Recently, Shangyao Kangli (Changzhou) Pharmaceutical Co., Ltd. (hereinafter referred to as "Shangyao Kangli"), a wholly-owned subsidiary of Shanghai Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Shanghai Pharmaceutical" or the "Company"), has received the Notice of Approval for Marketing Application of Chemical Active Pharmaceutical Ingredients (Notice No.: 2023YS00253) for Valganciclovir Hydrochloride API (hereinafter referred to as the "Product") issued by the National Medical Products Administration (hereinafter referred to as the "NMPA"). The Product has been approved for production.
1. Basic Information of the Product
Name: Valganciclovir Hydrochloride
Registration Standard No.: YBY63132023
Packaging Specifications: 1KG/drum, 5KG/drum, 10KG/drum, 20KG/drum, 25KG/drum
Application Type: Marketing application for domestically manufactured chemical active pharmaceutical ingredients
Approval Conclusion: In accordance with the Pharmaceutical Administration Law of the People's Republic of China and relevant provisions, upon review, the Product meets the relevant requirements for drug registration, and the registration application for the Product is approved.
2. Relevant Information of the Product
Valganciclovir Hydrochloride is mainly indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) and the prophylaxis of CMV infection in patients at high risk following solid organ transplantation.It was developed by Hoffmann-La Roche Limited of Switzerland and first launched in the United States in 2001.
