Bulk Pharmaceutical API Sources for ULESFIA

Bulk Pharmaceutical API Sources for ULESFIA

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		485128_ALDRICH
Sigma-Aldrich		499226_ALDRICH
Sigma-Aldrich		514764_ALDRICH
Sigma-Aldrich		547514_ALDRICH

Bulk Active Pharmaceutical Ingredient (API) Sources for Ulesfia

Last updated: July 29, 2025

Introduction

Ulesfia (benzyl alcohol) 5% lotion is a topical treatment approved by the FDA for head lice infestation. The active pharmaceutical ingredient (API) in Ulesfia—benzyl alcohol—is a critical component, and its quality, supply chain, and sourcing are vital for manufacturers, pharmaceutical distributors, and healthcare providers. Ensuring a reliable supply of high-quality API is fundamental to maintaining Ulesfia’s availability and regulatory compliance.

This article provides an in-depth overview of bulk API sources for benzyl alcohol, focusing on global suppliers, manufacturing consolidation, regulatory considerations, and market trends that influence sourcing strategies.

Global Market Overview for Benzyl Alcohol API

Benzyl alcohol is an aromatic alcohol used across pharmaceutical, cosmetic, and food industries. The pharmaceutical-grade benzyl alcohol required for Ulesfia adheres to strict quality standards, such as USP, EP, or JP specifications, to ensure safety and efficacy.

The primary production regions for benzyl alcohol include China, India, Europe, and the United States. The majority of the API production capacity resides in Asia, with China and India dominating the supply chain due to lower manufacturing costs and established chemical industries.

Major API Manufacturers for Benzyl Alcohol

1. Chinese API Manufacturers

China remains the dominant supplier of benzyl alcohol, with several large-scale API producers offering pharmaceutical-grade products. Key players include:

• Shandong Lianyun Chemical Co., Ltd. – Offers USP/EP grade benzyl alcohol with consistent quality, serving global pharmaceutical markets.
• Shandong Jinpu Chemical Co., Ltd. – Provides benzyl alcohol complying with international pharmacopeia standards; supplies large volumes to bulk API buyers.
• Hubei Zhenping Chemical Co., Ltd. – Focuses on high-purity benzyl alcohol suitable for injectable and topical applications.

These manufacturers are known for their capacity to produce large quantities, competitive pricing, and compliance with global quality standards. However, due diligence in regulatory adherence and supply chain transparency is essential when sourcing from Chinese producers.

2. Indian API Manufacturers

India’s pharmaceutical industry has expanded its API manufacturing capabilities over the past decade, offering high-quality benzyl alcohol for various applications:

• Gujarat State Fertilizers & Chemicals Ltd. (GSFC) – Produces benzyl alcohol complying with pharmacopeial standards, serving regional and international clients.
• Excel Industries Limited – Supplies USP-grade benzyl alcohol, with certifications suitable for pharmaceutical use.
• S. G. Fine Chemicals – Offers pharmaceutical grade benzyl alcohol, emphasizing quality control and adherence to international standards.

Indian manufacturers often have a reputation for quality focus, regulatory compliance, and shorter lead times, making them attractive options for global sourcing.

3. European Manufacturers

Although smaller in scale relative to Chinese and Indian producers, Europe hosts specialty chemical companies with high-quality standards:

• Merck KGaA (Germany) – Supplies benzyl alcohol with high purity, supporting pharmaceutical applications.
• BASF SE (Germany) – Offers benzyl alcohol derivatives for specialty uses; some APIs are suitable for pharmaceutical grade.

European suppliers typically emphasize compliance with strict regulatory standards and offer flexibility for custom manufacturing, albeit at higher costs.

4. U.S. API Producers

The United States hosts fewer large-scale benzyl alcohol manufacturers, with some companies specializing in specialty chemicals:

• BASF Corporation (U.S. subsidiary) – Offers benzyl alcohol complying with FDA and USP standards.
• Piramal Enterprises – Supplies pharmaceutical-grade benzyl alcohol, often sourced through partnerships with Indian manufacturers.

U.S. manufacturers tend to focus on high-quality, regulatory-compliant APIs and may offer enhanced supply chain assurance and regulatory support.

