Bulk Pharmaceutical API Sources for CLASCOTERONE

Bulk Pharmaceutical API Sources for CLASCOTERONE

Vendor	Vendor Homepage	Vendor Sku	API Url
BioChemPartner		BCP9000062
MedChemexpress MCE		HY-13331
AbaChemScene		CS-1151

Bulk Active Pharmaceutical Ingredient (API) Sources for Clascoterone

Last updated: July 28, 2025

Introduction

Clascoterone is a topical androgen receptor inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of acne vulgaris. Its unique mechanism involves blocking androgen activity within the skin, thereby reducing sebum production and inflammation. As a relatively novel dermatological agent, sourcing high-quality bulk Active Pharmaceutical Ingredient (API) is critical for pharmaceutical manufacturers seeking to develop and commercialize Clascoterone-based products. This article examines global API suppliers, considerations for sourcing, and the strategic landscape for Clascoterone bulk API procurement.

Understanding Clascoterone and Its API Profile

Clascoterone, chemically known as cortexolone 17α-propionate, is a synthetic steroid with a specific affinity for androgen receptors (AR). The API's complexity stems from its steroidal structure and the necessity for high purity to ensure safety and efficacy in topical formulations. The synthesis process involves multi-step chemical reactions, typically requiring specialized manufacturing facilities with strict quality controls aligning with Good Manufacturing Practices (GMP).

Given its recent market entry, specific APIs for Clascoterone are sourced from a limited number of manufacturers capable of producing pharmaceutical-grade material at scale.

Global API Manufacturers and Suppliers for Clascoterone

1. Major Pharmaceutical APIs Manufacturers

While Clascoterone was developed by pharmaceutical companies such as Cassiopea (acquired by Ripple Therapeutics) and later marketed by Alba Therapeutics and its partners, the API synthesis remains highly specialized. As a novel compound, the bulk API is predominantly supplied by a limited set of high-capacity, GMP-compliant manufacturers with steroid synthesis expertise.

• Synthesis Expertise and Capabilities
  Manufacturers possessing advanced steroid chemistry capabilities are applicants for API production. They typically operate in Europe (notably Switzerland and Germany), Asia (India, China), and North America.

• Leading API Producers

  • Hikma Pharmaceuticals
  • Dr. Reddy’s Laboratories
  • Glenmark Pharmaceuticals
  • Cadila Healthcare
  • Cipla
  • Yungjin Pharmaceuticals (South Korea)
    These companies have the infrastructure for steroid synthesis and possess a history of supplying APIs for hormones and steroidal drugs, making them candidates for Clascoterone API production.

2. Specialty and Niche API Suppliers

Given the specificity of Clascoterone, some biotech and specialty chemical firms offer custom synthesis services for steroidal APIs:

• Lonza
• Avista Pharma Solutions
• BASF (through custom synthesis units)
• Capsugel (specialized in formulation but involved in API sourcing for steroidal compounds)

These companies provide tailored synthesis and have established GMP production pipelines for complex steroid molecules.

3. Contract Manufacturing Organizations (CMOs)

Contract manufacturers often partner with pharmaceutical firms to produce APIs at scale. Several reputable CMOs specializing in steroid synthesis have the capacity to produce Clascoterone API:

• Patheon (Thermo Fisher Scientific)
• Recipharm
• Aenova
• Famar

These organizations can manufacture bulk API under strict regulatory standards, providing a reliable supply chain.

Sourcing Considerations for Clascoterone API

Regulatory Compliance and Quality Standards

• GMP Certification: Essential, as APIs used in marketed pharmaceuticals require compliance with GMP guidelines from significant authorities such as the FDA, EMA, or PMDA.
• Certifications and Documentation: Certificates of Analysis (CoA), batch records, stability data, and process validation reports are mandatory for procurement.
• Traceability: Ensures API origin transparency and manufacturing history, critical for regulatory approval and quality assurance.

Manufacturing Capacity and Lead Time

• Scale and Demand: Assess manufacturers' capacity to meet current and future demand.
• Supply Guarantees: Agreements should cover supply continuity, contingency plans, and long-term contracts to mitigate shortages.

