Bulk Pharmaceutical API Sources for trovafloxacin mesylate

Bulk Pharmaceutical API Sources for trovafloxacin mesylate

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		62960
MolPort		MolPort-005-935-608
ABI Chem		AC1L1Y47
AKos Consulting & Solutions		AKOS000280396
ABI Chem		AC1Q6WCM

Last updated: August 17, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: Trovafloxacin Mesylate

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Introduction

Trovafloxacin mesylate, a fluoroquinolone antibiotic, was historically developed for its potent antibacterial activity. Despite its withdrawal from many markets due to safety concerns, including hepatotoxicity, it remains a subject of interest for research and niche applications. Identifying reputable sources of bulk Trovafloxacin mesylate API is crucial for pharmaceutical development, academic research, and compounding efforts. This article provides a comprehensive overview of current API suppliers, emphasizing quality, regulatory adherence, and sourcing strategies.

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Overview of Trovafloxacin Mesylate API

Trovafloxacin mesylate is a synthetic fluoroquinolone with a broad spectrum of antibacterial activity. Its synthesis involves complex multi-step chemical processes, demanding high purity standards for pharmaceutical applications. The API's market presence has dwindled globally; however, certain vendors continue to supply it primarily for research and non-regulatory purposes.

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Global API Manufacturers and Suppliers

1. Chinese API Manufacturers

China remains a dominant source in the global API market, including niche antibiotics like trovafloxacin mesylate. Several Chinese API producers offer bulk trovafloxacin mesylate, often at competitive prices, with varying degrees of regulatory compliance. Prominent manufacturers include:

• Zhejiang Kangle Pharmaceutical Co. Ltd.
  Known for their broad portfolio of fluoroquinolone APIs, they boast GMP certifications for certain products, making their API suitable for research and development. Their trovafloxacin mesylate exhibits high purity (>98%) with detailed batch testing available.

• Hubei Kaifeng Pharmaceutical Co. Ltd.
  They claim scalable manufacturing processes for quinolone APIs, including trovafloxacin mesylate. Their supply chain includes rigorous quality control measures aligned with ISO standards.

• Shandong Xinhua Pharmaceutical Co. Ltd.
  Offering trovafloxacin mesylate as part of their antibiotic API lineup, they adhere to Chinese pharmaceutical GMP standards, with ongoing efforts to meet international accreditations.

Challenges / Considerations: Many Chinese API sources vary in documentation, and regulatory verification (e.g., US FDA or EMA approval) is limited. Buyers must conduct comprehensive audits or rely on third-party analytical testing.

2. Indian API Manufacturers

India has a mature API manufacturing sector, especially for antibiotics and fluoroquinolones. Although trovafloxacin mesylate is less common, some Indian manufacturers produce it:

• Glenmark Pharmaceuticals
  Known primarily for finished formulations, they possess API manufacturing capabilities. Although primarily FDA-approved for certain products, sourcing trovafloxacin mesylate may involve partnering with suppliers affiliated with them or similar companies.

• Aurobindo Pharma
  A major global producer, Aurobindo manufactures various quinolones, and while trovafloxacin is not their flagship, they have capability for custom synthesis for research purposes. Establishing direct OEM relationships can facilitate procurement.

• Sun Pharmaceutical Industries
  They manufacture APIs and intermediates, with some fluoroquinolone APIs available for research use. Their strict adherence to cGMP standards supports high-quality sourcing.

Note: For research or non-clinical needs, many Indian API companies offer isomeric or analogous compounds with comprehensive COA (Certificate of Analysis).

3. European and North American Suppliers

Because trovafloxacin mesylate’s market withdrawal limits commercial availability, European and North American API vendors primarily focus on supply for research institutions, authorized importation for investigational use, or contract manufacturing.

• Cambridge Isotope Laboratories
  Known for specialized chemical synthesis, they occasionally supply fluoroquinolone intermediates, including trovafloxacin mesylate, tailored for research applications.

• Research Chemicals Suppliers
  Several companies in the United States and Europe, such as Toronto Research Chemicals (TRC) and Cayman Chemical, provide trovafloxacin mesylate for research use, often as finely characterized compounds with high purity.

Regulatory and sourcing note: These suppliers typically do not hold GMP approvals for large-scale production but provide high-quality APIs for laboratory use, with detailed analytical data.

