbocaine are present mainly in the US and Canada, indicating a mature market with well‑distributed legacy brands. Patent expiry for this long‑established anesthetic has enabled sustained generic availability, reflected in the wide array of manufacturers and packagers active in the supply chain. |
|---|
Safety
| Toxicity | The mean seizure dosage of mepivacaine in rhesus monkeys was found to be 18.8 mg/kg with mean arterial plasma concentration of 24.4 µg/mL. The intravenous and subcutaneous LD 50 in mice is 23 mg/kg to 35 mg/kg and 280 mg/kg respectively. |
|---|
High Level Warnings:
- Seizure threshold observed in primates at ~18
- 8 mg/kg (arterial plasma ~24
- 4 µg/mL) indicates a narrow margin between effective concentrations and CNS toxicity
Mepivacaine 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.
Mepivacaine API manufacturers & distributors
Compare qualified Mepivacaine API suppliers worldwide. We currently have 4 companies offering Mepivacaine API, with manufacturing taking place in 4 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, JDMF, USDMF | 50 products |
| S.I.M.S. | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 18 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, ISO9001, USDMF | 157 products |
When sending a request, specify which Mepivacaine 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 Mepivacaine 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 Mepivacaine API
Sourcing
What matters most when sourcing GMP-grade Mepivacaine?
Key considerations include verifying compliance with Canadian and US GMP and ensuring the supplier can provide complete regulatory documentation. Source material should come from established manufacturers with consistent quality controls, given the mature market and broad generic production base. It is also important to confirm supply chain transparency from primary producers through secondary suppliers and packagers.
Which documents are typically required when sourcing Mepivacaine API?
Request the core API documentation set: CoA (4 companies), USDMF (3 companies), GMP (3 companies), CEP (2 companies), EDMF/ASMF (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Mepivacaine API?
Known or reported manufacturers for Mepivacaine: Senova Technology Co., Ltd., Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Mepivacaine 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 Mepivacaine manufacturers?
Audit reports may be requested for Mepivacaine: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Mepivacaine API on Pharmaoffer?
Reported supplier count for Mepivacaine: 4 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Mepivacaine API?
Production countries reported for Mepivacaine: China (1 producer), India (1 producer), Spain (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Mepivacaine usually hold?
Common certifications for Mepivacaine suppliers: CoA (4 companies), USDMF (3 companies), GMP (3 companies), CEP (2 companies), EDMF/ASMF (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Mepivacaine (CAS 96-88-8) used for?
Mepivacaine is an amide local anesthetic used to produce local or regional analgesia and anesthesia. It is administered for infiltration anesthesia, peripheral nerve blocks, and central neuraxial techniques such as epidural or caudal procedures. It has limited topical activity and is not recommended for routine topical use.
Which therapeutic class does Mepivacaine fall into?
Mepivacaine belongs to the following therapeutic categories: Amides, Anesthetics, Anesthetics, Local, Central Nervous System Agents, Central Nervous System Depressants. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Mepivacaine mainly prescribed for?
The primary indications for Mepivacaine: For production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Mepivacaine work?
Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: pain, temperature, touch, proprioception, and skeletal muscle tone.
What should someone know about the safety or toxicity profile of Mepivacaine?
Mepivacaine has a narrow safety margin, with primate data showing CNS toxicity, including seizure activity, at arterial plasma concentrations around 24 µg/mL. Systemic absorption from high doses or inadvertent intravascular injection can lead to CNS excitation or depression and, at higher levels, cardiovascular depression. Methemoglobinemia can occur but is uncommon. Reduced hepatic function may increase systemic exposure by slowing clearance.
What are important formulation and handling considerations for Mepivacaine as an API?
Important considerations include using aqueous injectable formulations with appropriate pH adjustment or co‑solvents to address its moderate lipophilicity and low water solubility. Solutions are typically buffered to maintain chemical stability and prevent precipitation during storage. Parenteral preparations should have low particulate levels and be compatible with materials used for infiltration, epidural, and dental administration. Proper handling focuses on maintaining solution clarity and avoiding conditions that could alter pH or stability.
Is Mepivacaine a small molecule?
Mepivacaine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Mepivacaine?
Mepivacaine is formulated exclusively for parenteral administration, so oral stability considerations do not apply. Its stability concerns relate to maintaining a buffered aqueous injectable solution that prevents precipitation and preserves potency. pH control and appropriate solubilization are important due to its moderate lipophilicity and low water solubility.
Regulatory
Where is Mepivacaine approved or in use globally?
Mepivacaine is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Mepivacaine right now?
Mepivacaine is regulated for use in Canada and the United States, where it is subject to each country’s standard requirements for active pharmaceutical ingredients. The context does not provide specific regulatory classifications or details. No patent information is supplied, so no current patent status can be described.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Mepivacaine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Mepivacaine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Mepivacaine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Mepivacaine: 74 verified transactions across 18 suppliers and 15 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Mepivacaine?
Market report availability for Mepivacaine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
