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Sulfanilamide | CAS No: 63-74-1 | GMP-certified suppliers
A medication that supports effective treatment of Candida albicans-associated vulvovaginitis, offering reliable anti‑infective utility for topical formulations in key North American markets.
Therapeutic categories
Primary indications
- For the treatment of vulvovaginitis caused by <i>Candida albicans</i>
Product Snapshot
- Sulfanilamide is a topical and intravaginal small‑molecule formulation available as creams and powder
- It is used for managing vulvovaginitis caused by Candida albicans
- It is approved in the US and Canada
Clinical Overview
Pharmacologically, sulfanilamide exhibits bacteriostatic activity against a broad range of organisms, including many gram‑positive and select gram‑negative species. Activity varies widely due to established resistance patterns, and cross‑resistance is common across the sulfonamide class. Its antibacterial effect is reduced in the presence of purulent material.
The mechanism of action involves competitive inhibition of the bacterial enzyme dihydropteroate synthetase. By blocking the utilization of para‑aminobenzoic acid in folate biosynthesis, the compound prevents formation of essential folate derivatives required for DNA replication, leading to impaired bacterial proliferation.
Systemic absorption can occur, although topical use limits bioavailability relative to oral sulfonamides. When absorbed, sulfonamides distribute widely into tissues and fluids, including pleural, peritoneal, synovial, and ocular compartments. Penetration into cerebrospinal fluid increases during meningeal inflammation. Metabolism and excretion characteristics align with the broader sulfonamide class, and the compound may interact with cytochrome P450 pathways, including CYP2C19 and CYP3A isoforms.
Safety considerations include hypersensitivity reactions typical of sulfonamides, potential hematologic effects, and the risk of methemoglobinemia. Tissue irritation can occur if alkaline salt forms are used parenterally, though this route is uncommon.
Sulfanilamide has historically appeared in topical gynecological formulations. Brand usage varies by region and has decreased with the availability of newer antifungal and antibacterial agents.
For API procurement, sourcing should prioritize confirmation of identity, control of sulfonamide‑related impurities, and verification of stability and particle characteristics suitable for topical formulation development. Quality documentation must support regulatory expectations for established sulfonamide substances.
Identification & chemistry
| Generic name | Sulfanilamide |
|---|---|
| Molecule type | Small molecule |
| CAS | 63-74-1 |
| UNII | 21240MF57M |
| DrugBank ID | DB00259 |
Pharmacology
| Summary | Sulfanilamide is a sulfonamide antimicrobial that competitively inhibits the bacterial enzyme dihydropteroate synthase, blocking incorporation of PABA into the folate synthesis pathway. This disruption prevents folate-dependent nucleotide production and limits microbial replication. Its pharmacodynamic profile is broadly bacteriostatic, with activity influenced by local tissue conditions and cross‑resistance across the sulfonamide class. |
|---|---|
| Mechanism of action | Sulfanilamide is a competitive inhibitor of bacterial enzyme dihydropteroate synthetase. This enzyme normally uses para-aminobenzoic acid (PABA) for synthesizing the necessary folic acid. The inhibited reaction is normally necessary in these organisms for the synthesis of folic acid. Without it, bacteria cannot replicate. |
| Pharmacodynamics | Sulfanilamide is a sulfonamide antibiotic. The sulfonamides are synthetic bacteriostatic antibiotics with a wide spectrum against most gram-positive and many gram-negative organisms. However, many strains of an individual species may be resistant. Sulfonamides inhibit multiplication of bacteria by acting as competitive inhibitors of <i>p</i>-aminobenzoic acid in the folic acid metabolism cycle. Bacterial sensitivity is the same for the various sulfonamides, and resistance to one sulfonamide indicates resistance to all. Most sulfonamides are readily absorbed orally. However, parenteral administration is difficult, since the soluble sulfonamide salts are highly alkaline and irritating to the tissues. The sulfonamides are widely distributed throughout all tissues. High levels are achieved in pleural, peritoneal, synovial, and ocular fluids. Although these drugs are no longer used to treat meningitis, CSF levels are high in meningeal infections. Their antibacterial action is inhibited by pus. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dihydropteroate synthase | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Sulfonamides are absorbed through the vaginal mucosa. There are no pharmacokinetic data available describing how much of an intravaginal dose reaches the systemic circulation. |
|---|
Formulation & handling
- High aqueous solubility and solid-state stability support simple topical and vaginal cream or powder formulations without complex solubilizers.
- Small‑molecule sulfonamide with good chemical stability; handle as a standard solid API with routine protection from moisture and light.
- Primarily for local (topical/vaginal) delivery, so systemic absorption is limited and excipient selection focuses on local tolerability and pH compatibility.
Regulatory status
| Lifecycle | Patent protection in the US and Canada is concluded or nearing conclusion, indicating a mature market stage for the API. With established availability in both markets, future competition is expected to reflect typical post‑patent dynamics. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Sulfanilamide is supplied by a small set of originator and established manufacturers, with additional distribution handled by multiple packagers. Branded formulations are present primarily in the US and Canada, reflecting a limited but stable geographic footprint. Patent expiry for this legacy compound indicates long‑standing availability of generics and mature market competition. |
|---|
Safety
| Toxicity | Oral, mouse LD<sub>50</sub> = 3700 mg/kg; Intravenous, mouse LD<sub>50</sub> = 621 mg/kg; Oral, rabbit LD<sub>50</sub> = 1300 mg/kg. Side effects include itching, burning, skin rash, redness, swelling, or other sign of irritation not present before use of this medicine and long-term use of sulfonamides may cause cancer of the thyroid gland. |
|---|
- Acute toxicity data indicate moderate oral toxicity in mice and rabbits (oral LD50 values around 3700 mg/kg and 1300 mg/kg, respectively) and higher hazard via intravenous exposure (mouse IV LD50 about 621 mg/kg), supporting controlled handling to limit systemic exposure
- Documented adverse reactions include cutaneous irritation such as itching, burning, rash, redness, or swelling, suggesting the need to minimize direct contact with skin or mucosa during processing
- Chronic exposure to sulfonamide compounds has been associated with thyroid carcinogenicity in long‑term studies, warranting precautions that reduce prolonged or repeated occupational exposure
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Sulfanilamide 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.
Sulfanilamide (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.
Sulfanilamide API manufacturers & distributors
Compare qualified Sulfanilamide API suppliers worldwide. We currently have 5 companies offering Sulfanilamide API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Chemsynlab | Producer | China | China | CoA | 11 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Quzhou Chemsyn | Producer | China | China | CEP, CoA | 1 products |
| Zhejiang Chemsyn | Producer | China | China | CoA | 9 products |
When sending a request, specify which Sulfanilamide 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 Sulfanilamide 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 Sulfanilamide API
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