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Milestone: Viwit’s Gadoterate Meglumine Injection Receives U.S. FDA Approval
Author：
VIWIT
Release Time：
2026-08-11
Gadoterate Meglumine Injection, independently developed by Viwit (5 mmol/10 mL, 7.5 mmol/15 mL, and 10 mmol/20 mL), has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA), authorizing the product for marketing in the United States.
Indications
Gadoterate Meglumine Injection is an intravenous contrast agent for magnetic resonance imaging (MRI). It is indicated for MRI of the brain (intracranial), spine, and associated tissues in adult and pediatric patients to detect areas with disruption of the blood-brain barrier and/or abnormal vascularity.
Core Advantage: Macrocyclic Stability
As a macrocyclic gadolinium-based contrast agent, Viwit’s Gadoterate Meglumine Injection is characterized by strong structural stability. Animal studies cited in the source material indicate lower gadolinium retention in tissues, including the brain, after repeated administration compared with linear contrast agents, supporting its use in clinical diagnostic imaging.
Quality Management System Recognized Through International Regulatory Inspection
Viwit’s sterile manufacturing facility has successfully completed a U.S. FDA inspection, demonstrating alignment of its cGMP quality management system with international regulatory expectations. The inspection covered facility systems, quality control, production processes, and materials management, reinforcing the quality foundation for the company’s global development.
Strategic Collaboration Supports U.S. Market Expansion
In September 2024, Viwit entered into a strategic collaboration with Zydus Lifesciences covering Gadobutrol Injection and Gadoterate Meglumine Injection. The parties are working together to advance commercialization of both products in the United States and support Viwit’s continued development in the North American market.
Integrated API and Finished-Dosage Capabilities Strengthen Global Supply
Gadoterate Meglumine Injection is another major product in Viwit’s gadolinium contrast media portfolio following Gadobutrol Injection. Both products are now approved in China and the United States. With integrated manufacturing capabilities spanning APIs, excipients, and finished dosage forms, Viwit maintains end-to-end quality oversight and supports reliable, timely supply for domestic and international customers.
End-to-End Capabilities Continue to Support Global Expansion
U.S. approval of Gadoterate Meglumine Injection further demonstrates Viwit’s end-to-end capabilities across R&D, manufacturing, regulatory registration, and commercialization. The company will continue pursuing innovation-driven growth and accelerating the global development of high-quality finished dosage forms to support precision diagnosis and treatment