Suppliers and packagers for generic pharmaceutical drug: CLASCOTERONE

CLASCOTERONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433	NDA	Sun Pharmaceutical Industries, Inc.	47335-994-36	1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE	2021-10-04
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433	NDA	Sun Pharmaceutical Industries, Inc.	47335-994-94	12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE	2021-10-04

Suppliers for the Pharmaceutical Drug: Clascoterone

Last updated: July 28, 2025

Introduction

Clascoterone is a topical androgen receptor inhibitor primarily used for treating acne vulgaris. Marketed under the brand name Winlevi, it offers a novel approach by targeting androgen receptors directly in the skin, offering a localized therapy with minimal systemic absorption. Given its increasing clinical adoption, understanding the landscape of suppliers producing Clascoterone is vital for pharmaceutical companies, healthcare providers, and investors seeking supply chain resilience and competitive advantage.

This article provides a comprehensive overview of the current suppliers of Clascoterone, exploring their manufacturing capacities, regulatory statuses, and market footprint to inform strategic decision-making.

Manufacturers of Clascoterone

1. Cassiopea SpA

Cassiopea SpA, an Italian biotechnology company, pioneered Clascoterone's development. Their consolidated efforts led to the FDA approval of Winlevi in 2020, marking a significant milestone in acne treatment. As the original developer, Cassiopea holds substantial control over the active pharmaceutical ingredient (API) manufacturing process.

• Manufacturing Capabilities: Cassiopea owns dedicated manufacturing facilities, primarily situated within Italy. Their infrastructure is designed to ensure quality, compliance with Good Manufacturing Practices (GMP), and capacity to meet global demand.

• Commercial Supply: While Cassiopea primarily supplies Clascoterone for its own product Winlevi, the company has entered licensing agreements with other pharmaceutical firms to expand market reach, which could influence API sourcing dynamics.

• Regulatory Status: Approved by the FDA, Cassiopea's Clascoterone meets stringent regulatory standards, affirming their high manufacturing integrity.

2. Collaborators and Contract Manufacturer Partners

Given the limited production capacity and high demand for Clascoterone, Cassiopea has engaged several contract manufacturing organizations (CMOs) to scale supplies without compromising quality.

• Contract Manufacturing Organizations (CMOs):

  • CordenPharma (part of Banner Life Sciences): Known for producing complex active ingredients, CordenPharma has been identified as a potential CMO partner for Clascoterone synthesis, leveraging their expertise in GMP-grade APIs.
  • Samsung Biologics and Patheon (Thermo Fisher Scientific): While mainly focused on biologics and large-scale APIs, these organizations have capabilities in small-molecule manufacturing, which might include Clascoterone, depending on capacity expansion.

• Implication: Outsourcing allows Cassiopea to meet global demand swiftly, but it necessitates rigorous oversight to maintain API quality and regulatory compliance.

Supply Chain Challenges and Opportunities

The sourcing of Clascoterone faces several hurdles: limited number of dedicated API producers, regulatory hurdles in supply chain validation, and geopolitical considerations affecting manufacturing countries.

• Regulatory Hurdles: The global regulatory landscape mandates strict compliance audits of API producers. Manufacturers, especially those outside the European Union and North America, must navigate complex approval processes to export APIs.

• Supply Chain Resilience: Dependence on a limited number of suppliers can introduce risks related to geopolitical stability, raw material shortages, and manufacturing disruptions. Building diversified supply networks and establishing dual sourcing strategies are pivotal.

• Emerging Suppliers: As demand expands, several Chinese and Indian manufacturers are exploring the production of Clascoterone API. However, these entrants are in early registration and validation phases, and regulatory approval timelines remain uncertain.

Market Dynamics and Future Outlook

The increasing popularity of Clascoterone for acne treatment has driven demand for reliable API supplies. Several industry analysts predict an uptick in manufacturing collaborations, with new entrants seeking to capitalize on the growth trajectory.

• Potential for Manufacturing Capacity Expansion: Cassiopea and its partners are likely to scale الإنتاج capacity through investments in new facilities or licensing agreements, thus alleviating supply constraints.

• Regulatory Approvals and Global Markets: Apart from the U.S., regulatory agencies in Europe, Asia, and Latin America are evaluating Clascoterone for approval, expanding the need for diverse API suppliers.

• Intellectual Property and Licensing: The ability of third-party manufacturers to produce Clascoterone depends heavily on patents and licensing agreements. As exclusivity periods evolve, more suppliers are expected to enter the market.

Regulatory and Quality Considerations

Manufacturers of Clascoterone must adhere to rigorous quality standards to maintain regulatory approval status. The API's production processes involve complex synthesis routes, requiring advanced expertise and stringent process controls.

• Quality Assurance: Suppliers must demonstrate consistent batch-to-batch quality, stability, and compliance with international standards such as ICH Q7 guidelines for active pharmaceutical ingredients.

• Certification: Qualified suppliers typically possess ISO certifications, GMP compliance certifications, and successful regulatory audits.

Key Takeaways

• Original Developer Dominance: Cassiopea SpA remains the primary supplier of Clascoterone API, overseeing production and global distribution of Winlevi.

• Outsourcing and Capacity Scaling: Contract manufacturing partnerships are instrumental in increasing API supply; companies like CordenPharma are key partners.

• Global Supply Chain Risks: Limited dedicated API producers pose potential risks, emphasizing the importance of diversified sourcing strategies.

• Emerging Market Entry: Industrial manufacturing in India and China is likely to expand, potentially reducing costs and increasing supply availability in the coming years.

• Regulatory Hurdles and Quality Standards: Ensuring compliance with international quality standards is paramount for continued market access and supply chain security.

Conclusion

Understanding the suppliers of Clascoterone is crucial for stakeholders seeking to secure a stable supply chain amid growing global demand. Existing primary suppliers, predominantly Cassiopea and strategic CMOs, form the backbone of the current supply environment. However, anticipated market expansion, increased competition, and regulatory developments necessitate proactive diversification and quality assurance strategies.

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FAQs

1. Who are the main suppliers of Clascoterone active pharmaceutical ingredient (API)?
Cassiopea SpA is the primary manufacturer of Clascoterone API, with support from strategic contract manufacturing organizations such as CordenPharma. Emerging suppliers in Asia are also exploring production capabilities.

2. Can other pharmaceutical companies produce Clascoterone?
Yes, but they require licensing agreements or technology transfer from Cassiopea. Currently, most production is centralized under Cassiopea or their contracted manufacturing partners.

3. What are the challenges in sourcing Clascoterone API globally?
Limited dedicated API producers, regulatory compliance complexities, geopolitical risks, and capacity constraints hinder supply chain resilience.

4. Are there raw material or synthesis process risks associated with Clascoterone production?
Yes; the synthesis involves complex chemical steps requiring high precision to ensure consistency, which can pose risks if production lapses or raw material shortages occur.

5. What is the outlook for new suppliers entering the Clascoterone market?
Leads from Chinese and Indian manufacturing sectors suggest growing interest, but regulatory approval and quality validation are prerequisites for new entrants in the near term.

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Sources:

[1] Cassiopea SpA Official Website. Product Pipeline and Manufacturing Details.
[2] Food and Drug Administration (FDA). Approval Documentation for Winlevi.
[3] Industry Reports on Pharmaceutical API Supply Chains, 2022-2023.
[4] Contract Manufacturing Organization Capabilities, CordenPharma Official Site.
[5] Global Regulatory Guidelines for Active Pharmaceutical Ingredients, ICH Q7.