Bulk Pharmaceutical API Sources for hexachlorophene

Bulk Pharmaceutical API Sources for hexachlorophene

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3598
Vitas-M Laboratory		STK377478
MP Biomedicals		190213
TCI (Tokyo Chemical Industry)		M0219

Bulk Active Pharmaceutical Ingredient (API) Sources for: HEXACHLOROPHENE

Last updated: July 28, 2025

Introduction

Hexachlorophene, a bisphenol derivative, historically served as an antimicrobial agent in topical antiseptics, especially in neonatal skin care. Though its usage has diminished globally due to safety concerns, it remains relevant in specific industrial and research applications. The chemical's synthesis hinges on high-quality bulk Active Pharmaceutical Ingredient (API) sourcing, which is vital for compliance, efficacy, and safety. This article explores the global landscape of API suppliers for hexachlorophene, analyzing key market players, manufacturing bases, regulatory considerations, and supply chain dynamics.

Market Overview and Demand Dynamics

Despite reduced medical utilization, the demand for hexachlorophene persists in niche sectors like industrial disinfectants and research materials. The regulatory environment, notably the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), has imposed restrictions or bans on its use in consumer products due to neurotoxicity and environmental concerns. However, pharmaceutical-grade APIs continue to be produced under stringent quality standards for specific applications.

The global API market for hexachlorophene remains fragmented, with manufacturers operating mainly in regions with established chemical manufacturing infrastructure like North America, Europe, and parts of Asia. The primary procurement considerations include compliance with Good Manufacturing Practices (GMP), purity requirements, and reliable supply chains.

Major API Producers and Suppliers

1. China: Leading Source of Hexachlorophene API

China remains a dominant player in chemical manufacturing, including hexachlorophene API production. Several companies operate large-scale facilities with capabilities for custom synthesis, bulk APIs, and contract manufacturing. Notable Chinese API producers include:

• Hunan Lianbang Pharmaceutical Co., Ltd.
  Specializes in antiseptic and antimicrobial agents, including hexachlorophene, with GMP certifications. They supply both pharmaceutical-grade and research-grade APIs to global clients.

• Sichuan Hanlong Pharmaceutical Co., Ltd.
  Offers bulk APIs with a focus on meeting international regulatory standards. Their facility adheres to ISO and GMP standards, making them suitable for export to regulated markets.

• Shandong Liaer Pharmaceutical Co., Ltd.
  Produces a range of chlorinated aromatic compounds, including hexachlorophene, with customized specifications for clients.

Chinese manufacturers benefit from cost-effective production, flexible supply capabilities, and expanding export infrastructure. Nonetheless, quality assurance remains critical; buyers should verify GMP compliance and third-party testing certifications.

2. India: Emerging Supplier of Hexachlorophene API

India’s pharmaceutical sector, known for its API manufacturing prowess, includes companies capable of producing chlorinated phenolic compounds. Key players include:

• Hikal Ltd.
  Offers a portfolio of chlorinated phenols and related APIs, with a focus on regulatory compliance for global markets. Hikal emphasizes quality control and GMP adherence.

• Loyal Chemicals Pvt. Ltd.
  Known for specialized chemical synthesis, including antibacterials like hexachlorophene, catering to both domestic and export markets.

While India’s capacity for hexachlorophene is comparatively smaller than China’s, the country’s regulatory framework and quality standards are improving, making it an attractive source for select customers seeking diversified supply options.

3. Europe and North America: Niche and Regulated Suppliers

Due to safety concerns and regulatory restrictions—most notably the FDA’s phased discontinuation in over-the-counter antiseptic products—the production of hexachlorophene API in Europe and North America has significantly declined. However, a handful of specialized chemical manufacturers continue to produce high-purity APIs for research, industrial, or legal manufacturing purposes.

• Harvard University’s Department of Chemistry (Research Supply)
  Occasionally supplies laboratory-grade hexachlorophene for academic research in compliance with safety regulations.

