Bulk Pharmaceutical API Sources for ALBENDAZOLE

Bulk Pharmaceutical API Sources for ALBENDAZOLE

Vendor	Vendor Homepage	Vendor Sku	API Url
Vitas-M Laboratory		STK387550
TCI (Tokyo Chemical Industry)		A1943
Molport		MolPort-000-726-929
Molport		MolPort-000-760-571
Molport		MolPort-001-932-918
Hangzhou APIChem Technology		AC-015
Vitas-M Laboratory		STL046130

Bulk Active Pharmaceutical Ingredient (API) Sources for Albendazole

Last updated: July 27, 2025

Introduction

Albendazole, a broad-spectrum anthelmintic agent, plays a pivotal role in combating parasitic worm infestations worldwide. As global demand for albendazole increases, especially with expanding pharmaceutical markets in emerging economies, understanding the landscape of API manufacturing sources becomes crucial for stakeholders across pharmaceutical supply chains. This overview provides a detailed analysis of bulk API sources for albendazole, covering key manufacturers, geographic distribution, quality considerations, and market trends to aid in strategic sourcing and supplier evaluation.

Global API Manufacturing Landscape for Albendazole

Major Producing Countries

The supply chain for albendazole API predominantly originates from several strategic regions. India and China emerge as leading manufacturing hubs, leveraging their robust pharmaceutical chemical sectors and extensive contract manufacturing organizations (CMOs). Both countries host numerous facilities capable of producing high-quality APIs at competitive costs, supported by an evolving regulatory framework that increasingly aligns with international standards.

Other notable contributors include European nations such as Germany and Italy, which focus on high-quality, often branded, API production, catering to stricter regulatory environments. Additionally, some active API manufacturing is conducted in Brazil and South Korea, driven by localized demand and strategic regional supply.

Key Manufacturers and Suppliers

• India

  Indian pharmaceutical companies dominate the albendazole API market, with major players such as:

  • Sun Pharmaceutical Industries: Known for extensive API production capabilities, including albendazole, with an emphasis on quality compliance to WHO and other international standards.

  • Gujarat Alkalies and Chemicals Ltd.: Specializes in bulk pharmaceutical chemicals, including benzimidazole derivatives like albendazole.

  • Aurobindo Pharma: Offers API manufacturing with a focus on generic versions of anthelmintics, including albendazole.

  • Hetero Labs: Supplies APIs to global markets backed by robust quality assurance processes.

• China

  Chinese manufacturers offer competitive prices with a growing emphasis on quality. Key players include:

  • AiChi Pharmaceutical (Nantong): Produces albendazole API with compliant manufacturing practices.

  • Hailir Pharmaceutical: Provides large-scale production with a focus on export markets.

  • Shandong Xinhua Pharmaceutical: Offers a range of API products, including albendazole, with controlled manufacturing conditions.

• Europe & North America

  While less dominant in raw API production, certain European and North American firms supply high-quality albendazole APIs, primarily for critical applications requiring stringent regulatory compliance.

Contract Manufacturing and Custom Synthesis

Many pharmaceutical companies rely on CMOs for albendazole API production, facilitating flexibility, cost efficiency, and risk management. Notable CMOs include those operating in India and China, offering scalable manufacturing capabilities with WHO-GMP certifications.

Quality and Regulatory Considerations

API sourcing mandates strict compliance with Good Manufacturing Practices (GMP). Manufacturers adhering to international standards such as the European Medicines Agency (EMA) and the US FDA are preferred, ensuring consistency and regulatory acceptance. Vendors with extensive quality documentation, stability data, and robust cGMP accreditation reduce procurement risks.

Additionally, the trend towards Good Trade Practices (GTP) and adherence to the Pharmacopoeia monographs (USP, EP, BP) is integral for API qualification, especially in highly regulated markets.

Market Trends Impacting API Sourcing

• Cost Dynamics

  Market pressures have intensified cost competition, leading to increased procurement from low-cost regions like India and China. However, quality concerns necessitate rigorous vetting processes to ensure compliance and reduce audits or rejections.

• Supply Chain Resilience

  COVID-19 underscored vulnerabilities in global supply chains. Consequently, some pharmaceutical firms now develop dual sourcing strategies or backup suppliers, including domestic vendors in the US and Europe.

• Regulatory Harmonization and Traceability

  The global push towards harmonized regulations, such as ICH Q7 guidelines, enhances API quality assurance. Traceability and analytical verification are now standard requirements, shaping supplier qualification processes.

• Environmental and Sustainability Factors

  Increasing emphasis on environmentally sustainable manufacturing practices influences supplier selection, favoring those with eco-friendly processes and waste management systems.

Emerging Sources and Innovation

Advances in synthetic chemistry and process intensification are enabling new sources of albendazole API. Innovations include greener synthesis routes, reduced solvent use, and energy-efficient processes. These efforts aim to lower costs and environmental impact, expanding the pool of potential suppliers.

Conclusion

The landscape of albendazole API sourcing is characterized by a diverse range of manufacturers primarily rooted in India and China, with high-quality options available from European and North American suppliers. Strategic procurement involves balancing cost, quality, regulatory compliance, and supply chain robustness. Emerging trends like sustainability and process innovation will shape future supply dynamics, offering both challenges and opportunities for pharmaceutical companies seeking reliable raw material inputs.

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Key Takeaways

• Primary Production Hubs: India and China dominate albendazole API manufacturing, offering cost-effective options with extensive capacity.
• Quality Assurance: Vendors meeting international GMP standards are essential to ensure regulatory compliance and product safety.
• Supply Chain Resilience: Diversification of suppliers and dual sourcing strategies mitigate risks associated with supply disruptions.
• Regulatory & Sustainability Trends: Emphasis on environmental practices and harmonized regulatory adherence influences supplier qualification.
• Innovation & Market Dynamics: New manufacturing processes and process optimization are expanding source options and reducing costs.

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FAQs

1. What are the top countries for albendazole API manufacturing?
India and China lead globally in albendazole API production, with European firms providing high-quality options suited for regulated markets.

2. How do I verify the quality of API suppliers for albendazole?
Ensure suppliers comply with GMP, hold relevant certifications (e.g., WHO-GMP), provide detailed analytical data, and have a proven regulatory track record.

3. Are there alternatives to Chinese and Indian suppliers?
Yes, high-quality albendazole APIs are available from select European and North American manufacturers, often used for critical or highly regulated applications.

4. How has COVID-19 impacted albendazole API sourcing?
The pandemic highlighted vulnerabilities in supply chains, prompting companies to diversify sourcing strategies, including establishing local and backup suppliers.

5. What trends are influencing future albendazole API supply?
Environmental sustainability, process innovation, and regulatory harmonization are key factors shaping the future of API sourcing strategies.

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References

[1] World Health Organization. (2021). Guidelines for the production of active pharmaceutical ingredients.
[2] U.S. Food and Drug Administration. (2022). API Drug Master Files and Manufacturing Quality Standards.
[3] European Medicines Agency. (2022). Guidelines on good manufacturing practices for active pharmaceutical ingredients.
[4] IQVIA. (2022). Global API Market Analysis.
[5] Pharmaceutical Technology. (2023). Emerging Trends in API Manufacturing.