Bulk Pharmaceutical API Sources for SODIUM TETRADECYL SULFATE

Bulk Pharmaceutical API Sources for SODIUM TETRADECYL SULFATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		4_SIGMA
Sigma-Aldrich		N1404_SIGMA
Molport		MolPort-003-931-842
Sigma-Aldrich		83714_SIAL

Bulk Active Pharmaceutical Ingredient (API) Sources for Sodium Tetradecyl Sulfate

Last updated: August 4, 2025

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Introduction

Sodium tetradecyl sulfate (STS) is an anionic surfactant primarily used as a sclerosing agent in medical procedures such as varicose vein treatment and other vascular malformations. As a critical therapeutic compound, the sourcing of high-quality bulk API is vital for manufacturers and healthcare providers. The global pharmaceutical supply chain for sodium tetradecyl sulfate involves multiple suppliers, predominantly based in Asia, Europe, and the Americas, offering varying standards of quality, regulatory compliance, and OEM capabilities. This article provides an in-depth review of key sources for bulk sodium tetradecyl sulfate, emphasizing supplier profiles, regional distributions, and procurement considerations for pharma companies.

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Global Market Overview for Sodium Tetradecyl Sulfate API

The API market for sodium tetradecyl sulfate is characterized by a limited number of specialized manufacturers, given its niche therapeutic application. Its production requires sophisticated chemical synthesis and stringent quality controls, aligning with pharmacopoeial standards such as USP, EP, or JP. The total global demand remains modest compared to generic oral pharmaceuticals; however, its importance in the dermatologic and vascular therapy sectors sustains a steady supply chain.

Major API producers for sodium tetradecyl sulfate operate mainly in Asia, with China and India leading, complemented by notable European and North American suppliers focused on high-quality and GMP-compliant products.

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Key API Suppliers and Regions

1. China

China dominates the API goods market for sodium tetradecyl sulfate, with numerous manufacturers offering bulk supplies at competitive prices. These suppliers typically serve both local and international markets, emphasizing cost competitiveness combined with compliance to international GMP standards.

• Zhejiang Corefluent Chemical Co., Ltd.

  • Specializes in surfactants including STS.
  • Features: GMP certification, extensive R&D, and bulk production capabilities.

• Shandong Laizhou Guangming Chemical Co., Ltd.

  • Focuses on surfactants and specialty chemicals.
  • Emphasizes quality management aligned with regulatory expectations.

• Jiangsu Brightmoon Chemical

  • Represents a major player with advanced manufacturing infrastructure.
  • Known for wide product range and export compliance.

2. India

Indian API manufacturers have gained recognition for producing high-quality pharmaceutical intermediates and APIs, including sodium tetradecyl sulfate, often meeting stringent regulatory standards suitable for global markets.

• Aarti Industries Ltd.

  • Certified for production of surfactants, with a strong international export footprint.
  • Complies with global GMP, ISO, and other certifications.

• Navin Fluorine International Ltd.

  • Known for specialty chemicals with pharmaceutical applications.
  • Supplies STS conforming to pharmacopeial standards.

• Gujarat Pharmaceutical Ltd.

  • Focuses on surfactants for medical formulations.
  • Emphasizes quality control and regulatory compliance.

3. Europe

European manufacturers mainly supply high-purity APIs compliant with rigorous pharmacopeial standards, often serving the North American and global markets.

• BASF SE (Germany)

  • Supplies surfactants and specialty chemicals.
  • Known for GMP-compliant facilities and high-quality standards.

• Evonik Industries (Germany)

  • Offers specialty surfactants and pharmaceutical-grade APIs.
  • Maintains strict regulatory and quality certifications.

4. North America

The North American market comprises mainly importers, distributors, and a few specialty chemical producers focusing on intermediates and custom synthesis.

