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Precision Diagnostics, Shared Globally | Viwit Ships First U.S. Commercial Batch of Gadobutrol Injection
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2026-08-18
On August 18, 2026, Viwit held a shipment ceremony at its sterile manufacturing facility to mark the first commercial export of Gadobutrol Injection to the United States. Municipal and district officials, representatives from local government agencies and customs, Viwit Chairman and President Dr. Keene Wei, Executive Vice President Guo Xinhai, General Manager of Operations Liu Yan, members of the media, and company representatives attended the event.
Integrated Supply Chain and Dual-Market Approvals Accelerate Global Expansion
The Gadobutrol Injection shipment is intended for contrast-enhanced magnetic resonance imaging (CE-MRI), including imaging of the brain and spinal cord, and contrast-enhanced magnetic resonance angiography (CE-MRA). The product uses a DOTA-based macrocyclic structure, which is more stable than conventional linear structures and is designed to reduce release of free gadolinium ions while supporting high-quality visualization of lesion details.
The product received NMPA approval in China in December 2025 and U.S. FDA approval in June 2026. Its API and finished-dosage manufacturing sites have passed China GMP compliance inspections and multiple U.S. FDA cGMP inspections, including inspections classified NAI or VAI with no Form 483 observations. With integrated capabilities spanning the core API, key excipients, and finished dosage form, Viwit manages R&D and manufacturing across the full value chain. The first U.S. shipment includes 7.5 mL/4.5354 g, 10 mL/6.0472 g, and 15 mL/9.0708 g presentations to support a range of clinical imaging needs.
Municipal and District Leaders Mark the Shipment, Supporting Global Expansion
In the presence of guests, Vice Mayor Li Shoujiang, Chen Zhongqi, Zhang Dapeng, and Dr. Keene Wei unveiled a commemorative plaque marking the first U.S. shipment and took part in a ceremonial send-off. Following the ceremony, visiting officials toured the company’s exhibition center and learned about Viwit’s progress in R&D innovation, integrated supply-chain development, and global expansion.
The participation of municipal and district officials and relevant agencies reflected strong local support for Viwit’s international development. Government departments have provided support in areas including international certification, product registration, export customs clearance, and the business environment, helping establish a solid foundation for the successful shipment and continued global growth.
More Than a Decade in Zaozhuang: Innovation Drives the Future
In his remarks, Dr. Keene Wei reviewed the company’s development in Zaozhuang. Founded in Shanghai in 2006, Viwit began with chiral borane products and has since progressed through a structured development path from boranes to APIs, specialty generic drugs, and innovative medicines.
Guided by its strategy of “Full Focus on Innovation, with Insight and Science First,” Viwit has launched frontier research in targeted gene and cell therapy. Using its proprietary targeted lipid nanoparticle (tLNP) technology platform, the company is exploring the feasibility of generating therapeutic cells directly in vivo through mRNA, with potential applications in autoimmune disease and cancer immunotherapy. This work is intended to establish a technology foundation for future expansion of Viwit’s innovative drug pipeline.
With the departure signal, trucks carrying Gadobutrol Injection began their journey to the United States. The shipment represents not only an international product launch, but also another demonstration of Viwit’s capabilities in precision diagnostics—supported by quality systems aligned with both Chinese and U.S. regulatory requirements, an integrated and independently managed supply chain, and sustained scientific innovation. Looking ahead, Viwit will continue advancing its global strategy from its Zaozhuang base, expanding its international market presence, and pursuing its mission, “Innovation for a Better Life.”