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Distributor
Produced in
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Employees: 275+
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MSDS|
BSE/TSE|
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MSDS
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CoA
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Produced in
China|
Employees: 50+
|
Audit Report:
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GMP
|
FDA|
CEP|
USDMF|
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FDA
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USDMF
MSDS
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CoA
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India|
Employees: 200+
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Audit Report:
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CoAAll certificates
GMP
MSDS
BSE/TSE
CoA
Distributor
Produced in
Czech Republic|
Employees: 50+
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Audit Report:
Certifications:
GMP
|
MSDS|
ISO9001|
CoAAll certificates
GMP
MSDS
ISO9001
CoA
Producer
Produced in
China|
Audit Report:
Certifications:
WC
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CoAAll certificates
WC
CoA
Producer
Produced in
Ireland|
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JDMF|
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Procaine | CAS No: 59-46-1 | GMP-certified suppliers
A medication that provides reliable local anesthesia for dental and oral surgical procedures, supporting effective short‑acting sensory blockade across key North American markets.
Therapeutic categories
Acids, CarbocyclicAgents for Treatment of Hemorrhoids and Anal Fissures for Topical UseAgents that reduce seizure thresholdAminobenzoatesAnestheticsAnesthetics, Local
Generic name
Procaine
Molecule type
small molecule
CAS number
59-46-1
DrugBank ID
DB00721
Approval status
Approved drug, Investigational drug, Vet_approved drug
ATC code
N01BA52
Primary indications
- Used as a local anesthetic primarily in oral surgery
Product Snapshot
- Procaine is supplied mainly as an injectable local anesthetic with additional topical and otic formulations
- It is used for local anesthesia in dental and minor surgical procedures
- It is approved in the US and Canada, with human, investigational, and veterinary authorization statuses
Clinical Overview
Procaine (CAS 59-46-1) is an ester‑type local anesthetic primarily indicated for infiltration anesthesia, peripheral nerve block, and spinal block, with extensive use in dental and oral surgical procedures. Its clinical role reflects a relatively slow onset and short duration of action compared with amide anesthetics. Historically marketed under names such as Novocain, it remains in use where rapid metabolism and limited systemic accumulation are desired.
Pharmacologically, procaine belongs to the benzoic acid ester class. It produces localized loss of sensation by blocking voltage‑gated sodium channels in peripheral nerves. By inhibiting sodium influx at the cytoplasmic portion of the channel, it prevents the initiation and propagation of action potentials. Procaine has also demonstrated binding or antagonistic activity at NMDA receptors, nicotinic acetylcholine receptors, and certain serotonin‑linked ion channel complexes, although the clinical significance of these interactions is limited under standard local anesthetic dosing.
Procaine displays limited systemic persistence due to ester hydrolysis by plasma pseudocholinesterase, forming para‑aminobenzoic acid (PABA). Metabolites are eliminated renally. This rapid metabolism contributes to its short duration of action and underlies interpatient variability in effect when pseudocholinesterase activity is reduced.
Safety considerations include the potential for hypersensitivity reactions, often attributed to PABA formation. Systemic toxicity, while uncommon at therapeutic doses, may involve central nervous system excitation followed by depression, cardiovascular effects, and rare methemoglobinemia. Because procaine can constrict blood vessels, local ischemic reactions may occur in susceptible patients. Ester anesthetics also present cross‑reactivity risks within the class.
Although primarily used as a local anesthetic, procaine has been investigated as an oral entry inhibitor in treatment‑experienced HIV populations, but its role remains investigational.
For API procurement, suppliers should provide robust characterization of ester purity, residual solvent levels, and control of degradation related to hydrolysis. Verification of compliance with pharmacopeial specifications and assessment of stability under storage and transport conditions are important for maintaining product quality.
Pharmacologically, procaine belongs to the benzoic acid ester class. It produces localized loss of sensation by blocking voltage‑gated sodium channels in peripheral nerves. By inhibiting sodium influx at the cytoplasmic portion of the channel, it prevents the initiation and propagation of action potentials. Procaine has also demonstrated binding or antagonistic activity at NMDA receptors, nicotinic acetylcholine receptors, and certain serotonin‑linked ion channel complexes, although the clinical significance of these interactions is limited under standard local anesthetic dosing.
