Bulk Pharmaceutical API Sources for FURAZOLIDONE

Bulk Pharmaceutical API Sources for FURAZOLIDONE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F9505_SIGMA
Biosynth		F-8900
NovoSeek		3435
NovoSeek		5323714
Vitas-M Laboratory		STK388219
ISpharm		I05-0078

Bulk Active Pharmaceutical Ingredient (API) Sources for Furazolidone

Last updated: July 28, 2025

Introduction

Furazolidone is a synthetic nitrofuran derivative historically used as an antimicrobial agent in veterinary medicine and in certain human infections. Despite declining use due to safety concerns and regulatory restrictions, the demand for bulk active pharmaceutical ingredients (APIs) such as furazolidone persists in some regions. Its manufacturing and sourcing are highly regulated, given the potential for residual toxicity and environmental impact. This article provides a comprehensive overview of current API sources for furazolidone, including primary manufacturers, geographic considerations, and regulatory factors influencing supply chains.

Overview of Furazolidone API Manufacturing

The synthesis of furazolidone involves complex chemical processes that require specialized facilities adhering to good manufacturing practices (GMP). Historically, several manufacturers in Asia—primarily China, India, and other developing countries—have emerged as major suppliers due to their lower manufacturing costs and established chemical manufacturing infrastructure. However, the regulatory landscape, especially within the European Union and the United States, has progressively restricted or banned furazolidone use owing to potential genotoxicity and carcinogenicity concerns, thereby impacting the API supply chain.

Major API Producers and Suppliers

1. Chinese API Manufacturers

China remains the dominant player in the production of furazolidone API, with multiple companies registered under various pharmaceutical licensing authorities. Chinese firms often supply both as finished APIs to local markets and as wholesale raw materials to international stakeholders. Notable producers include:

• Shandong Lukang Pharmaceutical Co., Ltd.
  Known for producing a broad spectrum of antibiotics and APIs, including furazolidone. The company operates under strict GMP compliance and exports globally, primarily to Asia, Africa, and South America.

• Haidian Pharmaceutical Group
  An established manufacturer with decades of experience in nitrofuran derivatives, offering high-purity furazolidone APIs. Their products meet ISO standards and are exported after rigorous quality control assessments.

• Fujian Gutian Medicinal Chemical Co., Ltd.
  Specializes in chemical synthesis of APIs, including furazolidone, with an emphasis on quality assurance and regulatory compliance in domestic and international markets.

2. Indian API Manufacturers

India’s API sector has a significant footprint in the global pharmaceutical supply chain. Although stricter regulations have curtailed the use of certain nitrofuran antibiotics domestically, some Indian firms continue to manufacture and export furazolidone API, mainly in generic or bulk form.

• Glenmark Pharmaceuticals
  While primarily focused on other pharmaceutical products, Indian API producers like Glenmark have historically supplied furazolidone for export, depending on regional regulations.

• AstraZeneca India Ltd.
  Although more prominent for branded pharmaceuticals, they possess facilities capable of producing and exporting APIs including furazolidone under controlled and compliant circumstances.

3. Other Regional Suppliers

• Pakistan and Bangladesh
  These countries have emerging API manufacturing sectors producing furazolidone for regional markets. However, supply stability and regulatory adherence remain variable.

• Vietnam and Thailand
  Certain chemical production firms in Southeast Asia manufacture nitrofuran derivatives including furazolidone. However, their export documentation and API purity standards require thorough vetting.

Regulatory Environment and Impact on API Supply

Global Regulatory Restrictions

Global health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have imposed bans or restrictions on furazolidone due to its carcinogenic potential and residues in animal food products. For instance, the EU banned furazolidone in animal feed in 2002, and the FDA prohibited its use in food-producing animals in 1993. Consequently, API manufacturers have scaled back or ceased production in regulated markets, leading to a constrained supply chain primarily serving non-regulated regions.

Compliance and Quality Standards

API suppliers targeting international markets must adhere to GMP and ISO standards, with strict documentation of purity, residual solvent levels, and contaminant testing. Due to safety concerns, many regulatory agencies require comprehensive toxicology data and residue analysis, further restricting API availability from non-compliant or uncertified sources.

Supply Chain Considerations

• Supply Reliability:
  The concentration of API manufacturing in China and India implies a certain dependency on regional factors such as labor policies, environmental regulations, and geopolitical stability. Disruptions, whether due to environmental regulations or trade disputes, can impact API availability.

• Pricing and Market Dynamics:
  The lower manufacturing costs in China and India translate to competitive pricing. However, ongoing regulatory restrictions could elevate costs as manufacturers seek to ensure compliance with new safety standards.

• Verification and Due Diligence:
  Buyers should conduct rigorous supplier verification, including audits, batch validation, and certification review, especially given the potential for counterfeit or substandard APIs in less regulated regions.

Future Outlook

The future of furazolidone API supply appears constrained, with supply chains narrowing due to regulatory bans in key markets and declining demand. Nonetheless, regional demand persists in areas with less stringent regulations, often supplied directly from Chinese and Indian manufacturers. Development of alternative antimicrobial agents with safer profiles is likely to further diminish API demand over the coming decade.

Key Takeaways

• The primary global API sources for furazolidone originate from China and India, with additional regional suppliers in Southeast Asia and South Asia.
• Regulatory restrictions notably in the EU and US significantly limit the global supply of furazolidone API.
• Manufacturers adhering to GMP and international standards are preferred, but vigilance is necessary due to counterfeit risk and variable quality.
• Supply chain stability depends on regional political and environmental factors, with potential for disruptions given regulatory and safety concerns.
• The market for furazolidone API is expected to decline further as safer alternatives and regulatory restrictions limit its use.

FAQs

1. Is furazolidone still available from API manufacturers globally?
Yes, primarily from Chinese and Indian producers, especially for regions with less restrictive regulations. However, its availability is diminishing due to safety concerns and regulatory bans.

2. Which countries are the main importers of furazolidone API?
Asian, African, and some South American countries continue to import furazolidone API for veterinary and limited human applications, often from Chinese and Indian manufacturers.

3. What are the risks associated with sourcing furazolidone API from non-regulated sources?
Risks include substandard purity, contaminant presence, counterfeit products, and regulatory non-compliance leading to legal and safety issues.

4. How can buyers ensure quality when sourcing furazolidone API?
By vetting suppliers thoroughly, requesting GMP certificates, batch testing results, and performing or commissioning independent analytical testing.

5. Are there alternatives to furazolidone with safer profiles?
Yes, newer antibiotics and antimicrobial agents with better safety profiles are available. The shift towards these alternatives is driven by regulatory pressures and toxicity concerns.

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Sources:

[1] World Health Organization (WHO). Regulations and safety concerns regarding nitrofuran derivatives.
[2] U.S. Food and Drug Administration (FDA). Restrictions on use of furazolidone in food animals.
[3] European Medicines Agency (EMA). Bans on nitrofuran antibiotics, including furazolidone.
[4] Global API manufacturing reports and market analyses.
[5] Industry-specific regulatory compliance guidelines and GMP standards.

Note: This article synthesizes information from publicly available sources up to 2023 and is intended for informational purposes for industry professionals.