Global API sourcing simplified
We connect API buyers and suppliers worldwide with speed, trust, and full transparency.

Filters

Filters
Filter
Custom request?
Type
Production region
Qualifications
Show more
Country of origin
Show more

Articaine API Manufacturers & Suppliers

10 verified results
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.

Commercial-scale Suppliers

Producer
Produced in  India
|

Employees: 200+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
MSDS
|
BSE/TSE
|
CoA

All certificates

GMP
MSDS
BSE/TSE
CoA
Producer
Produced in  China
|

Employees: 1000+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: MSDS
|
BSE/TSE
|
CoA

All certificates

MSDS
BSE/TSE
CoA
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Producer
Produced in  China
|

Employees: 25+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
ISO9001
|
CoA

All certificates

USDMF
ISO9001
CoA
Distributor
Produced in  Belgium
|

Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
MSDS
|
ISO9001
|
CoA

All certificates

GMP
MSDS
ISO9001
CoA
Producer
Produced in  Taiwan
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
Producer
Produced in  Italy
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
FDA
|
CEP
|
coa

All certificates

GMP
FDA
CEP
coa
Get full market intelligence report
Get full market intelligence report
€399,-
All Articaine data. Full access. Full negotiation power
Producer
Produced in  France
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
|
CEP
|
USDMF
|
coa

All certificates

GMP
FDA
CEP
USDMF
coa
Producer
Produced in  Unknown
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
FDA
|
CEP
|
USDMF
|
coa

All certificates

GMP
FDA
CEP
USDMF
coa
Get full market intelligence report
Get full market intelligence report
€399,-
All Articaine data. Full access. Full negotiation power
Producer
Produced in  Unknown
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
CEP
|
CoA

All certificates

GMP
CEP
CoA
Not active
Producer
Produced in  Spain
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CEP
|
USDMF
|
EDMF/ASMF
|
CoA

All certificates

GMP
CEP
USDMF
EDMF/ASMF
CoA
Not active
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency Total market transparency
|
Supplier trade data access Supplier trade data access
|
Buyer / supplier flow comparison Buyer / supplier flow comparison
Trusted by 30,000+ registered pharma professionals:
Reach multinationals, SMEs, compounding pharmacies & more!
Procaps
Pfizer
Reckitt
Sanofi
Blau
Abbvie

Articaine | CAS No: 23964-58-1 | GMP-certified suppliers

A medication that provides reliable local anesthesia for routine and complex dental procedures, supporting effective pain control for dental care in major markets.

Therapeutic categories

AmidesAnestheticsAnesthetics, LocalCentral Nervous System AgentsCentral Nervous System DepressantsHyperglycemia-Associated Agents
Generic name
Articaine
Molecule type
small molecule
CAS number
23964-58-1
DrugBank ID
DB09009
Approval status
Approved drug
ATC code
N01BB58

Product Snapshot

  • Articaine is supplied primarily as an injectable solution for dental and infiltration anesthesia applications
  • It is used for local anesthesia in dental procedures and related perineural or submucosal administration needs
  • It holds approved status in the US and Canada

Clinical Overview

Articaine (CAS 23964-58-1) is an amide-type local anesthetic used primarily for dental anesthesia. It is widely adopted in clinical dental practice and is the predominant local anesthetic agent in several European markets. Structurally, it is classified among thiophene carboxylic acid derivatives, incorporating a thiophene ring that contributes to its physicochemical profile.

The clinical use of articaine centers on achieving local infiltration or nerve block anesthesia for dental procedures. Its onset is rapid, and it provides a depth of anesthesia suitable for routine and complex dental interventions. As with other amide local anesthetics, its primary pharmacological action is the reversible inhibition of voltage-gated sodium channels in peripheral sensory nerves, preventing impulse conduction and producing localized loss of sensation.

Articaine exhibits high lipid solubility, supporting effective tissue penetration. After systemic absorption, it undergoes rapid hydrolysis by plasma esterases due to its unique ester side chain, leading to comparatively faster systemic clearance than many other amide anesthetics. Hepatic metabolism contributes to further biotransformation, and renal excretion accounts for elimination of metabolites.

Safety considerations include dose-dependent central nervous system and cardiovascular effects typical of local anesthetics, such as CNS excitation or depression and potential hemodynamic changes when systemic levels become elevated. Rare events such as methemoglobinemia have been reported. Articaine is commonly formulated with epinephrine to limit systemic absorption and prolong local effect, and commercially it is available under names such as Septocaine and Ubistesin.

For API procurement, sourcing should focus on suppliers with demonstrated control of stereochemistry, impurity profiles, and residual solvent levels, supported by comprehensive regulatory documentation and adherence to internationally recognized GMP standards.

Identification & chemistry

Generic name Articaine
Molecule type Small molecule
CAS 23964-58-1
UNII D3SQ406G9X
DrugBank ID DB09009

Formulation & handling

  • Articaine is formulated primarily as aqueous injectable solutions for dental, submucosal, and infiltration routes, with attention to its modest intrinsic water solubility.
  • As a small-molecule local anesthetic containing a thiophene ring, it is typically used as a hydrochloride salt to improve solubility and ensure rapid dissolution in parenteral formulations.
  • Solutions require protection from prolonged heat and light to maintain stability and prevent degradation of the ester-containing structure.

