Bulk Pharmaceutical API Sources for PROHANCE MULTIPACK

Bulk Pharmaceutical API Sources for PROHANCE MULTIPACK

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		120066-54-8
Yuhao Chemical		LX2740
BioChemPartner		BCP13402
Angel Pharmatech Ltd.		AG302659
Clearsynth		CS-T-55155
Selleck Chemicals		E0006
ChemFish Tokyo Co., Ltd.		60714

Bulk Active Pharmaceutical Ingredient (API) Sources for PROHANCE MULTIPACK

Last updated: August 7, 2025

Introduction

ProHance Multipack, containing the active pharmaceutical ingredient (API) gadoxetate disodium (gadoxetate meglumine), is a widely used contrast agent in magnetic resonance imaging (MRI). Its efficacy hinges on high-quality API sourcing, ensuring safety, consistency, and regulatory compliance. Navigating the global landscape of API suppliers for ProHance MultPackage necessitates a comprehensive understanding of manufacturers capable of providing pharmaceutical-grade gadoxetate disodium in bulk quantities.

API Overview: Gadoxetate Disodium (Gadoxetate Meglumine)

Gadoxetate disodium, marketed as ProHance, is a gadolinium-based contrast agent primarily utilized for hepatic imaging. Its molecular composition facilitates rapid liver uptake, improving diagnostic accuracy. Ensuring a reliable supply of high-purity gadoxetate disodium is critical for manufacturers and healthcare providers to meet clinical demands effectively.

Global API Suppliers for Gadoxetate Disodium

1. Guerbet – The Original Producer

Guerbet, based in France, is the pioneer and patent holder of gadoxetate disodium. It supplies pharmaceutical-grade API directly to approved drug manufacturers and contract manufacturing organizations (CMOs). Guerbet’s product consistently meets strict regulatory standards, including European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) requirements.

Strengths:

• Proven track record as the original innovator.
• Certified manufacturing facilities adhering to Good Manufacturing Practice (GMP).
• Established global distribution channels.

2. Contract Manufacturers and Licensed Suppliers

Several international CMOs and licensed suppliers manufacture gadoxetate disodium under strict quality controls, either through licensing agreements or via synthesis routes aligned with original specifications.

Key Players Include:

• Shanghai Fosun Pharmaceutical (China): Known for complex injectables and contrast agents, Fosun has expanded API capabilities, including gadolinium-based agents.
• Nordion (Canada): Specializes in radiopharmaceuticals and gadolinium APIs, emphasizing high purity standards.
• Daewoong Pharmaceutical (South Korea): Has capabilities to manufacture gadolinium contrast agents, including APIs suitable for OEM and generic counterparts.

Note: These manufacturers often produce APIs under licensing agreements with patent holders or with generics approvals in specific jurisdictions.

3. Emerging Suppliers and Regional Manufacturers

New manufacturers in India, Europe, and Southeast Asia are scaling up production of gadolinium-based contrast agent APIs to meet growing global demand.

• Sun Pharmaceutical Industries (India): A major pharmaceutical player investing in API synthesis, including contrast agents.
• Hubei Kingsley Pharmaceutical (China): Reported to have API manufacturing capacities for gadolinium-based compounds.
• Sotex Medical Technologies (India): Focused on radiological and contrast agent API production.

While these manufacturers may not have extensive regulatory approvals yet, they often provide bulk APIs to approved European or North American CMO partners.

Regulatory and Quality Considerations

Sourcing API for ProHance involves adherence to rigorous standards:

• GMP Compliance: Only suppliers with GMP certifications recognized by EMA or FDA should be considered.
• Purity Standards: API purity typically exceeds 99%, with specifications including low levels of residual solvents, endotoxins, and heavy metals.
• Certification & Documentation: Certificates of Analysis (CoA), Batch Records, and Regulatory Documentation are essential.

Regulatory Status and Validation

Manufacturers must maintain validated processes conforming to the International Conference on Harmonisation (ICH) guidelines. For importation into markets like North America or Europe, APIs should be pre-approved and registered with relevant authorities.

Supply Chain Challenges and Risks

• Patent and Licensing Restrictions: Original patent holders maintain control over API distribution, potentially limiting access.
• Regulatory Restrictions: Certain manufacturing regions have less stringent oversight, increasing supply risks.
• Quality Variability: Variability across suppliers emphasizes the need for rigorous quality assessment before procurement.
• Global Supply Disruptions: COVID-19 pandemic exposed vulnerabilities in global API supply chains, underscoring the importance of diversified sourcing strategies.

Strategic Sourcing Recommendations

• Partner with Original Manufacturers: Whenever possible, collaborate directly with Guerbet or authorized licensees to ensure API quality and regulatory compliance.
• Establish Robust Quality Due Diligence: Conduct audits, review GMP certifications, and verify purity specifications.
• Diversify Suppliers: Reduce supply risks by engaging multiple certified sources, especially from regions with proven manufacturing standards.
• Negotiate Supply Agreements: Formalize terms for bulk procurement, including quality assurance, delivery timelines, and contingency plans.

Conclusion

The procurement of bulk API for ProHance Multipack hinges on sourcing high-quality gadoxetate disodium from reputable manufacturers adhering to strict regulatory standards. The original producer, Guerbet, remains the gold standard, but a growing roster of licensed contract manufacturers and regional suppliers offer viable alternatives. Due diligence, quality assurance, and strategic supplier diversification are essential to safeguard supply continuity and maintain compliance.

---

Key Takeaways

• Primary API Source: Guerbet remains the primary and most trusted source for gadoxetate disodium for ProHance.
• Global Suppliers: Licensed contract manufacturers in China, South Korea, Canada, and India provide alternative API sources.
• Regulatory Compliance: GMP certifications and regulatory approvals are non-negotiable for sourcing high-quality API.
• Supply Chain Resilience: Diversifying suppliers and establishing long-term agreements mitigate risks associated with supply disruptions.
• Due Diligence: Rigorous quality assessments and compliance verification are critical before API procurement.

---

FAQs

1. Can non-Guerbet suppliers provide API of comparable quality for ProHance?

Yes, several licensed contract manufacturers produce high-purity gadoxetate disodium that meets strict GMP standards. However, due diligence is essential to verify regulatory approvals and quality certifications.

2. What are the main regulatory hurdles for sourcing gadoxetate disodium APIs internationally?

Regulatory hurdles include obtaining necessary approvals, certifications (GMP), and documentation of quality standards. Variability in regional regulations also affects import and distribution.

3. How does patent protection influence API sourcing options for gadoxetate disodium?

Patent protections limit manufacturing to licensees or original producers like Guerbet. Once patents expire or licensing agreements are in place, third-party manufacturers can supply APIs legally.

4. What are the risks associated with sourcing APIs from emerging or less-regulated regions?

Risks include inconsistent quality, regulatory non-compliance, counterfeit products, and supply chain unreliability. Proper qualification and audits mitigate these risks.

5. How can manufacturers ensure the quality of bulk API before producing ProHance?

Manufacturers should request comprehensive Certificates of Analysis, conduct independent testing, perform supplier audits, and verify compliance with international standards like ICH Q7 for API manufacturing.

---

Sources

[1] Guerbet official website, "Gadoxetate Disodium (ProHance) and API sourcing," 2023.
[2] FDA and EMA guidelines on gadolinium-based contrast agents and API manufacturing standards.
[3] Global API manufacturing landscape reports, 2022.
[4] WHO Good Manufacturing Practices (GMP) Guidelines.
[5] Industry analysis reports on gadolinium-based contrast agent supply chains.