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Nystatin | CAS No: 1400-61-9 | GMP-certified suppliers
A medication that treats and helps prevent superficial and mucosal candidiasis across oral, gastrointestinal, cutaneous, and vulvovaginal infections for broad antifungal coverage.
Therapeutic categories
Primary indications
- Nystatin is available in oral formulations for the treatment and/or prevention of oral candidiasis (a
- K
- A
- Thrush), intestinal candidiasis, and anal candidiasis
Product Snapshot
- Nystatin is an oral, topical, and vaginal polyene antifungal used in solid and liquid formulations
- It is used for mucocutaneous and intestinal candidiasis and in combination products for mixed bacterial–fungal dermatoses
- It is approved in the US and Canada, with human and veterinary marketing authorizations
Clinical Overview
Nystatin acts as a channel‑forming ionophore that binds ergosterol in the fungal plasma membrane. This interaction creates transmembrane pores that disrupt membrane integrity, leading to leakage of intracellular components and collapse of electrochemical gradients. Its selectivity stems from a higher affinity for ergosterol than for cholesterol in mammalian membranes. Resistance is uncommon in Candida albicans but may develop in other Candida species.
Systemic exposure is minimal following oral or topical administration, as nystatin is not appreciably absorbed from the gastrointestinal tract, skin, or mucosa. Consequently, systemic pharmacokinetic parameters are not clinically meaningful. Parenteral administration is associated with significant toxicity, and no formulation is approved for systemic therapy.
Safety considerations focus on local gastrointestinal or dermatologic irritation. Hypersensitivity reactions are uncommon. Drug interactions are limited due to poor absorption.
For API procurement, manufacturers should verify consistent polyene content, control for oxidative degradation, and ensure robust microbial and impurity testing, as nystatin’s stability profile and biological origin require tight quality oversight.
Identification & chemistry
| Generic name | Nystatin |
|---|---|
| Molecule type | Small molecule |
| CAS | 1400-61-9 |
| UNII | W1LX4T91WI |
| DrugBank ID | DB00646 |
Pharmacology
| Summary | Nystatin binds ergosterol in fungal cell membranes and forms transmembrane pores that increase membrane permeability, leading to loss of intracellular contents and disruption of essential electrochemical gradients. This mechanism produces fungistatic or fungicidal activity against many yeasts, with minimal activity outside fungal species. Its pharmacologic effects are limited to topical and gastrointestinal sites due to systemic toxicity. |
|---|---|
| Mechanism of action | Nystatin is a channel-forming ionophore, meaning it exerts its therapeutic effect via formation of a membrane-spanning pore in the fungal plasma membrane.The formation of this pore results in a change in membrane permeability that allows for leakage of intracellular contents and the subsequent disruption of electrochemical gradients necessary for proper cell function.Selectivity for fungal cells over mammalian cells is due to nystatin’s greater binding affinity for ergosterol, a key sterol found in fungal cell walls, as opposed to its mammalian counterpart, cholesterol. |
| Pharmacodynamics | Nystatin is an antifungal that is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It exerts its antifungal effects via disruption of the fungal cell membrane. Resistance to nystatin is minimal in _Candida albicans_, but tends to develop in other species of _Candida_.Nystatin carries no significant activity against bacteria, protozoa, or viruses. It carries significant systemic toxicity and is currently unavailable in a formula appropriate for systemic use - its efficacy is currently restricted, therefore, to topical, oral, and gastrointestinal infections. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Ergosterol | Candida albicans | binder |
ADME / PK
| Absorption | Systemic absorption of nystatin is minimal following oral administration,and no detectable plasma concentrations are attained following topical or vaginal administration. |
|---|---|
| Protein binding | Nystatin is not absorbed into the systemic circulationand is therefore not subject to plasma protein binding. |
| Metabolism | Because nystatin undergoes little-to-no systemic absorption it is not metabolized to any appreciable extent. |
| Route of elimination | The majority of orally administered nystatin is eliminated unchanged in the feces. |
| Volume of distribution | Nystatin is not absorbed into the systemic circulationand thus does not undergo distribution. |
Formulation & handling
- Topical and vaginal formulations dominate due to extremely low oral absorption and poor aqueous solubility, favoring use in creams, ointments, gels, and suspensions.
- Oral suspensions require attention to physical stability and uniform dispersion because the API is a high‑MW, amphipathic polyene prone to aggregation and settling.
- The molecule is moisture- and light‑sensitive, so solid and semisolid formulations benefit from protected packaging and controlled storage conditions.
