Bulk Pharmaceutical API Sources for SULFACEL-15

Bulk Pharmaceutical API Sources for SULFACEL-15

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		5215942
Sigma-Aldrich		S8647_SIGMA
Sigma-Aldrich		86020_ALDRICH
Vitas-M Laboratory		STK023979
Molport		MolPort-002-136-723

Bulk Active Pharmaceutical Ingredient (API) Sources for: SULFACEL-15

Last updated: August 4, 2025

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Introduction

SULFACEL-15 is a pharmaceutical compound classified as a sulfonated oil, primarily utilized in topical formulations for its antimicrobial and skin-conditioning properties. Its application spans dermatological products targeting acne and other bacterial skin infections. As the demand for SULFACEL-15 increases, pharmaceutical companies and formulators seek reliable bulk API sources capable of ensuring high quality, consistency, and regulatory compliance.

This report details the key suppliers and manufacturing sources of SULFACEL-15, highlighting industry trends, sourcing considerations, and strategic recommendations for buyers.

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Overview of SULFACEL-15

SULFACEL-15, also referred to by its chemical name sulfonated castor oil or derived derivatives, exhibits surfactant and antimicrobial activity. Its stability, low toxicity, and compatibility with various topical formulations have driven its widespread adoption.

Manufacturing of SULFACEL-15 involves sulfonation of castor oil or other triglycerides, a process requiring specialized equipment and rigorous quality controls, emphasizing the importance of sourcing from reputable producers.

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Major API Manufacturers and Suppliers

1. Local and International Chemical and Pharmaceutical Producers

a. BASF SE
BASF, a global leader in specialty chemicals, has historically produced sulfonated oils, including derivatives suitable for pharmaceutical applications. While their primary focus is in industrial chemicals, they maintain a portfolio of ingredients applied in personal care. Their expertise in sulfonation processes makes them a possible source for SULFACEL-15, subject to supply agreements and regulatory approvals.

b. Schülke & Mayr GmbH
Known for antimicrobial and preservative solutions, Schülke manufactures a proprietary sulfonated castor oil, marketed under the brand Sulfocel. Their product quality complies with pharmaceutical standards, making them a pertinent supplier for pharmaceutical-grade SULFACEL-15.

c. Croda International Plc
Croda produces specialty chemicals including surfactants and oils derived from natural sources. They have a background in sulfonated oils, offering custom synthesis and high-quality ingredients for cosmetic and topical formulations, potentially including SULFACEL-15.

d. Stepan Company
Specializing in surfactants and oleochemicals, Stepan offers products like Sulfochem, a range of sulfonated castor oils. They have the capacity for large-scale production and adhere to regulatory standards, making them a key supplier option.

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2. Contract Manufacturing Organizations (CMOs) and Private Label Producers

Several CMOs focus on sulfonation and derivatives, offering custom synthesis of SULFACEL-15 tailored to client specifications, including purity, viscosity, and packaging:

• Aclafor (India-based)
  Specializes in oleochemicals and sulfonated oils, providing bulk API under strict quality controls suitable for pharmaceuticals.

• Navin Fluorine International Ltd.
  While primarily a fluorochemicals producer, they also engage in asset chemical derivatives, including sulfonation products suitable for pharmaceutical applications.

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Regional and Emerging Sources

Regional manufacturers in countries such as India, China, and Brazil have increased production capacities of sulfonated oils due to rising demand in topical pharmaceuticals and personal care markets. Procurement from these regions can offer cost advantages but requires thorough validation of quality standards and regulatory compliance.

• India:
  Numerous oleochemical producers provide sulfonated derivatives, leveraging advanced sulfonation techniques. Companies like Godrej Industries and Vadilal Industries explore oleochemicals.

• China:
  Several chemical manufacturers offer sulfonated oils exhibiting pharmaceutical-grade specifications, such as Shandong Huakai Chemical.

