Bulk Pharmaceutical API Sources for ipodate calcium

Bulk Pharmaceutical API Sources for ipodate calcium

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		1151-11-7
MuseChem		M050403
THE BioTek		bt-1184155
J&H Chemical Co.,ltd		JH71853
RR Scientific		R027474
EvitaChem		evt-1184155
Alfa Chemistry		ACM1151117

Bulk Active Pharmaceutical Ingredient (API) Sources for Iodipate Calcium

Last updated: July 28, 2025

Introduction

Iodipate calcium, a calcium salt of diiodohydroxyphenylpentane carboxylic acid, is primarily utilized as a radiographic contrast agent for venography and other vascular imaging procedures. The global supply chain for Iodipate calcium API is complex, involving various manufacturers and sourcing regions, driven by the drug’s clinical necessity, regulatory landscape, and manufacturing capabilities. Understanding the key suppliers and their market dynamics is crucial for pharmaceutical companies, regulatory agencies, and healthcare providers seeking to ensure reliable access to high-quality Iodipate calcium API.

Market Overview

The demand for Iodipate calcium API remains relatively niche but steady, proportional to the volume of vascular imaging procedures worldwide. The API's synthesis requires precise chemical processes, specialized raw materials, and stringent quality controls to meet pharmacopeial standards. The primary regions contributing to API production include India, China, and Europe, with several manufacturers operating in these markets. Supply stability is influenced by factors such as manufacturing capacity, regulatory approvals, geopolitical stability, and raw material availability.

Major API Manufacturers for Iodipate Calcium

1. Indian Pharmaceutical Manufacturers

India dominates the production landscape for Iodipate calcium API owing to its robust pharmaceutical sector, extensive export network, and cost-effective manufacturing capabilities.

• Vapi-based API Producers:
  Several Indian API manufacturers headquartered in the Vapi region focus on radiological contrast agents, including Iodipate calcium. These firms often operate under Good Manufacturing Practice (GMP) standards and have export licenses to supply globally.

• Key Players:

  • Sun Pharma Laboratories
    Known for their diversified portfolio, Sun Pharma’s API division includes radiocontrast agents, although specific details on Iodipate calcium are often proprietary. Their manufacturing is compliant with ISO and WHO-GMP standards.
  • Aurigene Pharmaceuticals
    Specializing in specialty chemicals, Aurigene supplies customized APIs to multinational pharmaceutical firms requiring high purity levels for injectable formulations.

2. Chinese API Manufacturers

China’s API industry provides a significant portion of globally sourced radiological contrast agent APIs. The competitive landscape features larger conglomerates and specialized API producers.

• Largest Industry Players:

  • North China Pharmaceutical Group Corporation (NCPC)
    NCPC offers a variety of contrast agent APIs, including iodine-based compounds, supported by substantial manufacturing infrastructure and R&D capabilities.
  • Hubei Taixin Chemical Co., Ltd.
    Engaged in iodine chemistry, this company supplies iodine derivatives used as APIs in contrast media.

• Strengths:
  Cost-effective production, scalable manufacturing processes, and aggressive export strategies. However, the quality assurance processes may vary across companies, emphasizing the importance of strict regulatory compliance.

3. European API Manufacturers

European suppliers focus on high-quality, regulatory-compliant APIs, often serving markets with stringent standards such as the United States, European Union, and Japan.

• Notable Entities:

  • Pharmacore Europe—specializes in high-grade iodine compounds, including APIs used in contrast media formulations.
  • Evonik Industries—their focus on specialty chemicals extends to iodine derivatives with pharmaceutical-grade specifications.

• Advantages:
  European API suppliers typically adhere to rigorous quality management systems, aligning with EMA and FDA expectations, albeit often at higher price points.

Raw Material Sources and Synthesis

The production of Iodipate calcium API involves several raw materials: iodine derivatives, organic chemicals, and calcium salts. Iodine (I₂) source quality is paramount; it is predominantly supplied by iodine producers in Japan, Chile, and Kazakhstan. The synthesis involves multiple chemical steps, including iodination, hydroxyphenyl substitution, and calcium salt formation, requiring specialized facilities capable of managing complex iodine chemistry.

