Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Podofilox API Manufacturers & Suppliers
3 verified results
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Commercial-scale Suppliers
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Podofilox | CAS No: 518-28-5 | GMP-certified suppliers
A medication that treats external genital warts by targeting abnormal skin cell growth with antimitotic and keratolytic effects for topical dermatological use.
Therapeutic categories
Primary indications
- For treatment of external genital warts (<i>Condyloma acuminatum</i>)
Product Snapshot
- Podofilox is available as topical formulations including solutions, gels, creams, and liquids
- It is primarily indicated for the treatment of external genital warts (Condyloma acuminatum)
- Podofilox is approved for use in key regulatory markets such as the United States and Canada
Clinical Overview
Clinically, podofilox is indicated for the topical treatment of external genital warts, specifically Condyloma acuminatum. The compound acts locally by targeting rapidly proliferating wart tissue and promoting wart removal. It is a purified and stable form of podophyllin, containing only the biologically active component, thereby enhancing applicability and reducing variability compared to crude podophyllin extracts.
Pharmacodynamically, podofilox exerts its effect through antimitotic activity. Its mechanism of action, while not fully elucidated, involves binding to and inhibiting topoisomerase II during the late S and early G2 phases of the cell cycle. This binding stabilizes temporary breaks introduced by the enzyme, impeding DNA unwinding and replication, thereby arresting mitosis and subsequent cellular proliferation in wart lesions.
Pharmacokinetic data on podofilox are limited due to its primary topical use, but systemic absorption is generally minimal. When absorbed or administered internally, podofilox is known to be toxic, exhibiting potent spindle poison properties. Application to skin and mucous membranes results in significant irritation and cytotoxic effects, underscoring the need for controlled topical use. Side effects predominantly include local irritation and potential tissue damage; systemic toxicity is a concern if misused.
Podofilox shares structural and pharmacological characteristics with certain antineoplastic and antiviral agents, supporting investigation into broader therapeutic applications. Notable usage is confined primarily to dermatological formulations for wart treatment.
For API sourcing, stringent quality control is essential given podofilox’s high biological activity and toxicity. Purity, stability, and batch consistency must be verified to ensure safety and efficacy in topical formulations. Regulatory compliance with pharmacopeial standards and appropriate handling guidelines is critical to mitigate risks during manufacturing and application.
Identification & chemistry
| Generic name | Podofilox |
|---|---|
| Molecule type | Small molecule |
| CAS | 518-28-5 |
| UNII | L36H50F353 |
| DrugBank ID | DB01179 |
Pharmacology
| Summary | Podofilox exerts its therapeutic effect primarily through inhibition of DNA topoisomerase II and binding to tubulin subunits, disrupting microtubule function. This leads to interference with DNA replication and cell division, contributing to the resolution of external genital warts. Its pharmacodynamic action targets the alpha-4A and beta chains of tubulin as well as topoisomerase 2-alpha. |
|---|---|
| Mechanism of action | The exact mechanism of action is not well understood. It does appear, however, that it and its derivatives may bind and inhibit topoisomerase II during the late S and early G2 stage. The drug may bind and stabilize the temporary break caused by the enzyme. This disrupts the reparation of the break through which the double-stranded DNA passes, and consequently stops DNA unwinding and replication |
| Pharmacodynamics | Podofilox, also called podophyllotoxin, is a purer and more stable form of podophyllin in which only the biologically active portion of the compound is present. Podofilox is used to remove certain types of warts on the outside skin of the genital areas. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Tubulin alpha-4A chain | Humans | inhibitor |
| Tubulin beta chain | Humans | inhibitor |
| DNA topoisomerase 2-alpha | Humans | inhibitor |
ADME / PK
| Absorption | Topical application of 0.05 mL of 0.5% podofilox solution to external genitalia did not result in detectable serum levels. Applications of 0.1 to 1.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application. |
|---|---|
| Half-life | 1.0 to 4.5 hours. |
Formulation & handling
- Podofilox is a small molecule API primarily formulated for topical administration and is not intended for oral or injectable use.
- The API exhibits low water solubility and moderate lipophilicity (LogP 1.62), which should be considered when designing topical formulations for adequate skin penetration.
