Bulk Pharmaceutical API Sources for OCUCLEAR

Bulk Pharmaceutical API Sources for OCUCLEAR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		O2378_SIGMA
Molport		MolPort-000-709-375
AKos Consulting & Solutions		AKOS000280887
Finetech Industry Limited		FT-0673462
Key Organics/BIONET		KS-5222
AbaChemScene		CS-2533

Bulk Active Pharmaceutical Ingredient (API) Sources for OCUCLEAR

Last updated: July 28, 2025

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Introduction

OCUCLEAR (oxaliplatin) is a platinum-based chemotherapeutic agent utilized predominantly in the treatment of colorectal cancer, and less frequently for other tumors such as gastric and ovarian malignancies. As with all pharmaceutical agents, its manufacturing involves sourcing high-purity Active Pharmaceutical Ingredients (APIs) that comply with rigorous quality standards. The global supply chain for oxaliplatin API is complex, involving multiple specialized suppliers that meet regulatory, safety, and efficacy standards. This article explores key global sources for bulk oxaliplatin API, the landscape of suppliers, quality considerations, and market dynamics impacting procurement strategies.

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Market Overview of Oxaliplatin API

Oxaliplatin’s API is characterized by its platinum coordination complex structure, necessitating synthesis pathways that involve multiple chemical steps, including the formation of the platinum core, ligand attachment, and purification. The manufacturing process demands advanced expertise, controlled environments, and strict adherence to Good Manufacturing Practices (GMP).

Market-wise, the demand for oxaliplatin API correlates tightly with global cancer chemotherapy protocols, primarily in developed markets like North America, Europe, and parts of Asia. The API supplier landscape is dominated by a handful of specialized chemical producers capable of manufacturing at scale with high purity standards.

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Leading Suppliers of Oxaliplatin API

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

Zhejiang Hisun is one of the prominent producers of anticancer APIs including oxaliplatin. The company operates state-of-the-art manufacturing facilities in China, adhering to GMP standards and has established a significant export footprint. Their API offerings are aligned with international regulatory requirements, making them a viable source for global pharma companies seeking reliable supply chains.

Key Attributes:

• GMP-compliant facilities
• Extensive experience in platinum-based API synthesis
• Competitive pricing and scalable production

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Hengrui Medicine is a leading Chinese pharmaceutical manufacturer with a robust pipeline of anticancer APIs. Their production of oxaliplatin API has gained regulatory approvals in China and is increasingly sought after for exports to markets in Asia and beyond. Hengrui’s commitment to quality and compliance makes them a reputable bulk supplier.

Key Attributes:

• Proven regulatory compliance pathway
• High purity API production
• Integration with Hengrui’s global distribution network

3. Fresenius Kabi (Germany/Global)

Fresenius Kabi is a global leader in hospital and infusion therapies, including cytotoxic APIs. Though primarily known for finished products, they also manufacture bulk APIs, including oxaliplatin, sourced from their certified suppliers. Their extensive regulatory dossier and quality assurance systems position them as premium supply partners.

Key Attributes:

• GMP-certified manufacturing
• Stringent quality controls
• Strong regulatory presence in multiple markets

4. Hunan Wenlong Pharmaceutical Co., Ltd. (China)

A dedicated API manufacturer, Wenlong supplies a variety of oncology APIs, including oxaliplatin, to multinational pharmaceutical firms. Their expertise in platinum coordination chemistry, and adherence to safety and GMP standards, make them a dependable supplier.

Key Attributes:

• Focused API manufacturing expertise
• Cost-effective production
• ISO certifications supporting international trade

5. Ind-Ar Laboratory (India)

Ind-Ar Laboratory is among India’s specialized API producers, with capabilities to manufacture complex chemotherapeutic agents. While a smaller player compared to Chinese giants, they service a niche segment of the global API market for oxaliplatin, emphasizing quality and pricing advantages.

Key Attributes:

• Cost competitiveness
• GMP compliance
• Focused on complex chemotherapy API synthesis

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Quality and Regulatory Considerations

Ensuring the quality of oxaliplatin API is paramount, given its cytotoxic nature and strict regulatory requirements. Suppliers must comply with Good Manufacturing Practices (GMP), possess comprehensive regulatory dossiers, and provide Certificates of Analysis (CoA), stability data, and Good Distribution Practice (GDP) adherence.

