Bulk Pharmaceutical API Sources for fospropofol disodium

Bulk Pharmaceutical API Sources for fospropofol disodium

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3038497
ABI Chem		AC1MI4YF
ChemMol		49400018
Chembase.cn		4453

Bulk Active Pharmaceutical Ingredient (API) Sources for: Fospropofol Disodium

Last updated: August 3, 2025

Introduction

Fospropofol disodium, a water-soluble prodrug of propofol, is increasingly utilized in anesthesia and sedation practices due to its favorable pharmacokinetics and reduced injection pain profile. As a critical component in sedative formulations, sourcing high-quality bulk APIs like fospropofol disodium is essential for pharmaceutical manufacturers seeking regulatory compliance, consistency, and cost efficiency. This report offers a comprehensive analysis of primary API suppliers for fospropofol disodium, focusing on global manufacturers, compliance standards, sourcing considerations, and market trends.

Overview of Fospropofol Disodium

Fospropofol disodium (chemical name: 2,6-diisopropylphenol disodium salt phosphate) embodies a phosphate ester prodrug that converts enzymatically to propofol, facilitating sedation with a potentially improved safety profile. Its synthesis involves complex organic and inorganic chemistry, necessitating stringent quality controls for bulk production. The API's manufacturing is subject to rigorous regulatory oversight, primarily by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Primary API Manufacturing Sources

1. China-Based API Manufacturers

China remains a dominant force in pharmaceutical API production, including niche and complex molecules like fospropofol disodium. Leading Chinese API producers benefit from advanced manufacturing capabilities, large-scale production facilities, and cost competitiveness.

• Wuhan Hezhong Pharmaceutical Co., Ltd.
  Recognized for API manufacturing with a focus on anesthetic agents, Wuhan Hezhong has compliance certifications and a track record of producing specialty APIs for global markets. Their production lines adhere to Good Manufacturing Practices (GMP), aligning with international standards.

• Shandong Xinhua Pharmaceutical Co., Ltd.
  With extensive experience in the synthesis of pharmaceutical intermediates and APIs, the company supplies fospropofol disodium to regional and international clients. Their facilities are GMP-certified, with quality management systems compliant with ISO standards.

• Nanjing Sanhome Pharmaceutical Co., Ltd.
  Noted for complex molecule synthesis, Sanhome offers research-grade and bulk APIs, including fospropofol disodium, with a focus on quality and regulatory adherence.

2. Indian API Manufacturers

India’s pharmaceutical sector is renowned for its cost-effective manufacturing and growing capability in complex APIs.

• Bharat Biotech International Ltd.
  With robust GMP facilities, Bharat Biotech has a diversified portfolio, including APIs for anesthesia and sedatives, with potential production lines for fospropofol disodium.

• Sun Pharma Advanced Research Co. (SPARC)
  Known for innovative pharmaceutical research, SPARC provides high-quality APIs and intermediates, potentially including fospropofol disodium, leveraging extensive R&D capabilities.

3. European and North American API Manufacturers

The focus here is on suppliers with stringent regulatory oversight, high-quality standards, and reliable supply chains.

• Fresenius Kabi (Germany/Global)
  A leader in infusion and anesthesia products, Fresenius Kabi maintains GMP-certified manufacturing sites capable of producing advanced APIs, including complex sedatives and prodrugs, aligning with industry standards.

• Hospira (AbbVie) (United States)
  Known for extensive portfolio of injectable pharmaceuticals, Hospira’s manufacturing units are GMP-compliant, with the capacity to produce fospropofol disodium under strict regulatory frameworks.

• Vasculox, Inc. (United States)
  Specializing in specialty APIs, Vasculox offers custom synthesis and bulk APIs for research and clinical use, potentially including fospropofol disodium, contingent upon regulatory approval and client arrangements.

