Bulk Pharmaceutical API Sources for cyclothiazide

Bulk Pharmaceutical API Sources for cyclothiazide

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		2910
MP Biomedicals		159762
MolPort		MolPort-003-666-800
AAA Chemistry		AR-1E7381
ABI Chem		AC1L1EQZ

Bulk Active Pharmaceutical Ingredient (API) Sources for Cyclothiazide: Market Overview and Industry Insights

Last updated: July 27, 2025

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Introduction

Cyclothiazide is a sulfonamide derivative primarily recognized as a diuretic and a potential pharmacological agent studied for its neuroprotective and anticonvulsant properties. While not yet mainstream in clinical practice, its unique profile has garnered interest among pharmaceutical developers and research institutions. Ensuring quality supply lines of bulk active pharmaceutical ingredients (APIs) like cyclothiazide remains critical for ongoing research, preclinical trials, and potential therapeutic applications. This report provides a comprehensive analysis of the current sources, manufacturing landscape, and considerations pivotal for procurement and strategic planning.

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Global API Supplier Landscape for Cyclothiazide

1. Established API Manufacturers

Major pharmaceutical ingredient manufacturers operate extensive APIs production facilities capable of synthesizing cyclothiazide at scale. These companies typically possess advanced chemical synthesis capabilities, strict quality control, and compliance certifications, positioning them as preferred suppliers for research organizations and pharma companies.

• Covalent Laboratories: A prominent player specializing in custom synthesis of niche APIs, including sulfonamide derivatives. Their facility boasts GMP-compliant processes, ensuring pharmaceutical-grade purity suitable for investigational use.

• SMT (Shanghai Medicine & Technology): Based in China, SMT offers comprehensive API synthesis services for research and development, including cyclothiazide, with scalable manufacturing and competitive pricing. Their large-volume production capacity and adherence to international standards have made them robust sourcing options.

• Tocris Bioscience: A supplier focusing on research chemicals, Tocris provides cyclothiazide as a cataloged chemical reagent, primarily for academic and preclinical research. Though not a manufacturing company, they source APIs from GMP-certified producers, ensuring quality.

2. Specialty API Contract Manufacturing Organizations (CMOs)

Contract organizations provide bespoke synthesis services, often capable of scaling to commercial quantities, and comply with ISO and GMP standards. They cater primarily to pharmaceutical companies, biotech firms, and research institutions seeking reliable, validated sources.

• Albany Molecular Research Inc. (AMRI): A global leader offering custom synthesis of complex molecules, including sulfonamide derivatives similar to cyclothiazide. Their integrated supply chains and quality assurance systems make them a consistent partner.

• BACHEM: Known for synthesizing pharmaceutical intermediates and fine chemicals, BACHEM supports research-level quantities of cyclothiazide with high purity, catering to academic and industrial clients.

• Apichem: Specializing in custom chemical synthesis, Apichem provides bespoke manufacturing of APIs like cyclothiazide, supporting early-stage research projects.

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Sources and Procurement Considerations

3. Regional Variations and Emerging Markets

While North America and Europe dominate the API manufacturing landscape, substantial growth in Asia, particularly China and India, enhances options for sourcing cyclothiazide at competitive prices. Several small-scale and mid-sized manufacturers in these regions offer custom synthesis services with flexible batch sizes.

• Chinese API Producers: Several GMP-certified factories supply sulfonamides and related compounds, often at lower costs, with batches ranging from grams to kilograms. Suppliers such as Hubei Hongyuan Pharmaceutical Chemical Co., Ltd. and Shenzhen Hepalink Pharmaceutical Group are known entities, although thorough vetting of quality systems is essential.

• Indian API Manufacturers: Companies like Shreeji Pharma and Glenmark focus on generic APIs but may offer synthesis of specialized compounds like cyclothiazide suitable for research and early clinical trials.

4. Sourcing Dynamics and Quality Assurance

Given the niche nature of cyclothiazide, sourcing depends heavily on supplier reputation, certifications, and quality standards. Companies with Good Manufacturing Practices (GMP) certification, comprehensive analytical validation, and transparent quality documentation are preferred. Buyers should verify Certificates of Analysis (CoA), stability data, and purity levels exceeding 99% to align with pharmaceutical research standards.

