Bulk Pharmaceutical API Sources for SINOGRAFIN

Bulk Pharmaceutical API Sources for SINOGRAFIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M5266_SIGMA
NovoSeek		8566
MolPort		MolPort-003-958-766
AAA Chemistry		AR-1J2430
ABI Chem		AC1L1R9D

Last updated: July 29, 2025

lk Active Pharmaceutical Ingredient (API) Sources for SINOGRAFIN

Overview
SINOGRAFIN, a drug primarily used for diagnostic imaging, contains the active pharmaceutical ingredient (API) known as iopanoic acid. As a radiocontrast agent, the quality and sourcing of its API are crucial in ensuring efficacy, safety, and regulatory compliance. This overview delves into the key sources of iopanoic acid bulk API, highlighting global manufacturers, supply chain considerations, and strategic procurement insights for pharmaceutical companies aiming to produce SINOGRAFIN.

Understanding Iopanoic Acid as API
Iopanoic acid, chemically classified as an oral cholecystographic agent, functions by binding to cholecystographic components to facilitate imaging of the gallbladder. It was first introduced in the 1970s and has since seen applications primarily in diagnostic radiology. The API’s stability, purity, and consistent supply are vital in manufacturing SINOGRAFIN, which demands strict quality controls aligned with pharmacopeial standards such as the USP, European Pharmacopoeia, or JP.

Global API Manufacturing Landscape
The API manufacturing sector for iopanoic acid is concentrated among specialized chemical producers with expertise in synthesizing complex organic molecules. The landscape includes a mix of large pharmaceutical ingredient producers, contract manufacturing organizations (CMOs), and regional players with capabilities in synthesizing and lyophilizing APIs to conform with regulatory standards.

Major API Suppliers for Iopanoic Acid

1. Chinese API Manufacturers

China remains a dominant player in the global API market, including specialty and niche APIs like iopanoic acid. Several Chinese firms have developed expertise in synthesizing iodinated contrast agents, leveraging cost-efficient manufacturing processes. Notable companies include Shandong Xinhua Pharmaceutical and Zhejiang Tianyu Pharmaceutical, which have the capacity to supply bulk API in large quantities, often at competitive pricing.
Advantages: Cost-effectiveness, established manufacturing infrastructure, and ability to scale production.
Challenges: Varying quality control standards, potential regulatory hurdles, and intellectual property concerns.

2. Indian Pharmaceutical Producers

India hosts multiple CMO and API manufacturers specialized in contrast media APIs. Companies such as Sun Pharma Advanced Research Company (SPARC), Jubilant Life Sciences, and Axiom Lifesciences have experience in the development and manufacturing of iodinated contrast agents, including APIs akin to iopanoic acid.
Advantages: Robust regulatory compliance (USFDA, EMA), reliable quality standards, and extensive experience.
Challenges: Longer lead times due to regulatory audits and capacity constraints in certain facilities.

3. European API Suppliers

European companies like Micosafe and PharmaGievra operate with high-quality standards, adhering to stringent Good Manufacturing Practices (GMP). While their API offerings are generally niche, they supply pharmaceutical companies seeking compliant, high-purity APIs for clinical and commercial use.
Advantages: Superior quality assurance, consistent regulatory compliance, and proven supply reliability.
Challenges: Higher costs and longer lead times compared to Asian suppliers.

4. North American API Producers

Limited in number, US-based manufacturers such as AMRI and Cambrex focus on high-quality APIs for diagnostic agents and contrast media. Their APIs are often compliant with the US Pharmacopeia and FDA standards, making them suitable for markets requiring strict regulatory oversight.
Advantages: High regulatory compliance, advanced manufacturing technology, and strong intellectual property protections.
Challenges: Higher pricing and limited capacity for some niche APIs.

Emerging Sources and Contract Manufacturing

Contract manufacturing organizations (CMOs) in regions like Southeast Asia and Eastern Europe have expanded capabilities to produce iodinated contrast agent APIs owing to increasing demand for diagnostic imaging solutions. Engaging a reputable CMO can optimize supply chain flexibility, quality, and cost-efficiency.

