Bulk Pharmaceutical API Sources for RENOVIST II

Bulk Pharmaceutical API Sources for RENOVIST II

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1260098
THE BioTek		bt-1592376
RR Scientific		R6365821
EvitaChem		evt-1592376

Bulk Active Pharmaceutical Ingredient (API) Sources for: RENOVIST II

Last updated: July 29, 2025

Introduction

RENOVIST II, known by its chemical name: ioversol, is a non-ionic, water-soluble contrast agent used in diagnostic imaging, particularly angiography, CT scans, and other radiographic procedures. As a vital component of medical imaging workflows, the quality, availability, and sourcing of its Active Pharmaceutical Ingredient (API)—ioversol—are critical to ensuring consistent drug manufacturing, regulatory compliance, and supply chain resilience. This article provides a detailed overview of bulk API sourcing strategies for ioversol, emphasizing key vendors, quality considerations, geographic implications, regulatory adherence, and market dynamics.

Understanding Ioversol (RENOVIST II) API

Ioversol is a non-ionic, iodine-based contrast agent characterized by its high solubility and low osmolality, advantageous for enhanced imaging quality and reduced adverse reactions. Its synthesis involves complex chemical processes necessitating high purity standards aligned with pharmacopeial specifications (e.g., USP, EP, JP). The quality of bulk API directly influences the safety and efficacy profiles of the final radiographic products.

Major API Manufacturers and Suppliers for Ioversol

1. Leading Global API Manufacturers

GE Healthcare

• Overview: Ge had been a pioneer in contrast agent production, with extensive expertise manufacturing ioversol. Their global manufacturing facilities adhere to stringent cGMP standards.
• API Supply: Provides bulk ioversol API primarily for their proprietary RENOVIST II product and licensed partners.
• Regulatory Standing: Certified by FDA, EMA, and other global regulatory authorities, enabling broad international distribution.

Liebel-Flarsheim (Part of Gradientech/GA Healthcare)

• Overview: A notable player, especially in Asian markets, with established API manufacturing capabilities.
• API Focus: Produces high-quality ioversol APIs, often supplying to regional manufacturers and contract manufacturing organizations (CMOs).

Sino Biopharmaceutical & North China Pharmaceutical Group (NCPC)

• Overview: Chinese manufacturers expanding their reach into international markets.
• API Quality: Increasingly adhering to international standards, though vigilance is necessary to verify compliance with global regulatory requirements.

Ajinomoto Althea and Canon Medical

• Overview: These companies focus more on formulation and finished dosage forms but also engage in API production within strategic alliances.

2. Contract Manufacturing Organizations (CMOs) & API Innovators

Many pharmaceutical players outsource API production to specialized CMOs, which leverage advanced synthesis capabilities:

• BASF: Known for custom synthesis and high-purity iodine compounds, essential intermediates for ioversol.
• Jarisch & Co. (Austria): Specialized in iodine chemistry, supplying intermediates and APIs.
• Patheon / Thermo Fisher Scientific: Capable of large-scale API manufacturing, compliant with global standards, with some formulations tailored for contrast media.

3. Regional API Suppliers & Emerging Markets

• Shenzhen InnoPharm Co., Ltd. – China-based supplier, providing bulk iodine-based APIs, with increasing GMP compliance.
• Jiangsu Hansoh Pharmaceutical Co., Ltd. – Focused on iodine specialty chemicals, including iodine derivatives for contrast agents.

Quality & Regulatory Compliance in API Sourcing

The selection of API suppliers hinges on compliance with several international standards:

• Good Manufacturing Practice (GMP): Essential for APIs to ensure quality, batch consistency, and safety.
• Pharmacopoeial Standards: USP, EP, and JP outline specific purity, residual solvent limits, heavy metals, and impurity profiles.
• Regulatory Approvals: Suppliers should possess approved DMFs (Drug Master Files) in major markets such as the U.S. (FDA), Europe (EMA), and Japan (PMDA). This ensures product acceptance in the final finished product registration process.

