Last updated: July 29, 2025
Overview of Miglitol
Miglitol is an oral antihyperglycemic agent primarily prescribed for the management of type 2 diabetes mellitus. Classified as an alpha-glucosidase inhibitor, it works by delaying carbohydrate absorption in the small intestine, thus reducing postprandial blood glucose spikes. Since its initial approval, miglitol has gained utility through its efficacy in combination therapy and its role in glycemic control.
Global Manufacturing and Supply Landscape
The supply chain for miglitol involves multiple stakeholders spanning raw material providers, active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distributors. The pharmaceutical industry’s complex network of quality standards, regulatory compliance, and supply chain logistics influences the availability and cost of miglitol globally.
Key API Manufacturers for Miglitol
The pivotal component of miglitol’s production is its active pharmaceutical ingredient. Notable API producers include:
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Daiichi Sankyo Company, Limited: As the originator of the drug, Daiichi Sankyo holds exclusive rights in many regions and is the primary source for licensed API production. Their manufacturing facilities meet stringent regulatory standards, such as Good Manufacturing Practices (GMP), ensuring high-quality API supply.
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Sun Pharmaceutical Industries Ltd.: A leading generic pharmaceutical company, Sun Pharma has established capabilities for the production of alpha-glucosidase inhibitors, including miglitol. They supply APIs to various generic drug manufacturers in emerging markets.
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Core Pharmacceuticals & Chemicals Ltd.: This manufacturer supplies APIs globally and has invested in advanced synthesis processes for miglitol, adhering to international GMP standards.
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Other Regional API Players: Several small-to-medium-sized API developers in China, India, and Eastern Europe produce miglitol, often catering to regional markets with cost-efficient manufacturing.
Generic and Branded Drug Manufacturers
Once the API is procured, pharmaceutical companies develop formulations and commercialize miglitol under various brand names. Notable companies involved in manufacturing and marketing miglitol formulations include:
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Daiichi Sankyo: As the inventor and patent-holder, they continue to market Glyset in several countries. Their integrated supply chain ensures control over the product quality and distribution.
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Mitsubishi Tanabe Pharma Corporation: This Japanese pharmaceutical company markets miglitol under brand names like Basen and manages manufacturing operations aligned with local regulatory standards.
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Generic Manufacturers in India: Firms such as Sun Pharmaceutical, Cadila Healthcare, and Torrent Pharmaceuticals produce generic miglitol formulations for the domestic and export markets.
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Chinese Pharmaceutical Companies: Several manufacturers supply generic miglitol for regional markets, with some gaining WHO prequalification status, affecting global procurement options.
Distribution Channels and Suppliers
The distribution chain for miglitol spans wholesalers, hospital pharmacies, retail pharmacies, and online platforms. Major pharmaceutical distributors—such as McKesson, Cardinal Health, and Nippon Pharmaceutical—source from licensed manufacturers, ensuring quality and regulatory compliance.
In geographic terms, supply sources vary:
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North America and Europe: Predominantly supplied by Daiichi Sankyo, with additional sourcing from approved generic producers.
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Emerging Markets: A mix of licensed generics from Indian and Chinese manufacturers supports local access, often at reduced costs.
Regulatory Considerations and Supplier Qualification
Regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) regulate suppliers, requiring certifications like GMP and Good Laboratory Practice (GLP). Suppliers with certified manufacturing plants are preferred, as this ensures consistency, safety, and compliance with international standards.
Market Dynamics Affecting Supplier Choices
Several factors influence supplier selection for miglitol:
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Patent Status: As of 2023, the original patents held by Daiichi Sankyo have expired or are nearing expiration in certain regions, enabling generic firms to produce and market miglitol.
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Pricing & Cost Efficiency: Cost-effective manufacturing in India and China has increased availability of affordable generics, influencing procurement decisions.
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Quality Certifications: Suppliers with stringent quality controls, third-party audits, and compliance records are prioritized, particularly for markets with tight regulatory frameworks.
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Supply Chain Reliability: Long-term partnerships with established API manufacturers mitigate risks of shortages or delays.
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Regional Regulatory Approvals: Suppliers with approvals from regional regulatory bodies have better access to specific markets, influencing supplier selection.
Emerging Trends in Miglitol Supply
The evolving landscape of diabetes management, increasing global prevalence, and patent expirations are expanding the supplier base for miglitol. Notably:
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Expansion of Generics Production: Indian and Chinese generic manufacturers are increasing API manufacturing capacities, driven by market demand and cost advantages.
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Supply Chain Diversification: Pharmaceutical companies diversify sources of API to reduce risks related to regulatory changes, geopolitical tensions, and supply disruptions.
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Regional Manufacturing Hubs: Countries like India and China are positioning themselves as key hubs for API and formulation production, further Indonesian, South Korean, and Middle Eastern manufacturers entering the market.
Summary
The supplier landscape for miglitol is diverse, encompassing original manufacturers such as Daiichi Sankyo and a broad spectrum of generics producers predominantly in India and China. API sourcing is characterized by adherence to global regulatory standards, with regional manufacturers expanding capacity to meet increasing demand. Strategic procurement hinges on quality, regulatory compliance, cost-effectiveness, and supply chain resilience.
Key Takeaways
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Dominant API Providers: Daiichi Sankyo remains the primary licensed API manufacturer, but many generic companies in India and China are significant contributors.
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Market Expansion: Patent expirations have opened pathways for multiple generic manufacturers to supply miglitol globally, increasing accessibility and reducing costs.
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Regulatory Compliance: Suppliers with stringent GMP certifications and regulatory approvals are preferred, ensuring high-quality product supply.
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Supply Chain Risks: Diversification of suppliers and regional manufacturing hubs mitigate potential shortages and logistical delays.
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Future Outlook: Continued growth in generic production, increased regional manufacturing, and regulatory harmonization will shape the global miglitol supply chain.
FAQs
1. Who are the main API suppliers for miglitol globally?
Major API producers include Daiichi Sankyo (original manufacturer), Sun Pharmaceutical Industries, core chemical companies in India, and several Chinese API manufacturers. The choice of supplier depends on regional regulatory approvals, cost, and quality standards.
2. Are there any recent disruptions in the supply chain for miglitol?
While specific shortages are rare, potential disruptions can stem from regulatory changes, manufacturing capacity constraints, or geopolitical issues affecting regional suppliers. Diversifying sources helps mitigate these risks.
3. How does patent expiry influence the supplier market for miglitol?
Patent expiration has facilitated entry for generic manufacturers in India, China, and other regions, broadening the supplier base, enhancing competition, and driving down prices.
4. What regulatory standards must miglitol suppliers meet?
Suppliers need to hold GMP certification, along with compliance with regional regulatory approvals from agencies such as the FDA, EMA, or local authorities, to ensure product safety and efficacy.
5. How is the global demand for miglitol expected to impact future suppliers?
Growing diabetes prevalence globally will increase demand, encouraging existing manufacturers to expand capacities and induce new entrants, especially in emerging markets with cost advantages.
References
[1] Daiichi Sankyo Company, Limited. Glyset (miglitol) product information.
[2] Sun Pharmaceutical Industries Ltd. Annual Report 2022.
[3] WHO Prequalification of Medicines Programme. List of approved APIs and formulations.
[4] Indian Pharmaceutical Industry Reports, 2022.
[5] Regulatory standards for API manufacturing. U.S. FDA Guidance Document.
