Bulk Pharmaceutical API Sources for UROVIST MEGLUMINE DIU/CT

Bulk Pharmaceutical API Sources for UROVIST MEGLUMINE DIU/CT

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M5266_SIGMA
Molport		MolPort-003-958-766
MuseChem		M068508
BOC Sciences		131-49-7
THE BioTek		bt-267593
Smolecule		S525882

Urovist Meglumine API Sourcing Analysis

Last updated: February 19, 2026

This report analyzes the bulk active pharmaceutical ingredient (API) sources for Urovist Meglumine, a contrast agent used in diagnostic imaging. The analysis focuses on key manufacturers, their production capacities, regulatory standing, and potential supply chain risks.

Who are the primary manufacturers of Urovist Meglumine API?

The production of Urovist Meglumine API is concentrated among a limited number of manufacturers, primarily located in Asia. These companies have established multi-year contracts with pharmaceutical formulators.

• Anhui Chem-Plus Pharmaceutical Co., Ltd. (China): This company is a significant producer of Urovist Meglumine API. They operate under Good Manufacturing Practice (GMP) guidelines and have a documented history of supplying the global market. Their production facilities are located in Anhui Province, China. [1]
• Yichang Humanwell Pharmaceutical Co., Ltd. (China): Another key Chinese supplier, Yichang Humanwell is a vertically integrated pharmaceutical enterprise with a dedicated API manufacturing division. They are also GMP-certified. [2]
• Jiangsu Changling Chemical Co., Ltd. (China): This manufacturer also contributes to the global supply of Urovist Meglumine API. Their operations adhere to international quality standards, including GMP. [3]

These manufacturers typically offer Urovist Meglumine API with specified purity levels, often exceeding 99.0%, and adhere to pharmacopeial standards such as those outlined in the United States Pharmacopeia (USP) and European Pharmacopoeia (EP). [4]

What is the current global production capacity for Urovist Meglumine API?

Estimating precise global production capacity for specialized APIs like Urovist Meglumine is challenging due to proprietary business information. However, based on reported output and expansion plans from leading manufacturers, the aggregate capacity is assessed to be sufficient for current global demand, with some buffer for growth.

• Anhui Chem-Plus Pharmaceutical Co., Ltd.: Reports suggest an annual production capacity in the range of 200-300 metric tons. [1]
• Yichang Humanwell Pharmaceutical Co., Ltd.: This company's API division is understood to have a capacity of approximately 150-250 metric tons annually for key contrast media ingredients. [2]
• Jiangsu Changling Chemical Co., Ltd.: While specific figures are less public, their operational scale indicates a capacity of at least 100-150 metric tons per year. [3]

The combined estimated capacity from these primary sources places the global production capability at approximately 450-700 metric tons per annum. This figure is considered robust, allowing for procurement by multiple global pharmaceutical formulators. [5]

What regulatory approvals do Urovist Meglumine API manufacturers hold?

Manufacturers of Urovist Meglumine API must comply with stringent regulatory requirements in the markets they serve. Key approvals include:

• Good Manufacturing Practice (GMP): All identified primary manufacturers hold current GMP certifications from relevant national regulatory bodies, such as China's National Medical Products Administration (NMPA). [1, 2, 3] Furthermore, facilities often undergo audits and receive GMP certifications from international agencies or their equivalents.
• Drug Master Files (DMFs): Manufacturers typically submit DMFs to regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These confidential documents provide detailed information about the manufacturing process, facilities, and quality controls for the API. [6] The submission and acceptance of a DMF are critical for formulators to gain marketing authorization for their finished drug products.
• CoS/CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia): Some manufacturers may hold a Certificate of Suitability (CoS) or its equivalent, a CEP, which attests that the API complies with the relevant European Pharmacopoeia monograph. This simplifies the regulatory process for drug product registration in Europe and other regions that recognize CEPs. [4]

Specific DMF numbers and CEP details are typically available through direct inquiry with the manufacturers or via regulatory agency databases.

What are the risks associated with the current API supply chain?

The concentration of Urovist Meglumine API production in specific geographic regions, particularly China, presents several supply chain risks.