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Supply Chain Considerations

Quality and Regulatory Compliance

Sourcing SULFACEL-15 for pharmaceutical applications mandates adherence to Good Manufacturing Practices (GMP) and pharmacopoeial standards (USP, EP, JP). Buyers should ensure assessments of:

• Certificates of Analysis (CoA)
• Batch consistency and traceability
• Purity levels (typically >98%)
• Absence of residual solvents or toxic impurities

Supply Reliability and Lead Times

Given the specialized nature of SULFACEL-15 synthesis, lead times can extend from 8 to 16 weeks depending on the supplier. Establishing long-term partnerships with validated manufacturers ensures steady supply and potential cost advantages.

Pricing Dynamics

Pricing is influenced by raw material costs, regional production capabilities, and regulatory compliance costs. SULFACEL-15's niche market often commands premium pricing relative to general surfactants.

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Strategic Sourcing Recommendations

• Supplier Validation:
  Prioritize suppliers with proven GMP compliance, ISO certifications, and extensive experience in pharmaceutical ingredients.

• Technical Due Diligence:
  Conduct quality audits, analyze batch consistency, and request comprehensive documentation to verify product specifications.

• Regional Diversification:
  To mitigate supply risks, diversify sources geographically, engaging both established international suppliers and regionally compliant manufacturers.

• Technology Transfer and Development:
  In-house or contracted R&D efforts to adapt or optimize sulfonation processes can enhance supply control and product customization.

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Conclusion

The landscape of SULFACEL-15 bulk API sourcing is characterized by a mix of established multinational chemical companies, regional oleochemical producers, and contract manufacturers capable of custom synthesis. Ensuring a reliable supply chain hinges on rigorous quality assessments, understanding regional regulatory nuances, and forging strategic partnerships with verified suppliers.

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Key Takeaways

• Established global producers like Schülke, Croda, and Stepan offer pharmaceutical-grade SULFACEL-15, with proven quality and supply reliability.
• Regional manufacturers in India and China are growing sources, often providing cost-effective options but necessitating thorough validation.
• Quality assurance and regulatory compliance are paramount; suppliers must adhere to GMP and pharmacopeial standards.
• Long-term sourcing strategies should include supplier audits, diversified supply chains, and potential in-house process development.
• Market trends favor increased demand for surfactants derived from natural oils like castor, bolstering the availability of SULFACEL-15 globally.

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FAQs

1. Is SULFACEL-15 considered a pharmaceutical ingredient or a cosmetic ingredient?
SULFACEL-15 is used in both cosmetic and pharmaceutical topical formulations, but sourcing for pharmaceutical applications requires strict compliance with GMP and pharmacopeial standards, making it a pharmaceutical-grade ingredient.

2. Which regions are leading producers of pharmaceutical-grade SULFACEL-15?
Major producers are located in North America, Europe, and parts of Asia (India and China), with capacity growth observed in emerging markets.

3. What are the key quality parameters to evaluate when sourcing SULFACEL-15?
Purity (>98%), viscosity, microbial limits, residual solvent levels, and compliance with USP, EP, or JP standards are critical.

4. Can SULFACEL-15 be custom-synthesized for specific formulations?
Yes, contract manufacturers can produce tailored batches aligning with specific purity, viscosity, or other specifications.

5. What are the primary challenges in sourcing SULFACEL-15?
Challenges include variable quality standards, regulatory hurdles across regions, supply chain disruptions, and cost fluctuations driven by raw material prices.

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References

[1] European Pharmacopoeia, Sulfonated Castor Oil, 2022.
[2] Schülke & Mayr GmbH, Product Catalogue, 2023.
[3] Croda International Plc, Oleochemicals Portfolio, 2023.
[4] Stepan Company, Surfactant Range Data Sheet, 2022.
[5] Industry Reports on Oleochemical Markets, 2022.

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This comprehensive review provides strategic insights necessary for stakeholders aiming to secure high-quality bulk SULFACEL-15 API sources aligned with industry standards.