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Pramocaine | CAS No: 140-65-8 | GMP-certified suppliers
A medication that provides temporary topical relief from pain, itching, and discomfort associated with minor skin irritations and anorectal or anogenital conditions.
Therapeutic categories
Primary indications
- It is indicated for temporary relief of pain and pruritus from minor lip and skin irritations as well as for temporary relief from pain, burning, itching and discomfort associated with hemorrhoids and other anorectal/anogenital disorders
Product Snapshot
- Pramocaine is available in multiple formulation types including topical creams, liquids, aerosols, sprays, ointments, suppositories, gels, and kits for auricular, oral, topical, rectal, and vaginal administration
- It is primarily indicated for temporary relief of pain and pruritus associated with minor skin and lip irritations, as well as hemorrhoidal and other anorectal or anogenital conditions
- Pramocaine is approved for use in key regulatory markets including the United States and Canada
Clinical Overview
Pharmacologically, pramocaine operates by reversibly inhibiting voltage-gated sodium channels on peripheral neurons. This inhibition decreases sodium ion permeability across the neuronal membrane, stabilizing it and preventing the ionic shifts necessary for depolarization. Consequently, action potential propagation is blocked, leading to an effective reduction in pain and pruritic sensations at the site of application.
Pramocaine is classified chemically as a phenol ether, characterized by an aromatic benzene ring substituted with an ether group. Its local anesthetic effect is primarily peripheral and limited to the topical site of administration, resulting in minimal systemic absorption under normal use conditions. However, detailed pharmacokinetic data such as absorption rates, metabolism, distribution, and excretion profiles remain limited in the literature.
Safety and toxicity considerations include potential local skin reactions such as irritation or hypersensitivity. Systemic toxicity is rare due to minimal systemic exposure but may increase with use on large skin areas or compromised skin integrity. Pramocaine-containing products should be used according to labeled instructions to avoid adverse effects. Its use in sensitive populations including pregnant or breastfeeding individuals requires careful benefit-risk evaluation.
Pramocaine is included in several categories of topical therapies, including agents for hemorrhoids and anal fissures, local anesthetics, antipruritics, and dermatological agents. Notable commercial products may contain pramocaine in combination with vasoprotective or analgesic agents to address anorectal symptomatology.
For sourcing, pharmaceutical grade pramocaine APIs should comply with established pharmacopeial standards for identity, purity, and potency. Manufacturers and procurement specialists should ensure documentation on batch-to-batch consistency, residual solvents, and impurity profiles. Given its topical application and regulatory approvals, suppliers should provide relevant stability and microbiological data to support formulation development and regulatory submissions.
Identification & chemistry
| Generic name | Pramocaine |
|---|---|
| Molecule type | Small molecule |
| CAS | 140-65-8 |
| UNII | 068X84E056 |
| DrugBank ID | DB09345 |
Pharmacology
| Summary | Pramocaine is a local anesthetic that reversibly inhibits voltage-gated sodium channels on neuronal membranes, reducing sodium ion influx and stabilizing the membrane to block action potential propagation. This mechanism transiently alleviates pain, itching, and discomfort associated with minor skin irritations and anorectal/anogenital conditions. Its primary target is the alpha subunit of voltage-gated sodium channels. |
|---|---|
| Mechanism of action | Pramocaine reversibly binds and inhibits voltage gated sodium channels on neurons decreasing sodium permeability into the cell. This stabilizes the membrane and prevents ionic fluctuations needed for depolarization stopping any action potential propagation. |
| Pharmacodynamics | Pramocaine temporarily relieves pain, pruritis, burning and discomfort associated with minor lip and skin irritations and hemorrhoid's by inhibiting voltage gated sodium channels on neurons. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Voltage-gated sodium channel alpha subunit | Humans | blocker |
ADME / PK
| Absorption | There is minimal absorption after topical administration and it is not given orally. |
|---|
Formulation & handling
- Pramocaine is a small molecule suitable for multiple administration routes including topical, oral, rectal, auricular (otic), and vaginal formulations.
- Due to its low water solubility, formulation strategies should consider solubilizing agents or appropriate vehicles for topical and oral delivery.
- The compound's phenol ether structure suggests standard stability handling conditions, with no special sensitivity to food or high moisture reported.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is approaching patent expiry in the US and Canada, leading to increased availability of generic formulations. As a result, the market is expected to transition towards greater competition and broader access. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for pramocaine includes multiple originator companies producing branded products primarily marketed in the US and Canada. The presence of several branded formulations indicates established market penetration in these regions. Patent expirations have allowed for existing generic competition, facilitating broader availability of pramocaine-based products. |
|---|
Safety
| Toxicity | LD50 Mouse ip 300 mg/kg, LD50 Mouse sc 750 mg/kg |
|---|
- Moderate acute toxicity observed in murine models (LD50 ip 300 mg/kg
- Sc 750 mg/kg)
- Handle with appropriate personal protective equipment to minimize exposure risks
Pramoxine 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.
Pramoxine API manufacturers & distributors
Compare qualified Pramoxine API suppliers worldwide. We currently have 7 companies offering Pramoxine 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 |
|---|---|---|---|---|---|
| Abbvie | Producer | United States | United States | CoA, USDMF | 11 products |
| Albemarle | Producer | United States | United States | CoA, USDMF | 17 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Resonance Labs. | Producer | India | India | CoA, GMP, WHO-GMP | 34 products |
| Shandong Chenghui Shuangd... | Producer | China | China | BSE/TSE, CoA, MSDS | 98 products |
| Sichuan Benepure | Producer | China | China | CoA | 23 products |
| Syn-tech Chem | Producer | Taiwan | Taiwan | CoA, USDMF | 22 products |
When sending a request, specify which Pramoxine 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 Pramoxine 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.