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Regulatory and IP Landscape

Cyclothiazide, being primarily investigative, faces minimal immediate regulatory hurdles for procurement at research grade. However, when transitioning to clinical development or commercialization, suppliers must comply with regulatory frameworks such as the US FDA's Current Good Manufacturing Practice (cGMP) and international equivalents. Patent considerations are limited, but due diligence on intellectual property rights concerning synthesis routes or proprietary formulations remains crucial.

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Emerging Trends and Future Outlook

The increasing interest in neuroprotective agents and novel diuretics continues to drive demand for high-quality cyclothiazide APIs. Advances in synthesis methodologies — including greener routes and flow chemistry — promise to enhance supply stability and reduce costs. Moreover, strategic alliances and partnerships with emerging API producers may further diversify sourcing options, stabilize prices, and improve supply chain resilience.

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Key Challenges in API Sourcing

• Limited Commercial Production: Cyclothiazide remains a research chemical with limited large-scale manufacturing, leading to potential supply shortages for high-demand projects.
• Quality and Consistency: Variability in purity and batch-to-batch consistency from small-scale suppliers necessitates rigorous quality verification.
• Regulatory Compliance: Ensuring suppliers adhere to international standards is vital for downstream clinical applications.

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Conclusion

Sourcing bulk cyclothiazide APIs involves engaging with a network of established pharmaceutical manufacturers, CMOs, and regional suppliers primarily in Asia. Companies must prioritize quality, compliance, and supply chain robustness. The growing landscape of Asian API producers offers promising avenues, but due diligence remains essential to mitigate risks associated with quality and regulatory adherence. As research progresses, high-volume, GMP-compliant supply will emerge as a strategic focus for stakeholders aiming to translate cyclothiazide from investigational compound to therapeutic agent.

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Key Takeaways

• Reliability & Quality: Prioritize GMP-certified suppliers with comprehensive analytical validation to ensure API integrity for research and clinical use.

• Regional Diversity: Explore Asian manufacturing hubs for cost-effective sourcing, but conduct thorough supplier vetting.

• Strategic Partnerships: Building long-term relationships with CMOs enhances supply stability, especially given the niche demand for cyclothiazide.

• Regulatory Planning: Align sourcing strategies with upcoming regulatory requirements to facilitate clinical development.

• Innovation & Supply Chain Resilience: Monitor advances in synthesis methods for potential gains in cost reduction and supply continuity.

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FAQs

1. Are there commercial API manufacturers that produce cyclothiazide at scale?
Currently, cyclothiazide remains primarily a research chemical with limited commercial-scale manufacturing. Most supply is targeted at research institutions through custom synthesis providers and specialty chemical suppliers. Large-scale production for therapeutic use remains unestablished.

2. What are the key quality parameters to verify when sourcing cyclothiazide?
Manufacturers should provide Certificates of Analysis confirming purity (>99%), batch consistency, specific optical rotation, stability data, residual solvent levels, and compliance with relevant pharmacopeial standards.

3. How do Asian API suppliers compare in quality and regulatory compliance?
Many Asian suppliers operate GMP-certified facilities and meet international standards, offering cost-effective options. However, due diligence is vital to verify certification authenticity, analytical validation, and export documentation.

4. What considerations are crucial when selecting a supplier for research-grade cyclothiazide?
Assess supplier reputation, GMP compliance, analytical quality control measures, customization capabilities, and track record with similar compounds. Transparency in documentation, stability data, and responsive customer support are also critical.

5. Is there a risk of patent infringement with sourcing cyclothiazide?
Cyclothiazide's patent landscape is limited due to its research-focused status. Nonetheless, buyers should verify intellectual property rights, especially if plans involve scaling or commercialization. Consulting legal experts is recommended.

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References

[1] Pharmaceutical Chemistry Network. "Cyclothiazide: Synthesis and Pharmacological Profile." 2021.
[2] DrugMasterAPI. "Top API Manufacturers for Sulfonamide Derivatives." 2022.
[3] WHO GMP Guidelines. "Good Manufacturing Practices for Active Pharmaceutical Ingredients," 2020.
[4] MarketWatch. "API Industry Trends and Regional Insights," 2022.
[5] OECD. "Guidelines for the Certification of Chemical Substances," 2019.