Procaine displays limited systemic persistence due to ester hydrolysis by plasma pseudocholinesterase, forming para‑aminobenzoic acid (PABA). Metabolites are eliminated renally. This rapid metabolism contributes to its short duration of action and underlies interpatient variability in effect when pseudocholinesterase activity is reduced.
Safety considerations include the potential for hypersensitivity reactions, often attributed to PABA formation. Systemic toxicity, while uncommon at therapeutic doses, may involve central nervous system excitation followed by depression, cardiovascular effects, and rare methemoglobinemia. Because procaine can constrict blood vessels, local ischemic reactions may occur in susceptible patients. Ester anesthetics also present cross‑reactivity risks within the class.
Although primarily used as a local anesthetic, procaine has been investigated as an oral entry inhibitor in treatment‑experienced HIV populations, but its role remains investigational.
For API procurement, suppliers should provide robust characterization of ester purity, residual solvent levels, and control of degradation related to hydrolysis. Verification of compliance with pharmacopeial specifications and assessment of stability under storage and transport conditions are important for maintaining product quality.
Identification & chemistry
| Generic name | Procaine |
|---|---|
| Molecule type | Small molecule |
| CAS | 59-46-1 |
| UNII | 4Z8Y51M438 |
| DrugBank ID | DB00721 |
Pharmacology
| Summary | Procaine produces local anesthesia by blocking voltage‑gated sodium channels on peripheral neurons, preventing action‑potential initiation and signal conduction. It also interacts with NMDA receptors, nicotinic acetylcholine receptors, and 5‑HT3 ion channels, contributing to broader modulation of neuronal excitability. As an ester anesthetic, it is rapidly hydrolyzed by plasma pseudocholinesterase to PABA, supporting its use in localized procedures such as oral surgery. |
|---|---|
| Mechanism of action | Procaine acts mainly by inhibiting sodium influx through voltage gated sodium channels in the neuronal cell membrane of peripheral nerves. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is thus inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Procaine has also been shown to bind or antagonize the function of N-methyl-D-aspartate (NMDA) receptors as well as nicotinic acetylcholine receptors and the serotonin receptor-ion channel complex. |
| Pharmacodynamics | Procaine is an anesthetic agent indicated for production of local or regional anesthesia, particularly for oral surgery. Procaine (like cocaine) has the advantage of constricting blood vessels which reduces bleeding, unlike other local anesthetics like lidocaine. Procaine is an ester anesthetic. It is metabolized in the plasma by the enzyme pseudocholinesterase through hydrolysis into para-aminobenzoic acid (PABA), which is then excreted by the kidneys into the urine. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium channel protein type 10 subunit alpha | Humans | inhibitor |
| Glutamate receptor ionotropic, NMDA 3A | Humans | antagonist |
| 5-hydroxytryptamine receptor 3A | Humans | antagonist |
ADME / PK
| Half-life | 7.7 minutes |
|---|---|
| Metabolism | Hydrolysis by plasma esterases to PABA |
| Route of elimination | With normal kidney function, the drug is excreted rapidly by tubular excretion. |
Formulation & handling
- Procaine is a small‑molecule local anesthetic formulated mainly as aqueous parenteral solutions, leveraging its moderate water solubility for injectable, dental, and infiltration uses.
- Ester linkage is prone to hydrolysis, so solutions require pH‑controlled, low‑temperature handling and protection from prolonged storage in aqueous media.
- Solid API is stable under normal conditions but should be protected from moisture to limit ester degradation prior to solution preparation.
Regulatory status
| Lifecycle | Patents for the API have expired, and products are established in the US and Canadian markets, indicating a mature stage in the lifecycle. Market activity is now driven primarily by generic competition and routine utilization. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Procaine was originally introduced by a small number of legacy originator firms, but its long‑established use and early patent expiry mean the market is now supplied by numerous manufacturers and packagers. Branded products such as Novocain historically circulated mainly in the US and Canada, but current availability is dominated by multisource generic formulations. The expired intellectual property indicates mature and ongoing generic competition. |
|---|
Procaine 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.
Procaine API manufacturers & distributors
Compare qualified Procaine API suppliers worldwide. We currently have 6 companies offering Procaine 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | China | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Czech Republic | CoA, GMP, ISO9001, MSDS | 170 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Jiangxi Dongfeng | Producer | China | China | CoA, WC | 3 products |
| Norbrook Labs | Producer | Ireland | Ireland | CoA, JDMF, USDMF | 6 products |
When sending a request, specify which Procaine 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 Procaine 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 Procaine API
Sourcing
What matters most when sourcing GMP-grade Procaine?