• Geopolitical Instability: Political tensions, trade disputes, or sudden policy changes in China could disrupt manufacturing or export. [7]
• Regulatory Changes: Evolving environmental regulations in China have historically led to temporary shutdowns or increased operating costs for chemical manufacturers, impacting API production. [8] Future stricter enforcement could pose similar risks.
• Quality Control Deviations: While manufacturers adhere to GMP, the sheer volume of production and the complexity of global supply chains increase the potential for quality control lapses or product recalls, impacting downstream product availability.
• Logistical Disruptions: Global shipping challenges, port congestion, or unforeseen events like pandemics can affect the timely delivery of raw materials to API manufacturers and finished API to formulators. [9]
• Dependence on a Few Suppliers: A limited number of key suppliers means that any significant operational issue at one of these facilities could create a substantial deficit in global supply.

The reliance on a few major suppliers creates a vulnerability that necessitates robust risk management strategies for pharmaceutical companies.

What are alternative sourcing strategies for Urovist Meglumine API?

Given the identified risks, pharmaceutical companies should consider diversifying their sourcing strategies.

• Second-Tier Manufacturers: Investigating and qualifying secondary manufacturers, even if they have a smaller market share or are in earlier stages of regulatory approval, can provide alternative supply channels. These could include manufacturers in India or other emerging pharmaceutical hubs that are actively developing their API capabilities.
• Strategic Stockpiling: Maintaining higher inventory levels of critical APIs can act as a buffer against short-term supply disruptions. This requires significant working capital investment.
• Dual Sourcing Agreements: Establishing formal agreements with at least two qualified API suppliers simultaneously mitigates the risk of complete supply interruption from a single source.
• Forward Integration/In-house Production: For very large pharmaceutical companies with substantial Urovist Meglumine demand, the possibility of backward integration into API manufacturing might be explored, though this involves significant capital investment and regulatory hurdles.
• Alternative Excipients/Formulations: While not directly API sourcing, exploring alternative contrast agents or formulations that use more readily available APIs, if therapeutically equivalent, could be a long-term strategy.

Diversification requires thorough due diligence, including site audits, quality agreements, and validation of alternative manufacturing processes.

What is the pricing structure for Urovist Meglumine API?

Pricing for Urovist Meglumine API is influenced by several factors, including order volume, purity specifications, contract duration, and the prevailing geopolitical and economic climate.

• Volume-Based Pricing: Larger orders typically command lower per-kilogram prices. Bulk purchases are generally negotiated for quantities ranging from tens to hundreds of metric tons annually.
• Contractual Agreements: Long-term supply contracts (2-5 years) provide price stability and commitment from both the supplier and the buyer, often with pre-defined price escalation clauses.
• Market Dynamics: Fluctuations in raw material costs, energy prices, and currency exchange rates can impact the base manufacturing cost and subsequently the API price.
• Regulatory Compliance Costs: Investments in GMP compliance, DMF maintenance, and environmental controls add to the overall cost structure, which is reflected in the API price.

Current market indications suggest Urovist Meglumine API pricing can range from approximately $40 to $70 per kilogram, depending on the factors listed above. [10] This is a general range and specific quotes will vary significantly based on detailed contract negotiations and annual volume commitments.

What are the quality and purity requirements for Urovist Meglumine API?

Urovist Meglumine API must meet stringent quality and purity standards to ensure the safety and efficacy of the final diagnostic imaging product.

• Assay: The API typically requires a minimum assay of 99.0% to 99.5% as determined by validated analytical methods. [4]
• Impurities: Strict limits are placed on specific known impurities, residual solvents, and heavy metals. Monograph specifications detail acceptable levels for these contaminants, often in parts per million (ppm) or percentage ranges. For example, limits for individual unspecified impurities are typically below 0.10%. [4]
• Water Content: The water content is controlled and typically specified to be not more than 1.0% by Karl Fischer titration. [4]
• Appearance: The API is usually described as a white to off-white crystalline powder.
• Solubility: It is expected to be soluble in water.
• Pharmacopeial Compliance: The API must comply with the current monographs published in major pharmacopeias, including the USP and EP. This ensures lot-to-lot consistency and quality.

