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Bulk Pharmaceutical API Sources for TROGLITAZONE
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Bulk Pharmaceutical API Sources for TROGLITAZONE
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Sigma-Aldrich | ⤷ Start Trial | T2573_SIGMA | ⤷ Start Trial |
| Calbiochem | ⤷ Start Trial | 648469 | ⤷ Start Trial |
| NovoSeek | ⤷ Start Trial | 5591 | ⤷ Start Trial |
| ISpharm | ⤷ Start Trial | I14-1977 | ⤷ Start Trial |
| MolPort | ⤷ Start Trial | MolPort-003-666-725 | ⤷ Start Trial |
| ABI Chem | ⤷ Start Trial | AC1L1KOT | ⤷ Start Trial |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk Active Pharmaceutical Ingredient (API) Sources for Troglitazone
Troglitazone, a thiazolidinedione class drug previously used for type 2 diabetes, was withdrawn from the market due to safety concerns. Its bulk API sourcing involves identifying reliable manufacturers with the capacity to produce pharmaceutical-grade compounds adhering to regulatory standards.
Manufacturers and Suppliers of Troglitazone API
Certified API Suppliers
Few suppliers currently produce troglitazone API, primarily for research and legacy manufacturing purposes. Sourcing from these suppliers requires validation of Good Manufacturing Practice (GMP) compliance.
| Supplier Name | Location | Certification | Production Capacity | Notes |
|---|---|---|---|---|
| TCI Chemicals | Japan | GMP, ISO 9001 | Limited capacity | Supplies for research use only |
| Toronto Research Chemicals | Canada | Non-GMP, Research | Small scale | Focuses on research quantities |
| LGM Pharma | United States | GMP | Limited | Offers custom synthesis for limited batches |
| Target Molecule Corp | China | GMP, ISO 9001 | Modest capacity | Provides bulk API for global markets |
Market Landscape
- Research-Grade Vendors: Offer small quantities, suitable for preclinical trials or laboratory research.
- GMP-Certified Manufacturers: Enable commercial production but are scarce for troglitazone due to market withdrawal.
- Custom Synthesis Firms: Can produce batches on demand; often operate under confidentiality agreements.
Sourcing Challenges
- Regulatory Restrictions: Use of troglitazone API is restricted for clinical development or research, limiting manufacturer's willingness to produce.
- Market Discontinuation: Market withdrawal minimized production, leading to limited supply availability.
- Quality Assurance: Due to safety concerns, strict verification of purity and adherence to GMP standards is mandatory.
Regulatory and Compliance Considerations
- GMP Compliance: Sourcing from suppliers with GMP certification reduces regulatory risks.
- Exportation Restrictions: Certain jurisdictions impose export controls on APIs linked to discontinued or withdrawn drugs.
- Documentation: Certificates of Analysis (CoA) and batch records are essential for validation of API quality.
Alternative Sources and Routes
- Repurposing or Resynthesis: Some companies may resynthesize troglitazone for research, but such processes can be complex and costly.
- Ingredient Repositories: Academic institutions and research consortia occasionally maintain stocks, usually for non-commercial use.
Market Outlook
- Limited Commercial Demand: Decline in clinical use reduces procurement activity.
- Research Applications: Still used in specialized laboratory research, maintaining a niche supply market.
- Potential for Toxicology Studies: Limited API available for toxicity evaluations or legacy drug research.
Summary
Sourcing troglitazone API entails navigating a fragmented supply chain dominated by small research vendors and a handful of GMP-certified manufacturers. Market discontinuation and safety issues limit commercial production, making procurement primarily suitable for research or limited pharmacological investigations.
Key Takeaways
- Troglitazone API is mainly available for research and legacy purposes.
- Few GMP-certified suppliers operate due to market withdrawal.
- Quality verification remains critical when sourcing from non-commercial vendors.
- Regulatory restrictions influence supply dynamics, especially for export and use.
- Alternative synthesis routes are limited and costly.
FAQs
1. Why was troglitazone withdrawn from the market?
It was withdrawn because of safety concerns, primarily due to hepatotoxicity linked to its use.
2. Are there GMP-certified vendors selling troglitazone API today?
Few vendors provide GMP-grade troglitazone API, mostly for research purposes; large-scale commercial production has ceased.
3. Can I source troglitazone API for clinical trials?
Only if the supplier complies with GMP standards and regulatory approval, which is challenging given the drug's market withdrawal status.
4. How can I verify the quality of troglitazone API?
Request Certificates of Analysis, review batch documentation, and conduct independent testing if necessary.
5. Are there substitutes for troglitazone in research?
Other thiazolidinediones like pioglitazone and rosiglitazone may serve as alternatives depending on the research application.
References
[1] U.S. Food and Drug Administration. (2000). Final rule: Withdrawal of troglitazone (Rezulin). https://www.fda.gov/
[2] European Medicines Agency. (2000). Scientific discussion on troglitazone. https://www.ema.europa.eu/
[3] Toronto Research Chemicals. (2023). Troglitazone high-purity API supplier info. https://trcfrom.com/
[4] LGM Pharma. (2023). Custom synthesis of APIs. https://lgmpharma.com/
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