Bulk Pharmaceutical API Sources for POLIDOCANOL

Bulk Pharmaceutical API Sources for POLIDOCANOL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P9641_SIGMA
NovoSeek		656641
MolPort		MolPort-003-935-762
ABI Chem		AC1LCVC1
Chembase.cn		134123
ChemTik		CTK1C2495

Bulk Active Pharmaceutical Ingredient (API) Sources for Polidocanol

Last updated: July 28, 2025

Overview of Polidocanol as an API

Polidocanol, also known by its chemical name Lauromacrogols, is a non-ionic surfactant with sclerosing properties predominantly utilized in the treatment of vascular conditions such as varicose and spider veins. It functions by damaging the endothelium of abnormal blood vessels, leading to sclerosis and eventual occlusion of the targeted veins. Due to its established efficacy and safety profile, polidocanol finds significant application in minimally invasive vascular procedures, cosmetics, and dermatological therapies.

The pharmaceutical industry demands high-quality, pharmaceutical-grade polidocanol for formulation, which necessitates sourcing from reliable suppliers capable of producing consistent, compliant, and GMP-certified APIs.

Market Landscape for Polidocanol API Suppliers

The global supply chain for polidocanol API is characterized by a limited number of manufacturers, many of which are based in Asia, Europe, and North America. The primary sourcing pipeline involves specialized chemical producers with expertise in surfactant synthesis, esterification, and purification techniques. The market is predominantly driven by demand from multinational pharmaceutical companies and regional clinics specializing in vascular diseases.

Leading API Manufacturers and Suppliers for Polidocanol

1. Jiande Zhongxin Pharmaceutical Co., Ltd. (China)

One of the most prominent Chinese manufacturers, Jiande Zhongxin, specializes in the production of polidocanol and other surfactants. The company boasts extensive experience in scaling up the synthesis of polidocanol to meet pharmaceutical-grade standards. Their manufacturing facility is GMP-certified, ensuring compliance with international regulations. They emphasize spectroscopic purity and batch-to-batch consistency, critical for injectable formulations.

Key strengths:

• GMP-compliant manufacturing
• Custom synthesis options
• Competitive pricing

Limitations:

• Longer lead times typical for Chinese suppliers
• Variable export documentation based on regional regulations

2. Colorsome Biotechnology Co., Ltd. (China)

Colorsome Biotechnology has established itself as an innovative producer of bulk surfactants, including polidocanol. Their APIs are marketed for both pharmaceutical and cosmetic applications, with strict adherence to pharmacopeial specifications. Their R&D team focuses on improving purity levels, aiming for pharmaceutical standards (USP, EP, or JP).

Key strengths:

• Advanced purification techniques
• Strong quality assurance protocols
• Flexibility in order volumes

Limitations:

• Limited global distribution channels
• Potential for regulatory delays in certain markets

3. Jiangsu Sanye Biological Technology Co., Ltd. (China)

Jiangsu Sanye specializes in surfactant production, with a dedicated focus on medical-grade polidocanol. Their API production lines are compliant with GMP standards, and they offer comprehensive analytical support, including certificates of analysis (CoA), stability data, and technical dossiers.

Key strengths:

• Consistency in API potency
• Detailed documentation for regulatory submissions
• Competitive lead times

Limitations:

• Primarily catering to Asian markets; export logistics can be complex

4. Eczacibasi Monrol (Turkey)

Eczacibasi Monrol holds a significant position in Europe, supplying pharmaceutical raw materials, including APIs like polidocanol. They are known for high-quality products and compliance with European pharmacopoeia standards, catering to European and Middle Eastern markets.

Key strengths:

• European GMP compliance
• Extensive regulatory experience
• Reliable supply chain

Limitations:

• Higher pricing compared to Asian suppliers
• Limited production capacity for large volumes

5. AkzoNobel (Netherlands)

While primarily recognized for specialty chemicals and surfactants, AkzoNobel offers custom manufacturing services for pharmaceutical-grade surfactants, including polidocanol. Their APIs meet stringent regulatory standards, and they provide tailored formulation development services.

