Suppliers and packagers for CONDYLOX

CONDYLOX

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Allergan	CONDYLOX	podofilox	GEL;TOPICAL	020529	NDA	Allergan, Inc.	0023-6118-03	3.5 g in 1 TUBE, WITH APPLICATOR (0023-6118-03)	1997-03-13

Suppliers for the Pharmaceutical Drug: Condylox

Last updated: August 16, 2025

Introduction

Condylox, the brand name for podophyllotoxin topical solution (0.5%), is a prescription medication primarily used in the treatment of external genital warts caused by human papillomavirus (HPV). It functions as a plant-derived alkaloid that selectively destroys wart tissue, offering a non-invasive treatment option. Given its significance in dermatological and gynecological practices, understanding the landscape of suppliers for Condylox is vital for healthcare providers, pharma distributors, and stakeholders involved in procurement and supply chain management.

This report offers a comprehensive overview of current and potential suppliers for Condylox, analyzing manufacturing sources, distribution channels, and global market dynamics. It aims to inform strategic sourcing decisions amid regulatory, competitive, and supply chain considerations.

Manufacturers of Condylox

1. Originating Manufacturer: Mayne Pharma

Mayne Pharma, an Australian-based global specialty pharmaceutical company, originally developed and marketed Condylox. The company's manufacturing facility historically supplied initial volumes of the drug, leveraging its expertise in dermatological generics and niche formulations (1). Due to its early involvement, Mayne Pharma remains a key registered supplier recognized by regulatory agencies like the FDA and TGA.

2. Contract Manufacturing and Licensing Agreements

In recent years, manufacturing rights for Condylox have been licensed to various contract manufacturing organizations (CMOs), primarily to expand global distribution and meet increasing demand. These agreements include partnerships with established chemical and pharmaceutical manufacturers in countries such as India, China, and Europe, where generic production is prevalent (2).

3. Generic Manufacturers and Regional Suppliers

Post-patent expiration in several jurisdictions, multiple generic drug manufacturers began producing podophyllotoxin formulations, including solutions and creams. Notable regional suppliers include:

• Sun Pharmaceutical Industries Ltd. (India): Known for producing a broad array of dermatological and topical medications, Sun Pharma has manufacturing capacity aligned with global standards for podophyllotoxin products, including formulations comparable to Condylox (3).

• Mylan (now part of Viatris): Historically offered generic podophyllotoxin topical treatments in select markets, leveraging a robust distribution network across North America and Europe (4).

• Taro Pharmaceutical Industries Ltd.: An Israel-based firm active in dermatological generics, Taro supplies topical therapies that may include podophyllotoxin formulations appropriate for Condylox equivalents in specific markets (5).

• Dr. Reddy’s Laboratories (India): An established supplier of dermatological generics, involved in manufacturing podophyllotoxin solutions compliant with international standards (6).

4. Emerging and Regional Suppliers

Other regional players, especially in South-East Asia, Eastern Europe, and Latin America, are increasingly entering the market with locally produced podophyllotoxin formulations. These companies often manufacture under local regulatory approvals, which may impact quality control and international acceptance.

Distribution Channels and Market Dynamics

1. Regulatory Approvals and Market Access

Distribution of Condylox depends heavily on regulatory approvals in individual countries. While the United States, European Union, and Australia have well-defined approval pathways, many developing countries rely on regional registration or local import licenses. Manufacturers must navigate these pathways, which influence supply availability (7).

2. Supply Chain Considerations

The supply chain for Condylox involves raw material sourcing—primarily plant-derived podophyllotoxin—refined into active pharmaceutical ingredient (API) and formulated into topical solutions. The complexity of extraction and synthesis impacts supplier diversity. Furthermore, COVID-19 disruptions have underscored vulnerabilities within manufacturing and distribution networks, prompting diversification efforts.

3. Competition and Market Share

Although the market for external genital wart treatments includes other topical agents like imiquimod and sinecatechins, Condylox remains a standard, especially where it is approved. Suppliers positioning through cost competitiveness, compliance, and reliable delivery are gaining traction, increasing the importance of a diversified supplier base.

Regulatory and Patent Landscape

Condylox's patent protections have largely expired, fostering generic manufacturing and increasing supply options. However, proprietary formulation aspects or enhancements may still be under patent in certain jurisdictions, affecting access to licensed products versus generics. Companies adhering to stringent quality standards (e.g., cGMP) have a competitive advantage.

Emerging Trends and Strategic Considerations

• Localization of Production: Countries encouraging local manufacturing to reduce dependency on imports, such as India's "Make in India" initiative, are becoming significant suppliers.

• Supply Security: Ongoing geopolitical tensions and pandemic-related disruptions heighten the need for multiple suppliers to mitigate risks.

• Quality Assurance: Regulatory agencies emphasize Good Manufacturing Practices (GMP). Suppliers compliant with ISO, WHO-GMP, or FDA standards are preferred.

• Cost and Pricing: Generics heavily influence market pricing. Cost-effective suppliers provide competitiveness, especially in emerging markets.

Conclusion

The landscape of Condylox suppliers is characterized by a mix of original patent holders (primarily Mayne Pharma), licensed contract manufacturers, and numerous generic producers in emerging markets. Key regional suppliers include prominent firms such as Sun Pharma, Mylan, Taro, and Dr. Reddy's, with additional regional players expanding presence.

In planning procurement strategies, stakeholders must prioritize suppliers demonstrating compliance with international standards, secure regulatory approvals, and robust supply chains. Diversification and rigorous quality control are imperative for ensuring consistent availability and patient safety.

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Key Takeaways

• While Mayne Pharma remains a primary source, a broad base of generic manufacturers now supplies Condylox globally.

• Contract manufacturing has expanded supply capacity, notably in India and China, creating opportunities for cost-effective procurement.

• Regulatory compliance and quality certifications strongly influence supplier selection amid a competitive landscape.

• Local manufacturers in emerging markets offer alternative sources but may vary in quality assurance.

• Supply chain resilience relies on multi-source strategies, especially amidst global disruptions.

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FAQs

Q1: Is Condylox still under patent protection globally?
No. The patent protections for Condylox have largely expired in many jurisdictions, facilitating generic manufacturing and increasing supplier options.

Q2: Who are the primary global suppliers of Condylox?
Mayne Pharma remains a key original supplier, while generic manufacturers like Sun Pharma, Mylan, Taro, and Dr. Reddy’s serve regional and international markets.

Q3: How do regulations impact the availability of Condylox?
Regulatory approvals determine whether a supplier’s product can be marketed in specific countries. Stringent compliance with local and international standards ensures better market access.

Q4: Can I source Condylox directly from manufacturers?
Procurement typically occurs through authorized distributors or regional pharmacies. Direct sourcing requires meeting regulatory and quality assurance standards.

Q5: Are there regional alternatives to Condylox?
Yes, various countries' pharmaceutical companies produce podophyllotoxin formulations, which may serve as alternatives depending on local approvals and quality requirements.

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References

1. Mayne Pharma Annual Report 2022.
2. Contract manufacturing agreements disclosed in industry publications (2021).
3. Sun Pharmaceutical Industries Ltd. Product Portfolio.
4. Viatris (formerly Mylan) product listings.
5. Taro Pharmaceutical Industries Ltd. Market filings.
6. Dr. Reddy’s Laboratories Public Disclosures.
7. World Health Organization. Pharmaceutical Registration and Regulation Guidelines.