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Natamycin | CAS No: 7681-93-8 | GMP-certified suppliers
A medication that treats fungal eye infections including blepharitis, conjunctivitis, and keratitis caused by susceptible organisms such as Fusarium solani for topical ophthalmic use.
Therapeutic categories
Primary indications
- For the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including <i>Fusarium solani</i> keratitis
Product Snapshot
- Natamycin is available as ophthalmic and topical formulations including solutions, suspensions, and creams
- It is primarily used for treating fungal infections such as blepharitis, conjunctivitis, and keratitis caused by susceptible organisms
- Natamycin holds FDA approval for use in the United States market
Clinical Overview
Pharmacologically, natamycin is a tetraene polyene antibiotic with in vitro activity against various yeasts and filamentous fungi including Candida, Aspergillus, Cephalosporium, Fusarium, and Penicillium species. Unlike many antifungals, natamycin does not exhibit activity against gram-positive or gram-negative bacteria. When applied topically to the eye, it achieves effective concentrations in the corneal stroma, although it does not significantly penetrate intraocular fluids.
The mechanism of action of natamycin involves selective binding to ergosterol, a key sterol component of fungal cell membranes. This binding inhibits ergosterol-dependent membrane processes such as vacuole fusion and membrane fusion/fission events, thereby preventing fungal growth. This mode of action differs from other polyene antifungals, which commonly disrupt membrane permeability. Natamycin’s fungicidal activity is dose-dependent and is predominantly directed at fungal cell membrane structure rather than membrane permeability changes.
Key pharmacokinetic data, including absorption, distribution, metabolism, and excretion parameters, are limited due to the topical route of administration and minimal systemic exposure. Safety and toxicity profiles align with localized treatment; systemic toxicity is rare. Irritation and hypersensitivity reactions may occur at the site of application.
Natamycin is approved for ophthalmic use in multiple markets and is included in several therapeutic categories such as ophthalmologicals and antifungal agents for topical use. It is also utilized in other localized fungal infection contexts.
From a sourcing perspective, the natamycin API should be procured with attention to microbial origin and purity standards, ensuring compliance with pharmacopeial specifications to guarantee consistent efficacy and safety in pharmaceutical formulations. Quality control should verify the absence of contaminants and confirm the precise chemical identity, including stereochemical configuration, to maintain therapeutic reliability.
Identification & chemistry
| Generic name | Natamycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 7681-93-8 |
| UNII | 8O0C852CPO |
| DrugBank ID | DB00826 |
Pharmacology
| Summary | Natamycin is a polyene antifungal agent that exerts its effect by binding to ergosterol in fungal plasma membranes, inhibiting ergosterol-dependent membrane fusion processes critical for fungal growth. It demonstrates fungicidal activity against various yeasts and filamentous fungi including Candida, Aspergillus, and Fusarium species. Natamycin is primarily used topically for ocular fungal infections, with minimal antibacterial activity. |
|---|---|
| Mechanism of action | Like other polyene antibiotics, Natamycin inhibits fungal growth by binding to sterols. Specifically, Natamycin binds to ergosterol in the plasma membrane, preventing ergosterol-dependent fusion of vacuoles, as well as membrane fusion and fission. This differs from the mechanism of most other polyene antibiotics, which tend to work by altering fungal membrane permeability instead. |
| Pharmacodynamics | Natamycin is an antifungal drug for topical ophthalmic administration. It is a tetraene polyene antibiotic derived from <i>Streptomyces natalensis</i>. It possesses in vitro activity against a variety of yeast and filamentous fungi, including <i>Candida</i>, <i>Aspergillus</i>, <i>Cephalosporium</i>, <i>Fusarium</i> and <i>Penicillium</i>. Although the activity against fungi is dose-related, natamycin is predominantly fungicidal. Natamycin is not effective in vitro against gram-positive or gram-negative bacteria. Topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Ergosterol | Candida albicans | binder |
ADME / PK
| Absorption | Systemic absorption should not be expected following topical administration, and as with other polyene antibiotics, absorption from the gastrointestinal tract is very poor. |
|---|
Formulation & handling
- Natamycin is formulated primarily for topical and ophthalmic ophthalmic use, not for oral or injectable administration.
- As a small molecule aminoglycoside with low water solubility, it is often prepared as suspensions or solutions for ocular application.
- Formulations should consider its stability in suspension form and appropriate handling to maintain potency during storage and use.
Regulatory status
| Lifecycle | The API’s patent protection in the US has expired, resulting in a mature market with multiple generic versions available. Ongoing availability is supported primarily through off-patent formulations. |
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| Markets | US |
|---|
Supply Chain
| Supply chain summary | Natamycin is produced and packaged primarily by a single originator company, Alcon Laboratories, with its branded products available in the US market. There is no indication of a presence in the EU or other regions. The data does not specify patent expiry status, so the extent of generic competition cannot be determined from the provided information. |
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Natamycin 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.
Natamycin (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.
Natamycin API manufacturers & distributors
Compare qualified Natamycin API suppliers worldwide. We currently have 2 companies offering Natamycin API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, ISO9001 | 229 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, MSDS | 235 products |
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