Bulk Pharmaceutical API Sources for IOPAMIDOL-200

Bulk Pharmaceutical API Sources for IOPAMIDOL-200

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		65492
MolPort		MolPort-003-848-224
ISpharm		I01-8407
ABI Chem		AC1L23CM

Bulk Active Pharmaceutical Ingredient (API) Sources for Iopamidol-200

Last updated: August 2, 2025

Introduction

Iopamidol-200 is a non-ionic, water-soluble contrast agent extensively used in diagnostic imaging procedures, particularly in computed tomography (CT) scans. Its efficacy hinges on high-quality bulk Active Pharmaceutical Ingredient (API) sourcing, which ensures safety, efficacy, and regulatory compliance. The procurement landscape for Iopamidol-200 API features a combination of multinational manufacturers, specialized chemical suppliers, and emerging regional producers. This report evaluates the key API sources, considering their manufacturing capabilities, quality standards, market presence, and regulatory standing.

---

Market Landscape for Iopamidol-200 API

The global API market for contrast agents like Iopamidol-200 is characterized by a competitive environment dominated by a mix of established pharmaceutical giants and dedicated chemical manufacturers. The demand for quality API stems from stringent regulatory frameworks, such as FDA, EMA, and PMDA, which necessitate Good Manufacturing Practices (GMP) compliance. The supply chain's robustness directly influences drug availability and pricing.

---

Major API Suppliers for Iopamidol-200

1. Bracco Imaging S.p.A.

Overview:
Bracco, headquartered in Italy, is a leading player in imaging agents, including the manufacture of Iopamidol. Their manufacturing facilities adhere to stringent GMP standards, with API production integrated into their global supply chain.

API Capabilities:
Bracco supplies Iopamidol API directly to pharmaceutical companies worldwide, leveraging their extensive R&D and manufacturing expertise. Their APIs meet international regulatory standards, with documented stability and purity profiles.

Strengths:

• Proven regulatory compliance
• Strong global distribution network
• Integrated quality assurance systems

Limitations:

• Higher cost due to brand premium
• Limited transparency on detailed manufacturing processes publicly

2. Jiangsu Mid-East High-Tech (MEHT) Pharmaceutical Co., Ltd.

Overview:
Chinese pharmaceutical manufacturers have expanded their presence in contrast agent APIs, with MEHT emerging as a notable supplier in the Iopamidol market.

API Capabilities:
MEHT offers high-purity Iopamidol API, adhering to WHO-GMP standards, with competitive pricing. Their manufacturing processes employ advanced synthesis techniques optimized for purity and yield.

Strengths:

• Cost-efficient production
• Rapid supply chain responsiveness
• Growing acceptance in international markets

Limitations:

• Less extensive regulatory approval in Western markets
• Variability in quality documentation across batches

3. Piramal Enterprises

Overview:
Indian-based Piramal is a significant API manufacturer with a focus on contrast agents, including Iopamidol. Their API production facilities are certified by several international regulators.

API Capabilities:
Piramal supplies Iopamidol API characterized by high purity (≥99%), with supply agreements supporting large-volume procurement for global clients. Their manufacturing incorporates rigorous quality control and validation procedures.

Strengths:

• Extensive regional distribution network
• Certified compliance with USP, EP standards
• Competitive pricing

Limitations:

• Limited exposure in some Western markets due to regulatory nuances
• Supply chain dependency on regional logistics

4. GE Healthcare (Now part of Danaher)

Overview:
While primarily known for finished contrast agents, GE Healthcare/Danaher also engages in API manufacturing or partnerships with API producers.

API Capabilities:
The company ensures high-quality API sourced from certified suppliers, often through licensing agreements, emphasizing seamless integration with their contrast agent manufacturing.

Strengths:

• Stringent quality standards
• End-to-end quality control from API to finished product

Limitations:

• API primarily supplied through partnerships, not direct sales
• Limited publicly available API manufacturing details

5. Symbiotec Pharma

Overview:
An emerging Indian pharmaceutical manufacturer specializing in generics and API supply.

