Bulk Pharmaceutical API Sources for DEFINITY

Bulk Pharmaceutical API Sources for DEFINITY

Vendor	Vendor Homepage	Vendor Sku	API Url
Amadis Chemical		A838638
AKos Consulting & Solutions		AKOS006228213
TimTec		SBB090673
Debye Scientific Co., Ltd		DB-056033
abcr GmbH		AB104454
Finetech Industry Limited		FT-0621948

Bulk Active Pharmaceutical Ingredient (API) Sources for Definity

Last updated: July 27, 2025

Introduction

Definity, a lipid-based contrast agent primarily used in echocardiography, relies on specific Active Pharmaceutical Ingredients (APIs) that enable its efficacy and safety profiles. As the demand for cardiovascular imaging agents grows, understanding the bulk API sources that support Definity's manufacturing becomes critical for stakeholders. This article provides a comprehensive analysis of suppliers, manufacturing practices, and global sourcing strategies for key APIs used in Definity, enabling healthcare providers, manufacturers, and investors to make informed decisions.

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Understanding Definity and Its API Components

Definity's primary active component is Perflutren Lipid Microspheres, which are stabilized gas-filled lipid microspheres designed for ultrasound contrast imaging. The core API effectively enhances ultrasonic signals by reflecting sound waves, improving visualization of cardiac structures.

The key APIs involved include:

• Perflutren (perfluoropropane): The principal gaseous core of the microspheres.
• Lipid shell components: Comprising phospholipids such as distearoylphosphatidylcholine (DSPC) and polyethylene glycol (PEG) conjugated lipids, which stabilize the microspheres.

While Perflutren forms the core of the contrast agent, the lipid shell components are also critical Active Pharmaceutical Ingredients sourced from specialized suppliers.

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Major API Suppliers and Manufacturing Sources for Definity

1. Perflutren (Perfluoropropane) Gas

Perflutren is a perfluorocarbon (PFC) gas used widely in ultrasound contrast agents due to its inert properties and high stability.

• Leading Suppliers:

  • Chemours (formerly parts of DuPont): Recognized for their high purity perfluorocarbon gases, including perfluoropropane. Chemours has extensive manufacturing capacity and global distribution channels that support pharmaceutical-grade applications.
  • 3M Company: Supplies specialized PFC gases for medical diagnostics. Their stringent quality controls align with regulatory requirements.
  • Linde Group: Provides perfluorocarbon gases with pharmaceutical-grade purity, manufactured at their advanced air separation units.
  • HaloPerfluorochemicals: A notable supplier specializing in PFCs for medical and industrial uses, with significant R&D investments in medical-grade formulations.

• Manufacturing Considerations:

  • Purity standards align with USP<781> (Perfluorocarbons).
  • Gas production involves extensive purification processes, including fractional distillation, to ensure inertness and eliminate contaminants.

2. Lipid Components (Stabilizing Shell)

The lipid shell’s composition is crucial for microsphere stability, biocompatibility, and echogenicity.

• Distearoylphosphatidylcholine (DSPC):

  • Lipoid GmbH (Germany): A leading supplier of pharmaceutical-grade phospholipids, including DSPC, widely used in lipid-based drugs.
  • Avanti Polar Lipids (USA): Offers high-purity DSPC with specifications compliant with pharmacopeial standards, supporting large-scale pharmaceutical manufacturing.

• Polyethylene Glycol (PEG) conjugated lipids:

  • NOF America Corporation: Supplies PEG-lipid conjugates, critical for extending circulation time.
  • Lipoid GmbH and Lipoid North America: Also produce PEGylated phospholipids suitable for injectable formulations.

• Manufacturing and Quality Control:

  • Suppliers adhere to cGMP standards (Current Good Manufacturing Practices).
  • Batch-to-batch consistency, endotoxin testing, and particle size control are critical quality benchmarks.

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Global Sourcing Strategies

Localization and diversification of API sources reduce supply chain risks and help meet regulatory standards efficiently.

