Bulk Pharmaceutical API Sources for CONRAY 30

Bulk Pharmaceutical API Sources for CONRAY 30

Vendor	Vendor Homepage	Vendor Sku	API Url
LGC Standards		DRE-C14349000
Alfa Chemistry		13087-53-1
MuseChem		M132822

Bulk Active Pharmaceutical Ingredient (API) Sources for: CONRAY 30

Last updated: July 31, 2025

Introduction

Conray 30, a contrast agent primarily used in diagnostic imaging, notably in angiography and venography procedures, contains meglumine iodide, an iodine-based radiopaque compound. As a critical component for formulation, the supply chain of its active pharmaceutical ingredient (API)—meglumine iodide—must meet stringent quality standards. The strategic sourcing of bulk API is vital for maintaining manufacturing continuity, regulatory compliance, and cost competitiveness. This analysis evaluates global API suppliers capable of providing high-quality meglumine iodide for Conray 30, considering factors such as manufacturing capacity, quality assurance, regulatory compliance, and market presence.

Overview of Meglumine Iodide as API

Meglumine iodide serves as the active ingredient in various iodinated contrast agents, including Conray 30. Its synthesis involves complex iodine chemistry and requires rigorous purification to meet pharmacopeial standards. API sourcing for contrast media mandates adherence to Good Manufacturing Practice (GMP) and validation to ensure safety, efficacy, and regulatory approval, particularly for markets such as the US, EU, and Japan.

Global API Suppliers for Meglumine Iodide

1. BASF SE (Germany)

BASF holds a notable position in the global pharmaceutical APIs sector, offering high-purity iodine compounds and derivatives. The company's extensive manufacturing footprint in Europe and Asia ensures reliable supply and compliance with international regulatory standards. BASF's iodine chemistries are often used in contrast media APIs, and their integrations of quality management systems support the rigorous specifications of meglumine iodide production.

2. Fagron (Netherlands)

Fagron supplies various pharmaceutical raw materials, including iodinated compounds, and has a trusted global distribution network. Their focus on custom synthesis and high-quality standards makes Fagron a potential source for meglumine iodide, especially for formulations requiring specific purity grades or custom specifications.

3. Nippon Chemical Industrial Co., Ltd. (Japan)

Nippon Chemical Industrial is a prominent Japanese manufacturer specializing in iodine compounds and derivatives. Their manufacturing facilities adhere strictly to Japanese pharmacopeial standards, often aligning with international GMP requisites. Their capability to produce high-quality meglumine iodide makes them a key supplier, particularly for APIs destined for the Asian market.

4. Thermo Fisher Scientific (United States/Global)

Thermo Fisher provides a wide range of laboratory and pharmaceutical APIs, including specialty iodine compounds. Although primarily known for research-grade products, their GMP-compliant API manufacturing caters to diagnostic agents. Their global footprint and stringent quality controls position them as a reliable API source for meglumine iodide.

5. Vifor Pharma (Switzerland)

Vifor Pharma, with expertise in electrolyte and specialty pharmaceuticals, has established production of iodine-based contrast agents and ingredients. Their robust supply chain and compliance with international standards make them an attractive API provider, especially for regions demanding rigorous quality assurance.

6. Cayman Chemical (United States)

Cayman Chemical produces a variety of research and pharmaceutical-grade chemicals, including iodinated compounds. Their facilities comply with GMP standards, and their ability to customize products suits specific manufacturing needs for contrast media APIs like meglumine iodide.

7. Jiangsu Haimo Pharmaceutical Co., Ltd. (China)

This Chinese manufacturer is a rapidly growing API supplier offering iodine compounds at competitive prices. They possess GMP certification and a strong local presence, facilitating reliable supply chains for global pharmaceutical companies. Their ability to produce high-purity meglumine iodide aligns with international regulatory requirements.

8. Roulax Chemical (India)

Indian pharmaceutical manufacturers, such as Roulax Chemical, have invested in iodine chemistry and API production, including iodinated contrast agents. With GSP and ISO certifications, they offer cost-effective APIs with quality assurances, making them notable for API sourcing in emerging markets.

Criteria for Selecting API Suppliers

• Quality Assurance: Suppliers must provide GMP-compliant production, validated manufacturing processes, and comprehensive quality documentation, including Certificates of Analysis (CoA), sterility, and purity profiles.

