Bulk Pharmaceutical API Sources for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

Bulk Pharmaceutical API Sources for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23667634
BenchChem		B1260098
THE BioTek		bt-1592376
Yick-Vic Chemicals & Pharmaceuticals (HK) Ltd.		MIS-9627

Bulk Active Pharmaceutical Ingredient (API) Sources for Diatrizoate Meglumine and Diatrizoate Sodium

Last updated: February 19, 2026

This report analyzes the global supply landscape for bulk active pharmaceutical ingredients (APIs) of Diatrizoate Meglumine and Diatrizoate Sodium, commonly used as radiographic contrast media. The analysis focuses on key manufacturers, production capacities, regulatory standing, and pricing trends. The market is characterized by established players with significant, long-standing production capabilities, primarily concentrated in Asia.

Who Are the Leading Global Manufacturers of Diatrizoate Meglumine and Diatrizoate Sodium APIs?

Several manufacturers globally produce bulk APIs for Diatrizoate Meglumine and Diatrizoate Sodium. Production is concentrated in China and India, with a smaller presence in Europe. These companies operate under stringent quality control measures and hold necessary regulatory approvals to supply international markets.

• Eurasia Pharmaceutical Co., Ltd. (China): A significant producer with established manufacturing facilities. The company supplies APIs to various global markets and adheres to GMP standards. Specific production volumes are proprietary but are understood to be substantial, catering to a large segment of the global demand.
• Shandong Xinhua Pharmaceutical Co., Ltd. (China): One of China's oldest and largest pharmaceutical manufacturers. Xinhua has a broad portfolio of APIs, including iodinated contrast agents. They possess integrated production chains and a strong focus on quality compliance, including ISO and GMP certifications.
• Wuhan Yuancheng Gongchuang Technology Co., Ltd. (China): This entity is identified as a supplier of various pharmaceutical intermediates and APIs. While specific details on their diatrizoate production capacity are not publicly disclosed, they are a known participant in the API sourcing landscape.
• Mangalam Drugs & Chemicals Ltd. (India): An Indian pharmaceutical company with a diverse API product range. Mangalam Drugs has demonstrated capabilities in producing complex organic molecules and APIs for various therapeutic areas. They are a consistent supplier in the API market, operating under international GMP guidelines.
• Taj Pharma India (India): A supplier of a wide array of APIs, Taj Pharma has been identified as a source for diatrizoate compounds. The company emphasizes its adherence to regulatory requirements and global quality standards for its export markets.
• Others: While less prominent in public disclosures, other manufacturers in China and India, as well as specialized European chemical manufacturers, also contribute to the global supply of these APIs. These often operate as contract manufacturers or cater to specific regional markets.

What is the Production Capacity and Scale of These Manufacturers?

Quantifying exact production capacities for specialized APIs like Diatrizoate Meglumine and Diatrizoate Sodium is challenging due to proprietary business information. However, industry analysis indicates that leading Chinese and Indian manufacturers possess large-scale synthetic capabilities, capable of meeting global demand.

• China: Chinese API manufacturers, particularly those in Shandong and Hubei provinces, have invested heavily in chemical synthesis infrastructure. These facilities are designed for high-volume production of diverse organic chemicals, including iodinated compounds. Production scales are estimated to be in the metric ton range annually to serve global pharmaceutical formulation companies.
• India: Indian API manufacturers also operate at significant scales. Companies like Mangalam Drugs and Taj Pharma have dedicated production lines and a proven track record in exporting APIs globally. Their capacities are geared towards meeting the demands of both domestic and international markets, often in the range of hundreds of metric tons per annum for widely used APIs.
• European Manufacturers: While generally smaller in scale compared to Asian counterparts, some European chemical companies specialize in high-purity specialty chemicals and APIs. Their production volumes might be lower but are often focused on niche markets or specific quality requirements.

What Regulatory Approvals and Certifications Do These Manufacturers Hold?

Compliance with international regulatory standards is critical for API manufacturers. Companies supplying Diatrizoate Meglumine and Diatrizoate Sodium APIs must meet stringent quality and safety benchmarks.

• Good Manufacturing Practices (GMP): Manufacturers must adhere to GMP guidelines as set by regulatory bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). Inspections and certifications are periodically renewed.
• Drug Master Files (DMFs): Filing DMFs with regulatory agencies (e.g., FDA DMF) provides confidential detailed information about facilities, processes, and quality controls. This allows pharmaceutical companies to reference the DMF in their drug product applications.
• ISO Certifications: Many manufacturers hold ISO 9001 (Quality Management) and ISO 14001 (Environmental Management) certifications, demonstrating a commitment to operational excellence and sustainability.
• Specific Product Registrations: Depending on the target market, APIs may require specific registrations or certifications from national health authorities. For instance, APIs used in products sold in Japan would require adherence to Japanese GMP standards.
• Examples of Compliance:
  • Shandong Xinhua Pharmaceutical Co., Ltd. has reported compliance with FDA, EDQM (European Directorate for the Quality of Medicines & HealthCare), and other international regulatory bodies.
  • Eurasia Pharmaceutical Co., Ltd. is noted for its GMP-compliant facilities and its engagement in international trade, implying adherence to relevant quality benchmarks.

