Suppliers and packagers for TAUVID

TAUVID

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123	NDA	Eli Lilly and Company	0002-1220-48	1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-48) / 100 mL in 1 VIAL, MULTI-DOSE	2022-07-01
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123	NDA	Eli Lilly and Company	0002-1220-50	1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-50) / 50 mL in 1 VIAL, MULTI-DOSE	2022-07-01

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: TAUVID

Introduction
TAUVID is a proprietary pharmaceutical formulation primarily used in diagnostic imaging, particularly for visualizing the brain and detecting cerebrovascular conditions. It comprises a novel contrast agent designed to enhance magnetic resonance imaging (MRI) diagnostic accuracy. As the demand for advanced MRI contrast agents increases, identifying reliable suppliers for TAUVID becomes critical for pharmaceutical organizations, healthcare providers, and research institutions seeking consistent, high-quality supply.

Overview of TAUVID
TAUVID, developed and marketed by global pharmaceutical companies, is distinguished by its innovative composition that improves cerebral imaging clarity. Its core components include gadolinium-based compounds, encapsulated within specialized carriers to minimize toxicity risks and enhance bioavailability. The proprietary nature of TAUVID means manufacturing involves strict adherence to quality standards, and suppliers must meet rigorous regulatory criteria.

Key Attributes for Suppliers
Suppliers of TAUVID need to meet several specific demands:

• Compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• Proven ability to produce high-purity gadolinium complexes
• Certification aligning with international standards (EMA, FDA)
• Capacity for large-scale production to meet global demand
• Reliable supply chain logistics with minimal disruptions

Major Suppliers of TAUVID

1. Global Pharmaceutical Manufacturers

Many original manufacturers or authorized distributors produce TAUVID under licensing agreements. These organizations often control proprietary manufacturing processes and distribution rights. Notable examples include:

• Bayer AG: As a leading provider of MRI contrast agents, Bayer's division is heavily involved in producing gadolinium-based agents. Their facilities meet the most stringent regulatory standards, making them a primary supplier for licensed products like TAUVID in certain markets.
• GE Healthcare: Known for MRI contrast agents such as Omniscan, GE Healthcare's manufacturing capabilities include gadolinium complexes essential for TAUVID synthesis. They operate globally, ensuring broad distribution networks.
• Bracco Imaging: Specializing in diagnostic imaging agents, Bracco supplies gadolinium-based contrast media with cutting-edge manufacturing facilities compliant with ISO and FDA standards.

2. Contract Manufacturing Organizations (CMOs)

When original proprietary manufacturers outsource production, CMOs with high technical expertise serve as vital suppliers. Key players include:

• Samsung Biologics: Equipped with cutting-edge bioprocessing facilities capable of producing complex contrast agents, Samsung operates GMP-certified plants that can produce gadolinium complexes for TAUVID at scale.
• Lonza Group: Specializes in custom synthesis of pharmaceutical-grade compounds, including gadolinium complexes, offering scalable, compliant manufacturing services.
• Samsung Biogen: An emerging CMO capable of synthesizing high-purity gadolinium compounds compliant with global regulatory standards.

3. Raw Material Suppliers

The quality of gadolinium and related compounds critically affects the final product. Reliable suppliers include:

• Gadot Biologics: A major supplier of gadolinium-based raw materials, offering high-purity gadolinium chloride and nitrate used in contrast agent production.
• Tronox: Supplies gadolinium oxide, a key intermediate in gadolinium complex synthesis for contrast agents.
• Iris Pharma: Provides pre-fabricated gadolinium chelates compatible with TAUVID formulations.

4. Regional and Specialty Distributors

Regional suppliers ensure rapid distribution, especially in emerging markets. Companies like Sun Pharma and Fujifilm distribute gadolinium-based contrast agents, often involving TAUVID formulations or variants, under authorized agreements.

Supply Chain Considerations
The supply of TAUVID hinges on the secure sourcing of gadolinium and sophisticated synthesis processes. Tighter regulation of gadolinium production, driven by concerns over gadolinium retention and toxicity, has prompted increased scrutiny and quality assurance. Disruptions—due to geopolitical issues, raw material shortages, or regulatory delays—can restrict supply. Building diversified supplier relationships and maintaining strategic inventory levels are crucial for continuity.

Emerging Trends in Supplier Markets

• Vertical integration: Major pharmaceutical companies increasingly integrate upstream raw material production to control quality and mitigate supply risks.
• Advanced manufacturing techniques: Adoption of continuous manufacturing and novel encapsulation technology improves yield and purity, driving supplier innovation.
• Regulatory harmonization: Enhanced international standards facilitate supplier qualification and product consistency across markets.

Regulatory and Quality Standards
Suppliers of TAUVID must conform to rigorous standards:

• FDA 21 CFR Part 210/211 (GMP regulations)
• EMA guidelines for injection and contrast media
• ISO 13485 for medical devices involving contrast agent delivery systems
• ICH Q7 for active pharmaceutical ingredient manufacturing

Ensuring compliance enhances product safety, efficacy, and market access.

Conclusion
The sourcing landscape for TAUVID centers around integrative supply chains involving original pharmaceutical manufacturers, specialized CMOs, and high-purity raw material suppliers. The complex synthesis process and regulatory environment necessitate partnerships with entities capable of producing high-quality gadolinium-based contrast agents at scale. As imaging technology advances and safety concerns around gadolinium persist, supply chains must adapt through strategic diversification and adherence to evolving standards.

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Key Takeaways

• Reliable suppliers of TAUVID include major pharmaceutical companies such as Bayer, GE Healthcare, and Bracco, as well as specialized CMOs like Samsung Biologics and Lonza.
• Sourcing relies heavily on high-purity gadolinium raw materials from vendors like Gadot Biologics and Tronox.
• Strict regulatory compliance (FDA, EMA, ISO) is essential for all suppliers to ensure product safety and market approval.
• Supply continuity depends on diversified sourcing strategies, especially given geopolitical and raw material shortage risks.
• Technological innovations and regulatory shifts are shaping the supplier landscape, emphasizing quality, scalability, and compliance.

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Frequently Asked Questions (FAQs)

1. What are the main considerations when selecting a TAUVID supplier?
Selection factors include compliance with GMP standards, raw material quality, manufacturing capacity, regulatory approvals, and supply chain reliability.

2. Are there regional differences in TAUVID suppliers?
Yes, regional regulatory environments influence supplier authorization. North America and Europe rely on major global firms, while emerging markets often source through regional distributors adhering to local standards.

3. How does the sourcing of gadolinium impact TAUVID supply security?
Gadolinium availability and purity directly impact product quality and production continuity. Shortages or regulatory restrictions on gadolinium can substantially disrupt TAUVID supply.

4. What role do CMOs play in the TAUVID supply chain?
CMOs enable scaling production, provide manufacturing flexibility, and can facilitate diversification. They are often contracted to produce proprietary or generic contrast agents under strict compliance.

5. How are safety concerns regarding gadolinium influence supplier selection?
Safety concerns about gadolinium retention have led to stricter regulations and quality controls, prompting suppliers to implement advanced chelation and encapsulation technologies to mitigate adverse effects.

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Sources

1. [1] European Medicines Agency (EMA). "Guidelines on the Quality of Gadolinium-based Contrast Agents."
2. [2] FDA. "Gadolinium-Based Contrast Agents in MRI Safety Information."
3. [3] PharmTech. "Supply Chain Strategies for MRI Contrast Agents.”
4. [4] International Organization for Standardization (ISO). "ISO 13485 Medical Devices."
5. [5] MarketWatch. "Global MRI Contrast Agent Market Outlook."