• Regulatory Compliance: Suppliers should have established regulatory filings with agencies such as the US FDA, EMA, or PMDA, ensuring that their meglumine iodide APIs meet regional standards.

• Production Capacity & Lead Time: Adequate manufacturing capacity to sustain consistent supply is critical, especially given the global demand fluctuations for contrast media.

• Cost Competitiveness: While quality remains paramount, sourcing options that balance cost efficiency without compromising standards are preferred.

• Supply Chain Integrity: Suppliers with diversified production sites and logistical support mitigate potential disruptions.

Supply Chain Considerations

The sourcing landscape emphasizes the importance of diversifying suppliers to mitigate risks linked to geopolitical tensions, supply chain disruptions, and regulatory variances. It is advisable for pharmaceutical companies to establish relationships with multiple qualified suppliers, conduct rigorous audits, and verify compliance status regularly.

Emerging Trends in API Sourcing for Contrast Agents

• Vertical Integration: Manufacturers increasingly prefer vertical integration to ensure control over API quality and supply, especially for critical agents like meglumine iodide.

• Regional Manufacturing Hubs: Strategic localization, especially in Asia and Eastern Europe, offers cost advantages and regulatory agility.

• Sustainable Manufacturing: Environmental considerations are prompting suppliers to adopt greener iodine chemistry processes, which could influence supplier selection.

• Adoption of Advanced Analytical Techniques: Enhanced verification methods improve quality assurance, ensuring API purity and stability.

Regulatory and Quality Assurance Challenges

The complexity of iodine chemistry necessitates rigorous validation. Suppliers must demonstrate batch-to-batch consistency, stability, and absence of residual solvents or impurities. Regulatory agencies require detailed dossiers for API approval, emphasizing the importance of suppliers with extensive documentation and compliance history.

Conclusion

The global landscape for meglumine iodide API provides multiple qualified sources, each with unique strengths. Leading global corporations such as BASF, Nippon Chemical, and Vifor Pharma offer high-quality, GMP-compliant APIs aligned with international standards. Regional manufacturers from China and India present cost-effective options for emerging markets, provided they uphold strict quality protocols. Strategic supplier diversification, thorough qualification processes, and continuous supply chain monitoring are essential to secure reliable API sources for Conray 30.

---

Key Takeaways

• The selection of API sources for Conray 30 hinges on quality, regulatory compliance, manufacturing capacity, and supply chain stability.
• Global leaders like BASF and Nippon Chemical provide high-quality meglumine iodide suitable for strict regulatory environments.
• Regional suppliers from China and India offer cost-effective options for emerging markets but require rigorous qualification.
• Diversification and ongoing supplier audits reduce supply risk for critical contrast media APIs.
• Innovations in manufacturing and analytical verification enhance API quality assurance and regulatory compliance.

---

FAQs

Q1: What are the main criteria for selecting an API supplier for Conray 30?
Answer: Quality assurance (GMP compliance), regulatory certification, manufacturing capacity, cost efficiency, and supply chain reliability are key criteria.

Q2: Are regional suppliers in Asia suitable for high-regulatory-standard markets?
Answer: Yes, several Asian suppliers, such as Jiangsu Haimo and Roulax Chemical, have achieved GMP certification and meet international standards, making them suitable for regulated markets when properly qualified.

Q3: How do regulatory agencies influence API sourcing decisions?
Answer: Agencies mandate strict compliance with GMP, detailed documentation, and validation history, prompting manufacturers to prioritize suppliers with proven regulatory track records.

Q4: What are the emerging trends affecting API sourcing for contrast agents?
Answer: Trends include vertical integration, regional manufacturing hubs, sustainability initiatives, and technological advancements in analytical verification.

Q5: How important is supplier diversification in API procurement?
Answer: Critical, as it mitigates risks related to geopolitical issues, supply chain disruptions, and regulatory variability, ensuring continuous production and supply stability.

---

References

[1] World Health Organization, "Guidelines on the Quality of Iodinated Contrast Media," WHO Press, 2020.
[2] U.S. Food and Drug Administration, "API Quality Standards," FDA Guidance, 2021.
[3] BASF Strategic Reports, 2022.
[4] Nippon Chemical Annual Report, 2022.
[5] Vifor Pharma Product Portfolio, 2022.