Bulk Pharmaceutical API Sources for triclabendazole

Bulk Pharmaceutical API Sources for triclabendazole

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		6962480
ChemBlock		A3375/0143230
NIH Clinical Collection		SAM001246681
Hangzhou Trylead Chemical Technology		TL8004821
NovoSeek		50248

Bulk Active Pharmaceutical Ingredient (API) Sources for: TRICLABENDAZOLE

Last updated: July 30, 2025

Introduction

Triclabendazole is a benzimidazole derivative primarily used for treating fascioliasis, an infection caused by the liver fluke Fasciola hepatica and Fasciola gigantica. Its efficacy depends significantly on the quality and purity of the active pharmaceutical ingredient (API). Globally, sourcing high-grade Triclabendazole API is critical for pharmaceutical manufacturing, regulatory compliance, and cost management. This article examines the key API suppliers worldwide, highlights sourcing considerations, and provides insights into procurement strategies for pharmaceutical companies.

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Overview of Triclabendazole API Market

Triclabendazole gained prominence due to its unique efficacy against both immature and adult flukes, unlike other benzimidazoles. As a niche antihelminthic, its API manufacturing is concentrated among a limited number of producers specialized in anthelmintic compounds. The market landscape is divided into:

• Domestic producers in China, India, and Europe
• Contract manufacturing organizations (CMOs)
• Research and pilot-scale suppliers

High purity (generally ≥99%) and compliance with pharmacopeial standards (such as USP, EP, or JP) are crucial for API suppliers in this sector.

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Major API Manufacturers and Suppliers

1. China-Based API Suppliers

China is a dominant source of bulk APIs for global pharmaceutical companies, including Triclabendazole. The country boasts numerous API manufacturers capable of producing high-volume, cost-effective API batches, often with rapid lead times. Cited for their scale and manufacturing capabilities, Chinese suppliers include:

• Shandong Xinhua Pharmaceutical Co., Ltd.
  Capable of producing benzimidazole derivatives, including Triclabendazole, with certifications aligning with international standards. The company offers both technical grades and pharmaceutical-grade APIs.

• Zhejiang Huadong Medicine Co., Ltd.
  Engaged in API synthesis with adherence to Good Manufacturing Practices (GMP). Supplies to global markets, especially in developing countries.

• Jiangsu Hengrui Medicine Co., Ltd.
  Known for extensive R&D and API manufacturing; offers custom synthesis services for benzimidazoles.

2. Indian API Manufacturers

India's pharmaceutical sector is recognized for high-quality generics and complex API production:

• Granules India Ltd.
  Supplies APIs including benzimidazole series, with GMP accreditation and a robust distribution network.

• Strides Pharma Science Ltd.
  Offers API manufacturing facilities with ISO certifications, including APIs for anthelmintic drugs.

• Glenmark Pharmaceuticals
  Engaged in API manufacturing with proven quality standards and regulatory compliance.

3. European and North American Suppliers

While less prominent due to higher production costs, certain European and North American companies emphasize stringent quality and regulatory compliance:

• BASF SE (Germany)
  Offers custom synthesis services for benzimidazole-based APIs, including high-grade Triclabendazole under rigorous quality assurance standards.

• Alfasigma (Italy)
  A known pharmaceutical manufacturer for specialty APIs and intermediates, compliant with European regulations.

• Cambridge Commodities (UK)
  Provides API sourcing and supply chain management for research-grade and pharmaceutical-grade products.

4. Contract Manufacturing and Custom Synthesis Organizations

Several CMOs and CROs offer custom synthesis of Triclabendazole API, often to meet bespoke quality parameters:

• Boehringer Ingelheim (Germany)
  Known for custom API synthesis with strict regulatory adherence.

• Luina Bio (Australia)
  Specialists in small-batch and pilot-scale API manufacturing, suitable for clinical and early commercial supply.

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Criteria for Selecting API Suppliers

When sourcing Triclabendazole API, pharmaceutical companies should consider:

• Regulatory Certifications: GMP, ISO, and other compliance standards.
• Quality Assurance: Batch-to-batch consistency, residual impurities, and purity levels.
• Supply Capacity: Ability to meet demand fluctuations and lead times.
• Cost Effectiveness: Balance quality with competitive pricing.
• Intellectual Property (IP) Considerations: Verify non-infringement and licensing requirements.

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Sourcing Challenges and Mitigation Strategies

1. Quality Variability:
Due to differences in manufacturing practices, quality inconsistency can occur. Mitigation involves auditing facilities, requesting Certificates of Analysis (CoA), and performing independent testing.

2. Regulatory Hurdles:
Ensuring API compliance with cGMP and regional standards is paramount. Supplier audits and dossier review facilitate compliance adherence.

3. Supply Chain Risks:
Geopolitical issues, logistics delays, and raw material scarcity may disrupt supply. Building relationships with multiple suppliers and maintaining safety stock mitigate these risks.

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Emerging Trends and Future Outlook

• Shift towards regional suppliers: In response to regulatory and supply chain disruptions, geographically diversified sourcing is gaining prominence.
• Enhanced quality standards: Suppliers comply with evolving international standards, tightening quality controls.
• Sustainability and green chemistry: Suppliers adopting environmentally friendly practices may become preferred partners.
• Custom synthesis and API innovation: R&D-focused organizations are developing improved formulations with better bioavailability and cost profiles.

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Key Takeaways

• The global supply of Triclabendazole API is predominantly centered in China and India, with European suppliers emphasizing quality and regulatory compliance.
• Pharmaceutical companies should prioritize suppliers with robust GMP certification, consistent quality, and reliable supply capacity.
• Due diligence through audits, certificates, and independent testing is critical to mitigate quality and compliance risks.
• Sourcing strategies should balance cost, quality, and supply chain resilience, especially amid geopolitical and logistical uncertainties.
• Future sourcing trends involve diversification, sustainability, and technological innovation to ensure reliable supply and regulatory adherence.

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FAQs

Q1: What are the key quality specifications to consider when sourcing Triclabendazole API?
A1: Major specifications include purity (≥99%), residual solvents, heavy metals, microbiological limits, and compliance with pharmacopeial standards such as USP or EP.

Q2: Which regions offer the most cost-effective Triclabendazole API?
A2: China and India currently offer the most cost-effective options due to manufacturing scale and lower production costs, provided regulatory standards are met.

Q3: Are there risks associated with sourcing API from emerging markets?
A3: Yes, risks include variable quality control, regulatory discrepancies, and supply chain disruptions. Mitigating strategies involve rigorous qualification processes and supplier audits.

Q4: How does regulatory compliance influence API sourcing decisions?
A4: Maintaining compliance ensures smooth registration processes, reduces regulatory risks, and safeguards product efficacy and safety.

Q5: Can custom synthesis be an alternative to bulk API sourcing?
A5: Yes, especially for specialty or clinical-grade APIs, custom synthesis ensures tailored quality parameters and can help in early-phase production or pilot studies.

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Sources

[1] European Pharmacopoeia, 10th Edition.
[2] U.S. Pharmacopeia (USP).
[3] Chinese Pharmacopoeia, 2020 edition.
[4] Pharmaceutical industry reports and supplier disclosures.