Regulatory and Quality Considerations

Sourcing fospropofol disodium APIs requires rigorous assessment of compliance standards, including:

• GMP Certification: Essential for ensuring consistent quality suitable for human pharmaceutical use.
• Regulatory Approvals: Suppliers should possess approvals or certifications from major regulators (FDA, EMA, PMDA) or international quality assurance bodies.
• Analytical Documentation: Detailed Certificates of Analysis (CoA), stability data, and impurity profiles are critical for validation.

Market Dynamics and Sourcing Trends

The pharmaceutical API market for fospropofol disodium is characterized by:

• Demand Driven by Clinical and Institutional Use: Hospitals and clinical research organizations prefer suppliers with proven compliance.
• Global Supply Chain Volatility: Political, logistical, and regulatory factors influence the availability and pricing.
• Preference for Regional Sourcing: Manufacturers often prefer regional suppliers to mitigate logistical risks and meet local regulatory requirements.

Sourcing Challenges and Considerations

• Purity and Consistency: APIs must meet stringent purity standards to ensure safety and efficacy.
• Regulatory Track Record: Preference for suppliers with proven compliance to avoid delays in product approval.
• Pricing and Lead Times: Balancing cost efficiencies with reliable supply and certification.
• Intellectual Property (IP): Ensuring sourcing complies with patent and licensing arrangements.

Future Outlook

Advancements in synthesis technology and increasing regulatory scrutiny may influence the availability of fospropofol disodium from traditional suppliers. Increased global collaboration and regulatory harmonization could facilitate broader access to high-quality APIs. The trend toward regional manufacturing operations to reduce dependency on distant suppliers is anticipated to grow.

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Key Takeaways

• The primary bulk API sources for fospropofol disodium are predominantly located in China, India, Europe, and North America, each offering varying advantages in cost, compliance, and capacity.
• Ensuring GMP compliance, regulatory approvals, and rigorous quality documentation remains paramount when selecting an API supplier.
• Market dynamics favor regional sourcing to mitigate logistical and regulatory risks, especially given the complexity of fospropofol disodium synthesis.
• Manufacturers should evaluate supplier reliability, purity standards, and certification status amid evolving regulatory landscapes.
• Future sourcing strategies may involve exploring collaborations with emerging API producers leveraging advanced synthesis technologies and compliance frameworks.

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FAQs

1. Is fospropofol disodium readily available from global API suppliers?
Availability depends on the supplier’s manufacturing capabilities and regulatory approval status. While some producers in China and India supply fospropofol disodium, clinical or commercial manufacturing requires verified GMP-certified sources.

2. What regulatory considerations are critical when sourcing fospropofol disodium APIs?
Suppliers must demonstrate GMP compliance, possess valid regulatory certifications (FDA, EMA), and provide comprehensive analytical data, including Certificates of Analysis, to ensure quality and traceability.

3. Are there differences in API quality standards between Chinese, Indian, and Western suppliers?
Yes. While many Chinese and Indian manufacturers produce APIs compliant with international standards, additional verification through audits and documentation is essential. Western manufacturers often have more stringent oversight but may have higher costs.

4. How do market trends influence the sourcing of fospropofol disodium?
Growing demand for anesthesia and sedation agents, alongside regulatory shifts, prompts manufacturers to seek reliable, certified, and cost-effective suppliers—favoring regional sourcing and diversified supply chains.

5. What should future investors consider when evaluating API suppliers for fospropofol disodium?
Investors should assess the supplier’s regulatory track record, quality assurance processes, manufacturing capacity, compliance certifications, and strategic positioning to mitigate supply chain risks.

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References

1. [1] U.S. FDA Drug Master Files (DMFs) and European Certification Documentation.
2. [2] Industry reports on pharmaceutical API manufacturing capabilities (IQVIA, 2022).
3. [3] International Pharmacopoeia standards and GMP compliance details.
4. [4] Market analyses from GlobalData and PharmSource.
5. [5] Regulatory guidance documents from FDA, EMA, and WHO.

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This report aims to support pharmaceutical decision-makers in establishing reliable, compliant, and cost-effective sourcing channels for fospropofol disodium.