- Being a small molecule podophyllotoxin derivative, podofilox requires controlled handling to prevent dermal exposure and maintain stability in solution or gel formulations.
Regulatory status
| Lifecycle | The API is approaching patent expiry in major markets including the US and Canada, indicating a transition towards increased generic competition and market maturity. This phase typically corresponds with broader product availability and pricing adjustments. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The Podofilox supply landscape includes multiple originator companies involved primarily in packaging and distribution across the US and Canada markets. Branded products such as Condyline and Condylox have a presence predominantly in North America, with no significant mention of EU or other global markets. Patent expiries in this category have allowed for existing generic competition, as indicated by multiple manufacturers producing under various labels. |
|---|
Podofilox is a type of Antivirals
Antivirals are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a pivotal role in combating viral infections. These specialized compounds are designed to inhibit the growth and replication of viruses within the human body.
Antivirals target various stages of the viral life cycle, including viral attachment, entry, and replication. They can interfere with viral enzymes, block viral receptors, or disrupt viral protein synthesis. By doing so, antivirals effectively suppress the viral infection, reduce symptoms, and improve patient outcomes.
The development of antiviral APIs requires extensive research and scientific expertise. Pharmaceutical companies employ cutting-edge technologies to identify potential antiviral compounds, screen their efficacy, and optimize their therapeutic properties. The most promising candidates undergo rigorous testing in preclinical and clinical trials to ensure their safety and effectiveness.
Antivirals have proven to be indispensable in the management of various viral infections, such as influenza, HIV, hepatitis B and C, herpes, and respiratory syncytial virus (RSV). They not only provide symptomatic relief but also prevent viral transmission and reduce the risk of complications.
With the ongoing global concern over emerging viral diseases and the impact of pandemics, the demand for effective antiviral therapies continues to rise. Pharmaceutical companies and researchers are actively exploring new avenues, such as broad-spectrum antivirals and novel drug delivery systems, to enhance the antiviral arsenal.
In conclusion, antiviral APIs are vital components of the pharmaceutical industry, offering hope in the fight against viral infections. Through continuous innovation and research, these substances contribute to improving public health by mitigating the impact of viral diseases.
Podofilox (Antivirals), classified under Anti-infective Agents
Anti-infective agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various infectious diseases. These agents play a crucial role in combating bacterial, viral, fungal, and parasitic infections. The demand for effective anti-infective APIs has grown significantly due to the increasing prevalence of drug-resistant microorganisms.
Anti-infective APIs encompass a wide range of substances, including antibiotics, antivirals, antifungals, and antiparasitics. Antibiotics are particularly important in fighting bacterial infections and are further categorized into different classes based on their mode of action and target bacteria. Antivirals are designed to inhibit viral replication and are essential in the treatment of viral infections such as influenza and HIV. Antifungals combat fungal infections, while antiparasitics are used to eliminate parasites that cause diseases like malaria and helminthiasis.
The development and production of high-quality anti-infective APIs require stringent manufacturing processes and adherence to regulatory standards. Pharmaceutical companies invest heavily in research and development to discover new and more effective anti-infective agents. Additionally, ensuring the safety, efficacy, and stability of these APIs is of utmost importance.
The global market for anti-infective APIs is driven by factors such as the rising incidence of infectious diseases, the emergence of new and drug-resistant pathogens, and the growing demand for improved healthcare infrastructure. Continuous advancements in pharmaceutical technology and the development of innovative drug delivery systems further contribute to the expansion of this market.
In conclusion, anti-infective agents are a critical category of pharmaceutical APIs that play a pivotal role in treating infectious diseases. Their effectiveness in combating various types of infections makes them essential components in the arsenal of modern medicine.
Podofilox API manufacturers & distributors
Compare qualified Podofilox API suppliers worldwide. We currently have 3 companies offering Podofilox 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 |
|---|---|---|---|---|---|
| Ferro Pfanstiehl Labs. | Producer | United States | United States | CoA, USDMF | 6 products |
| PCI SYNTHESIS | Producer | Unknown | Unknown | CoA, USDMF | 4 products |
| Zydus Takeda Healthcare | Producer | India | India | CoA, WC | 7 products |
When sending a request, specify which Podofilox 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 Podofilox 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.