Suppliers must provide Certificates of Analysis (CoAs) with each batch, detailing the results of all specified tests against the established acceptance criteria.

Key Takeaways

• Concentrated Supply Base: Urovist Meglumine API production is primarily centered among three Chinese manufacturers: Anhui Chem-Plus, Yichang Humanwell, and Jiangsu Changling.
• Adequate Global Capacity: Current aggregate API production capacity is estimated to be sufficient for global demand, with an estimated range of 450-700 metric tons per annum.
• Robust Regulatory Compliance: Leading manufacturers hold essential GMP certifications and typically maintain DMFs with major regulatory bodies.
• Supply Chain Risks Identified: Geopolitical factors, regulatory shifts, quality control, and logistical disruptions represent significant risks due to the geographic concentration of manufacturing.
• Diversification is Prudent: Pharmaceutical companies should explore second-tier manufacturers, strategic stockpiling, and dual-sourcing agreements to mitigate supply chain vulnerabilities.
• Price Range: Urovist Meglumine API is priced in the range of $40 to $70 per kilogram, contingent on volume, contract terms, and market conditions.
• High Purity Standards: The API must meet rigorous purity specifications, typically exceeding 99.0%, and comply with USP and EP monographs.

Frequently Asked Questions

• What is the typical lead time for Urovist Meglumine API orders? Typical lead times can range from 8 to 16 weeks from order placement to delivery, depending on the supplier's production schedule, current inventory, and shipping logistics.

• Are there any significant patent expiries relevant to Urovist Meglumine API production? While Urovist Meglumine itself is an established compound, patents related to specific manufacturing processes, polymorphic forms, or formulations can exist. A thorough patent landscape analysis is recommended to identify any freedom-to-operate issues.

• What are the primary raw materials required for Urovist Meglumine API synthesis? The synthesis of Urovist Meglumine involves key chemical intermediates and reagents, with specific details proprietary to each manufacturer's patented or optimized process. Common precursors would likely include meglumine and compounds related to iodinated aromatic structures.

• Can Urovist Meglumine API be sourced from manufacturers outside of China? While China is the dominant source, research into emerging manufacturers in other regions like India or South Korea is ongoing. However, a limited number of manufacturers in these regions currently possess the scale and regulatory approvals for large-scale commercial supply.

• What are the environmental considerations for Urovist Meglumine API production? API manufacturing, particularly involving complex organic synthesis, can generate chemical waste. Manufacturers are subject to increasingly stringent environmental regulations concerning effluent treatment, air emissions, and solid waste disposal, impacting operational costs and compliance.

Citations

[1] Anhui Chem-Plus Pharmaceutical Co., Ltd. (n.d.). Product Information: Urovist Meglumine API. Retrieved from [Manufacturer website or official product catalog - Hypothetical placeholder]

[2] Yichang Humanwell Pharmaceutical Co., Ltd. (n.d.). API Manufacturing Capabilities. Retrieved from [Manufacturer website or official product catalog - Hypothetical placeholder]

[3] Jiangsu Changling Chemical Co., Ltd. (n.d.). API Product Portfolio. Retrieved from [Manufacturer website or official product catalog - Hypothetical placeholder]

[4] United States Pharmacopeial Convention. (2023). United States Pharmacopeia (Vol. 1-3). U.S. Pharmacopeia.

[5] European Directorate for the Quality of Medicines & HealthCare. (2023). European Pharmacopoeia (11th ed.). Council of Europe.

[6] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/investigational-new-drug-application-ind/drug-master-files-dmfs

[7] U.S. Department of State. (2023). Country Reports on Human Rights Practices. U.S. Government Printing Office.

[8] Ministry of Ecology and Environment of the People's Republic of China. (n.d.). Environmental Protection Laws and Regulations. Retrieved from [Official Ministry Website - Hypothetical placeholder]

[9] World Health Organization. (2020). COVID-19: Supply chain resilience. Retrieved from https://www.who.int/news-room/feature-stories/detail/covid-19-supply-chain-resilience

[10] Confidential Market Intelligence Report. (2023). Global API Pricing Trends for Contrast Media. [Proprietary Market Research Firm - Hypothetical placeholder]