Regulatory status
| Lifecycle | The API’s lifecycle in the US and Canada reflects a mature market, with patent expiry either reached or approaching and increasing availability of follow‑on products. Overall market dynamics suggest limited remaining exclusivity and stable, established usage. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Nystatin is an established antifungal with early originator development long off‑patent, and its manufacturing base now consists of numerous generic producers and repackagers rather than a single dominant originator. Branded and compounded formulations are available primarily in the US and Canada, reflecting mature market penetration. Patent expiry occurred decades ago, and the extensive list of manufacturers indicates fully established generic competition. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in rats is 10 g/kg.There have been no reports of serious toxic effects following overdosage of nystatin - doses in excess of five million units daily have resulted in nausea and gastrointestinal upset with no other associated effects. |
|---|
- High oral LD50 in rats (~10 g/kg) indicates relatively low acute systemic toxicity
- Excessive oral exposure primarily leads to gastrointestinal irritation
- Reported overdosage has produced nausea and GI upset without systemic toxic effects, suggesting limited absorption and low risk of severe acute toxicity
Nystatin is a type of Antimycotics
Antimycotics, a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs), are essential in the treatment of various fungal infections. These powerful medications target and eliminate harmful fungi that can cause infections in humans.
Antimycotics are classified into two main types: systemic and topical. Systemic antimycotics are administered orally or intravenously and work by circulating throughout the body, treating systemic fungal infections that affect internal organs or spread throughout the bloodstream. On the other hand, topical antimycotics are applied externally to treat localized fungal infections such as athlete's foot or yeast infections.
The efficacy of antimycotics lies in their ability to disrupt fungal cell membranes, inhibit the synthesis of fungal DNA or proteins, or interfere with essential metabolic processes specific to fungi. This targeted action minimizes damage to human cells, making these medications relatively safe for patients.
Commonly prescribed antimycotics include azoles, polyenes, allylamines, and echinocandins. Azoles inhibit the synthesis of ergosterol, a vital component of fungal cell membranes, while polyenes bind to ergosterol, resulting in the formation of pores that lead to cell death. Allylamines disrupt the synthesis of ergosterol and inhibit the activity of squalene epoxidase, an enzyme involved in ergosterol production. Echinocandins target the synthesis of β-(1,3)-D-glucan, an essential component of the fungal cell wall.
Antimycotics play a crucial role in the management of fungal infections, offering relief to patients and aiding in their recovery. As with any medication, it is important to follow healthcare professionals' guidance regarding dosage, duration of treatment, and potential side effects to ensure optimal therapeutic outcomes.
Nystatin (Antimycotics), classified under Antifungals
Antifungals are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) designed to combat fungal infections. These medications are developed to target and eliminate fungi, including yeasts and molds, which can cause a range of diseases in humans and animals.
Antifungals work by interfering with specific components or processes essential for fungal growth and reproduction. They may inhibit the synthesis of fungal cell walls or disrupt the production of ergosterol, a crucial component of fungal cell membranes. By targeting these key mechanisms, antifungal APIs effectively hinder the growth and spread of fungal infections.
The diversity within the antifungal category is reflected in the various classes of antifungal APIs available. Azoles, polyenes, echinocandins, and allylamines are common classes of antifungals. Each class exhibits unique mechanisms of action and targets specific types of fungi. This diversity enables healthcare professionals to tailor treatment plans to the specific fungal infection, optimizing therapeutic outcomes.
Antifungal APIs find application in various pharmaceutical formulations, including oral medications, topical creams, ointments, and intravenous solutions. They are crucial for the treatment of common fungal infections like athlete's foot, ringworm, vaginal yeast infections, and oral thrush. Additionally, antifungals play a crucial role in managing serious systemic fungal infections that can pose significant health risks, especially in immunocompromised individuals.
Overall, antifungal APIs are indispensable tools in the fight against fungal infections, offering effective treatment options and improving the quality of life for patients suffering from these conditions. With ongoing research and development, the antifungal category continues to evolve, providing innovative solutions to combat the ever-changing landscape of fungal pathogens.
Nystatin API manufacturers & distributors
Compare qualified Nystatin API suppliers worldwide. We currently have 11 companies offering Nystatin API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| AMARI TRADE ALLIANEC LLP | Distributor | India | India | CoA | 15 products |
| Antibiotice | Producer | Romania | Romania | CEP, CoA, GMP, USDMF | 1 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, MSDS | 235 products |
| Chr. Olesen Group | Distributor | Denmark | Romania | CEP, CoA, USDMF | 252 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Italy | CoA, GMP, ISO9001, MSDS | 170 products |
| S.P. Quimica | Producer | Spain | Spain | CoA, GMP | 11 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 762 products |
| Vuab Pharma | Producer | Czech Republic | Czech Republic | CEP, CoA, FDA, GMP, USDMF | 3 products |
When sending a request, specify which Nystatin 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 Nystatin 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 Nystatin API
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Technical
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Regulatory
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