中文
EN
News Center
News Center
Milestone: Viwit’s Gadobutrol API US DMF Receives First Adequate Letter
Author：
VIWIT
Release Time：
2026-06-17
Viwit recently received a First Adequate Letter from the U.S. Food and Drug Administration (FDA) for its Gadobutrol API (US DMF No. 039094). The letter confirms that the DMF has successfully completed FDA technical review and can support customers’ U.S. regulatory submissions for finished drug products in accordance with applicable FDA requirements.
Gadobutrol is a next-generation macrocyclic contrast agent used in magnetic resonance imaging (MRI). Its high concentration, high relaxivity, and strong stability support enhanced lesion visualization. The product is used in contrast-enhanced MRI (CE-MRI) and contrast-enhanced magnetic resonance angiography (CE-MRA) for adults and pediatric patients across age groups and plays an important role in clinical diagnostic imaging worldwide.
Continued Regulatory Progress Strengthens Global Market Presence
Europe: In January and August 2025, Viwit obtained Certificates of Suitability (CEPs) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM), CEP 2023-442-Rev 01 and CEP 2025-342-Rev 00.
Russia: In February 2025, market access was obtained through a strategic partner.
China: In May 2025, Viwit received an API approval notification from China’s National Medical Products Administration (NMPA), Registration No. Y20230000590.
India and South Korea: Regulatory submissions were completed in both markets in June 2025.
Brazil: A regulatory submission was completed in September 2025.
Türkiye: Market access was obtained through a strategic partner in December 2025.
United States: In June 2026, the U.S. FDA issued a First Adequate Letter for Gadobutrol API US DMF No. 039094.
Robust Quality Management Demonstrates Global Manufacturing Capabilities
Viwit’s Gadobutrol API manufacturing site has successfully passed China GMP compliance inspection and completed a U.S. FDA cGMP inspection with no Form 483 observations, demonstrating the company’s high standards in manufacturing management and quality systems.
03 | Expanding the Global Contrast Media Portfolio and Serving International Customers
Viwit has established a contrast media portfolio centered on gadobutrol and gadoterate meglumine and has achieved regulatory market access in multiple jurisdictions, including China, the United States, and Europe.
Going forward, Viwit will further integrate its API and finished-dosage-form capabilities, continue advancing its global strategy, and deliver high-standard, high-quality contrast media products that create value for customers and support healthcare worldwide.