Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Sulfadoxine API Manufacturers & Suppliers
7 verified results
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Commercial-scale Suppliers
All certificates
Employees: 100+
All certificates
Employees: 150
All certificates
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Sulfadoxine | CAS No: 2447-57-6 | GMP-certified suppliers
A medication that supports treatment and prevention of malaria, especially in resistant Plasmodium falciparum settings, and assists in managing selected veterinary infections.
Therapeutic categories
Primary indications
- Sulfadoxine is used in combination with pyrimethamine for the treatment or prevention of malaria
- It can also be used to treat various infections in livestock as well
- Sulfadoxine and pyrimethamine is indicated for the treatment of Plasmodium falciparum malaria in those patients in whom chloroquine resistance is suspected
Product Snapshot
- Oral small‑molecule API supplied in tablet and suspension formulations
- Used with pyrimethamine for malaria management and for certain veterinary infectious disease applications
- Approved in the US and Canada, with additional investigational status in some regions
Clinical Overview
The pharmacologic activity of sulfadoxine is based on inhibition of dihydropteroate synthase, blocking the conversion of para‑aminobenzoic acid to dihydropteroic acid, a precursor in folic acid biosynthesis. Because Plasmodium species rely on de novo folate synthesis, suppression of this pathway limits folate availability for DNA synthesis and cell replication. Combined administration with pyrimethamine provides sequential blockade of folate metabolism through additional inhibition of dihydrofolate reductase, producing a complementary antiprotozoal effect.
Sulfadoxine is considered long acting and demonstrates prolonged systemic exposure, a feature associated with its extended elimination profile. As with other sulfonamides, it is systemically absorbed after oral administration and distributes widely into tissues and extracellular fluid. The compound is cleared primarily through renal excretion of unchanged drug and metabolites, although the relative contributions of metabolic pathways may vary.
Safety considerations focus on sulfonamide‑associated hypersensitivity reactions, including severe cutaneous adverse reactions. Hematologic effects and hepatic or renal dysfunction have been reported with the class. Use is generally restricted to combination therapy and guided by regional resistance patterns. In many markets, sulfadoxine is supplied only within fixed‑dose sulfadoxine‑pyrimethamine products.
For API procurement, suppliers should provide evidence of compliance with pharmacopoeial specifications, control of sulfonamide‑related impurities, and robust documentation supporting identity, purity, and stability. Batch consistency and verification of long‑term impurity profiles are key considerations for formulation and regulatory review.
Identification & chemistry
| Generic name | Sulfadoxine |
|---|---|
| Molecule type | Small molecule |
| CAS | 2447-57-6 |
| UNII | 88463U4SM5 |
| DrugBank ID | DB01299 |
Pharmacology
| Summary | Sulfadoxine is an antimetabolite that targets Plasmodium folate synthesis by inhibiting dihydropteroate synthase, limiting production of folate required for parasite DNA synthesis and replication. In combination therapy, it complements inhibition of dihydrofolate reductase, producing sequential blockade of the folate pathway. This dual interference suppresses growth of Plasmodium species, including strains with reduced susceptibility to other antimalarials. |
|---|---|
| Mechanism of action | Sulfadoxine is a sulfa drug, often used in combination with pyrimethamine to treat malaria. This medicine may also be used to prevent malaria in people who are living in, or will be traveling to, an area where there is a chance of getting malaria. Sulfadoxine targets Plasmodium dihydropteroate synthase and dihydrofolate reductase. Sulfa drugs or Sulfonamides are antimetabolites. They compete with para-aminobenzoic acid (PABA) for incorporation into folic acid. The action of sulfonamides exploits the difference between mammal cells and other kinds of cells in their folic acid metabolism. All cells require folic acid for growth. Folic acid (as a vitamin) diffuses or is transported into human cells. However, folic acid cannot cross bacterial (and certain protozoan) cell walls by diffusion or active transport. For this reason bacteria must synthesize folic acid from p-aminobenzoic acid. |
| Pharmacodynamics | Sulfadoxine helps inhibit the enzyme dihydropteroate synthetase which is an enzyme necessary in the conversion of PABA to folic acid. As folic acid is vital to the synthesis, repair, and methylation of DNA which is vital to cell growth in Plasmodium falciparum. With this vital nutrient lacking, the parasite has difficulty in reproducing. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dihydropteroate synthetase | Plasmodium falciparum | |
| Bifunctional dihydrofolate reductase-thymidylate synthase | Plasmodium falciparum (isolate K1 / Thailand) | inhibitor |
Formulation & handling
- Oral small‑molecule sulfonamide with moderate aqueous solubility, commonly formulated as solid tablets or liquid suspensions.
- Low LogP and limited solubility may require solubility‑enhancing excipients for robust oral absorption.
- Generally taken with food to reduce gastrointestinal irritation, with no special stability or cold‑chain handling requirements.
Regulatory status
| Lifecycle | Available information does not specify patent expiry timing for this API, but its presence in both the US and Canadian markets suggests it is in an established phase of commercialization. If key patents have expired or are nearing expiry, the markets are likely transitioning toward greater generic participation and price‑mature conditions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Sulfadoxine has historically been supplied by a single originator group, with Roche-associated entities responsible for branded Fansidar products. The branded formulation has been marketed in the US and Canada, while global distribution has largely shifted to generic manufacturers. Patent expiry occurred years ago, and the ingredient is widely available from multiple generic producers, indicating established generic competition. |
|---|
Sulfadoxine 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.
Sulfadoxine (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.
Sulfadoxine API manufacturers & distributors
Compare qualified Sulfadoxine API suppliers worldwide. We currently have 7 companies offering Sulfadoxine 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 |
|---|---|---|---|---|---|
| Atilus Pharma | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, HALAL, Kosher, MSDS | 11 products |
| Chr. Olesen Group | Distributor | Denmark | China | CoA, USDMF | 252 products |
| F Hoffmann-La Roche | Producer | Switzerland | Switzerland | CEP, CoA, FDA | 8 products |
| Innova | Producer | India | India | CoA, WC | 4 products |
| Ipca Labs. | Producer | India | India | CoA, GMP, WC | 69 products |
| K. Sevantilal & Co. | Producer | India | India | CoA | 8 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 133 products |
When sending a request, specify which Sulfadoxine 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 Sulfadoxine 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 Sulfadoxine API
Sourcing
What matters most when sourcing GMP-grade Sulfadoxine?
Which documents are typically required when sourcing Sulfadoxine API?
Which manufacturers are known to produce Sulfadoxine API?
How can I request quotes for Sulfadoxine API from GMP suppliers?
Is a GMP audit report available for Sulfadoxine manufacturers?
How many suppliers offer Sulfadoxine API on Pharmaoffer?
Which countries are known to manufacture Sulfadoxine API?
Which certifications do suppliers of Sulfadoxine usually hold?
Technical
What is Sulfadoxine (CAS 2447-57-6) used for?
Which therapeutic class does Sulfadoxine fall into?
What conditions is Sulfadoxine mainly prescribed for?
How does Sulfadoxine work?
What should someone know about the safety or toxicity profile of Sulfadoxine?
What are important formulation and handling considerations for Sulfadoxine as an API?
Is Sulfadoxine a small molecule?
Are there special stability concerns for oral Sulfadoxine?
Regulatory
Where is Sulfadoxine approved or in use globally?
What’s the regulatory and patent landscape for Sulfadoxine right now?
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Sulfadoxine procurement?
Is Sulfadoxine included in the PRO Data Insights coverage?
Where can I access the API market report for Sulfadoxine?
