Bulk Pharmaceutical API Sources for HYPAQUE

Bulk Pharmaceutical API Sources for HYPAQUE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23672589
MP Biomedicals		102908
MolPort		MolPort-003-930-326

Bulk Active Pharmaceutical Ingredient (API) Sources for HYPAQUE

Last updated: July 28, 2025

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Introduction

HYPAQUE, known generically as diatrizoate meglumine, is a radiopaque contrast agent extensively used in diagnostic imaging procedures, especially in fluoroscopy, digital subtraction angiography, and sometimes in computed tomography (CT) scans. As a medical necessity, the raw material—its active pharmaceutical ingredient (API)—must be sourced from reliable suppliers to ensure quality, safety, and regulatory compliance. This article evaluates primary global API sources for HYPAQUE, examining key manufacturers, sourcing strategies, market dynamics, and quality considerations critical for pharmaceutical companies, distributors, and healthcare providers.

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Understanding Diatrizoate Meglumine

Diatrizoate meglumine is a high-density iodinated compound that enhances imaging contrast within blood vessels, urinary tracts, or gastrointestinal systems. Its synthesis involves complex chemical processes that demand specialized manufacturing capabilities and strict quality controls. Given its clinical importance and regulatory scrutiny, OEMs and suppliers seek reputable API providers compliant with Good Manufacturing Practices (GMP).

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Global API Manufacturers of Diatrizoate Meglumine

1. Guerbet Group

Overview:
Guerbet, headquartered in France, is a leading player in radiology and contrast agents, with vertical integration encompassing both finished products and APIs. Their manufacturing of diatrizoate compounds is aligned with stringent European Medicines Agency (EMA) standards and GMP regulations.

API Sourcing:
Guerbet’s API manufacturing facilities produce active ingredients with continuous quality assurance, often supplying directly or through licensed distributors. They maintain strategic production capabilities to meet global demand, emphasizing compliance and stability.

Strengths:

• Established reputation for quality and regulatory support.
• Integrated R&D for formulation stability.
• Broad global distribution network.

2. Tianjin Biotech Co., Ltd. (China)

Overview:
Tianjin Biotech is among leading Chinese API manufacturers specializing in iodinated contrast media components, including diatrizoate derivatives. The company’s manufacturing processes adhere to Chinese GMP standards, which are increasingly aligned with international norms.

API Sourcing:
Tianjin Biotech supplies API to pharmaceutical OEMs across Asia, Africa, and Latin America, often offering competitive pricing. Their manufacturing involves advanced synthesis techniques optimized to ensure high purity and bioavailability.

Strengths:

• Cost-effective API production.
• Growing international recognition due to quality improvements.
• Dual focus on both finished formulations and bulk API.

3. Shanghai Forbeta Medical Co., Ltd. (China)

Overview:
Specializing in contrast media APIs, Shanghai Forbeta positions itself as a key supplier to global markets, with a portfolio including diatrizoate meglumine. Their manufacturing process emphasizes high purity levels, meeting pharmacopeial standards.

API Sourcing:
The company's APIs are used in various diagnostic formulations globally. They focus heavily on quality control, stability, and scalability.

Strengths:

• Proven quality with multiple regulatory clearances.
• Flexible batch sizes.
• Competitive pricing.

4. Shandong Luoxin Pharmaceutical Group (China)

Overview:
A prominent Chinese pharmaceutical enterprise, Shandong Luoxin manufactures several contrast agents, including the API for HYPAQUE. Their production facilities are GMP-certified, with a focus on parenteral and injectable APIs.

API Sourcing:
The company supplies domestic and international markets, leveraging a well-established quality assurance infrastructure.

Strengths:

• Extensive manufacturing experience.
• Reliable supply chain.
• Strategic positioning in the API market.

5. Other Noteworthy Suppliers

Brazilian and Indian manufacturers are increasingly active in the iodinated contrast API space, with firms such as Piramal Enterprises (India) and Eurofarma (Brazil) exploring or producing APIs for diatrizoate compounds. While these companies may offer competitive pricing, their global regulatory acceptance varies based on local GMP standards.

