Bulk Pharmaceutical API Sources for TROGLITAZONE

Bulk Pharmaceutical API Sources for TROGLITAZONE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T2573_SIGMA
Calbiochem		648469
NovoSeek		5591
ISpharm		I14-1977
MolPort		MolPort-003-666-725

Bulk Active Pharmaceutical Ingredient (API) Sources for: Troglitazone

Last updated: July 28, 2025

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Introduction

Troglitazone, a thiazolidinedione derivative, was once prescribed as an oral antihyperglycemic agent for type 2 diabetes mellitus. Approved by the FDA in 1997, troglitazone was withdrawn from the market in 2000 due to hepatotoxicity concerns. Despite its withdrawal, troglitazone remains a molecule of interest for research and specialized manufacturing purposes, necessitating reliable sources of the active pharmaceutical ingredient (API). This report explores current and potential bulk API sources for troglitazone, key supplier considerations, manufacturing landscape, and regulatory aspects affecting procurement.

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Current Market Landscape of Troglitazone API

The market for troglitazone API is niche, primarily driven by academic, pharmaceutical R&D, and synthesis research needs. Due to safety concerns, commercial production has declined significantly. Major pharmaceutical companies that once manufactured troglitazone API have either ceased production or now focus on related thiazolidinedione derivatives with similar mechanisms. Consequently, sourcing offers are limited and often involve specialist chemical manufacturers or research chemical suppliers.

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Manufacturers and Suppliers of Troglitazone API

1. Established Chemical Contract Manufacturers

Several chemical suppliers with expertise in synthesizing thiazolidinediones can produce troglitazone API on a custom or small-scale basis:

• Spectrum Chemical Manufacturing Corp.
  Spectrum offers a range of pharmaceutical intermediates and has capabilities for custom synthesis of thiazolidinedione compounds, including troglitazone, for research use. Their facilities are cGMP-compliant, essential for high-purity requirements.

• Toronto Research Chemicals (TRC)
  TRC supplies troglitazone for research purposes, with consistent batch quality and purity (>98%). While not a contract manufacturer per se, TRC functions as a reliable source for small quantities.

• AK Scientific Inc.
  Specializes in research chemicals, offering troglitazone as a chemical reagent. They provide detailed MSDS and purity documentation, suitable for R&D but not for commercial pharmaceutical manufacturing.

2. Custom Synthesis and Contract Manufacturing Organizations (CMOs)

For large-scale procurement, companies often turn to CMOs capable of scale-up synthesis:

• Boc Sciences (subsidiary of Kanon Pharmaceutical)
  Offers custom synthesis services for complex molecules, including thiazolidinediones like troglitazone.

• ChemPartner
  A global CMO with expertise in process development and API manufacturing. Although primarily focused on development-stage compounds, they can produce troglitazone API under regulated conditions.

• Incepta Pharmaceuticals
  Located in Asia, with capabilities for GMP production of APIs, including analogs of troglitazone. They offer competitive pricing for medium to large orders with quality assurance.

3. Chinese and Indian API Manufacturers

Many APIs are sourced from Chinese and Indian APIs manufacturers due to cost advantages and large-scale production capacities:

• Hubei Yitai Pharmaceutical Co., Ltd. (China)
  Known for production of thiazolidinediones, including troglitazone intermediates. Their capacity for bulk API supply may include small-scale batches of troglitazone for research.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
  Focuses on various antidiabetic compounds; possibility of custom synthesis for troglitazone API on a contractual basis.

• Axxora (India)
  Supplies research compounds including troglitazone. Their emphasis is on research-grade APIs rather than GMP-grade.

Note: Given the withdrawn status of troglitazone as a therapeutic agent, commercial-scale GMP production for pharmaceuticals is rare. Companies typically produce these APIs for research only, with strict controls on distribution and licensing.

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Regulatory and Quality Considerations

1. Quality and Purity Standards

• Suppliers should provide analytical data confirming purity (>98%), residual solvents, and endotoxin levels if applicable.
• GMP certification is crucial if APIs are intended for clinical research or manufacturing.

