Last updated: July 27, 2025
Introduction
Disulfiram, commercially known as Antabuse, is a long-established medication primarily utilized in the treatment of chronic alcoholism. Its mechanism involves inhibiting aldehyde dehydrogenase, causing unpleasant physiological reactions when alcohol is consumed, thereby discouraging alcohol intake. As a crucial component of addiction management, disulfiram’s supply chain remains vital for healthcare providers worldwide. This article explores key suppliers, manufacturing sources, regulatory considerations, and market dynamics for disulfiram.
Manufacturers and Primary Suppliers
Global Production Landscape
The global supply of disulfiram is concentrated among a limited number of pharmaceutical manufacturers, with most producing it in generic or branded forms. Notable companies contributing to the supply include:
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Ningbo Second Chemical Pharmaceutical Factory (China): A primary supplier engaged in the manufacturing of disulfiram raw material and finished pharmaceutical products. Its production capacity aligns with the increasing demand for affordable generics.
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Teva Pharmaceuticals (Israel): A significant global player in generic drugs, including disulfiram. Teva's extensive manufacturing facilities and distribution networks facilitate wide accessibility.
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Zhejiang Hisoar Pharmaceutical Co., Ltd. (China): Known for producing a variety of active pharmaceutical ingredients (APIs), Hisoar offers disulfiram both as an API and finished dosage form, catering to international markets.
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LGM Pharma (United States): Specializing in high-quality APIs and intermediates, LGM Pharma supplies disulfiram to contract manufacturers and pharmaceutical companies, emphasizing purity and compliance.
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Hunan Yuercheng Medicine Co., Ltd. (China): A growing supplier emphasizing cost-effective manufacturing with export capabilities.
These manufacturers typically produce disulfiram in accordance with Good Manufacturing Practices (GMP), ensuring quality and regulatory compliance for global markets.
Sources of Disulfiram Raw Material (API)
Chemical and Manufacturing Processes
Disulfiram is synthesized via the reaction of diethyldithiocarbamic acid with carbon disulfide, followed by crystallization. The quality of the API depends on precise control of synthesis parameters and purification processes, which well-established manufacturers maintain.
Key Oil and Chemical Suppliers
APIs are sourced from a network of chemical intermediates suppliers:
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Sigma-Aldrich (Merck Group): Supplies high-purity disulfiram API for research and pharmaceutical manufacturing with comprehensive regulatory documentation.
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Zhejiang Haizheng Chemical Co., Ltd.: Provides intermediates used in disulfiram synthesis, supporting the production chain.
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Alfa Aesar (Thermo Fisher Scientific): Offers disulfiram APIs for research purposes, with formats suitable for laboratory-scale synthesis.
Distribution Channels
Disulfiram distribution relies on multiple channels:
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Major Pharmaceutical Distributors: Companies like McKesson, Cardinal Health, and AmerisourceBergen distribute finished formulations and APIs to hospitals, clinics, and pharmacies.
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Generic Drug Suppliers: Many generic manufacturers acquire APIs from Chinese and Indian API producers and manufacture finished dosage forms (tablets, dispersible forms).
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Regional Importers/Distributors: In emerging markets, local firms handle importation, warehousing, and distribution, often sourcing from Chinese or Indian manufacturers.
Regulatory Considerations and Compliance
GMP Certification & Quality Assurance
Suppliers aiming for international markets must demonstrate compliance with GMP standards set by agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent authorities in other jurisdictions.
Registration & Documents
Registration dossiers verify API purity, stability data, and manufacturing processes. Suppliers with approved dossiers in major markets gain comparative advantage for worldwide distribution.
Import/Export Regulations
The importation of APIs like disulfiram involves adherence to Customs and International Trade regulations, especially in countries with stringent drug precursor controls, such as the U.S. (DEA regulations) and China.
Market Dynamics and Supply Chain Risks
Dependence on Chinese and Indian Manufacturers
The majority of disulfiram's API production occurs in China and India, exposing the supply chain to geopolitical, regulatory, and logistical risks. Disruptions—such as supply chain interruptions, trade restrictions, or compliance issues—can impact availability and pricing.
Demand Fluctuations
Global awareness and medical guidelines on alcohol dependence treatment influence demand. The increasing recognition of disulfiram’s role in addiction therapies sustains steady demand but remains sensitive to market shifts towards newer modalities.
Pricing Trends
Consolidation among suppliers has driven price stabilization for generic disulfiram, but raw material costs, regulatory compliance expenses, and transportation costs continue to influence final pricing.
Emerging Production Trends
Bioequivalent and Novel Formulations
There is limited development in alternatives due to disulfiram’s longstanding patent expiration. However, efforts focus on improving formulations—liquid options, extended-release forms—and ensuring stable, high-quality API supply.
Sustainable Manufacturing
Environmental concerns prompt suppliers to adopt greener synthesis routes and waste management practices, aligning with global sustainability goals.
Key Takeaways
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The primary global suppliers for disulfiram include Chinese manufacturers like Ningbo Second Chemical Pharmaceutical Factory and Hunan Yuercheng Medicine, alongside established players like Teva and LGM Pharma.
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API quality and GMP compliance are critical for market access; suppliers with registered dossiers enjoy competitive advantages.
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The supply chain predominantly hinges on Chinese and Indian manufacturing, raising concerns over geopolitical risks and regulatory compliance.
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Disulfiram's steady demand underscores its importance in addiction therapy, though suppliers face market pressures from newer treatment modalities.
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Transparency, quality assurance, and adherence to international regulatory standards remain essential for suppliers aiming for global market share.
FAQs
1. What are the leading global manufacturers of disulfiram?
Major manufacturers include Chinese firms such as Ningbo Second Chemical Pharmaceutical Factory and Zhejiang Hisoar Pharmaceutical, alongside international players like Teva Pharmaceuticals and LGM Pharma, which supply both API and finished products worldwide.
2. How does regulatory compliance impact disulfiram suppliers?
Suppliers must demonstrate GMP compliance and possess appropriate registration dossiers with agencies such as the FDA and EMA. This compliance ensures quality, safety, and regulatory approval crucial for market access.
3. Are there regional differences in disulfiram supply chains?
Yes. While Chinese manufacturers dominate API production, finished dosage forms are distributed through regional distributors worldwide, with variations based on local regulatory requirements and market demand.
4. What risks are associated with disulfiram supply chains?
Risks include geopolitical tensions affecting trade, dependency on specific manufacturing regions, regulatory hurdles, and disruptions caused by global events like pandemics.
5. What trends could influence future disulfiram supply?
Emerging trends include development of new formulations, stricter regulation of supply chains, and increased focus on sustainability practices; however, innovation in disulfiram production remains limited due to its patent expiration and longstanding market presence.
References
[1] U.S. Food and Drug Administration, “Disulfiram (Antabuse) – Drug Details,” 2022.
[2] GlobalData, “Pharmaceutical API Market Report 2022.”
[3] PharmaSync, “Top Disulfiram API Manufacturers,” 2022.
[4] Chinese National Medical Products Administration (NMPA), “API Registration Database,” 2022.
[5] IQVIA, “Global Pharmaceutical Distribution & Supply Chain Trends,” 2022.
