Bulk Pharmaceutical API Sources for ANTABUSE

Bulk Pharmaceutical API Sources for ANTABUSE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		86720_ALDRICH
TCI (Tokyo Chemical Industry)		B0479
Molport		MolPort-001-792-519
Vitas-M Laboratory		STL069539

Bulk Active Pharmaceutical Ingredient (API) Sources for: ANTABUSE

Last updated: July 28, 2025

Introduction

Disulfiram, commercially known as ANTABUSE, is a widely prescribed medication for alcohol dependence treatment. As an important pharmaceutical compound, its supply chain robustness hinges on reliable sources of bulk Active Pharmaceutical Ingredient (API). Ensuring the availability of high-quality, compliant APIs is critical for manufacturers, regulatory bodies, and healthcare providers. This article provides an authoritative overview of bulk API sources for ANTABUSE, analyzing key sourcing regions, manufacturers, quality considerations, and supply chain trends.

Understanding Disulfiram (ANTABUSE) API

Disulfiram operates as an aldehyde dehydrogenase inhibitor, producing aversive reactions when alcohol is consumed. The API's synthesis involves complex organic reactions, primarily the carbamide route, with stringent quality standards for pharmaceutical applications (USP, Ph. Eur., and other pharmacopeias). Given its therapeutic importance, APIs must meet regulatory compliance, purity, and stability parameters.

Global API Manufacturing hubs for Disulfiram

The primary manufacturing centers for disulfiram API are located in regions with established APIs production infrastructure, particularly:

• China: Leading producer, offering cost-effective APIs with increasing compliance standards.
• India: Noted for high-quality, regulated API manufacturing, supported by a robust pharmaceutical industry.
• Europe & North America: Limited API production, mostly reliant on regional or international suppliers adhering to stricter standards.
• Other regions: Emerging players with nascent API manufacturing capabilities.

China: The Largest API Supplier for Disulfiram

China dominates the disulfiram API supply landscape primarily due to scale and cost advantages. Its API producers often serve both domestic and international markets, with several facilities accredited by global regulatory bodies (e.g., GMP certificates issued by NMPA). These producers frequently comply with international quality standards, though buyers must verify documentation to ensure regulatory compliance.

India: Growing API Production with Emphasis on Quality

Indian pharmaceutical manufacturers have expanded their API portfolio, including disulfiram, with many facilities validated by WHO-GMP and US FDA. Indian APIs benefit from a combination of cost competitiveness and quality assurance, making them attractive for brand-name and generic drug production. Notable Indian API producers for disulfiram include companies with established track records in chemical synthesis and regulatory compliance.

European & North American Suppliers

Manufacturers in Europe and North America producing disulfiram API are fewer but often operate under strict regulatory oversight, offering APIs with assured high purity and consistent quality. However, higher production costs and scale limitations often mean these sources serve premium markets or specific regulatory demands.

Key API Manufacturers and Suppliers

Several prominent companies are recognized for disulfiram API sourcing, including:

• Shandong Luoxin Pharmaceutical Group (China): A major API producer, with GMP-certified facilities for disulfiram.
• Xingyu Pharmaceutical (China): Known for chemical APIs, including disulfiram, with regulatory approvals.
• Sanjing Pharma (India): Focused on chemical APIs with US FDA ANDA approvals and WHO-GMP certification.
• Indovax & Hetero Labs (India): Notable for global API supply, including pharmaceutical intermediates.
• Hikal Ltd. (India): Provides customized APIs and intermediates with high regulatory compliance.

Emerging and Niche Suppliers

Emerging suppliers in Southeast Asia and Eastern Europe are expanding capabilities, often promising competitive pricing and quality assurance aligned with international standards.

Quality & Regulatory Considerations

Sourcing disulfiram API requires meticulous evaluation of quality credentials. Pharmaceutical-grade APIs must adhere to Good Manufacturing Practice (GMP), with comprehensive documentation such as DMFs (Drug Master Files), Certificates of Analysis (CoA), and regulatory approvals.

Buyers should verify:

• Regulatory compliance: GMP, US FDA, EMA, or equivalent approvals.
• Purity specifications: Typically >99% purity, with low levels of residual solvents and impurities.
• Stability data: Ensuring API maintains quality over the shelf life.
• Traceability: Full documentation tracking throughout manufacturing and supply.

Supply Chain Trends & Risks

The API supply landscape for disulfiram reflects broader trends:

• Globalization: Increased reliance on Chinese and Indian APIs poses supply chain risks due to geopolitical tensions, trade tariffs, and quality variability.
• Regulatory tightening: International agencies' scrutiny on API manufacturing practices necessitates thorough due diligence.
• Supply chain resilience: Diversification across regions and suppliers becomes essential to mitigate shortages and ensure consistent supply.
• Environmental and sustainability considerations: Growing pressure for green synthesis routes and sustainable practices influences sourcing decisions.

Emerging Challenges and Opportunities

While the cost advantage from Chinese and Indian API producers remains significant, quality assurance and regulatory compliance are non-negotiable. Manufacturers increasingly prefer suppliers with validated processes adhering to internationally recognized standards, including comprehensive documentation and batch-to-batch consistency.

Opportunities lie in developing regional API hubs in Europe and North America to reduce reliance on imports, enhance supply security, and meet stricter compliance requirements.

Conclusion

The global supply of bulk disulfiram API is characterized by dominant Chinese and Indian sources, with reputable manufacturers offering compliant, high-quality APIs suitable for pharmaceutical production. While low-cost sourcing remains attractive, pharmaceutical companies must rigorously evaluate regulatory credentials, quality standards, and supply stability. As regulatory frameworks tighten and supply chain resilience gains importance, diversification of API sources will become increasingly strategic.

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Key Takeaways

• Major suppliers: China and India lead disulfiram API production, supported by a handful of European and North American manufacturers.
• Quality assurance: Strict adherence to GMP and regulatory standards is essential for API procurement.
• Supply chain resilience: Diversifying suppliers and regions mitigates risks associated with geopolitical and regulatory disruptions.
• Regulatory compliance: Engaging approved suppliers with comprehensive documentation ensures compliance with global standards.
• Emerging trends: Development of regional API hubs and green manufacturing practices will shape future sourcing strategies.

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Frequently Asked Questions (FAQs)

Q1: What are the primary regions supplying bulk APIs for ANTABUSE (disulfiram)?
A: The primary regions are China and India, with smaller contributions from Europe and North America.

Q2: How can I verify the regulatory compliance of an API supplier?
A: Verify their GMP certifications, DMFs, Certificates of Analysis, and regulatory approvals from agencies like US FDA or EMA.

Q3: What quality standards should a pharmaceutical-grade disulfiram API meet?
A: It should meet USP, Ph. Eur., or other relevant pharmacopeial standards, with >99% purity and low residual impurities.

Q4: What are the risks associated with sourcing disulfiram API primarily from China?
A: Risks include quality variability, regulatory differences, and supply disruptions due to geopolitical or trade issues, which can be mitigated through supplier qualification and diversification.

Q5: Are there environmentally sustainable options for disulfiram API manufacturing?
A: Emerging green synthesis methods aim to reduce environmental impact, and some suppliers are adopting sustainable practices aligned with global environmental standards.

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Sources

[1] United States Pharmacopeia. USP Monograph on Disulfiram.
[2] European Pharmacopoeia. Disulfiram Entry.
[3] Global API Market Analysis Reports. Pharma CI Magazine, 2022.
[4] Chinese GMP Certificates Database (NMPA).
[5] Indian GMP-certified API manufacturers listings.