• North America: Dominates API production with chemists and facilities in the USA and Canada. Linde, Avanti, and HaloPerfluorochemicals maintain significant manufacturing bases.
• Europe: Germany (Lipoid GmbH) and other EU countries provide high-quality phospholipids and PFC gases, compliant with EMA standards.
• Asia: Increasingly prominent suppliers, especially in China and India, providing cost-effective lipid raw materials under strict regulatory oversight.

Regulatory Landscape and Quality Standards

Sourcing APIs for Definity involves strict adherence to regulatory standards:

• USP and EP compliance for gases and lipids.
• FDA approval: APIs must meet FDA pharmacopoeial standards for injectable products.
• EMA standards: For European manufacturing and distribution.

Suppliers typically support regulatory submissions with detailed Certificates of Analysis (CoA), stability data, and manufacturing process validations.

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Supply Chain Challenges and Risk Management

• Perfluorocarbon purity and stability: Require rigorous manufacturing controls, as impurities can compromise product safety.
• Lipid source variability: Plant-based phospholipids demand quality assurance for consistency and absence of contaminants.
• Global geopolitical factors: Can impact procurement, especially for high-precision chemicals like PFCs.
• Environmental regulations: Emerging restrictions on PFCs and lipid production emissions may influence long-term sourcing strategies.

To mitigate risks, manufacturers diversify suppliers and establish long-term agreements with high-quality API producers, incorporating quality audits and supply chain transparency.

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Emerging Trends and Future Outlook

• Synthetic biology and bioengineered lipids: May provide more sustainable and consistent API sources.
• Alternative PFC gases: Research into environmentally friendly substitutes could reshape supply options.
• In-house API manufacturing: Larger pharmaceutical companies may develop in-house capabilities to enhance supply security.

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Key Takeaways

• Diverse supplier landscape is essential for the stable supply of APIs for Definity, with primary contributions from Chemours, Lipoid GmbH, Avanti, and Linde Group.
• Regulatory compliance remains paramount, necessitating rigorous quality standards and documentation from API suppliers.
• Supply chain resilience involves diversification, strategic partnerships, and continuous monitoring of geopolitical and environmental factors.
• Innovations in API sourcing, such as bioengineered lipids and green PFCs, could influence future procurement strategies.
• Stakeholders should prioritize supplier due diligence, quality audits, and ongoing regulatory compliance to mitigate risks in API sourcing.

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FAQs

1. What are the main API sources for the gas core of Definity?
Perfluoropropane (perflutren) is sourced from major chemical suppliers like Chemours, Linde, and HaloPerfluorochemicals, providing pharmaceutical-grade PFC gases.

2. Which companies supply the lipid shell components of Definity?
Lipoid GmbH and Avanti Polar Lipids are leading manufacturers of phospholipids such as DSPC, while NOF America supplies PEGylated lipids essential for microsphere stability.

3. How do regulatory standards influence API sourcing for Definity?
APIs must comply with USP, EP, FDA, and EMA standards, requiring extensive documentation, quality testing, and validation from suppliers.

4. Are there emerging alternative API sources for contrast agents like Definity?
Yes, advancements in synthetic biology and the development of environmentally friendly PFC gases may offer future alternative API sources.

5. What are the risks associated with global API sourcing for Definity?
Supply disruptions due to geopolitical issues, environmental regulations, or quality inconsistencies pose risks, emphasizing the need for diversified supplier networks.

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References

[1] U.S. Pharmacopeia, "Perfluorocarbons and Related Compounds," USP <781>
[2] Chemours, "Perfluorocarbon Gases for Medical Applications," Technical Data Sheet, 2022
[3] Linde Group, "Pharmaceutical Grade Perfluorocarbons," Product Brochure, 2023
[4] Lipoid GmbH, "Phospholipids for Pharmaceutical Use," catalog 2022
[5] Avanti Polar Lipids, "Application Notes on DSPC," 2022