Regulatory status

LifecycleWith patent protection expired or nearing expiry in the US and Canada, the API is in a mature stage of its lifecycle. Market participation in both countries reflects an established, post‑exclusivity environment with expected generic competition.
MarketsCanada, US
Supply Chain
Supply chain summaryArticaine was originally developed by a small number of originator firms, and its long-established use has led to wide availability of branded and non‑branded formulations. Branded products are marketed in North America and are also distributed in other regions through various dental anesthetic lines. The compound’s historical patent expiry means generic competition is already well established in global supply channels.

Certificate of Analysis

A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
 

Articaine 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.

Articaine API manufacturers & distributors

Compare qualified Articaine API suppliers worldwide. We currently have 10 companies offering Articaine API, with manufacturing taking place in 8 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Distributor
Netherlands Belgium CoA, GMP, ISO9001, MSDS170 products
Producer
India India BSE/TSE, CoA, GMP, MSDS166 products
Producer
Spain Spain CEP, CoA, EDMF/ASMF, GMP, USDMF50 products
Producer
France France CEP, CoA, FDA, GMP, USDMF9 products
Producer
France Unknown CEP, CoA, FDA, GMP, USDMF29 products
Producer
Italy Italy CEP, CoA, FDA, GMP18 products
Producer
France Unknown CEP, CoA, GMP93 products
Producer
China China CoA, ISO9001, USDMF157 products
Producer
China China BSE/TSE, CoA, MSDS98 products
Producer
Taiwan Taiwan CoA22 products

When sending a request, specify which Articaine 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 Articaine 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 Articaine API


Sourcing

What matters most when sourcing GMP-grade Articaine?
Key factors include confirming the manufacturer meets applicable GMP standards and regulatory expectations in Canada and the US. It is also important to verify licensing status and documentation supporting quality, consistency, and traceability. Given the mature market with multiple generic sources, assessing supplier reliability and supply chain stability is essential.
Which documents are typically required when sourcing Articaine API?
Request the core API documentation set: CoA (10 companies), GMP (7 companies), CEP (5 companies), USDMF (4 companies), MSDS (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Articaine API?
Known or reported manufacturers for Articaine: Duchefa Farma B.V., Senova Technology Co., Ltd., Shandong Chenghui Shuangda Pharmaceutical Co. Ltd., Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Articaine 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 Articaine manufacturers?
Audit reports may be requested for Articaine: 3 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Articaine API on Pharmaoffer?
Reported supplier count for Articaine: 10 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Articaine API?
Production countries reported for Articaine: China (2 producers), Belgium (1 producer), India (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Articaine usually hold?
Common certifications for Articaine suppliers: CoA (10 companies), GMP (7 companies), CEP (5 companies), USDMF (4 companies), MSDS (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Articaine (CAS 23964-58-1) used for?
Articaine is used to produce local anesthesia for dental procedures through infiltration or nerve‑block techniques. It provides rapid onset and sufficient depth of anesthesia for routine and complex dental interventions by reversibly blocking voltage‑gated sodium channels in peripheral nerves.
Which therapeutic class does Articaine fall into?
Articaine 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 should someone know about the safety or toxicity profile of Articaine?
Articaine has dose‑dependent central nervous system and cardiovascular risks consistent with other amide local anesthetics, including possible CNS excitation, depression, and hemodynamic changes when systemic concentrations rise. Rare cases of methemoglobinemia have been reported. Its rapid hydrolysis by plasma esterases helps limit systemic exposure, and epinephrine-containing formulations further reduce absorption. Proper control of impurities and stereochemistry during API manufacture supports consistent safety performance.
What are important formulation and handling considerations for Articaine as an API?
Articaine is typically used as the hydrochloride salt to enhance its modest water solubility and allow rapid dissolution in aqueous injectable solutions. Formulations are designed for dental, submucosal, or infiltration use, with attention to maintaining solution clarity and stability. Because the molecule contains an ester group susceptible to degradation, solutions should be protected from prolonged heat and light during storage and handling.
Is Articaine a small molecule?
Articaine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Articaine?
Articaine’s ester-containing structure is sensitive to heat and light, and it can degrade in aqueous environments. These same stability considerations would apply to any oral aqueous presentation, requiring protection from prolonged heat and light exposure.

Regulatory

Where is Articaine approved or in use globally?
Articaine 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 Articaine right now?
Articaine is regulated for use in both Canada and the United States. Its regulatory status in these markets supports availability of approved formulations for clinical use. Patent considerations for Articaine are jurisdiction‑specific and generally relate to any proprietary formulations or manufacturing processes rather than the long‑established active ingredient itself.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Articaine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Articaine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Articaine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Articaine: 390 verified transactions across 66 suppliers and 42 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Articaine?
Market report availability for Articaine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.