Bulk Pharmaceutical API Sources for trilostane

Bulk Pharmaceutical API Sources for trilostane

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		656583
MolPort		MolPort-003-850-727
Hangzhou APIChem Technology		AC-927
ABI Chem		AC1LCV8M
ChemMol		2101448

Bulk Active Pharmaceutical Ingredient (API) Sources for Trilostane

Last updated: July 28, 2025

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Introduction

Trilostane, a steroidal enzyme inhibitor primarily used in veterinary medicine for managing conditions such as hyperadrenocorticism (Cushing’s disease) in dogs, is gaining attention for its therapeutic efficacy. As demand for this API increases, understanding its global sourcing landscape becomes paramount for pharmaceutical companies, veterinary formulators, and contract manufacturers. Bulk sourcing strategies for trilostane encompass a spectrum from established chemical suppliers to emerging markets, with considerations around quality, regulatory compliance, cost, and reliability shaping procurement decisions.

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Overview of Trilostane API

Trilostane (4β,17α-Dihydro-3′-methyl-17β-hydroxyandrosta-1,4-diene-3,20-dione) is synthesized via complex chemical pathways involving multiple chemical intermediates. The API’s chemical stability, purity, and compliance with pharmacopeial standards (e.g., USP, EP, JP) influence sourcing choices. The global market for trilostane remains relatively niche but shows growth aligned with expanding veterinary therapeutic needs.

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Major API Suppliers for Trilostane

1. Established Multi-National Pharmaceutical Ingredient Producers

Several well-known multinational API manufacturers dominate the trilostane supply chain, often serving large pharmaceutical companies and contract manufacturing organizations (CMOs).

• BASF: A global leader in fine chemicals and pharmaceutical intermediates, BASF supplies high-quality trilostane for veterinary use, adhering strictly to international regulatory standards. Their manufacturing facilities in Europe and Asia ensure consistent supply.

• Hikal Ltd. (India): Recognized for producing veterinary APIs, Hikal offers trilostane contracted via licensing agreements with originators, with manufacturing sites compliant with USFDA and EMA standards. Indian suppliers provide competitively priced trilostane, though selection depends on regulatory acceptance.

• Aenova Group (Germany): Focuses on generic and livestock APIs, with trilostane offerings that meet European pharmacopeial standards. Their rigorous quality management systems ensure API compliance with global standards.

2. Contract Manufacturing Organizations and Custom API Manufacturers

• Shaanxi Top Pharm Chemical Co., Ltd. (China): This manufacturer specializes in veterinary APIs, including trilostane, providing tailored synthesis services with quality certifications such as ISO 9001.

• Suzhou Good Place Chemical Co., Ltd. (China): Offers development and bulk manufacturing of veterinary APIs, including trilostane. Emphasizes cost-effective production with adherence to international standards.

• West Midlands Pharmaceuticals (UK): Known for custom synthesis of steroidal APIs, including trilostane, with a focus on regulatory compliance and high-quality cGMP manufacturing.

3. Emerging Markets and Regional Suppliers

• Cayman Chemical (USA): Primarily supplies research-grade trilostane but occasionally offers GMP-grade APIs for animal health applications, serving as a bridge between research and production.

• Bio-Verde (India): An emerging manufacturer with growing capabilities in veterinary APIs, offering trilostane at competitive prices, though with varying regulatory clarity.

• Zhejiang Medicine Co., Ltd. (China): Engaged in steroidal API manufacturing, with some offerings in trilostane, primarily aimed at regional veterinary markets.

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Regulatory and Quality Considerations

Quality assurance remains central in API sourcing. Suppliers compliant with cGMP (current Good Manufacturing Practice), ISO standards, and possessing relevant certifications (e.g., GMP, DEA licensing for controlled substances if applicable) are preferred. For veterinary APIs like trilostane, regulatory approvals (FDA, EMA, APVMA in Australia) influence supplier selection, especially for export markets.

Traceability, robust documentation, and adherence to pharmacopeial specifications (e.g., USP, EP) ensure product integrity. Many suppliers provide Certificates of Analysis (CoA), stability data, and allergen statements to facilitate GMP compliance.

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Pricing and Supply Chain Dynamics

The cost of trilostane API varies significantly depending on the supplier’s location, scale, and purity standards. Indian and Chinese producers typically offer more competitive pricing due to lower manufacturing costs but may face additional regulatory scrutiny. European and North American suppliers, despite higher costs, often provide greater assurance regarding regulatory compliance and consistent quality, critical for pharmaceuticals with higher safety thresholds.

Supply chain reliability hinges on geopolitical stability, currency exchange rates, and geopolitical considerations affecting trade tariffs and import-export regulations. Diversifying sources across regions mitigates risks associated with supply disruptions.

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Emerging Trends in API Sourcing

• Increased Localized Production: Regulatory pressures and trade tariffs are incentivizing regional manufacturing of veterinary APIs like trilostane to ensure supply chain resilience.

• Digital Sourcing Platforms: Platforms such as PharmaCompass and ChemSpider facilitate supplier evaluation, providing real-time data on product availability, regulatory status, and quality certifications.

• Sustainability Drive: Suppliers emphasizing environmentally sustainable manufacturing processes are gaining favor among conscientious pharmaceutical companies.

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Summary of Key Sourcing Factors

Factor	Considerations
Regulatory Compliance	cGMP, pharmacopeial standards, GMP certification, approval status
Quality Assurance	CoA, stability data, impurity profiles
Pricing	Cost competitiveness balanced with quality assurance
Supply Reliability	Production capacity, lead times, geopolitical stability
Traceability & Documentation	Robust supply chain documentation, batch records

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Key Takeaways

• Major suppliers of trilostane API include multinational firms like BASF, Hikal, and Aenova, alongside Chinese and Indian regional manufacturers.
• Regulatory compliance, high purity standards, and supply chain robustness are critical factors when selecting an API source.
• Cost considerations often favor emerging markets; however, due diligence regarding quality and regulatory approval remains essential.
• Diversification of suppliers reduces risks associated with geopolitical and supply chain disruptions.
• The rising trend toward sustainable and transparent manufacturing practices influences sourcing decisions in the veterinary API sector.

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FAQs

1. What are the primary regions supplying trilostane API for veterinary use?
India, China, Europe, and North America are key regions, with India and China dominating due to cost-effective manufacturing, while Europe and North America emphasize regulatory compliance and quality.

2. How does regulatory compliance influence sourcing decisions for trilostane?
Suppliers with cGMP certification and approval from regulatory bodies (FDA, EMA) ensure high-quality API production, vital for veterinary and pharmaceutical applications.

3. Are there differences in quality standards among regional suppliers?
Yes. European and North American suppliers typically adhere to stricter regulations, whereas Indian and Chinese suppliers may vary but often meet pharmacopeial standards if properly audited.

4. What factors should companies consider when evaluating trilostane API suppliers?
Regulatory compliance, quality certifications, purity profiles, supply stability, cost, and documentation transparency.

5. Is there a trend toward regional manufacturing of veterinary APIs like trilostane?
Yes. To mitigate supply chain risks and meet localized regulatory requirements, companies are increasingly establishing regional manufacturing capacities.

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References

[1] PharmaCompass, “API Market Reports,” 2022.
[2] BASF, “Steroid Intermediates and APIs Portfolio,” 2022.
[3] Hikal Ltd., “Veterinary API Offerings,” 2022.
[4] European Pharmacopoeia, “Trilostane Monograph,” 2023.
[5] World Health Organization, “Veterinary Medicine Regulations,” 2021.