Zhejiang Jianfeng Group (600668.SH) announced that its wholly-owned subsidiary Zhejiang Jianfeng Pharmaceutical Co., Ltd. (referred to as "...
According to the Zhithong Finance APP, Zhejiang Jianfeng Group (600668.SH) announced that its wholly-owned subsidiary Zhejiang Jianfeng Pharmaceutical Co., Ltd. (referred to as "Jianfeng Pharmaceutical") accepted the on-site inspection by the USA Food and Drug Administration (referred to as "USA FDA") for the production project of 2 billion solid formulations at the Jinxin production base from July 17, 2023, to July 21, 2023. This inspection is the pre-approval on-site inspection (referred to as "PAI") by the USA FDA for the addition of Jianfeng Pharmaceutical as a new production site for the LevETIRacetam extended-release tablets produced on behalf of Jianfeng Pharmaceutical. Recently, Jianfeng Pharmaceutical received the establishment inspection report (EIR) issued by the USA FDA, indicating that the PAI inspection by the USA FDA for Jianfeng Pharmaceutical has concluded, and Jianfeng Pharmaceutical has passed the on-site inspection, qualifying for the production of this product.
The successful passing of the USA FDA on-site inspection indicates that the PAI inspection by the USA FDA for Jianfeng Pharmaceutical has concluded, and Jianfeng Pharmaceutical has passed the on-site inspection, which positively contributes to enhancing the company's overall competitiveness and future development.
