Bulk Pharmaceutical API Sources for ACETOHYDROXAMIC ACID

Bulk Pharmaceutical API Sources for ACETOHYDROXAMIC ACID

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		sJX`HLdmMAH`
Sigma-Aldrich		159034_ALDRICH
NovoSeek		1990
MP Biomedicals		100018
ISpharm		I08-0057

Bulk Active Pharmaceutical Ingredient (API) Sources for: Acetohydroxamic Acid

Last updated: July 28, 2025

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Introduction

Acetohydroxamic acid (AHA), also known as hydroxylamine O-acetylhydrazone, is a small-molecule pharmaceutical intermediate widely utilized in the synthesis of urease inhibitors and various therapeutic agents. Its unique chemical properties necessitate sourcing from specialized API manufacturers capable of maintaining high purity standards suitable for pharmaceutical applications. This article provides an in-depth analysis of existing bulk API sources for acetohydroxamic acid, highlighting key suppliers, manufacturing regions, and considerations for procurement.

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Overview of Acetohydroxamic Acid

Acetohydroxamic acid serves primarily as a urease inhibitor in medical research and therapeutic contexts, especially in urinary tract infections and related diseases. Its synthesis involves careful chemical handling due to its reactive hydroxamic functional group. Regulatory stringent quality standards, including Good Manufacturing Practice (GMP), influence sourcing decisions, emphasizing the importance of reliable suppliers with proven quality assurance.

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Global API Suppliers for Acetohydroxamic Acid

1. China-Based Manufacturers

China remains a dominant force in the bulk API market due to its extensive chemical manufacturing infrastructure. Several companies produce acetohydroxamic acid at scale, often supplying both domestic and international markets.

• Jiangsu Hualan Bio-Medical Co., Ltd.
  Specializes in custom synthesis of hydroxamic acids, including acetohydroxamic acid, with GMP certifications aligning with international regulatory standards. Their facilities emphasize strict quality control, and they cater to pharmaceutical and research institutions globally.

• Shandong Top Pharm Chemical Co., Ltd.
  Offers bulk API production with a focus on hydroxamic compounds. Their capacity includes large-scale synthesis and export to North America and Europe, adhering to ISO and GMP guidelines.

• Nanjing Chemlin Pharmaceutical Co., Ltd.
  Provides AMC-certified API manufacturing, including acetohydroxamic acid, emphasizing high purity (≥98%) suitable for pharmaceutical use.

2. Indian API Manufacturers

India's pharmaceutical industry has seen substantial growth, with many companies certified under WHO-GMP standards capable of producing acetohydroxamic acid.

• Ankur Drugs and Pharma Ltd.
  Offers acetohydroxamic acid in bulk quantities, primarily targeting the global market. Their manufacturing processes align with cGMP norms, ensuring regulatory compliance.

• S. R. Drugs & Pharmaceuticals Ltd.
  Provides custom synthesis and bulk supply of hydroxamic acids, including acetohydroxamic acid, with dedicated quality assurance processes.

• Hetero Labs Ltd.
  Known for a broad catalog of APIs, including intermediates for urease inhibitors, with established export channels and adherence to international standards.

3. European and North American Suppliers

European and North American companies mainly focus on specialized API production, often catering to regulated markets with stringent quality requirements.

• BASF SE (Germany)
  A global leader in specialty chemicals and pharmaceuticals, BASF produces certain hydroxamic acid derivatives, potentially including acetohydroxamic acid, under highly controlled GMP conditions.

• Thermo Fisher Scientific (USA)
  Offers custom API synthesis services and has the capacity for small to large-scale production, leveraging advanced manufacturing technology in compliance with regulatory standards.

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Key Considerations for Sourcing Acetohydroxamic Acid

Quality and Purity:
Pharmaceutical applications demand high-purity AHA, typically ≥98%, with certificates of analysis (CoA) verifying absence of impurities. Suppliers with validated GMP processes and ISO certifications are preferred.

Regulatory Compliance:
Manufacturers with documented compliance levels—e.g., FDA, EMA, or WHO-GMP certifications—reduce regulatory risk and facilitate international procurement.

Scalability and Reliability:
Capacity to supply bulk quantities reliably is critical. Long-term supplier relationships, with transparent production and quality control records, are advantageous.

Cost and Lead Time:
While quality remains paramount, competitive pricing and predictable lead times influence sourcing decisions. Suppliers from regions with robust chemical manufacturing infrastructure often provide more consistent supply chains.

Environmental and Ethical Practices:
Sustainable manufacturing practices and adherence to environmental standards ensure compliance with global regulations and corporate responsibility policies.

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Emerging Trends and Future Outlook

The global API market is increasingly moving toward outsourcing manufacturing to regions with cost advantages, like China and India. However, heightened regulatory scrutiny necessitates suppliers with proven quality management systems. Advances in green chemistry and process optimization are expected to improve yields, reduce costs, and minimize environmental impact for acetohydroxamic acid production.

Furthermore, with the surge in biopharmaceuticals and targeted therapies, demand for high-purity, scalable API sources for compounds like AHA is poised to increase. Companies investing in process innovation and regulatory compliance will likely become preferred partners in the global supply chain.

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Conclusion

Securing a reliable bulk API source for acetohydroxamic acid requires evaluating multiple factors, including quality assurance, regulatory compliance, manufacturing capacity, and cost. Major producers in China and India currently dominate the market, delivering high-quality API suitable for pharmaceutical use. European and North American suppliers, while potentially more expensive, offer rigorous compliance standards, vital for regulated markets.

Business professionals should prioritize establishing relationships with certified suppliers, verify batch consistency, and ensure supply chain robustness to mitigate risks associated with sourcing this specialized API.

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Key Takeaways

• Major global suppliers of acetohydroxamic acid include Chinese and Indian manufacturers with GMP certification.
• High purity (≥98%) and rigorous quality control protocols are essential for pharmaceutical-grade API.
• Regulatory compliance with agencies like FDA, EMA, or WHO-GMP enhances procurement confidence.
• Supplier reliability, production capacity, and environmental standards are crucial factors influencing sourcing decisions.
• Emerging trends favor process innovations and sustainability, impacting future API supply dynamics.

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FAQs

1. Is acetohydroxamic acid available from multiple suppliers globally?
Yes, primarily from China and India, with some European and North American companies offering specialized manufacturing that meets international regulatory standards.

2. What quality standards should I verify when sourcing AHA?
Look for GMP certification, a certificate of analysis indicating ≥98% purity, and compliance with relevant regulatory agencies like FDA or EMA.

3. Can I source acetohydroxamic acid in large bulk quantities?
Most established suppliers can provide bulk quantities ranging from kilograms to several tons, depending on your contractual arrangements.

4. What are the major risks in sourcing AHA internationally?
Potential risks include supply chain disruptions, quality inconsistencies, regulatory non-compliance, and intellectual property concerns.

5. Are there any ongoing innovations in acetohydroxamic acid manufacturing?
Yes, efforts focus on greener synthesis methods, process optimization for higher yields, and ensuring consistency to meet evolving pharmaceutical standards.

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References

1. [1] Market Research Reports on API manufacturing.
2. [2] Chemical and pharmaceutical supplier certifications and standards.
3. [3] Global API manufacturing capacity reports.
4. [4] Industry publications on hydroxamic acid derivatives.
5. [5] Regulatory agency guidelines for pharmaceutical API sourcing.

Note: Exact supplier details and capacity information should be verified through direct engagement with manufacturers or industry databases.