Zydus signs exclusive US deal for two MRI contrast agents

AHMEDABAD, India, Sept. 13, 2024 -- Zydus Lifesciences Ltd., a prominent global healthcare organization, has announced that its fully owned subsidiary, Zydus Lifesciences Global FZE, has formed an exclusive licensing and supply agreement with Viwit Pharmaceuticals. Viwit, a biopharmaceutical and healthcare company known for its innovative approaches, will supply gadobutrol injection and gadoterate meglumine injection for the US market. These injections are generic versions of GADAVISTTM and DOTAREM®, respectively.

Under the agreement, Viwit will handle the ANDA (Abbreviated New Drug Application) submission process, along with the manufacturing and supply of the generic versions following the necessary regulatory approvals. Zydus, on the other hand, will be responsible for marketing, distributing, and selling these MRI contrast agents exclusively in the US market. This partnership marks the introduction of the first contrast agent products in Zydus' injectable portfolio specifically for the US market.

The potential market for gadobutrol injection in the US is estimated at approximately $120 million, while gadoterate meglumine injection is expected to reach around $117 million, according to IQVIA MAT Jul - 2024 data.

About Zydus

Zydus Lifesciences Ltd. is dedicated to empowering individuals to live healthier, more fulfilling lives through its innovative healthcare solutions. The company is active in discovering, developing, manufacturing, and marketing a broad spectrum of healthcare therapies. Zydus has a notable presence in cancer-related treatments and offers an array of solutions that include cytotoxic, supportive, and targeted drugs. Employing over 27,000 people globally, including 1,400 scientists engaged in research and development, Zydus is committed to delivering quality healthcare solutions that make a significant impact on lives. Their mission is to unlock new possibilities in lifesciences and transform lives through pioneering discoveries.

About Viwit Pharmaceuticals

Viwit Pharmaceuticals is a company focused on biopharmaceutical innovation and healthcare solutions. The organization offers integrated research and development, production, and marketing systems. Viwit aims to create a platform for pharmaceutical innovation and commercialization, establishing an ecosystem that addresses public healthcare needs. Initially starting as a producer of Boranes, Viwit has evolved into a comprehensive healthcare company providing API (Active Pharmaceutical Ingredient) and drug product development, manufacturing, and CDMO (Contract Development and Manufacturing Organization) services. With three integrated product R&D centers and three cGMP (current Good Manufacturing Practices) US FDA-inspected production facilities, Viwit is committed to continuous improvement in innovation to provide superior health products and services. The company's vision is encapsulated in its motto, "Innovation for a Better Life."

The collaboration between Zydus Lifesciences Ltd. and Viwit Pharmaceuticals represents a significant stride in making advanced healthcare solutions more accessible in the US market. As these two companies pool their expertise and resources, the outcome is expected to benefit a large number of patients through enhanced MRI diagnostic imaging options.