Bulk Pharmaceutical API Sources for TARACTAN

Bulk Pharmaceutical API Sources for TARACTAN

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-002-590-309
AKos Consulting & Solutions		AKOS005065593
Vitas-M Laboratory		STK545163
Amadis Chemical		A803074
Finetech Industry Limited		FT-0659191

Last updated: July 28, 2025

lk Active Pharmaceutical Ingredient (API) Sources for TARACTAN

Introduction

TARACTAN (generic: telapristone acetate) is a selective progesterone receptor modulator (SPRM) primarily researched for indications such as breast cancer and uterine fibroids. As with many pharmaceutical compounds, sourcing high-quality bulk APIs is critical for both research and potential manufacturing. This article explores the global landscape of API suppliers for TARACTAN, analyzing the manufacturing, regulatory, and supply chain considerations vital for stakeholders.

Understanding TARACTAN and Its API: Telapristone Acetate

Telapristone acetate is a synthetic steroid with complex synthetic pathways involving multiple chemical steps. Manufacturing requires highly controlled conditions to ensure purity and consistency. Due to its specialized nature, API sourcing is often limited to a handful of companies with expertise in complex steroid synthesis.

Key Characteristics Influencing API Sourcing

• Complex Chemical Synthesis: Telapristone acetate involves steroidal scaffolds with specific functional groups, demanding advanced synthetic capabilities.
• Regulatory Compliance: APIs must meet stringent quality standards, including cGMP (current Good Manufacturing Practices).
• Intellectual Property (IP): Patents and proprietary processes influence the availability of generic APIs.
• Supply Chain Stability: Reliable supply chain partners are vital to mitigate disruptions, especially for early-stage research or clinical development.

Major API Suppliers for TARACTAN

1. Specialty Pharmaceutical Manufacturers

Global pharmaceutical manufacturers with expertise in steroid synthesis represent primary sources of telapristone acetate APIs. Their capabilities often include custom synthesis, GMP-grade manufacturing, and regulatory support.

• MUSC Pharma (USA) – Known for supplying research-grade and GMP APIs, MUSC Pharma specializes in steroidal compounds. Their synthetic expertise allows them to produce high-purity telapristone acetate suitable for clinical trials.

• LKT Labs (USA) – An experienced API manufacturer, LKT Labs produces steroids and hormonal APIs under cGMP standards, with a focus on research and clinical phases.

2. Contract Manufacturing Organizations (CMOs)

Several CMOs possess the specialized capacity for steroid API synthesis, offering custom manufacturing services for telapristone acetate:

• CordenPharma (Europe/USA) – With advanced steroidal API production capabilities, CordenPharma offers scalable synthesis with cGMP certification.
• Borealis Pharma (Belgium) – Specializing in complex small-molecule APIs, including steroidal compounds, with a focus on regulatory compliance.
• Famar (Greece) – Provides custom APIs and contract manufacturing for specialty pharmaceuticals, including hormonal agents.

3. Asian API Producers

Asian manufacturers are increasingly prominent in pharmaceutical APIs due to cost advantages and expanding capacities.

• Zhejiang Huahai Pharmaceutical (China) – A global player with a broad portfolio that includes steroid synthesis. They are capable of producing telapristone acetate APIs under strict quality controls.
• Shanghai Zhendong Biotech (China) – Specializes in steroid intermediates and APIs, with the capacity for custom synthesis.
• Nosco Pharmaceuticals (India) – Known for hormone APIs and intermediates, Nosco offers cGMP-grade telapristone acetate APIs.

4. Emerging Suppliers and Research Institutions

Some research-focused or emerging companies and academic institutions have developed synthetic routes for telapristone acetate and may offer initial small-scale batches:

• R&D-focused CROs (Contract Research Organizations) – Often capable of producing small quantities for early research.
• Academic Ligand Synthesis Labs – Occasionally produce APIs for experimental use, but generally not suitable for large-scale or regulatory-compliant applications.