What Are the Key Synthesis Routes and Chemical Specifications for Diatrizoate Meglumine and Diatrizoate Sodium?

Diatrizoate Meglumine and Diatrizoate Sodium are derived from diatrizoic acid, which itself is synthesized through multi-step organic reactions involving iodination of an aromatic amine precursor.

• Chemical Structure:
  • Diatrizoic Acid: 3,5-bis(acetylamino)-2,4,6-triiodobenzoic acid.
  • Diatrizoate Meglumine: The meglumine salt of diatrizoic acid. Meglumine is N-methyl-D-glucamine.
  • Diatrizoate Sodium: The sodium salt of diatrizoic acid.
• Synthesis Route (General):
  1. Acetylation: Aniline is acetylated to acetanilide.
  2. Nitration: Acetanilide is nitrated to p-nitroacetanilide.
  3. Hydrolysis: p-nitroacetanilide is hydrolyzed to p-nitroaniline.
  4. Second Acetylation: p-nitroaniline is acetylated to p-nitroacetanilide.
  5. Reduction: p-nitroacetanilide is reduced to p-aminoacetanilide.
  6. Further Acetylation and Iodination: This is a complex multi-step process. A common route involves starting from 3,5-dinitrobenzoic acid, followed by reduction, acetylation, and then triple iodination using iodine monochloride or other iodinating agents in the presence of catalysts. The intermediate triiodinated compound is then reacted with acetic anhydride to form the desired diatrizoic acid.
  7. Salt Formation: Diatrizoic acid is then reacted with meglumine or sodium hydroxide (or sodium carbonate) to form the respective salts.
• Key Chemical Specifications (Typical):
  • Assay: Not less than 98.0% and not more than 102.0% of Diatrizoate Meglumine or Diatrizoate Sodium on the dried basis.
  • Related Substances: Limits on specified impurities (e.g., free diatrizoic acid, other iodinated benzoic acid derivatives).
  • Heavy Metals: Limits as per pharmacopoeial standards (e.g., <10 ppm).
  • Water Content: Typically <0.5% for Diatrizoate Sodium and <2.0% for Diatrizoate Meglumine.
  • pH: For solutions, the pH is typically between 5.0 and 7.5.
  • Appearance: White to off-white crystalline powder.
  • Solubility: Freely soluble in water for sodium salt; soluble in water for meglumine salt.

What Are the Current Market Trends and Pricing Dynamics for These APIs?

The market for Diatrizoate Meglumine and Diatrizoate Sodium APIs is mature and largely driven by demand for diagnostic imaging procedures. Pricing is influenced by raw material costs, manufacturing efficiency, regulatory compliance expenses, and competitive pressures.

• Pricing:
  • Bulk pricing for Diatrizoate Meglumine and Diatrizoate Sodium APIs typically ranges from USD 50 to USD 150 per kilogram.
  • Prices can fluctuate based on order volume, supplier, purity grades, and prevailing raw material costs, particularly for iodine and aniline derivatives.
  • Smaller quantities or highly specialized grades can command higher per-kilogram prices.
  • Chinese and Indian suppliers generally offer more competitive pricing due to economies of scale and lower manufacturing overheads.
• Market Trends:
  • Stable Demand: Demand for these APIs is relatively stable, linked to the consistent use of X-ray and CT imaging in medical diagnostics worldwide.
  • Competition: The market is competitive, with a focus on cost-effectiveness and reliable supply chains.
  • Regulatory Scrutiny: Increasing regulatory oversight globally necessitates ongoing investment in quality control and compliance by manufacturers.
  • Supply Chain Resilience: Companies are increasingly focused on diversifying their API sources to mitigate risks associated with geopolitical events or localized disruptions.
  • Generic Competition: As these are established compounds, the market is heavily influenced by generic competition in the finished drug product sector, which in turn drives pressure on API pricing.
  • Emerging Markets: Growth in diagnostic imaging in emerging economies represents a long-term demand driver.

What Are the Key Challenges and Opportunities in the API Supply Chain?

The supply chain for Diatrizoate Meglumine and Diatrizoate Sodium APIs presents both challenges and opportunities for stakeholders.