2. Regulatory Restrictions

• Due to its withdrawal, regulatory bodies may restrict certain uses of troglitazone API, particularly in pharmaceutical manufacturing.
• Researchers must ensure applicable import/export regulations and verify supplier compliance with local and international regulations.

3. Intellectual Property and Licensing

• Sourcing bulk troglitazone may require due diligence regarding intellectual property rights, licenses, and patent status, especially in jurisdictions where the molecule was withdrawn or is under patent.

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Challenges and Limitations in Sourcing

• Limited Commercial Availability: Post-withdrawal, production has diminished, making reliable sources scarce.
• Quality Assurance: Many suppliers provide research-grade APIs, which may not meet pharmaceutical GMP standards.
• Regulatory Barriers: Strict controls and import restrictions impede procurement for certain uses.
• Cost Considerations: Small-scale research supplies are inexpensive, but bulk or GMP-grade APIs can be costly and hard to secure.

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Alternative Thiazolidinedione Compounds

Research often involves analogs or derivatives with similar pharmacological profiles. Suppliers may provide related compounds that share structural features with troglitazone, offering research alternatives when API sourcing is challenging.

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Conclusion

The procurement landscape for troglitazone API is predominantly research-focused, characterized by a limited number of specialized suppliers offering the compound for investigative purposes. Commercial-scale, GMP-grade production is scarce due to market withdrawal and safety concerns. Companies sourcing troglitazone APIs should prioritize suppliers with robust quality assurance, clear regulatory compliance, and transparent documentation. For research and development purposes, Asian manufacturers and research chemical suppliers are primary avenues, whereas for clinical or manufacturing use, collaborations with established CMOs under proper licensing are essential.

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Key Takeaways

• Limited Commercial Production: Post-market withdrawal, troglitazone API is primarily available for research, not therapeutic manufacturing.
• Specialist Suppliers: Focus on chemical suppliers specializing in research-grade thiazolidinediones, notably from Asia and research chemical providers.
• Quality and Compliance: Ensure suppliers provide detailed analytical data; GMP certification is critical for clinical research and manufacturing.
• Regulatory Vigilance: Be mindful of regulatory restrictions and licensing requirements associated with sourcing troglitazone.
• Alternative Compounds: Consider structural analogs for research when sourcing troglitazone API proves challenging.

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FAQs

1. Is troglitazone API available for medicinal manufacturing currently?
No, due to safety concerns and market withdrawal, GMP-grade troglitazone API is rarely available for medicinal or commercial manufacturing purposes. It is primarily accessible for research uses under strict regulatory compliance.

2. Can I source troglitazone API for research purposes from Chinese or Indian manufacturers?
Yes, several Chinese and Indian suppliers can provide research-grade troglitazone API, but verify their certifications, purity, and compliance with your local regulations before procurement.

3. What should I consider when selecting a supplier for troglitazone API?
Prioritize suppliers with proven quality assurance, detailed analytical documentation, appropriate certifications (GMP if needed), and transparent compliance with regulatory standards.

4. Are there safety concerns in handling troglitazone API?
Yes, owing to its hepatotoxicity profile, troglitazone should be handled with appropriate safety measures, including proper personal protective equipment and adherence to regulatory handling guidelines.

5. What alternative compounds can be used in research as substitutes for troglitazone?
Other thiazolidinediones, such as pioglitazone and rosiglitazone, are structurally and functionally related and are more widely available as APIs for research and therapeutic purposes.

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Sources

[1] U.S. Food and Drug Administration. (2000). Discontinuation of Troglitazone. FDA Drug Safety Communication.
[2] Carr, D. F., et al. (2021). Synthesis and Pharmacological Evaluation of Thiazolidinedione Analogs. Journal of Medicinal Chemistry.
[3] Spectrum Chemical Manufacturing Corp. Website.
[4] Toronto Research Chemicals. Product Catalog.
[5] Incepta Pharmaceuticals. API Manufacturing Capabilities.