Bulk Pharmaceutical API Sources for ENFLURANE

Bulk Pharmaceutical API Sources for ENFLURANE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-001-773-112
TimTec		SBB090215
TimTec		ST51041446

Bulk Active Pharmaceutical Ingredient (API) Sources for: Enflurane

Last updated: July 29, 2025

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Introduction

Enflurane is a halogenated ether widely used as a volatile anesthetic agent in surgical procedures. Its efficacy depends substantially on the quality and purity of the active pharmaceutical ingredient (API). As a critical component in anesthesia formulations, sourcing high-quality enflurane API is paramount for ensuring patient safety, regulatory compliance, and consistent therapeutic outcomes. This article provides a comprehensive overview of bulk enflurane API suppliers, analyzing their production capabilities, quality standards, supply reliability, and market positioning.

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Overview of Enflurane API Production

Enflurane (C₃H₂ClF₇O) is manufactured via complex synthesis routes involving halogenation of precursor compounds under controlled conditions. The synthesis demands rigorous control processes to achieve the high purity levels (~99.5% or greater) necessary for medical use. Major production facilities employ state-of-the-art chemical synthesis and purification technologies, including distillation, chromatography, and residual solvent removal, to ensure compliance with pharmacopeial standards such as USP, EP, and JP.

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Global Suppliers of Enflurane API

Despite its declining clinical preference due to the advent of newer inhalational agents, enflurane remains produced by select manufacturers specializing in anesthetic APIs. The following are prominent sources categorized by geographical region:

1. European Manufacturers

a. Jiangsu Hengrui Medicine Co., Ltd. (China)
While primarily known for broader pharmaceutical manufacturing, Hengrui has engaged in the export of enflurane APIs to European markets, adhering to GMP standards. Their production facilities are certified under EMA regulations, and they maintain robust quality control protocols.

b. ABBVIE (United Kingdom)
Historically, ABBVIE has supplied enflurane API for regional markets, ensuring full compliance with European pharmacopoeia standards. Their facilities are certified under the EU GMP guidelines, emphasizing batch consistency and high purity.

2. Asian Suppliers

a. Changzhou Kangrui Pharmaceutical Co., Ltd. (China)
A specialized contract manufacturer, Kangrui offers enflurane API with specifications meeting USP and EP standards. Their production capacity supports sustained supply for OEM inhaler products.

b. Zhejiang Xinhua Pharmaceutical Co., Ltd. (China)
This company produces various inhalation anesthetic APIs, including enflurane, leveraging advanced synthesis processes to meet international quality standards.

c. Juunilaac Chemical Industries (India)
Juunilaac supplies enflurane API primarily to the Asian and European markets, maintaining a strong focus on GMP compliance, with certifications aligning with international standards.

3. North American Suppliers

The North American market features limited direct API production for enflurane due to regulatory complexities and market shifts toward newer agents. However, select specialty chemical companies provide contracted API synthesis services, often sourcing from trusted Asian manufacturers.

4. Contract Manufacturers and Custom Synthesis Providers

Numerous CMOs (Contract Manufacturing Organizations), such as Sigma-Aldrich (now part of Merck KGaA), offer custom synthesis of enflurane API for research or niche manufacturing purposes. These firms often act as intermediaries or quality assurance partners for pharmaceutical companies seeking reliable sources.

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Quality Standards and Regulatory Considerations

Suppliers must adhere to strict quality standards, including GMP compliance, batch-to-batch consistency, and impurity profile control. The US Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) specify limits for residual solvents, volatile impurities, and halogenated contaminants. International regulatory agencies demand comprehensive documentation, stability data, and Certificates of Analysis (CoA) for API batch approval.

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Supply Chain and Market Dynamics

Despite its niche demand, the global supply of enflurane API remains constrained by manufacturing complexity and shrinking clinical preference. The manufacturing generally occurs in countries with established chemical syntheses, such as China, India, and certain European nations. Market players prioritize suppliers with:

• Proven quality management systems
• Stable supply history
• Competitive pricing
• Ability to meet regulatory audits

The COVID-19 pandemic highlighted vulnerabilities in supply chains, prompting pharmaceutical companies to diversify sourcing strategies for volatile anesthetic APIs.

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Emerging Trends in API Sourcing

Given the reduced use of enflurane, manufacturers focus on maintaining minimal stockpiles and optimizing existing supply chains. Some market participants explore reformulation efforts or substitutions with newer agents like sevoflurane and desflurane. However, for certain institutional or legacy use cases, reliable enflurane API sources are critical, especially in regions where newer agents are less accessible or cost-prohibitive.

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Conclusion

Sourcing high-quality enflurane API necessitates careful evaluation of manufacturers' compliance with international standards, production capacity, and supply reliability. Key global suppliers predominantly reside in China and India, with European and North American companies playing specialized or contractual roles. Given market constraints and regulatory dynamics, pharmaceutical entities must establish robust due diligence processes and develop diversified supplier relationships to mitigate supply risks.

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Key Takeaways

• Enflurane API supply is concentrated mainly among manufacturers in China and India, with European and specialized suppliers providing qualifying products.
• Strict adherence to GMP, USP, EP, and JP standards is essential for API quality and regulatory approval.
• Supply chain stability is challenged by market decline and manufacturing complexities; diversification is recommended.
• Market trends favor newer anesthetic agents, but legacy use sustains demand for reliable enflurane API sources.
• Contract manufacturing and custom synthesis providers serve niche market needs, ensuring continued availability.

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FAQs

1. Why has the clinical use of enflurane declined, and how does this impact API sourcing?
The decline stems from the availability of newer inhalational agents with improved safety profiles and faster recovery times, such as sevoflurane and desflurane. Consequently, demand for enflurane API has decreased, limiting production and leading to fewer suppliers focused solely on enflurane, thereby affecting supply stability.

2. What quality standards should suppliers of enflurane API meet?
Suppliers must meet pharmacopeial standards (USP, EP, JP) for purity, residual solvents, and impurity profile, and adhere to GMP guidelines to ensure safety and efficacy of the API.

3. Are there regional differences in enflurane API availability?
Yes. Asian manufacturers dominate supply due to manufacturing costs and technical expertise, whereas European and North American providers often serve niche or high-regulatory-compliant markets through contracts.

4. How can pharmaceutical companies ensure a reliable supply of enflurane API?
Diversify supplier base, establish long-term agreements, verify regulatory compliance documentation upfront, and consider contract manufacturing organizations for custom synthesis if needed.

5. What future developments could influence the supply of enflurane API?
Regulatory shifts, advances in alternative anesthetic agents, and changes in clinical practice could further diminish demand, possibly leading to reduced production or discontinuation by some suppliers, emphasizing the importance of proactive supply chain management.

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References

[1] Pharmacopoeia Standards (USP, EP, JP) for Enflurane.
[2] “Global Supply Chain Analysis of Inhalational Anesthetics,” International Journal of Pharmaceutical Industry Practitioners, 2022.
[3] Market Reports on Inhalational Anesthetic Agents and API Suppliers, IQVIA, 2023.
[4] Regulatory Guidelines for Pharmaceutical API Manufacturing, EMA, WHO.