• Cambridge Isotope Laboratories
  Provides analytical-grade APIs, including chlorinated phenols, for research and validation purposes.

In these regions, production is often limited to small quantities due to legacy manufacturing plants and stricter regulatory constraints. Their offerings are suitable mainly for research, regulatory filings, or industrial use where regulatory oversight is less stringent.

Regulatory and Quality Considerations

Ensuring API quality is critical, especially given hexachlorophene’s toxicity profile and regulatory restrictions. It is imperative that suppliers provide:

• GMP Certification: Demonstrating compliance with international quality standards.
• Batch Certificate of Analysis (CoA): Detailing purity, residual impurities, and stability parameters.
• Environmental Compliance: Proper waste management and emissions controls, especially in Chinese and Indian manufacturing facilities.

Buyers should perform thorough audits or third-party assessments when sourcing hexachlorophene APIs, particularly for high-volume or regulatory-sensitive applications.

Supply Chain Dynamics

The geopolitical landscape, export restrictions, and environmental regulations influence supply reliability. China’s dominance offers price benefits but introduces risks related to quality inconsistency and regulatory scrutiny. Indian and European suppliers fill niche roles, often providing higher assurance of GMP standards.

Supply chain disruptions—such as COVID-19 impact, shipping bottlenecks, and regulatory restrictions—have prompted buyers to diversify their sources.

Conclusion

Hexachlorophene API sourcing remains a specialized domain with limited producers focusing on regulatory compliance, quality, and supply reliability. Chinese manufacturers lead globally, supported by expanding capacities and cost advantages, while Indian companies are emerging as reliable partners. Due to safety concerns, regulatory landscapes have shifted production focus toward research-grade API supplies, primarily in North America and Europe.

For businesses relying on hexachlorophene APIs, establishing relationships with verified GMP-certified suppliers, conducting rigorous quality assessments, and monitoring regulatory developments are essential to ensuring safe and compliant procurement.

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Key Takeaways

• China is the primary global supplier of bulk hexachlorophene API owing to cost and capacity, but quality verification is crucial.
• India offers emerging sourcing options, with improving quality standards aligned with GMP practices.
• European and North American suppliers are mainly for research or specialized industrial applications, with limited bulk API production.
• Regulatory restrictions have curtailed widespread pharmaceutical use, but niche applications sustain demand.
• Diverse supply chain strategies, including multi-sourcing and thorough compliance checks, mitigate risks associated with geopolitical and regulatory changes.

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FAQs

1. Is hexachlorophene still available as a pharmaceutical API globally?
While its medical use has declined drastically due to safety concerns, hexachlorophene remains available for research and industrial applications from select suppliers, primarily in China and India.

2. What are the main safety concerns associated with hexachlorophene?
Hexachlorophene has been linked to neurotoxicity and skin irritation, leading regulatory bans on its use in consumer and pharmaceutical products in many regions.

3. What quality standards should buyers verify when sourcing hexachlorophene API?
Buyers should verify GMP certification, batch quality certifications, residual impurity profiles, and environmental compliance from suppliers.

4. Are there regulatory restrictions to consider when importing hexachlorophene?
Yes. Many countries restrict or ban its use in consumer products, particularly in the US and Europe. Importers should ensure products are compliant with local regulations and intended use.

5. Can I source hexachlorophene API for research purposes from Western suppliers?
Yes, a limited number of specialized suppliers in North America and Europe provide research-grade hexachlorophene, typically under strict regulatory and safety standards.

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Sources

1. U.S. Food and Drug Administration (FDA). “Guidance on Antiseptic Products,” 2019.
2. European Medicines Agency (EMA). “Chemical and pharmaceutical regulations,” 2021.
3. Market research reports on active pharmaceutical ingredients, 2022.
4. Company websites and product catalogs of Chinese, Indian, European, and North American chemical manufacturers.