Zydus Partners with Viwit for $237M US Market Entry with MRI Contrast Agents

16 Sep 2024 , 03:58 PM

Zydus Lifesciences’ subsidiary, Zydus Lifesciences Global FZE, signed an exclusive licensing and supply agreement with Viwit Pharmaceuticals for two gadolinium-based MRI contrast agents targeting the US market.

The agreement includes the supply of gadobutrol injection, a generic version of Gadavist, and gadoterate meglumine injection, a generic version of Dotarem, which enhance visibility in MRI scans.

Viwit Pharmaceuticals will handle the ANDA submission, manufacturing, and supply of the generic versions of Gadavist™ and Dotarem upon receiving regulatory approval.

Zydus will take charge of marketing, distributing, and selling these MRI contrast agents in the US market, marking its entry into the contrast agent product category.

According to IQVIA MAT July 2024 data, the market for gadobutrol injection in the US is valued at $120 million, while gadoterate meglumine injection is estimated at $117 million.

On September 12, it was reported that the US FDA issued a warning to Zydus Lifesciences’ drug manufacturing facility in Jarod, Gujarat, following an April 2024 inspection.

The warning letter cited issues with cross-contamination, particulate contamination, and poor aseptic procedures, indicating inadequate current good manufacturing practices (CGMP) at the facility.