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Viwit’s Gadobutrol Injection Receives U.S. FDA Approval
Author：
VIWIT
Release Time：
2026-06-12
Recently, Gadobutrol Injection, independently developed by Viwit (7.5 mmol/7.5 mL, 10 mmol/10 mL, and 15 mmol/15 mL), 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
Gadobutrol Injection is a macrocyclic gadolinium-based contrast agent characterized by high concentration, high relaxivity, and strong stability. It is designed to enhance image resolution and tissue contrast in contrast-enhanced magnetic resonance imaging (CE-MRI) and contrast-enhanced magnetic resonance angiography (CE-MRA), supporting clear visualization of lesion details and reliable diagnostic imaging for conditions involving the central nervous system, tumors, and the vascular system.
Another International Regulatory Milestone Advances Viwit’s Global Strategy
Following receipt of Drug Registration Certificates from China’s National Medical Products Administration (NMPA) in December 2025 (Approval Nos. H20256150, H20256151, and H20256152), Gadobutrol Injection has now also received U.S. FDA approval. The approvals in two major markets—China and the United States—represent another important milestone in Viwit’s continued global expansion.
High-Standard Quality Management Demonstrates Global Manufacturing Capabilities
The sterile manufacturing site for Gadobutrol Injection has successfully passed both China GMP compliance inspection and a U.S. FDA cGMP inspection, demonstrating Viwit’s high standards in manufacturing management, quality systems, and global regulatory readiness.
Integrated Supply Chain Supports Reliable Global Supply
With end-to-end capabilities spanning the core active pharmaceutical ingredient (API), gadobutrol, the key excipient calcium sodium calbutrol, and the finished dosage form, Viwit has established a stable and reliable global supply system designed to support continuity of clinical supply.
Looking ahead, Viwit will continue to pursue innovation-driven growth and global development, deepen its capabilities in advanced diagnostic imaging, and bring more high-quality finished dosage forms to international markets.