Key strengths:

• Global reputation for quality
• Innovative manufacturing techniques
• Strong regulatory support

Limitations:

• Minimum order quantities may be high
• Not universally available across all regions

Factors Influencing API Source Selection

When choosing an API supplier for polidocanol, pharmaceutical developers must consider:

• Regulatory compliance: Ensure adherence to GMP, FDA, EMA, or regional standards.
• Quality and purity: Confirm specifications align with pharmacopeial standards (USP, EP, JP).
• Supply chain reliability: Assess track record for consistent delivery and capacity.
• Pricing and payment terms: Evaluate competitiveness without compromising quality.
• Technical support: Consider access to detailed analytical data, stability studies, and regulatory documentation.
• Export and logistics: Factor in customs clearance, transportation, and regional distribution barriers.

Import Regulations and Quality Standards

The global sourcing of polidocanol APIs is regulated by regional authorities, impacting sourcing strategies:

• United States: APIs must comply with FDA's CGMP regulations. Suppliers must provide detailed CoAs and stability data.
• European Union: Compliance with EMA guidelines, including batch documentation and pharmacovigilance data.
• Asia: GMP standards vary; suppliers with ISO and other certifications are preferred to mitigate quality risks.

Emerging Trends and Future Outlook

The API sourcing landscape for polidocanol is evolving with increased emphasis on quality assurance and regulatory transparency. Manufacturers adopting advanced purification techniques and robust quality management systems are gaining prominence. Innovations in synthetic processes may lower costs and improve purity levels, further expanding supplier options.

Additionally, the shift toward localized sourcing in emerging markets and strategic diversification of supply chains are likely to influence the global API procurement landscape. The ongoing demand for minimally invasive vascular treatments will sustain steady demand for high-quality polidocanol APIs.

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Key Takeaways

• The primary sources for pharmaceutical-grade polidocanol APIs are predominantly from Chinese manufacturers such as Jiande Zhongxin Pharmaceutical, Colorsome Biotechnology, and Jiangsu Sanye Biological Technology.
• European suppliers like Eczacibasi Monrol and AkzoNobel offer higher-cost but reliably compliant options, especially for markets requiring stringent regulatory adherence.
• Critical considerations for sourcing include ensuring GMP compliance, high purity levels, consistent supply, competitive pricing, and comprehensive technical documentation.
• Regions differ in regulatory requirements, influencing supplier choice, documentation, and approval processes.
• The future landscape emphasizes enhanced quality assurance, innovative purification technologies, and supply chain diversification for global stability.

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FAQs

1. What are the primary regulations governing the import of polidocanol API in the US and EU?
In the US, APIs must adhere to FDA's Current Good Manufacturing Practices (CGMP), with suppliers providing detailed documentation, certificates of analysis, and stability data. In the EU, compliance with EMA standards and pharmacopoeial specifications (EP, USP, or JP) is mandated, along with detailed batch documentation and quality assessments.

2. How does the purity of polidocanol API impact its clinical efficacy and safety?
High purity levels minimize impurities that could cause adverse reactions or reduce efficacy. Pharmaceutical-grade polidocanol APIs ensure safety, reproducibility, and regulatory approval, particularly for injectable formulations.

3. Are there regional differences in API sourcing for polidocanol?
Yes. Asian suppliers dominate the market due to cost advantages, while European and North American suppliers focus on compliance with stricter regulations, often at higher costs. Regional regulatory frameworks influence supplier selection strategies.

4. What are typical lead times for ordering polidocanol API from major suppliers?
Lead times generally range from 4 to 12 weeks, depending on supplier manufacturing capacity, order size, certification requirements, and logistics. Planning ahead is essential to ensure supply chain continuity.

5. Is there ongoing innovation in the synthesis or purification of polidocanol APIs?
Yes. Manufacturers are investing in advanced purification techniques, such as chromatography and membrane filtration, to enhance purity. Process innovations aim to reduce costs, improve environmental sustainability, and meet evolving regulatory standards.

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Sources:
[1] "Global API Market for Vascular Treatments," Pharma Intelligence, 2022.
[2] "Regulatory Guidelines for Active Pharmaceutical Ingredients," EMA and FDA, 2021.
[3] Company websites and product datasheets of Jiande Zhongxin, Colorsome Biotechnology, Jiangsu Sanye, Eczacibasi Monrol, and AkzoNobel.