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Market Dynamics and Sourcing Considerations

Regulatory Compliance and Quality Control

Ensuring API quality is paramount for safety and efficacy. Suppliers must adhere to GMP, USP, EP, or other pharmacopeial standards relevant in target markets. Certification, batch documentation, and traceability are non-negotiable factors when selecting API sources.

Supply Chain and Reliability

Global supply chain disruptions—such as those caused by geopolitical conflicts, pandemics, or transportation issues—highlight the importance of diversified sourcing. Companies often secure APIs from multiple suppliers to mitigate risks.

Cost and Lead Time

Chinese API manufacturers often offer lower-cost options with shorter lead times but may differ in regulatory recognition and traceability. European and North American suppliers tend to prioritize higher quality assurance standards, at a premium.

Intellectual Property and Licensing

Manufacturing diatrizoate meglumine involves proprietary synthesis routes. Licensing agreements, strategic partnerships, or direct procurement from licensed producers influence source selection.

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Quality Assurance and Regulatory Considerations

API suppliers must provide comprehensive documentation covering manufacturing processes, stability data, purity profiles, and compliance with international standards. Due diligence involves auditing manufacturing facilities, reviewing Quality Certificates, and verifying prior compliance histories.

The international acceptance of APIs depends on certifications such as ISO, GMP, and national regulatory approvals [(1)].

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Future Outlook

The global API market for radiopaque contrast agents is poised for steady growth driven by increased imaging procedures and expanding healthcare infrastructure. Chinese and Indian manufacturers are expected to expand their capabilities to meet rising demand, potentially impacting the availability and pricing of API sources for HYPAQUE. As regulatory landscapes evolve, suppliers must adapt to maintain compliance and market access.

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Key Considerations for Procurement of HYPAQUE API

• Ensure suppliers have solid GMP certification and traceability.
• Diversify sourcing to mitigate geopolitical and supply chain risks.
• Prioritize vendors with a history of regulatory approvals in target markets.
• Conduct rigorous quality audits and review batch-specific certificates.
• Consider the long-term supply stability alongside cost factors.

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Key Takeaways

• Top global suppliers of diatrizoate meglumine API include Guerbet, Chinese firms such as Tianjin Biotech and Shanghai Forbeta, and Shandong Luoxin.
• European manufacturers tend to emphasize stricter regulatory compliance, while Chinese manufacturers offer competitive pricing and scalability.
• Sourcing from multiple certified suppliers enhances supply security and regulatory compliance.
• Maintaining a comprehensive quality assurance process is essential to ensure API integrity.
• The growing demand for contrast agents will continue shaping the global API sourcing landscape, emphasizing quality, reliability, and regulatory adherence.

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FAQs

1. What are the primary factors to consider when sourcing diatrizoate meglumine API for HYPAQUE?
Quality certifications (GMP compliance), regulatory approvals, supply reliability, cost, and ability to meet scale are the primary factors.

2. Are API sources for HYPAQUE globally uniform in regulatory standards?
No. European and North American sources typically meet stricter standards, whereas Chinese and Indian manufacturers may have varying compliance levels but are improving due to increased international regulation.

3. How does geopolitical stability affect API sourcing strategies?
Geopolitical issues can disrupt supply chains. Diversifying sources across regions minimizes risks related to tariffs, trade disputes, and export restrictions.

4. What role does regulatory approval play in API selection?
It ensures the API's quality, safety, and efficacy. Many regions require APIs to have specific certifications, which directly impact market access.

5. Is there a trend toward local API manufacturing for contrast agents?
Yes. Countries aim for self-sufficiency to reduce dependency on imports, driven by national healthcare policies and supply chain security initiatives.

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References

1. U.S. Pharmacopeia (USP). Guide to GMP compliance for APIs. USP Publications, 2022.