Supply Chain Considerations

• Quality Assurance: Ensuring API sourcing from GMP-compliant manufacturers with demonstrated track records in producing iodinated contrast agents is critical. Regulatory agencies such as the FDA and EMA rigorously inspect API suppliers, emphasizing purity, impurity profiles, and batch-to-batch consistency.
• Regulatory Approvals: Importing APIs into the manufacturing locality requires full documentation per local regulatory standards, including Certificates of Analysis (CoA) and compliance certificates.
• Pricing & Lead Times: Asian manufacturers typically offer lower prices but may involve longer lead times due to regulatory clearance and logistics. European and North American suppliers provide faster, more reliable deliveries but at a premium.
• Intellectual Property & Licensing: While API synthesis for iodinated contrast agents is largely well-established, some proprietary manufacturing processes or formulations may be protected, necessitating licensing agreements.

Strategic Sourcing Recommendations

• Diversify Suppliers: To mitigate risk, multiple reliable sources provide stability, especially during supply disruptions or regulatory audits.
• Conduct Due Diligence: Prioritize suppliers with proven GMP compliance, experience in contrast media APIs, and transparent quality documentation.
• Establish Long-term Contracts: Locking in supply and pricing can benefit forecasts and ensure steady production of SINOGRAFIN.
• Monitor Regulatory Changes: Continuous compliance with evolving standards ensures uninterrupted supply and market access.

Conclusion
The procurement of high-quality bulk API sources for iopanoic acid is vital for the consistent production of SINOGRAFIN. Leading suppliers span China, India, Europe, and North America, with regional advantages and challenges. Strategic partnership and rigorous quality assurance underpin a resilient supply chain, enabling pharmaceutical companies to meet clinical demand and regulatory expectations efficiently.

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Key Takeaways

• Diversify sourcing to mitigate geopolitical and supply chain risks associated with iopanoic acid API.
• Prioritize GMP-compliant suppliers with proven track records in iodinated contrast media manufacturing.
• Balance cost and quality by evaluating Asian low-cost producers against high-quality European and North American firms.
• Engage early with regulatory authorities to ensure seamless importation and compliance of APIs for SINOGRAFIN manufacturing.
• Maintain ongoing supplier audits and quality assessments to uphold product standards and avoid regulatory non-compliance.

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FAQs

Q1: What are the primary regions producing bulk iopanoic acid API for SINOGRAFIN?
A1: The main regions include China, India, Europe, and North America, each offering distinct advantages in cost, quality, and regulatory compliance.

Q2: How does API quality impact SINOGRAFIN's efficacy and safety?
A2: High-purity, well-characterized API ensures consistent imaging quality, minimizes adverse reactions, and complies with regulatory standards, directly affecting patient safety and diagnostic reliability.

Q3: What are the key considerations when selecting an API supplier for iopanoic acid?
A3: Consider GMP compliance, quality control measures, supply stability, regulatory certifications, pricing, and delivery lead times.

Q4: Are there any regulatory hurdles specific to sourcing iopanoic acid API internationally?
A4: Yes. Importing APIs requires adherence to local regulations, import licenses, certificates of analysis, and supplier audits, especially when sourcing from regions with varying regulatory stringency.

Q5: Can contract manufacturing organizations (CMOs) effectively supply iopanoic acid APIs?
A5: Yes, reputable CMOs with expertise in iodinated contrast agents can be reliable partners, offering flexible manufacturing and supply chain management for API procurement.

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Sources
[1] U.S. Pharmacopeia. Iopanoic Acid Monograph.
[2] European Pharmacopoeia. Contrast Media API Standards.
[3] Industry reports on iodinated contrast agents supply chain.
[4] Public disclosures from Chinese and Indian API manufacturers.
[5] Regulatory guidelines from FDA and EMA for contrast media APIs.