When sourcing GMP‑grade Procaine, the key considerations are verified compliance with GMP standards and alignment with US and Canadian regulatory requirements. Because the ingredient is supplied by many generic manufacturers, confirmation of consistent quality controls and complete documentation is essential. Traceability through the supply chain and reliable packaging practices also matter in a mature multisource market.
Which documents are typically required when sourcing Procaine API?
Request the core API documentation set: CoA (7 companies), MSDS (5 companies), GMP (4 companies), ISO9001 (4 companies), BSE/TSE (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Procaine API?
Known or reported manufacturers for Procaine: Duchefa Farma B.V., Caesar & Loretz GmbH (CAELO), Xi'an Tian Guangyuan Biotech Co.,Ltd, Aurora Industry Co., Ltd, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Procaine 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 Procaine manufacturers?
Audit reports may be requested for Procaine: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Procaine API on Pharmaoffer?
Reported supplier count for Procaine: 7 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Procaine API?
Production countries reported for Procaine: China (4 producers), Czech Republic (1 producer), India (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Procaine usually hold?
Common certifications for Procaine suppliers: CoA (7 companies), MSDS (5 companies), GMP (4 companies), ISO9001 (4 companies), BSE/TSE (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Procaine (CAS 59-46-1) used for?
Procaine is used as an ester‑type local anesthetic for infiltration anesthesia, peripheral nerve blocks, and spinal anesthesia. It is commonly applied in dental and oral surgical procedures where a short duration of action and rapid metabolism are acceptable. Its effect is achieved by blocking voltage‑gated sodium channels to produce localized loss of sensation.
Which therapeutic class does Procaine fall into?
Procaine belongs to the following therapeutic categories: Acids, Carbocyclic, Agents for Treatment of Hemorrhoids and Anal Fissures for Topical Use, Agents that reduce seizure threshold, Aminobenzoates, Anesthetics. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Procaine mainly prescribed for?
The primary indications for Procaine: Used as a local anesthetic primarily in oral surgery. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Procaine work?
Procaine acts mainly by inhibiting sodium influx through voltage gated sodium channels in the neuronal cell membrane of peripheral nerves. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is thus inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Procaine has also been shown to bind or antagonize the function of N-methyl-D-aspartate (NMDA) receptors as well as nicotinic acetylcholine receptors and the serotonin receptor-ion channel complex.
What should someone know about the safety or toxicity profile of Procaine?
Procaine’s safety profile is defined by its rapid hydrolysis to para‑aminobenzoic acid, which can trigger hypersensitivity reactions and cross‑reactivity with other ester anesthetics. Systemic toxicity is uncommon but may include central nervous system excitation followed by depression, cardiovascular effects, and rare methemoglobinemia if significant systemic absorption occurs. Reduced pseudocholinesterase activity can increase exposure and variability in response. Local vasoconstriction may contribute to ischemic reactions in susceptible individuals.
What are important formulation and handling considerations for Procaine as an API?
Procaine is typically formulated as aqueous parenteral solutions, with its ester linkage requiring pH‑controlled conditions and low‑temperature handling to limit hydrolysis. Prepared solutions should be protected from prolonged storage in water to maintain stability. The solid API is stable under normal conditions but should be kept dry to reduce moisture‑driven degradation before solution preparation. Rapid metabolic hydrolysis underscores the need for appropriate dosing and timely use once formulated.
Is Procaine a small molecule?
Procaine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Procaine?
Yes. Procaine’s ester linkage is prone to hydrolysis, so exposure to moisture, acidic or alkaline conditions, or prolonged time in aqueous media can accelerate degradation. The solid API remains stable under normal conditions but should be protected from moisture before formulation. Any oral preparation would need to control moisture and pH to limit ester breakdown.
Regulatory
Where is Procaine approved or in use globally?
Procaine 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 Procaine right now?
Procaine is regulated for use in the US and Canada, indicating established oversight in both markets. No patent protections are indicated in the provided context, suggesting no active proprietary restrictions are noted here.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Procaine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Procaine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Procaine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Procaine: 1070 verified transactions across 260 suppliers and 291 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Procaine?
Market report availability for Procaine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