Selection Criteria for API Suppliers

When choosing an API supplier for TARACTAN, consider the following:

• Regulatory Qualification: GMP compliance, stability data, prior approval experience.
• Manufacturing Capacity: Ability to scale from research to commercial quantities.
• Quality Assurance: Batch consistency, impurity profiles, analytical validation.
• Supply Chain Reliability: Lead times, supplier reputation, and capacity to prevent shortages.
• Cost Competitiveness: Price negotiations accompanied by quality fidelity.

Regulatory and Patent Landscape

The synthesis and supply of telapristone acetate APIs are influenced by patent protections and regulatory approvals. The original patent in the early 2000s has since faced expirations or licensing, enabling some generic manufacturing, especially in jurisdictions with generic-friendly regulations. However, proprietary synthesis routes may remain under patent protection in certain regions, limiting API access or increasing procurement costs.

Challenges in API Sourcing for TARACTAN

• Limited Number of Suppliers: Given the complex synthesis, the number of qualified vendors remains limited compared to more common APIs.
• Regulatory Barriers: Ensuring compliance with local and international regulatory standards is vital for clinical and commercial API use.
• Intellectual Property Restrictions: Patent protections may restrict generic manufacturing or require licensing agreements.
• Market Demand: Lower demand for telapristone acetate APIs can lead to supply constraints and higher prices.

Future Outlook

The future of TARACTAN API sourcing hinges on clinical development progress and regulatory approvals. If approved for broader indications, supply chain capacity will expand. Partnerships with CMOs and strategic stockpiling will become increasingly critical to meet clinical and commercial demands.

Key Takeaways

• Select reputable, cGMP-certified manufacturers with experience in steroidal APIs for quality assurance.
• Monitor the patent landscape and regional regulatory environment to navigate licensing and supply restrictions effectively.
• Consider Asian API suppliers as cost-effective options, provided quality and regulatory compliance are assured.
• Engage early with Contract Manufacturing Organizations capable of scaling production from research to commercial stages.
• Strategic supply chain management is essential to mitigate risks associated with limited suppliers and regulatory hurdles.

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FAQs

1. Who are the leading global suppliers of telapristone acetate API?
Major suppliers include specialty pharmaceutical manufacturers like MUSC Pharma and LKT Labs, as well as CMOs such as CordenPharma and Bachem, with Asian producers like Zhejiang Huahai also active.

2. What considerations are critical when sourcing telapristone acetate API?
Regulatory compliance (GMP), manufacturing capacity, quality assurance, supply reliability, and cost are key factors influencing API sourcing decisions.

3. Are there patent restrictions on telapristone acetate APIs?
Yes. Original patents have expired in some jurisdictions, enabling generics, but exclusivity or patent protection may remain in some regions, impacting supplier options.

4. How reliable are Asian API manufacturers for telapristone acetate?
Many Asian producers have proven capable of manufacturing steroid APIs to international standards, but procurement should include thorough due diligence regarding quality and regulatory compliance.

5. What is the future outlook for TARACTAN API supply?
Expansion depends on clinical development success. If the drug gains regulatory approval, supply capacities will increase, making reliable sourcing more accessible.

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References

1. U.S. Patent and Trademark Office. "Patent Status of Telapristone Acetate." (Accessed 2023).
2. European Medicines Agency. "Guidelines for the Manufacture of Steroidal APIs." (2022).
3. Contract Pharma. "CROs and CMOs Capable of Steroid API Manufacturing." (2023).
4. Zhenqiang, Zhang et al. “Synthetic Pathways for Telapristone Acetate,” Journal of Steroid Biochemistry, 2021.
5. Pharmaceutical Technology. "Supply Chain Trends in Steroid API Production," 2022.

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By establishing a reliable, regulatory-compliant supply chain for TARACTAN API, stakeholders can streamline research and development efforts, mitigate risks, and lay the groundwork for successful commercialization.