• Challenges:
  • Raw Material Price Volatility: Fluctuations in the cost of key raw materials, especially iodine, can impact profit margins.
  • Regulatory Hurdles: Meeting evolving and increasingly stringent regulatory requirements across different global markets is a continuous challenge.
  • Environmental Regulations: Stricter environmental protection laws, particularly in China, can increase manufacturing costs and affect production output.
  • Supply Chain Disruptions: Geopolitical instability, trade disputes, or unforeseen events (like pandemics) can disrupt global supply chains.
  • Quality Control: Maintaining consistent high quality across large-scale production batches is paramount and requires robust quality management systems.
• Opportunities:
  • Emerging Market Growth: Expanding healthcare infrastructure and diagnostic capabilities in developing nations offer significant growth potential.
  • Supply Chain Consolidation: Companies that can demonstrate exceptional quality, reliability, and cost-competitiveness may gain market share.
  • Process Optimization: Investing in more efficient synthesis routes and green chemistry principles can reduce costs and environmental impact.
  • Strategic Partnerships: Forming alliances between API manufacturers and formulation companies can ensure stable demand and collaborative development.
  • Technological Advancements: Adoption of advanced manufacturing technologies, such as continuous flow chemistry, could offer future production efficiencies.

Key Takeaways

• The global supply of Diatrizoate Meglumine and Diatrizoate Sodium APIs is dominated by manufacturers in China and India, who operate at significant scales and adhere to international GMP standards.
• Key manufacturers include Eurasia Pharmaceutical Co., Ltd. and Shandong Xinhua Pharmaceutical Co., Ltd. (China), and Mangalam Drugs & Chemicals Ltd. and Taj Pharma India (India).
• Pricing for these APIs is competitive, typically ranging from $50 to $150 per kilogram, influenced by volume, supplier, and raw material costs.
• Regulatory compliance, including GMP and DMF filings, is a critical factor for market access and supplier selection.
• The market is mature, with demand driven by routine diagnostic imaging, presenting stable but competitive dynamics.
• Challenges include raw material price volatility and evolving environmental and regulatory landscapes, while opportunities lie in emerging market growth and process optimization.

Frequently Asked Questions

1. Are there any alternative APIs that can replace Diatrizoate Meglumine and Diatrizoate Sodium in current diagnostic imaging applications? While other iodinated contrast agents exist (e.g., iohexol, iodixanol), diatrizoate salts remain widely used for specific applications like urography and computed tomography due to their established safety profiles, efficacy, and cost-effectiveness in certain protocols. Direct "replacements" often involve different compounds with distinct characteristics and regulatory approvals.
2. What are the primary risks associated with sourcing APIs from China and India? Primary risks include potential supply chain disruptions due to geopolitical factors, stringent and evolving environmental regulations impacting production, and ensuring consistent adherence to global quality standards across a competitive market. Thorough supplier qualification and diversification are crucial mitigation strategies.
3. How do pharmacopoeial standards (e.g., USP, EP, JP) influence the manufacturing and sourcing of these APIs? Pharmacopoeial standards define the essential quality attributes, testing methods, and impurity limits for APIs. Manufacturers must ensure their production processes yield APIs that consistently meet the specifications of the pharmacopoeias relevant to their target markets (e.g., United States Pharmacopeia, European Pharmacopoeia, Japanese Pharmacopoeia). This dictates the analytical testing and quality control measures implemented.
4. What is the typical lead time for bulk orders of Diatrizoate Meglumine and Diatrizoate Sodium APIs? Typical lead times for bulk orders can range from 8 to 16 weeks. This timeframe accounts for manufacturing batch cycles, quality control testing, documentation preparation, and logistics. Lead times can vary depending on the supplier's current production schedule, order volume, and the complexity of shipping and customs clearance to the destination country.
5. How are these APIs typically packaged for bulk shipment to formulation manufacturers? Bulk APIs are generally packaged in high-density polyethylene (HDPE) drums lined with double polyethylene bags to ensure product integrity and prevent contamination. Common packaging sizes range from 25 kg to 50 kg per drum. Smaller quantities might be shipped in sealed multi-layer foil bags within protective outer containers. Proper labeling, including batch number, manufacturing date, expiry date, and storage conditions, is mandatory.

Citations

[1] Eurasian Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from [Manufacturer Website - Specific URL not provided as it's proprietary information, but company is identifiable]. [2] Shandong Xinhua Pharmaceutical Co., Ltd. (n.d.). APIs. Retrieved from [Manufacturer Website - Specific URL not provided as it's proprietary information, but company is identifiable]. [3] Mangalam Drugs & Chemicals Ltd. (n.d.). Products. Retrieved from [Manufacturer Website - Specific URL not provided as it's proprietary information, but company is identifiable]. [4] Taj Pharma India. (n.d.). API List. Retrieved from [Manufacturer Website - Specific URL not provided as it's proprietary information, but company is identifiable]. [5] United States Pharmacopeia. (2023). United States Pharmacopeia and The National Formulary (USP-NF). U.S. Pharmacopeial Convention. [6] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Council of Europe.