Pril Pharma: Second contrast agent FDA Approval after iodoparol injection!

Hainan Puli Pharmaceutical Co., LTD. (" Puli Pharma "or the" Company ") announced in a recent announcement that it has received marketing authorization for its gadobul injection from the United States Food and Drug Administration (" FDA ").

Basic information of drugs

Drug name: gadobul injection

Indication: For diagnostic purposes, intravenous administration only. Suitable for adults and children of all ages (including full-term newborns). It is used for the examination of contrastive enhanced magnetic resonance imaging (CE-MRI) and contrastive enhanced magnetic resonance angiography (CE-MRA) of all parts of the body (including brain and spinal cord).

Dosage form: injection

Specifications: 7.5mL:4.5354g, 15mL:9.0708g

ANDA number: 217480

Manufacturer: Hainan Puli Pharmaceutical Co., LTD

Drug introduction

Gadobul injection is a gadolinium-based magnetic resonance imaging (MRI) based non-ionic contrast agent (GBCA) developed by Bayer, Germany for contrast enhanced MRI scans of the brain and spinal cord. Gadobril inj was first approved for marketing in Switzerland in 1998. To date, gadobril inJ has been approved for marketing in more than 100 countries, including the United States, the European Union, China, Canada, Mexico, Australia, New Zealand, South Korea, Russia and Brazil.

Sino-us double production

After the company successfully developed the generic version of gadobril injection, it submitted the generic registration application in the United States and China respectively, belonging to the common line product. The company recently received marketing approval from the United States Food and Drug Administration for its gadobuliol injection, marking the company's eligibility to market gadobuliol injection in the United States. The approval of this product has expanded the sales market of our company's contrast media products, and laid a solid foundation for Puli Pharmaceutical to enter the field of contrast media, which will have a positive impact on the company's future development.