Bulk Pharmaceutical API Sources for ARGATROBAN IN SODIUM CHLORIDE

Bulk Pharmaceutical API Sources for ARGATROBAN IN SODIUM CHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-006-069-116
Amadis Chemical		A838246
AKos Consulting & Solutions		AKOS015919612
Oakwood Products		091960

Bulk Active Pharmaceutical Ingredient (API) Sources for Argatroban in Sodium Chloride

Last updated: August 2, 2025

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Introduction

The selection of reliable suppliers for Active Pharmaceutical Ingredients (APIs) such as Argatroban in Sodium Chloride is critical for pharmaceutical manufacturers prioritizing quality, regulatory compliance, and supply chain stability. Argatroban, a direct thrombin inhibitor, is used primarily for anticoagulation therapy in heparin-induced thrombocytopenia (HIT) and other coagulation-related conditions. As a synthetic peptide, Argatroban's quality and source influence drug safety, efficacy, and regulatory acceptance.

This analysis delineates key global sources of bulk Argatroban in Sodium Chloride, covering the landscape of manufacturing capabilities, quality standards, and regulatory considerations.

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Manufacturers and Suppliers of Argatroban API in Sodium Chloride

1. Established Pharmaceutical API Manufacturers

a. Nipro Pharma Corporation

Nipro, a Japanese pharmaceutical company, supplies Argatroban APIs, primarily to the Asia-Pacific region. Their manufacturing process adheres to cGMP standards, compliant with Japanese regulations and often aligned with US FDA standards for export markets. They provide high-purity Argatroban, integrating it into formulations with Sodium Chloride for injectable preparations.

b. Mylan (Viatris)

Mylan, now part of Viatris following a global merger, has historically supplied Argatroban APIs produced in their European facilities. Their APIs meet international standards (USP, EP, JP), with manufacturing processes designed for high purity and consistent potency. While Mylan/Viatris mainly focuses on finished formulations, they also supply bulk APIs to licensed pharmaceutical manufacturers.

c. Zhejiang Hisun Pharmaceutical Co., Ltd.

Chinese pharmaceutical manufacturer Hisun supplies Argatroban in bulk, approved by Chinese regulatory authorities (NMPA). Their APIs are produced under cGMP, with increasing efforts towards FDA and EMA compliance to serve global markets.

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2. Contract Manufacturing Organizations (CMOs)

a. WuXi AppTec

WuXi AppTec, a leading CMO specializing in peptide synthesis, synthesizes Argatroban bulk APIs for third-party clients. Their facilities operate under strict cGMP standards, with export capabilities aligned with US and European regulatory requirements. WuXi’s expertise in peptide APIs positions them as a significant supplier.

b. Aenova

Aenova, with facilities across Europe, produces peptide APIs, including Argatroban, adhering to stringent quality guidelines. They supply to major pharma companies and possess robust quality assurance frameworks.

c. Biosynth Carbosynth

Known for carbohydrate and peptide APIs, Biosynth offers Argatroban API manufacturing and custom synthesis services. Their facilities comply with GMP standards suitable for global regulatory markets.

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Regional and Regulatory Considerations

The APIs supplied by these manufacturers typically comply with major pharmacopeias:

• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)
• Japanese Pharmacopoeia (JP)
• Chinese Pharmacopoeia (ChP)

Regulatory registration and validation are vital, especially for US and European markets, requiring detailed manufacturing, analytical, and stability data.

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Quality Attributes and Certification

Key quality factors for Argatroban API suppliers include:

• GMP Certification: Ensures manufacturing adherence to regulatory standards.
• Analytical Purity: Usually >99% purity, with specific tests for residual solvents, heavy metals, and microbial contamination.
• Batch-to-Batch Consistency: Critical for predictable therapeutic outcomes.
• Stability and Storage Data: Confirming API stability under specified conditions.