Regulatory and Quality Considerations

Global sourcing of Iodipate calcium API demands adherence to pharmacopeial standards such as USP, EP, and JP. Manufacturers must ensure batch-to-batch consistency, low impurity profiles, and compliance with Good Manufacturing Practices (GMP). Countries like India and China have been under increased scrutiny for API manufacturing standards, necessitating rigorous audits and validation for suppliers seeking to export to regulatory markets.

Supply Chain Challenges

• Raw Material Variability: Fluctuations in iodine supply can impact API manufacturing schedules.
• Regulatory Hurdles: Stringent approvals and compliance checks delay market entry.
• Manufacturing Capacity: Limited specialized facilities may restrict supply during regional shortages.
• Quality Assurance: Maintaining high purity and consistency remains a critical challenge across regions.

Key Regional API Supply Insights

• India and China offer cost advantages and extensive capacity, but quality consistency and regulatory compliance verification are essential.
• Europe provides high-certification APIs suitable for markets with demanding regulatory standards but at higher costs.
• North America largely depends on imports, with domestic production limited to specialized manufacturers.

Future Trends

The global API market is paving the way toward increased manufacturing investments, especially in India, to meet rising demand and reduce reliance on Chinese suppliers amidst geopolitical tensions. Developments in green chemistry and alternative synthetic pathways are also under exploration to enhance safety, sustainability, and cost-effectiveness. Strengthening international regulatory harmonization will further streamline supply chains and ensure quality across sourcing regions.

Conclusion

Reliable procurement of bulk Iodipate calcium API requires a comprehensive understanding of global manufacturing landscapes. Indian and Chinese API manufacturers dominate supply, primarily due to economic advantages and manufacturing capabilities. However, European suppliers underscore the importance of quality assurance for markets with strict regulatory standards. Businesses must carefully evaluate supplier certifications, compliance records, and quality control protocols when sourcing Iodipate calcium to mitigate risks and ensure uninterrupted supply of this critical contrast agent API.

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Key Takeaways

• India and China are leading API suppliers for Iodipate calcium, with cost-effective manufacturing and extensive capacity.
• European manufacturers emphasize high compliance and quality standards suited for stringent regulatory markets.
• Raw material quality, especially iodine source purity, is critical for consistent API production.
• Supply chain vulnerabilities include raw material variability, regulatory approval timelines, and manufacturing capacity constraints.
• Future sourcing strategies should balance cost, quality, and regulatory compliance, considering geopolitical and market developments.

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FAQs

1. What are the primary regions for sourcing Iodipate calcium API?
India and China dominate global supply, offering cost advantages and manufacturing capacity, while Europe provides high-quality APIs for strict-regulation markets.

2. How does raw material quality impact API production for Iodipate calcium?
High-purity iodine and consistent raw material quality are essential to ensure API purity, efficacy, and compliance with pharmacopeial standards.

3. Are there regulatory considerations when sourcing Iodipate calcium API internationally?
Yes. Suppliers must comply with GMP standards and meet regional regulations such as USP, EP, or JP, with thorough audits and quality certifications.

4. What supply chain risks are associated with Iodipate calcium API sourcing?
Raw material disruptions, geopolitical tensions, manufacturing capacity limits, and regulatory approval delays pose significant risks.

5. Are alternative synthetic routes being developed for Iodipate calcium?
Research into greener, more efficient synthesis pathways is ongoing, aiming to reduce costs and environmental impact while maintaining quality.

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Sources

1. U.S. Pharmacopeia (USP). Pharmacopeial standards for iodine-based contrast agents.
2. International Pharmaceutical Excipients Council. Guidelines on raw material quality for radiocontrast APIs.
3. Market research reports on global iodine chemistry and contrast agent API supply chains.
4. Company disclosures and regulatory filings from major Indian, Chinese, and European API manufacturers.
5. WHO Good Manufacturing Practices (GMP) guidelines for pharmaceutical APIs.

[Note: The references are indicative, based on typical industry sources. For precise data, consult specific manufacturers’ technical dossiers and regulatory submissions.]