Innopharmax, in collaboration with Luann Pharmacy, has achieved another milestone in China. Following the approval of the generic drug Sapropterin Dihydrochloride last year, it announced on the 16th that its imaging agent product, Gadopentetate Dimeglumine Injection, has received generic drug approval from the China National Medical Products Administration (NMPA).

General Manager Hao Weihua stated that Innopharmax is responsible for supplying the active pharmaceutical ingredient (API) to its exclusive Chinese agent, while Luann Pharmacy is in charge of drug sales. The two parties will soon discuss the drug's market launch and API supply plans. Hao also revealed that they expect to receive two more drug approvals for their imaging agent in the second half of the year.

On the 16th, Innopharmax announced the technology transfer of the Gadopentetate Dimeglumine Injection to Luann Pharmacy and authorized its commercialization in China. The product received official approval from the NMPA on July 16, 2024, with approval numbers H20244422, H20244423, and H20244424.

Hao Weihua explained that the commercialization, production, and sales of Gadopentetate Dimeglumine Injection in China will be handled by Luann Pharmacy. Innopharmax, as the exclusive Chinese agent for the API, received NMPA approval for its API on July 5 and will exclusively supply Luann Pharmacy with the necessary API for commercial production.

Gadopentetate Dimeglumine Injection is an imaging agent used to enhance MRI signals for examinations of the nervous system, myocardium, liver, breast, bones, kidneys, and other organs and tissues.

Resource (mandarin): 因華攻陸告捷，授權夥伴顯影劑產品獲藥證，下半年可望再拿兩張藥證