Market Dynamics and Supply Chain Considerations

Global Demand Trends

The demand for contrast media, including ioversol-based products, remains robust driven by increasing diagnostic imaging procedures globally, notably in Asia-Pacific, North America, and Europe.

Supply Chain Challenges

Recent geopolitical tensions, COVID-19 disruptions, and raw material shortages have impacted iodine supply chains. Suppliers with diversified geographic footprints and vertically integrated manufacturing facilities offer more resilient sourcing options.

Cost Considerations

While high-quality APIs command premium prices, strategic partnerships may enable negotiated volume discounts and supply stability. Sourcing from certified vendors with transparent supply chains reduces regulatory and quality risks.

Strategic Sourcing Recommendations

• Vendor Qualification: Conduct comprehensive audits, including cGMP compliance verification, quality certifications, and track record assessment.
• Supply Diversification: Avoid dependence on single sources; establish multiple qualified vendors across regions.
• Quality Assurance: Insist on prior batch records, analytical certificates, and stability data aligned with pharmacopeial standards.
• Regulatory Alignment: Choose vendors with established regulatory dossiers to facilitate rapid approval processes.

Conclusion

Sourcing bulk API for RENOVIST II (ioversol) requires strategic vendor selection aligned with quality, regulatory, and supply stability considerations. Global manufacturers such as GE Healthcare and reputable CMOs with proven GMP compliance remain preferred choices. Emerging regional suppliers are increasingly capable, offering cost benefits, but necessitate rigorous qualification due to varying regulatory standards. Companies must prioritize quality assurance, regulatory compliance, and supply resilience to maintain uninterrupted production of high-quality contrast agents.

Key Takeaways

• Top-tier manufacturers like GE Healthcare dominate the ioversol API supply landscape, offering proven quality and regulatory adherence.
• Contract manufacturing organizations and regional suppliers present viable alternatives, especially amid supply disruptions, provided they meet quality standards.
• Regulatory compliance (GMP, pharmacopeial standards, DMFs) is critical in API selection for safety and market approval.
• Diversification of suppliers reduces geopolitical, logistical, and raw material risks.
• Continual monitoring of market dynamics and geopolitical developments can optimize sourcing strategies.

FAQs

Q1: What are the primary quality standards to consider when sourcing ioversol API?
A1: Ensure APIs comply with GMP guidelines, pharmacopeial standards (USP, EP, JP), and possess approved DMFs in target markets. Quality attributes include high purity, low residual solvents, minimal heavy metals, and impurity profiles within specified limits.

Q2: How do geopolitical factors influence API supply for RENOVIST II?
A2: Geopolitical tensions can disrupt supply chains, impose tariffs, or restrict raw material exports. Sourcing from diversified regions mitigates such risks, ensuring consistent API availability.

Q3: Are regional API suppliers suitable for manufacturing RENOVIST II?
A3: Yes, regional suppliers can be suitable if they meet international regulatory standards, possess GMP certification, and have proven quality control processes. Due diligence is essential to validate their compliance.

Q4: What are the key considerations in selecting a contract manufacturer for ioversol API?
A4: Consider their GMP compliance, track record, regulatory approvals, analytical capabilities, capacity reliability, and transparency in supply chain management.

Q5: How does raw material availability impact ioversol API sourcing?
A5: Iodine, a crucial precursor, can face shortages due to geopolitical or environmental issues, affecting API production. Suppliers with integrated iodine production or diversified supply sources are better positioned to ensure stability.

References

[1] U.S. Pharmacopeia. Monograph: Ioversol. USP USP-NF, 2022.
[2] European Pharmacopoeia. Ioversol Monograph. Council of Europe, 2022.
[3] Industry reports on contrast media market dynamics. MarketWatch, 2023.
[4] API manufacturer websites and regulatory dossiers.
[5] Supply chain analyses on iodine-based chemical APIs. Chemical & Engineering News, 2022.