Bulk Pharmaceutical API Sources for ALBENZA

Bulk Pharmaceutical API Sources for ALBENZA

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 ALBENZA

Last updated: July 30, 2025

Introduction

Albenza, the brand name for albendazole, is a broad-spectrum anthelmintic widely used in the treatment of parasitic infections such as neurocysticercosis, echinococcosis, and other helminthic diseases. The drug’s efficacy hinges on the consistent quality and supply of its active pharmaceutical ingredient (API). Identifying reliable bulk API sources is critical for pharmaceutical companies, healthcare providers, and policymakers aiming to ensure drug quality, supply stability, and cost management.

This comprehensive review examines global API sourcing options for albendazole, analyzing key manufacturers, geographic distribution, regulatory statuses, and supply chain considerations to inform stakeholders’ procurement strategies and risk management plans.

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Global API Manufacturing Landscape

The API manufacturing market for albendazole is predominantly concentrated in Asia, owing to lower production costs, established chemical manufacturing expertise, and the presence of multiple generic API producers. However, several manufacturers across different regions supply albendazole API to both generic and branded pharmaceutical companies.

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Leading API Manufacturers of Albendazole

1. Zhejiang Hisoar Pharmaceutical Co., Ltd. (China)

   • Profile: A prominent Chinese API producer specializing in antiparasitic compounds, including albendazole.
   • Capacity & Quality: Capable of supplying large volumes to meet global demand; adheres to cGMP standards aligned with WHO and international regulatory expectations.
   • Certifications: ISO 9001, GMP compliance, and optional US FDA certification for large-scale manufacturing.

2. Jubilant Pharma (India)

   • Profile: Indian pharmaceutical company with established API manufacturing facilities producing albendazole.
   • Advantages: Competitive pricing, extensive export history, and compliance with international standards such as WHO GMP.
   • Market Access: Supplies to multiple regions, including North America, Europe, and emerging markets.

3. CordenPharma (Germany)

   • Profile: A high-quality API manufacturer with a strong presence in specialty APIs, including albendazole.
   • Quality Focus: Emphasizes high-purity APIs compliant with stringent regulatory standards such as EMA and US FDA.
   • Supply Flexibility: Offers tailored supply chain solutions for global clients.

4. FarmaChem (India)

   • Profile: A mid-scale API manufacturer with a focus on antiparasitic drugs.
   • Certifications: Meets WHO GMP standards, with certifications suitable for export to regulated markets.
   • Supply Capabilities: Suitable for both large-volume and niche requirements.

5. Synthon (Netherlands)

   • Profile: An international pharmaceutical API producer with verified manufacturing facilities for albendazole.
   • Strengths: High quality, reliable supply chain, and compliance with multiple regulatory standards.

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Regional Considerations and Supply Chain Dynamics

• Asia (China, India, Vietnam):
  The primary source for bulk albendazole API, offering cost-effective production but varying regulatory standards. Companies exporting to regulated markets often pursue third-party certifications or submit to inspections to ensure compliance [1].

• Europe (Germany, Netherlands):
  Known for high standards and regulatory oversight, European API producers like CordenPharma cater to markets demanding stringent quality assurance. They often command premium prices but provide reliable supply and regulatory credibility.

• North America:
  Fewer domestic API manufacturers; reliance on imports from international producers with US FDA-approved facilities. These sources are critical for manufacturers intending to launch products in the US market, owing to stringent regulatory requirements.

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Regulatory Compliance and Certification

API sourcing for ALBENZA demands adherence to international quality standards. Suppliers often obtain certifications such as:

• WHO GMP Certification: Facilitates entry into developing markets and ensures baseline quality standards.
• US FDA Registration: Critical for APIs intended for US-market products; demonstrates compliance with US regulatory expectations.
• EMA Certification: Relevant for European markets and aligns with European pharmacopoeia standards.

Importantly, buyers should verify source certifications, conduct audit visits, and request regulatory dossiers (DMFs – Drug Master Files) to mitigate compliance risks.

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Supply Chain Risks and Mitigation Strategies

• Quality Variability: Variability in quality can lead to regulatory hurdles and market rejection; sourcing from certified manufacturers reduces this risk.
• Supply Disruptions: Geopolitical tensions, pandemics, or natural disasters can disrupt supply chains; maintaining multiple vendors from different regions mitigates procurement risk.
• Pricing Fluctuations: Commodity price fluctuations impact API costs; long-term contracts and strategic stockpiling can stabilize costs.
• Regulatory Changes: Evolving regulations require continuous supplier audits and dossier updates; partnerships with suppliers holding comprehensive compliance documentation are advantageous.

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Emerging Trends in API Sourcing for Albendazole

• Locally Sourced APIs: Countries facing supply shortages or seeking benign supply chain security are exploring local API manufacturing capabilities, though these are yet to be widely established for albendazole.
• Quality Enhancements: Suppliers investing in advanced purification and quality control processes synthesize higher-grade APIs, supporting quality-demanding markets.
• Sustainability Initiatives: Environmental considerations are increasingly influencing supplier selection, favoring manufacturers employing greener synthesis routes and waste management practices.

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Conclusion

The API landscape for ALBENZA (albendazole) is predominantly driven by Asian producers, notably China and India, offering cost-effective, certified APIs suitable for a broad range of markets. European and North American providers tend to offer higher assurance of regulatory compliance, albeit at premium costs.

For pharmaceutical companies and stakeholders, strategic sourcing involves balancing cost, regulatory compliance, supply reliability, and quality assurance. Diversifying API suppliers and establishing early engagement with certified manufacturers are essential best practices.

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Key Takeaways

• Global sourcing options are abundant, with Chinese and Indian manufacturers dominating albendazole API production, equipped with certifications meeting international standards.
• Regulatory compliance is critical. Ensuring suppliers possess WHO GMP, US FDA, or EMA certifications reduces regulatory hurdles downstream.
• Diversification of supply sources safeguards against disruptions, especially given geopolitical and logistical risks.
• Quality assurance through audits and dossier reviews is vital in selecting credible API vendors.
• Emerging supply chain strategies include local manufacturing initiatives and sustainability considerations to ensure long-term affordability and compliance.

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FAQs

1. What are the primary regions supplying albendazole API globally?
   Mainly China and India, with European manufacturers providing higher-quality APIs for regulated markets.

2. How can buyers verify the regulatory compliance of API suppliers?
   By reviewing certifications such as WHO GMP, US FDA registration, and requesting detailed regulatory dossiers and audit reports.

3. Are there local API manufacturing options for albendazole in North America or Europe?
   Currently limited; most sourcing occurs through imports from Asian and European producers, although some regional facilities are developing capabilities.

4. What risks are associated with sourcing albendazole API from Asian suppliers?
   Potential risks include quality variability, supply disruptions, and regulatory uncertainties, which can be mitigated through rigorous qualification and diversified sourcing.

5. What emerging trends influence albendazole API sourcing strategies?
   Increasing emphasis on supply chain resilience, quality enhancements, sustainability, and local manufacturing initiatives are shaping future sourcing approaches.

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References

[1] World Health Organization. "Guidelines on Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients." WHO Technical Report Series. 2017.