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Suppliers and packagers for generic pharmaceutical drug: ETHIODIZED OIL
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ETHIODIZED OIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Guerbet | LIPIODOL | ethiodized oil | OIL;INTRALYMPHATIC, INTRAUTERINE | 009190 | NDA | Guerbet LLC | 67684-1901-1 | 1 AMPULE in 1 CARTON (67684-1901-1) / 10 mL in 1 AMPULE | 2014-03-21 |
| Guerbet | LIPIODOL | ethiodized oil | OIL;INTRALYMPHATIC, INTRAUTERINE | 009190 | NDA | Guerbet LLC | 67684-1901-2 | 1 VIAL in 1 CARTON (67684-1901-2) / 10 mL in 1 VIAL | 2014-03-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ETHIODIZED OIL
Introduction
Ethiodized Oil, commonly known by trade names such as Lipiodol, is a diagnostic and therapeutic radiopaque oil used primarily in imaging procedures and certain interventional treatments. Its unique viscosity and iodine content make it crucial for lymphography, embolization, and chemoembolization procedures, especially in oncology. Given its specialized application, sourcing ethically compliant, high-quality Ethiodized Oil is vital for pharmaceutical companies, healthcare providers, and distributors. This article provides an in-depth analysis of global suppliers, including manufacturing giants, regional manufacturers, and the supply chain considerations surrounding Ethiodized Oil.
Overview of Ethiodized Oil
Ethiodized Oil is an iodinated, sterilized oil that provides radiopacity, allowing visualization on X-ray and fluoroscopy. It is produced through a complex manufacturing process involving the iodination of esterified fatty acids, typically derived from poppyseed and sesame oil bases. The pharmaceutical-grade Ethiodized Oil adheres to strict purity standards set by regulatory authorities such as the FDA, EMA, and WHO.
The global demand for Ethiodized Oil largely stems from its use in lymphangiography, hepatic artery embolization, and as a carrier in drug delivery systems. Its medical applications necessitate suppliers that can guarantee high purity, consistency, and compliance with pharmacopoeial standards.
Leading Suppliers of Ethiodized Oil
1. Guerbet Group (France)
Overview: Guerbet is a prominent global provider of contrast agents and injectable oils, including Lipiodol. With a history dating back over a century, Guerbet maintains a significant market share in Ethiodized Oil production.
Production and Distribution: Guerbet produces Lipiodol ULTROPE® and Lipiodol® Ultra Fluide, which are widely available across North America, Europe, and Asia. The company boasts robust manufacturing facilities adhering to Good Manufacturing Practices (GMP), ensuring pharmaceutical-grade quality.
Regulatory Status: Lipiodol from Guerbet is approved or authorized for use by numerous agencies worldwide, including the FDA and EMA.
2. Guerbet's Competitors
a) Slayback Pharma (USA)
Overview: Slayback Pharma has positioned itself as a key supplier within the U.S. market, offering generic and branded Ethiodized Oil products. The company's manufacturing facilities are FDA-inspected and compliant.
Market Presence: Their Ethiodized Oil products are utilized for lymphography and embolization procedures, with a focus on quality, affordability, and supply reliability.
b) PT. MC Jaya (Indonesia)
Overview: A regional producer serving the Southeast Asian market, PT. MC Jaya manufactures Ethiodized Oil in compliance with Indonesian and international standards.
Availability: Their product distribution primarily targets local hospitals and regional distributors, with increasing export efforts.
c) Carvery Innovative Pharma (India)
Overview: This Indian pharmaceutical manufacturer produces Ethiodized Oil conforming to WHO GMP standards, focusing on South Asian and African markets. Their offerings meet stringent pharmacopoeia standards, including BP and USP.
Emerging and Regional Suppliers
Several regional and emerging manufacturers are entering the Ethiodized Oil supply chain, driven by demand in developing markets. These suppliers often compete on price and availability but must meet the rigorous quality standards mandated by health authorities.
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Shandong Weigao Group (China): Engaged in producing iodine-based contrast media and injectable oils, with plans expanding into Ethiodized Oil.
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BioMed MENA (Middle East & North Africa): Distributes Ethiodized Oil under regional regulatory approvals, emphasizing supply chain robustness.
These regional players contribute to diversification but require careful validation for clinical use and regulatory compliance.