Supply Chain and Regulatory Considerations

Quality Certifications and Regulatory Compliance

Sourcing pharmaceutical-grade benzyl alcohol requires verification of compliance with pharmacopeial standards such as USP, EP, or JP. Suppliers must provide Certificates of Analysis (CoA), Good Manufacturing Practice (GMP) certification, and ISO quality certifications.

Supply Chain Risks

Supply chain disruptions, geopolitical tensions, and raw material shortages impact API availability. Suppliers from China and India have faced scrutiny for regulatory compliance and manufacturing practices, prompting buyers to conduct thorough audits and supplier qualification processes.

Regulatory Approvals and Documentation

Manufacturers sourcing benzyl alcohol for Ulesfia must ensure their suppliers possess necessary regulatory approvals and documentation to facilitate importation and market approval in various jurisdictions.

Market Trends and Emerging Sourcing Strategies

Consolidation and Diversification

The API supply market for benzyl alcohol is witnessing consolidation among top manufacturers to ensure quality and stability. Simultaneously, buyers seek diversified sourcing strategies to mitigate supply risks, including engaging multiple suppliers across regions.

Shift Toward Certified and Verified Suppliers

Pharmaceutical companies are increasingly prioritizing suppliers with verified GMP compliance, robust quality assurance protocols, and transparent supply chains. Such preferences influence procurement strategies and contractual arrangements.

Technological Innovation

Advances in green chemistry and process optimization contribute to more sustainable and cost-effective API production. Manufacturers investing in environmentally friendly processes are gaining competitive advantage and attracting buyers committed to sustainability.

Conclusion

Securing reliable sources for bulk benzyl alcohol API is crucial for the sustained production of Ulesfia. Leading suppliers predominantly operate in China, India, Europe, and the U.S., each offering distinct advantages in terms of quality, supply stability, and regulatory compliance. Due diligence, supplier qualification, and diversification remain essential to mitigate risks and ensure consistent quality.

Key Takeaways:

• Major suppliers include Chinese giants (e.g., Shandong Lianyun, Jinpu Chemical), Indian manufacturers (e.g., GSFC, Excel Industries), European firms (e.g., Merck, BASF), and select U.S. producers.
• Regulatory compliance with USP, EP, or JP standards is mandatory; detailed verification of certifications is necessary.
• Supply chain risks necessitate diversification and pre-qualification of suppliers, especially amid geopolitical and logistical challenges.
• Market trends focus on sustainability, quality assurance, and technological innovation for API production.
• Strategic sourcing involves balancing cost, quality, regulatory compliance, and supply continuity, especially for high-demand APIs like benzyl alcohol.

Final note: Buyers should continually monitor the API landscape through supplier audits, regulatory updates, and market intelligence to maintain a secure, compliant supply chain for Ulesfia.

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FAQs

1. What are the primary regions producing pharmaceutical-grade benzyl alcohol?
China and India are the leading producers, with European and U.S. manufacturers also supplying high-quality APIs.

2. How can buyers ensure the quality of benzyl alcohol API?
By verifying Certificates of Analysis, GMP certifications, supplier audits, and ensuring conformity with pharmacopeial standards such as USP or EP.

3. What are the risks associated with sourcing benzyl alcohol from China?
Potential risks include supply chain disruptions, regulatory compliance issues, and quality inconsistencies; thorough due diligence mitigates these risks.

4. Are there sustainable or green manufacturing options for benzyl alcohol?
Yes, some manufacturers invest in environmentally friendly processes, reducing ecological impact and aligning with industry sustainability initiatives.

5. How does market demand affect API sourcing strategies for Ulesfia?
Increasing demand reinforces the importance of secure, diversified sourcing to maintain supply stability and comply with regulatory requirements.

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References

[1] U.S. Food and Drug Administration. (2023). Ulesfia (benzyl alcohol) Lotion, for topical use.
[2] Global Pharmaceutical API Market Analysis, MarketsandMarkets, 2022.
[3] Chinese Chemical Industry Association Reports, 2022.
[4] Indian Chemical Industry Profiles, Directorate General of Foreign Trade, 2022.
[5] European Chemical Industry Council (Cefic), 2023.