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Nitrofurantoin | CAS No: 67-20-9 | GMP-certified suppliers
A medication that treats acute uncomplicated urinary tract infections by providing effective antibacterial activity with renal excretion, suitable for systemic anti-infective use.
Therapeutic categories
Primary indications
- Nitrofurantoin is indicated to treat acute uncomplicated urinary tract infections
Product Snapshot
- Nitrofurantoin is available primarily as oral tablets, capsules, suspensions, and powders
- It is indicated for the treatment of acute uncomplicated urinary tract infections
- The API is approved for use in major regulatory markets including the United States and Canada
Clinical Overview
Pharmacologically, nitrofurantoin exerts its antibacterial effect after bacterial nitroreductases convert it into reactive electrophilic intermediates. These intermediates disrupt several critical bacterial processes by inhibiting the citric acid cycle and the synthesis of DNA, RNA, and proteins. This multi-target action contributes to its relative resistance to the development of bacterial resistance compared to agents with single targets.
After oral administration, nitrofurantoin achieves rapid therapeutic concentrations in the urinary tract, facilitating its clinical efficacy in urinary infections. The compound exhibits predominantly renal excretion, which justifies its use in urinary tract infections due to high local concentrations in urine. Nitrofurantoin is classified chemically as a hydantoin derivative, a heterocyclic compound with imidazolidine substituted by ketone groups.
Safety considerations include potential risks of hypersensitivity reactions, pulmonary toxicity in prolonged usage, and rare instances of hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency. Nitrofurantoin is also associated with a risk of methemoglobinemia and requires caution in patients with renal impairment, as reduced clearance may increase toxicity.
Notable for its inclusion in various anti-infective and urinary antibacterial classifications, nitrofurantoin is also a substrate of several efflux transporters such as P-glycoprotein and BCRP/ABCG2, influencing its renal handling and systemic exposure.
From a sourcing and quality perspective, procurement of nitrofurantoin active pharmaceutical ingredient should ensure compliance with pharmacopeial standards relevant to nitrofuran derivatives, with attention to impurities that may arise from nitro group reduction. Consistent monitoring of physicochemical properties and purity is essential to maintain the safety and efficacy profile of the final pharmaceutical formulations.
Identification & chemistry
| Generic name | Nitrofurantoin |
|---|---|
| Molecule type | Small molecule |
| CAS | 67-20-9 |
| UNII | 927AH8112L |
| DrugBank ID | DB00698 |
Pharmacology
| Summary | Nitrofurantoin exerts antibacterial effects by conversion into reactive intermediates that inhibit bacterial DNA, RNA, protein synthesis, and the citric acid cycle. Its primary targets include bacterial nitroreductases and the 30S ribosomal subunit, disrupting essential metabolic and replication processes. The compound rapidly attains therapeutic concentrations in urine, supporting its use in treating uncomplicated urinary tract infections. |
|---|---|
| Mechanism of action | Nitrofurantoin is converted by bacterial nitroreductases to electrophilic intermediates which inhibit the citric acid cycle as well as synthesis of DNA, RNA, and protein. |
| Pharmacodynamics | Nitrofurantoin interferes with vital processes in bacteria, which leads to their death. Nitrofurantoin rapidly reaches therapeutic concentrations in the urine and is also cleared rapidly. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Probable pyruvate-flavodoxin oxidoreductase | Escherichia coli (strain K12) | potentiator |
| Oxygen-insensitive NADPH nitroreductase | Escherichia coli (strain K12) | potentiator |
| 30S ribosomal protein S10 | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Nitrofurantoin reaches a C<sub>max</sub> of 0.875-0.963mg/L with an AUC of 2.21-2.42mg\*h/L. It is 38.8-44.3% bioavailable. Taking nitrofurantoin with food increases the absorption and duration of therapeutic concentrations in the urine. |
|---|---|
| Half-life | The half life of nitrofurantoin is 0.72-0.78h. |
| Protein binding | Nitrofurantoin could be up to 90% protein bound in plasma. |
| Metabolism | 0.8-1.8% of a dose is metabolized to aminofurantoin, and ≤0.9% of a dose is metabolized to other metabolites. |
| Route of elimination | 27-50% of an oral dose is excreted in the urine as unchanged nitrofurantoin. 90% of the total dose is eliminated in the urine. |
| Volume of distribution | Data regarding the volume of distribution in humans is scarce but it has been reported as 0.46L/kg in dogs. |
| Clearance | The clearance of nitrofurantoin is 16.7-19.4L/h. |
Formulation & handling
- Nitrofurantoin is a small molecule API primarily formulated for oral administration in tablet, capsule, and suspension forms.
- It exhibits moderate water solubility and a low logP, indicating limited lipophilicity suitable for oral bioavailability enhancement with food.
- Formulations should consider administration with food to reduce gastrointestinal irritation and improve systemic absorption.
Regulatory status
| Lifecycle | The API’s key patents have expired in both Canada and the US, resulting in established generic competition across these mature markets. Ongoing availability is supported by multiple manufacturers without patent restrictions. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Nitrofurantoin is manufactured by multiple originator and generic pharmaceutical companies, including established firms such as Watson Laboratories, Shionogi Pharma, and Teva Pharmaceuticals, reflecting a diverse supplier base. Branded products are primarily marketed in North America, notably the US and Canada, with several brand names in use. The presence of numerous generic manufacturers and widespread packaging entities indicates existing generic competition following patent expirations. |
|---|
Safety
| Toxicity | Symptoms of overdose include vomiting. In case of overdose, induce vomiting if it has not already occurred and increase fluid intake to promote urination. In extreme cases, nitrofurantoin can be removed from circulation by dialysis. |
|---|
- Overdose symptoms may include vomiting
- Monitor accordingly
- Dialysis can be utilized to remove nitrofurantoin in severe toxicity cases
Nitrofurantoin is a type of 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.
Nitrofurantoin API manufacturers & distributors
Compare qualified Nitrofurantoin API suppliers worldwide. We currently have 9 companies offering Nitrofurantoin API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Bidachem | Producer | Italy | Italy | CoA, GMP | 14 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Italy | CoA, GMP, ISO9001, MSDS | 170 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Olpha | Producer | Latvia | Latvia | BSE/TSE, CoA, EDMF/ASMF, GMP, MSDS, USDMF | 13 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Shandong Fangxing Technol... | Producer | China | China | CoA | 5 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 764 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 144 products |
When sending a request, specify which Nitrofurantoin 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 Nitrofurantoin 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.