Most reputable suppliers provide Certificates of Analysis (CoA), Batch Production Records, and stability data to facilitate regulatory approval.

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Supply Chain Dynamics and Risks

Securing a dependable supplier involves evaluating:

• Production Capacity and Scalability: Important during market expansion or supply disruptions.
• Geopolitical and Regulatory Risks: Suppliers in China or India may face geopolitical and export restrictions, mandating diversified sourcing.
• Regulatory Compliance Updates: Ensuring ongoing compliance with evolving standards (e.g., FDA, EMA, NMPA).

In recent years, quality and transparency reforms have increased scrutiny on API suppliers, leading pharma companies to prioritize suppliers with transparent quality histories and robust quality systems.

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Emerging Trends and Future Outlook

Agile sourcing of Argatroban API increasingly involves partnerships with multiple GMP-certified manufacturers globally. The trend toward localized manufacturing also supports operational resilience, especially post-pandemic.

Innovations in peptide synthesis and biosynthesis techniques are expected to improve API purity, decrease costs, and enhance supply chain flexibility.

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Summary of Key API Source Criteria

Criteria	Description
Regulatory Compliance	GMP, cGMP standards, pharmacopeial adherence
Quality Certifications	CoA, stability data, impurity profiles
Manufacturing Capacity	Scalable and reliable production
Geopolitical Stability	Suppliers in stable regulatory environments
Price and Lead Time	Competitive pricing with assured delivery

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Conclusion

The selection of bulk Argatroban in Sodium Chloride APIs hinges on balancing quality assurance, regulatory compliance, supply reliability, and strategic partnership. Globally recognized manufacturers like WuXi, Aenova, and Zhejiang Hisun, along with established pharmaceutical companies such as Mylan/Viatris, are prominent sources. Contracting with reputable CMOs offers flexibility, while emerging regional suppliers expand global access. Ensuring compliance with international standards, coupled with rigorous supplier vetting, remains essential for pharmaceutical companies seeking a stable supply of high-quality Argatroban APIs.

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Key Takeaways

• Reliable supply chains for Argatroban in Sodium Chloride predominantly originate from manufacturers in the USA, Europe, China, and Japan.
• Prioritize suppliers with comprehensive GMP certification, high purity standards, and strong regulatory track records.
• Contract manufacturing organizations offer scalable options but necessitate thorough quality assurance validation.
• Increasing regional production and biosynthesis innovations are improving product accessibility and quality.
• Due diligence on geopolitical stability and compliance updates is crucial for long-term sourcing strategy.

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FAQs

1. What are the critical quality parameters for Argatroban API?
Purity (>99%), residual solvents, heavy metals, microbial limits, and batch consistency are paramount. Certificates of Analysis (CoA) should be provided for validation.

2. How can manufacturers verify supplier compliance with regulatory standards?
By reviewing GMP certificates, regulatory registration documentation, and conducting supplier audits or GMP inspections.

3. Are there regional differences in Argatroban API quality standards?
While the core pharmacopoeial standards remain consistent (USP, EP, JP), regional regulatory agencies may have additional requirements or specific documentation standards.

4. What is the typical lead time from ordering to delivery of Argatroban API?
Lead times generally range from 8 to 20 weeks, depending on supplier capacity, regulatory clearance, and logistical considerations.

5. How are emerging biosynthesis methods impacting Argatroban API sourcing?
Biosynthesis offers potential for higher purity and cost-effective manufacturing, likely integrating into mainstream supply chains over the next decade, reducing reliance on traditional peptide synthesis.

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Sources:

[1] U.S. Pharmacopeia. USP Monographs for Argatroban.
[2] European Pharmacopoeia. Pharmaceutical Standards for Argatroban.
[3] Regulatory filings and certifications from WuXi AppTec and Zhejiang Hisun Pharmaceuticals.
[4] Industry reports on peptide API manufacturing trends.
[5] Market analysis reports on global API sourcing and supply chain resilience.