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Mafenide | CAS No: 138-39-6 | GMP-certified suppliers
A medication that serves as a topical antimicrobial agent to control bacterial infection and support healing of severe burn wounds treated with meshed autografts.
Therapeutic categories
Primary indications
- Indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds
Product Snapshot
- Mafenide is available as a topical cream and powder for solution, formulated for antimicrobial use in wound care
- It is primarily indicated as an adjunctive agent to control bacterial infection in burn wound management under moist dressings
- The product holds approvals in the US and Canada, with both human and veterinary regulatory status, though some formulations have been withdrawn
Clinical Overview
Clinically, mafenide is utilized to reduce microbial colonization in avascular burn tissue and to support the healing process of deep burns. Although its exact mechanism of action remains undefined, mafenide is known to decrease the bacterial burden within the affected tissues, contributing to improved wound healing outcomes.
Pharmacokinetic details such as absorption, distribution, metabolism, and excretion are limited; however, mafenide and its metabolites are primarily renally excreted. This suggests the potential for systemic exposure and the need for caution in patients with impaired renal function. Mafenide is classified as a folic acid antagonist and enzyme inhibitor, consistent with its sulfonamide antibacterial activity, which may contribute to its antimicrobial effects.
Safety and toxicity considerations include potential hypersensitivity reactions common to sulfonamide compounds. Notably, mafenide has been associated with the risk of methemoglobinemia, a condition involving elevated levels of methemoglobin in the blood, warranting monitoring during treatment. In November 2022, the U.S. FDA withdrew approval for mafenide acetate in the form of a 5% topical solution due to the absence of a confirmatory study following its initial accelerated approval in 1998.
From a sourcing and quality perspective, procurement of mafenide API requires adherence to stringent regulatory guidelines reflecting its withdrawn status for certain formulations. Suppliers must demonstrate compliance with current good manufacturing practices (cGMP) and provide comprehensive documentation to support purity, identity, and quality attributes essential for topical burn treatment applications.
Identification & chemistry
| Generic name | Mafenide |
|---|---|
| Molecule type | Small molecule |
| CAS | 138-39-6 |
| UNII | 58447S8P4L |
| DrugBank ID | DB06795 |
Pharmacology
| Summary | Mafenide acts as a topical antimicrobial agent primarily targeting bacterial populations in avascular burn tissue. It inhibits carbonic anhydrase 6, which may contribute to its antimicrobial effects. The drug is used adjunctively to control infection and support healing in deep burn wounds treated with meshed autografts. |
|---|---|
| Mechanism of action | The precise mechanism of mafenide is unknown. However, mafenide reduces the bacterial population in the avascular burn tissue and promotes spontaneous heeling of deep burns. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Carbonic anhydrase 6 | Humans | antagonist |
ADME / PK
| Absorption | Mafenide is absorbed through devascularized areas into the systemic circulation following topical administration. |
|---|---|
| Metabolism | Metabolized to a carbonic anhydrase inhibitor. |
| Route of elimination | Renal—Metabolite rapidly excreted in urine in high concentrations; however, the parent compound has not been detected in urine. |
Formulation & handling
- Mafenide is a small molecule sulfonamide primarily formulated for topical administration as a cream or solution.
- Due to its water solubility and acidic sulfonamide group, formulations should consider pH stability and potential skin irritation.
- Not intended for injectable or oral use; handling requires precautions to avoid contamination and maintain potency during topical application.
Regulatory status
| Lifecycle | The API is currently marketed in the US and Canada with patent protection recently expired, leading to increased availability of generic versions and a mature market landscape. Ongoing competition is expected to influence pricing and product differentiation. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Mafenide includes several originator companies producing branded products primarily in the US and Canadian markets. Branded formulations such as Mafenide acetate and Sulfamylon have established presence in these regions, with no significant activity noted in the EU or other markets. Patent expirations indicate opportunities for existing generic competition, supporting a competitive supply environment. |
|---|
Safety
| Toxicity | Since mafenide is metabolized to a carbonic anhydrase inhibitor, metabolic acidosis could occur. |
|---|
- Mafenide metabolism may lead to systemic carbonic anhydrase inhibition, posing a risk of metabolic acidosis
- Use under controlled conditions to prevent accumulation and systemic exposure
- Handle with appropriate protective equipment to avoid dermal absorption and inhalation
Mafenide is a type of Sulfonamides and trimethoprim
Sulfonamides and trimethoprim are essential pharmaceutical active ingredients (APIs) widely used in the production of antibiotics. Sulfonamides belong to a class of synthetic antimicrobial agents that inhibit the growth of bacteria by interfering with their folic acid synthesis. These drugs are highly effective against various bacterial infections, including urinary tract infections, respiratory tract infections, and certain skin infections.
Trimethoprim, on the other hand, is a synthetic antibacterial agent that belongs to the diaminopyrimidine class. It works by inhibiting the enzyme dihydrofolate reductase, which is crucial for the synthesis of DNA and RNA in bacteria. By targeting this enzyme, trimethoprim effectively prevents bacterial replication, making it a valuable component in combination therapies for bacterial infections.
The combination of sulfonamides and trimethoprim is particularly potent, as it provides a synergistic effect against a broad spectrum of bacteria. This combination therapy is commonly used to treat urinary tract infections caused by susceptible strains of bacteria, such as Escherichia coli. The two APIs work together to disrupt multiple steps in the bacterial metabolic pathway, enhancing their overall antibacterial activity.
Pharmaceutical companies produce sulfonamides and trimethoprim APIs through rigorous manufacturing processes, ensuring high quality and purity. These APIs are then used in the formulation of various antibiotic products, such as tablets, capsules, and suspensions, which are prescribed by healthcare professionals for the treatment of bacterial infections.
Overall, sulfonamides and trimethoprim are vital pharmaceutical subcategories that play a crucial role in combating bacterial infections, providing patients with effective and targeted antibiotic therapies.
Mafenide (Sulfonamides and trimethoprim), classified under Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Mafenide API manufacturers & distributors
Compare qualified Mafenide API suppliers worldwide. We currently have 3 companies offering Mafenide 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.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Alchymars ICM SM | Producer | India | India | CoA, USDMF | 8 products |
| Curia | Producer | United States | United States | CoA, GMP, MSDS, USDMF | 106 products |
| Mylan | Producer | India | India | CoA, USDMF | 201 products |
When sending a request, specify which Mafenide 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 Mafenide 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.