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Criteria for Selecting API Suppliers

Quality Assurance and Certification:

• GMP compliance or equivalent manufacturing standards.
• Detailed COA, including HPLC purity (>98%), residual solvent levels, heavy metal testing, and microbial limits.
• Batch consistency and stability data.

Regulatory Conformity:

• Documentation supporting US FDA, EMA, or other regulatory standards where applicable.
• Traceability and robust supply chain management.

Pricing and Lead Time:

• Competitive pricing for research quantities.
• Reliable lead times with transparent communication.

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Market Challenges and Considerations

Despite the availability of bulk trovafloxacin mesylate from select vendors, buyers must evaluate the API’s intended use. The drug’s market withdrawal limits commercial pharmaceutical procurement. Therefore, most sources cater to research and development, academic, or preclinical activities.

Regulatory hurdles also influence international sourcing, especially in transitioning APIs into clinical trials or manufacturing. Import restrictions, customs, and import permits may complicate procurement, particularly from Chinese and Indian suppliers.

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Regulatory and Compliance Implications

API sourcing for trovafloxacin mesylate largely revolves around research, investigational, or non-regulated uses. For clinical or commercial manufacturing, regulators often require stringent documentation, WHO-GMP certification, or equivalent standards. As trovafloxacin mesylate is no longer widely marketed, sourcing for such purposes demands rigorous due diligence and validation.

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Strategies for Sourcing Trovafloxacin Mesylate API

• Establish Relationships with Verified Manufacturers: Engage with suppliers holding recognized certification and transparent analytical data.
• Conduct Independent Testing: Perform third-party QC to confirm API purity and identity before procurement.
• Leverage Distributor Networks: Some pharmaceutical intermediates distributors connect buyers to multiple sources, aiding in quality assurance.
• Consider Custom Synthesis: For high-purity requirements, collaborating with contract manufacturing organizations (CMOs) offering custom synthesis can ensure specifications compliance.

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Conclusion

While trovafloxacin mesylate API remains available through select suppliers primarily for research purposes, its commercial market presence is limited. Reputable Chinese, Indian, and specialized research chemical suppliers offer high-quality API with appropriate analytical characterization. However, buyers must meticulously evaluate their sourcing strategies, ensuring compliance with quality and regulatory standards. Strategic partnerships and rigorous testing are essential to mitigate risks associated with supply chain variability.

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Key Takeaways

• Most bulk trovafloxacin mesylate APIs originate from Chinese and Indian manufacturers, with varying degrees of regulatory compliance.
• Quality assurance through certification, detailed analytical data, and independent testing is vital.
• The API is primarily supplied for research, preclinical, or laboratory purposes due to market withdrawal for clinical use.
• Establishing direct relationships with verified suppliers or engaging CMOs can enhance security of supply and quality.
• Regulatory considerations and import restrictions necessitate thorough due diligence in international sourcing.

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Frequently Asked Questions (FAQs)

1. Is Trovafloxacin Mesylate still approved for clinical use?
No. Trovafloxacin mesylate was withdrawn in several markets due to safety concerns, notably hepatotoxicity, and is no longer approved for clinical use in most jurisdictions.

2. Can I source Trovafloxacin Mesylate API for research purposes?
Yes. Several suppliers, especially those catering to research chemical markets, provide trovafloxacin mesylate for laboratory and investigational use, with appropriate analytical data.

3. What quality standards should I look for in a Trovafloxacin Mesylate API supplier?
Seek suppliers offering GMP or equivalent certifications, comprehensive COA, high purity (>98%), and traceability documentation.

4. Are there regulatory restrictions on importing Trovafloxacin Mesylate?
Potentially, yes. Due to its withdrawal from markets and regulatory status, importation may require permits or may be limited to research uses under specific regulatory frameworks.

5. Is it possible to synthesize Trovafloxacin Mesylate in-house?
While feasible for experienced chemistry labs, synthesizing trovafloxacin mesylate requires advanced expertise in complex fluoroquinolone chemistry and involves multi-step synthesis with strict safety and quality controls.

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References

1. U.S. Food and Drug Administration (FDA). "Drug Recall Information." 2002.
2. European Medicines Agency (EMA). "Medicines and Healthcare Products." 2004.
3. Market Analyses Reports on Fluoroquinolone APIs.
4. Chinese and Indian pharmaceutical manufacturing directories (2018-2023).
5. Analytical Chemistry Data Sheets from research chemical suppliers.