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Benoxil (Oxybuprocaine) API Manufacturers & Suppliers

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Commercial-scale Suppliers

Distributor
Produced in  China
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Employees: 50+

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

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

All certificates

JDMF
CoA
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Oxybuprocaine | CAS No: 99-43-4 | GMP-certified suppliers

A medication that provides temporary topical anesthesia of the eye, facilitating diagnostic procedures and foreign body removal with minimal systemic absorption and rapid onset.

Therapeutic categories

Acids, CarbocyclicAminobenzoatesAnestheticsAnesthetics for Topical UseAnesthetics, LocalAntipruritics, Incl. Antihistamines, Anesthetics, Etc.
Generic name
Oxybuprocaine
Molecule type
small molecule
CAS number
99-43-4
DrugBank ID
DB00892
Approval status
Approved drug, Investigational drug
ATC code
S01HA02

Primary indications

  • Used to temporarily numb the front surface of the eye so that the eye pressure can be measured or a foreign body removed

Product Snapshot

  • Oxybuprocaine is available primarily as ophthalmic solutions and drops for topical application, with some tablet and liquid formulations
  • It is used mainly for ocular anesthesia to facilitate diagnostic procedures or foreign body removal
  • The product is approved for use in the US and Canada and also has investigational status

Clinical Overview

Oxybuprocaine, also known as Benoxinate, is a local anesthetic primarily utilized in ophthalmology and otolaryngology. It is principally indicated for the temporary topical anesthesia of the ocular surface, facilitating diagnostic procedures such as tonometry and the removal of foreign bodies from the eye. Its use is limited to short-term applications due to its pharmacologic profile.

Pharmacologically, oxybuprocaine belongs to the class of benzoic acid esters. It exerts its anesthetic effect through reversible binding to voltage-gated sodium channels in neuronal membranes. This interaction stabilizes the membrane and decreases its permeability to sodium ions, thereby inhibiting depolarization and blocking the initiation and propagation of nerve impulses. The resultant effect is a reversible interruption of sensory nerve conduction in the treated area.

Clinical onset and duration of action for oxybuprocaine are comparable to those of tetracaine, with potentially less irritation upon administration. The compound is administered topically and acts locally with minimal systemic absorption. However, due to limited systemic exposure in typical ophthalmic use, detailed ADME (Absorption, Distribution, Metabolism, Excretion) profiles are not extensively characterized in literature. Nevertheless, systemic toxicity risk is low with recommended dosing, though hypersensitivity reactions or local toxicity may occur with repeated or excessive use.

Safety considerations include avoidance of prolonged or repeated dosing, which may lead to corneal epithelial toxicity. Appropriate formulation, sterility, and concentration control are important in minimizing adverse reactions. Oxybuprocaine is available in various ophthalmic preparations under multiple brands globally, often as sterile solutions.

From an API sourcing and quality perspective, oxybuprocaine must meet stringent purity criteria due to its local application in sensitive tissues. Ensuring compliance with pharmacopeial standards and regulatory requirements for residual solvents, impurities, and microbial limits is critical. Reliable suppliers should provide detailed certificates of analysis and evidence of Good Manufacturing Practice (GMP) compliance to support regulatory submissions and maintain product safety and efficacy.

Identification & chemistry

Generic name Oxybuprocaine
Molecule type Small molecule
CAS 99-43-4
UNII AXQ0JYM303
DrugBank ID DB00892

Pharmacology

SummaryOxybuprocaine is a local anesthetic that targets voltage-gated sodium channels, specifically the sodium channel protein type 10 subunit alpha. It reversibly stabilizes neuronal membranes by inhibiting sodium ion permeability, which blocks nerve impulse initiation and conduction. This leads to temporary numbness of the ocular surface for diagnostic or minor procedural use.
Mechanism of actionOxybuprocaine binds to sodium channel and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited thereby blocking the initiation and conduction of nerve impulses.
PharmacodynamicsOxybuprocaine is a local anaesthetic. It may be less irritating than tetracaine, and the onset and duration of action are similar to tetracaine.
Targets
TargetOrganismActions
Sodium channel protein type 10 subunit alphaHumansinhibitor

Formulation & handling

  • Oxybuprocaine is a small molecule local anesthetic suitable for oral, buccal, topical, and ophthalmic formulations.
  • Due to moderate water solubility and LogP of 3.05, consideration of solubilization and stability in aqueous ophthalmic solutions is necessary.
  • Handling should ensure protection from hydrolysis and maintain sterility in ophthalmic and topical liquid dosage forms.

Regulatory status

LifecycleThe active pharmaceutical ingredient is currently protected by patents in the United States until November 15, 2037. It is marketed in the US and Canada, with market maturity expected to progress as patent protection remains in place.
MarketsUS, Canada
Supply Chain
Supply chain summaryOxybuprocaine is supplied by a limited number of originator manufacturers with packaging handled by a separate company, serving primarily the US and Canadian markets. Branded products are established within these regions, but all key US patents extend until 2037, indicating that generic competition is not currently present and is unlikely to emerge in the near term.

Oxybuprocaine 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.

Oxybuprocaine API manufacturers & distributors

Compare qualified Oxybuprocaine API suppliers worldwide. We currently have 2 companies offering Oxybuprocaine API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
Japan Japan CoA, JDMF7 products
Distributor
China China CoA, ISO9001, MSDS762 products

When sending a request, specify which Oxybuprocaine 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 Oxybuprocaine 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.