• Stepan Company (USA)
  • Supplies surfactants and specialty chemicals; some sources for medical-grade products.
• QualityChemical Supply Inc.
  • Distributes bulk surfactants, including sodium tetradecyl sulfate, often sourced from Asian manufacturers.

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Procurement Considerations

When sourcing sodium tetradecyl sulfate API, pharmaceutical companies should evaluate critical factors:

• Regulatory Compliance: Ensure suppliers maintain GMP accreditation, and the API conforms to relevant pharmacopeial standards (USP, EP, or JP).

• Quality Certifications: Certificates of Analysis (CoA), batch consistency, purity levels (>98%), and impurity profiles are essential for clinical and commercial applications.

• Pricing and Lead Times: Competitive pricing is prevalent among Asian suppliers, but longer lead times and potential import tariffs may influence procurement strategies.

• Supply Chain Stability: Consider supplier track records, manufacturing capacity, and regional geopolitical stability.

• OEM and Custom Synthesis: For unique formulation needs, select suppliers with R&D capabilities for custom synthesis and formulation assistance.

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Regulatory and Quality Challenges

The chemical synthesis of sodium tetradecyl sulfate involves complex processes, with impurities and residuals posing regulatory scrutiny. Suppliers capable of providing comprehensive stability data, validated manufacturing processes, and thorough documentation are preferred to mitigate QA/QC risks.

Counterfeit or substandard APIs pose significant risk, underscoring the importance of sourcing from manufacturers with proven compliance and validated manufacturing processes.

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Future Trends and Market Outlook

Demand for sodium tetradecyl sulfate is poised to grow steadily, aligning with increased adoption in minimally invasive vascular treatments. Continuous innovations in formulation techniques and regulatory harmonization are expected to expand sourcing options. Suppliers investing in quality upgrade pathways and expanding GMP-certified capacity will likely gain competitive advantage.

The emergence of global supply chains and diversification of sources may reduce dependency on Asian suppliers alone, increasing access to high-quality European and North American manufacturers.

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Key Takeaways

• The primary API sources for sodium tetradecyl sulfate are predominantly located in China, India, and Europe, with varying focal points on quality, cost, and regulatory compliance.
• Ensuring GMP compliance, high purity, and thorough documentation is essential for procurement, especially for clinical and critical therapeutic use.
• Asian manufacturers offer cost-effective bulk supplies, but regulatory diligence and quality assurance are paramount.
• European suppliers emphasize high-quality standards suitable for markets with stringent regulatory requirements.
• Building supply chain resilience involves diversifying sources, maintaining quality certifications, and engaging with suppliers capable of custom synthesis and comprehensive documentation.

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FAQs

1. What are the primary regions supplying bulk sodium tetradecyl sulfate globally?
China and India dominate the manufacturing landscape with cost-competitive products, while Europe supplies high-purity APIs compliant with stringent regulations.

2. How can I verify the quality of sodium tetradecyl sulfate from a supplier?
Request Certificates of Analysis, GMP certifications, and detailed impurity profiles. Prefer suppliers with track records of regulatory compliance and third-party audits.

3. What are the key regulatory standards for pharmaceutical-grade sodium tetradecyl sulfate?
USP, European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) standards are the main benchmarks for API purity, safety, and quality.

4. Are there any notable risks in sourcing sodium tetradecyl sulfate API from Asia?
Risks include quality consistency, regulatory disparities, and supply chain disruptions. Due diligence and audits mitigate these concerns.

5. Will the demand for sodium tetradecyl sulfate increase in future years?
Yes, as minimally invasive vascular procedures grow, so will demand, prompting suppliers to enhance capacity and quality offerings accordingly.

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References

[1] PharmTech, "Sourcing Surfactants in Pharmaceuticals," 2022.
[2] GlobalData, "Pharmaceutical Surfactant Market," 2023.
[3] U.S. Pharmacopeia, "USP Monograph for Sodium Tetradecyl Sulfate," 2021.
[4] European Pharmacopoeia, "EP Standards for Surfactants," 2022.