API Capabilities:
Symbiotec supplies Iopamidol API adhering to international pharmacopoeias, with a focus on cost competitiveness and regulatory compliance for emerging markets.

Strengths:

• Flexible manufacturing scale
• Lower entry barrier for regional markets

Limitations:

• Less comprehensive regulatory approval in major Western regions
• Need for further quality validation for specific markets

---

Emerging and Regional API Sources

In addition to globally recognized producers, regional suppliers from Southeast Asia, Eastern Europe, and Latin America are increasingly involved in Iopamidol API production. These sources focus on cost-effective production, albeit with variable regulatory acceptance, necessitating stringent qualification processes.

---

Key Considerations in API Sourcing

• Regulatory Compliance: Ensuring APIs are sourced from suppliers with GMP certification, batch validation, and thorough documentation compatible with regional regulatory standards.
• Quality Assurance: High purity levels (≥99%), low endotoxin levels, and consistent batch-to-batch quality are critical.
• Supply Reliability: Ability to meet demand fluctuations, especially given the global dependency on limited suppliers.
• Pricing Structures: Competitive pricing balanced with regulatory and quality assurances.
• Intellectual Property and Licensing: Confirming licensure rights for API production and licensing agreements to avoid infringement.

---

Conclusion

The procurement of Iopamidol-200 API involves assessing tiered suppliers ranging from established international companies to regional manufacturers. Bracco and Piramal remain top-tier sources due to their proven quality and regulatory acceptance. Chinese suppliers like MEHT offer cost advantages but require rigorous qualification. As the market evolves, increasing regional participation, driven by cost pressures and supply chain diversification, will influence sourcing strategies. Ensuring compliance with regulatory standards remains paramount in selecting API sources.

---

Key Takeaways

• Regulatory certification and GMP compliance are essential in API supplier qualification for Iopamidol-200.
• Established global producers such as Bracco and Piramal dominate the supply landscape due to quality assurance.
• Regional suppliers present cost-effective options but demand extensive validation to meet international standards.
• Supply chain resilience and quality consistency are critical factors amid fluctuating global logistics and regulatory environments.
• Third-party testing and validation should confirm API purity, stability, and compliance.

---

FAQs

Q1: What are the primary regulatory considerations when sourcing Iopamidol-200 API?
A1: Suppliers must have GMP certification, provide comprehensive batch documentation, and comply with pharmacopoeia standards such as USP, EP, or JP. Regulatory acceptance in target markets, especially the US, EU, and Japan, is vital.

Q2: How does API purity impact the safety of Iopamidol-200?
A2: High purity (>99%) ensures minimal impurities and endotoxins, reducing adverse reactions and ensuring image clarity during diagnostic procedures.

Q3: Are regional API suppliers suitable for global pharmaceutical companies?
A3: They can be, provided they meet international quality standards and regulatory requirements. Validation, qualification, and ongoing compliance monitoring are necessary.

Q4: What are the risks associated with sourcing Iopamidol API from emerging or lesser-known suppliers?
A4: Risks include inconsistent quality, regulatory non-approval, supply delays, and potential regulatory sanctions. Rigorous audits and testing are essential.

Q5: How does market demand influence API sourcing strategies for Iopamidol-200?
A5: Growing demand prompts diversification, emphasizing supply stability and cost management. Companies may balance sourcing from reliable international suppliers with regional providers to optimize cost and supply security.

---

References

1. European Directorate for the Quality of Medicines & HealthCare (EDQM). Iopamidol specifications.
2. Bracco Imaging official website. Product portfolio details.
3. Jiangsu Mid-East High-Tech Pharmaceutical Co., Ltd. public disclosures and certifications.
4. Piramal Enterprises Ltd. API manufacturing standards and GMP certifications.
5. Industry analysis reports on contrast agent APIs, 2022-2023.