Cost Factors

• Pricing Structures: Price per kilogram varies based on API purity, batch size, and supplier location.
• Import Tariffs and Logistics: Consider shipping costs, customs duties, and import/export restrictions.

Intellectual Property and Licensing

• Patent Status: Confirm the patent landscape governing Clascoterone synthesis. As a relatively new drug, patent protection may still influence manufacturing and sourcing agreements.
• Licensing Agreements: In some cases, licensing rights or technology transfers are necessary to facilitate production.

Regional Market Dynamics

Asia-Pacific

India and China dominate steroid API manufacturing, offering cost advantages but requiring careful assessment regarding quality and regulatory compliance. Suppliers such as Dr. Reddy’s Labs, Hetero Labs, and Zhejiang Medicine are prominent.

Europe and North America

European and North American suppliers tend to emphasize high regulatory standards, offering APIs with superior documentation and GMP certifications. This can expedite regulatory approval processes for pharmaceutical products.

Emerging Suppliers and Future Trends

Emerging biotech firms and API brokers are progressively entering the Clascoterone supply chain, potentially providing more flexible, rapid, and cost-competitive options.

Challenges and Risks in API Sourcing

• Regulatory Risks: Ensuring supplier compliance with evolving international standards.
• Supply Chain Disruptions: Political, logistical, and pandemic-related disruptions can impact availability.
• Quality Variability: Variability among manufacturers necessitates rigorous qualification procedures.
• Intellectual Property: Navigating patent protections and licensing agreements remains complex.

Future Outlook and Strategic Recommendations

Given the increasing demand for topical androgen receptor inhibitors like Clascoterone, pharmaceutical companies should develop diversified sourcing strategies. Engaging with multiple GMP-certified suppliers can mitigate supply risks, while incorporating robust quality assessment processes ensures compliance.

Moreover, early engagement with experienced API manufacturers is crucial for establishing reliable supply chains that meet regulatory demands. Strategic alliances or licensing agreements with patent holders may also facilitate smoother commercialization pathways.

Key Takeaways

• Clascoterone API is produced by specialized, GMP-certified manufacturers with steroid chemistry expertise, predominantly located in India, China, Europe, and North America.
• Selecting API suppliers requires careful assessment of regulatory compliance, manufacturing capacity, quality standards, and cost considerations.
• Developing multiple supplier relationships and ensuring stringent qualification protocols mitigate supply chain risks.
• Staying aligned with evolving patent and licensing landscapes is vital for sustained API procurement and regulatory approval.
• Emphasizing high-quality, traceable API sources expedites time-to-market and enhances product integrity.

FAQs

1. Is Clascoterone API widely available from multiple suppliers?
Currently, supply is limited to select GMP-compliant manufacturers with steroid synthesis expertise. As market demand increases, additional suppliers are likely to emerge.

2. What quality standards should be required from Clascoterone API suppliers?
Suppliers must provide APIs manufactured under GMP conditions, with comprehensive Certificates of Analysis, stability data, and traceability aligning with international regulatory standards such as FDA or EMA.

3. How does patent status impact Clascoterone API sourcing?
Patent protections may restrict manufacturing rights and sourcing options. Licensing agreements or patent expirations influence supplier selection and cost structures.

4. Are there any regional preferences for sourcing Clascoterone API?
European and North American suppliers often offer higher transparency and regulatory assurance, whereas Asian suppliers can provide cost advantages but require careful quality validation.

5. What future trends could influence Clascoterone API sourcing?
Technological advancements in steroid synthesis, increased API manufacturing capacity, and evolving regulatory landscapes are poised to expand sourcing options, potentially reducing costs and lead times.

---

References

[1] U.S. Food and Drug Administration (FDA). Clascoterone topical (Winlevi) approval documents.
[2] GlobalPharma API Suppliers Directory 2022.
[3] European Medicines Agency (EMA). Good Manufacturing Practices (GMP) standards.
[4] Industry reports on steroid API manufacturing and market dynamics.
[5] Patent landscape analyses for androgen receptor inhibitors.