International regulatory bodies like the FDA, EMA, and PMDA emphasize rigorous testing for impurities, residual solvents, and endotoxins. Suppliers operating in China and India have increasingly obtained international certifications, such as ISO, cGMP, and approvals from respective health authorities, corroborating their quality standards.

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Supply Chain Dynamics and Market Influences

The sourcing landscape is influenced by geopolitical factors, manufacturing capacities, and market demand. Chinese API manufacturers currently dominate the global market share for oxaliplatin API owing to their large-scale production and competitive pricing. However, recent regulatory tightenings and geopolitical considerations are prompting some pharmaceutical companies to diversify their supply chains, including integrating European and Indian suppliers.

Supply shortages occasionally occur due to raw material constraints, manufacturing disruptions, or regulatory non-compliance issues. Therefore, strategic procurement involves establishing relationships with multiple suppliers, conducting rigorous audits, and maintaining quality assurance systems.

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Emerging Trends in API Sourcing

• Localization and Diversification: Pharma companies aim to reduce reliance on single-source suppliers by engaging multiple vendors across different regions.
• Regulatory Harmonization: Suppliers are increasingly aligning with international standards to access global markets.
• Technology Upgrades: Automation and continuous manufacturing processes are enhancing API quality and supply consistency.
• Sustainability: Green chemistry initiatives are emerging, with suppliers adopting environmentally friendly production methods.

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Conclusion

The procurement of bulk oxaliplatin API hinges on sourcing from vetted, GMP-compliant manufacturers capable of meeting international quality standards. Chinese companies like Zhejiang Hisun and Jiangsu Hengrui are leading suppliers, offering cost-effective, quality APIs suitable for global markets. European firms such as Fresenius Kabi maintain a high quality, regulation-compliant supply chain for premium segments. Indian manufacturers like Ind-Ar Laboratory provide competitive options, especially in cost-sensitive contexts.

Despite potential supply chain vulnerabilities, a diversified sourcing approach—coupled with rigorous quality control—can mitigate risks and ensure steady API availability for the production of OCUCLEAR.

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Key Takeaways

• Chinese API manufacturers dominate oxaliplatin sourcing due to scale and pricing; ensure rigorous quality validation.
• European suppliers like Fresenius Kabi offer premium quality with extensive regulatory compliance.
• Indian manufacturers provide cost-effective alternatives with growing regulatory acceptance.
• Diversifying supplier base enhances supply stability amidst geopolitical and regulatory uncertainties.
• Staying updated on regulatory standards and supplier certifications is essential for maintaining compliance.

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FAQs

1. What are the primary regions sourcing oxaliplatin API globally?
China leads in manufacturing volume, followed by India and European countries such as Germany, with a focus on maintaining high-quality standards to meet international regulations.

2. How does regulatory compliance impact API sourcing decisions?
Compliance with GMP, ISO, and other international standards ensures quality, safety, and regulatory approval, which are critical for pharmaceutical licensing, export, and commercial success.

3. What factors should be considered when evaluating oxaliplatin API suppliers?
Quality certifications, manufacturing capacity, regulatory track record, pricing, lead times, and supply chain stability.

4. Are there quality differences between Chinese and European API suppliers?
European suppliers typically adhere to stricter regulatory standards due to rigorous EU and US oversight, but many Chinese manufacturers now meet global standards, offering competitive quality.

5. What future trends will influence oxaliplatin API sourcing?
Further globalization of supply chains, adoption of advanced manufacturing technologies, focus on sustainability, and geopolitical shifts affecting trade agreements.

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Sources

[1] Bureau of Industry and Security, U.S. Department of Commerce. "Global API Manufacturing Dynamics." 2022.
[2] U.S. Food and Drug Administration (FDA). "Guidance for Industry: Content and Format of Applications for Drug Approvals." 2021.
[3] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practices." 2022.
[4] MarketWatch. "Global Oncology API Market Analysis." 2023.
[5] Company websites and official certifications, including Zhejiang Hisun Pharmaceutical, Jiangsu Hengrui, Fresenius Kabi, and others.