Supply Chain and Quality Assurance
Sourcing Ethiodized Oil involves stringent validation protocols. Buyers should verify:
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Regulatory Compliance: Ensure products are approved by relevant authorities such as the FDA, EMA, or regional equivalents.
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Manufacturing Standards: Confirm GMP certification and adherence to pharmacopoeial standards like USP, BP, or EP.
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Quality Certifications: ISO 13485 and other relevant quality management certifications are indicators of consistent manufacturing quality.
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Traceability and Documentation: Complete batch records, stability data, and certificates of analysis (CoA) are essential for clinical and regulatory validation.
Regional Market Dynamics and Challenges
In mature markets (North America and Europe), supply chains are well-established, with limited supply disruptions and high-quality standards. Conversely, markets in Asia, Africa, and Latin America often see increased regional manufacturing, though their products may face more rigorous validation requirements for international use.
Potential challenges include:
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Regulatory Barriers: Variations in approval status and registration procedures.
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Supply Reliability: Dependence on regional production facilities with limited capacity.
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Price Sensitivity: Competitive pressures from emerging suppliers often lead to price fluctuations.
Regulatory Considerations
Suppliers of Ethiodized Oil must comply with national and international regulations including:
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FDA (US): Requires manufacturing adherence to cGMP, proper labeling, and pre-market approval where applicable.
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EMA (Europe): Needs marketing authorization, dossiers, and pharmacovigilance compliance.
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WHO Prequalification: Critical for products supplied to developing countries.
Procurement entities must conduct thorough due diligence to ensure that supplier certifications and product verifications align with regulatory standards.
Future Trends and Market Outlook
The Ethiodized Oil market is expected to evolve with innovations in drug delivery systems and imaging technologies. The rise in minimally invasive interventional procedures will sustain demand. Additionally, regulatory shifts toward stricter quality controls will favor established suppliers while posing barriers to lower-quality regional manufacturers.
Emerging manufacturers focusing on biosimilar or generic Ethiodized Oil formulations are likely to intensify market competition. Consequently, purchasers should prioritize suppliers with proven compliance, reliable supply, and competitive pricing.
Key Takeaways
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Market dominance: Guerbet remains the leading global manufacturer, with a broad distribution network and established regulatory approvals.
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Regional suppliers: Companies like Slayback Pharma, PT. MC Jaya, and Carvery Innovative Pharma serve localized markets, often with high-quality products.
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Supply assurance: Rigorous validation of supplier certifications, manufacturing standards, and regulatory compliance is crucial in sourcing Ethiodized Oil.
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Emerging players: Regional manufacturers are increasing their share; due diligence is essential to verify product quality and regulatory acceptance.
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Future landscape: Market growth hinges on technological advancements, regulatory standards, and supply chain resilience.
FAQs
1. What are the primary regulatory considerations when sourcing Ethiodized Oil?
Manufacturers must demonstrate GMP compliance, obtain necessary approvals from agencies like the FDA or EMA, and provide comprehensive documentation, including certificates of analysis and batch traceability.
2. How can I verify the quality of Ethiodized Oil from regional suppliers?
Request detailed product certificates, review manufacturing certifications (e.g., GMP, ISO 13485), and, where possible, conduct site audits or third-party assessments to verify adherence to pharmacopoeial standards.
3. Is Lipiodol suitable for all medical imaging procedures?
Lipiodol is primarily used in lymphography, embolization, and chemoembolization. Its suitability depends on the procedure, regulatory approvals, and clinician preferences.
4. What are the risks of sourcing Ethiodized Oil from unverified suppliers?
Potential risks include substandard product quality, contamination, regulatory non-compliance, and consequent clinical or legal liabilities.
5. How will market trends influence Ethiodized Oil supply in the next decade?
Growing minimally invasive procedures and imaging innovations will sustain demand. Compliance with evolving regulations will favor established suppliers, while regional manufacturers may need certification upgrades to access new markets.
Sources:
- Guerbet Group Official Website. https://www.guerbet.com
- U.S. Food and Drug Administration (FDA). Lipiodol Injection Approval Details.
- World Health Organization (WHO). Prequalification of Medical Devices and Pharmaceuticals.
- Slayback Pharma Official Product Catalog.
- Regional Regulatory Agencies and Market Reports.
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