Hengdi Pharmaceutical (301211.SZ): Baikai Pharmaceutical passes on-site inspection by the US FDA.

date
17/05/2025
Zh tng cijng APP xn, hng d yo y (301211.SZ) gnggo, gngs qunz zgngs whn bik yow kif yuxin gngs (jinchng "bik yow") y 2025 nin 3 yu 10 r-14 r jishule liz migu shw fnggun jioy gunl jugun (jinchng "FDA") de cGMP (xinxng yow shngchn zhling gunlio gufn) rch jingun de xinch jinch. Jnr bik yow shudo FDA chj de xinch jinch bogo (EIR), nzho migu 21CFR fgu (migu linfng fgu d 21 zhng) de gudng, FDA qurn bnc jinch y jish, bik yow tnggu bnc xinch jinch. According to the latest news from the Zhitong Finance APP, Hengdi Pharmaceutical (301211.SZ) announced that its wholly-owned subsidiary, Wuhan Baike Pharmaceutical Development Co., Ltd. (referred to as "Baike Pharmaceutical"), underwent an on-site inspection for cGMP (Current Good Manufacturing Practice) by the Food and Drug Administration (FDA) of the United States from March 10th to 14th, 2025. Recently, Baike Pharmaceutical received the on-site inspection report (EIR) issued by the FDA. In accordance with the regulations of the United States 21CFR law (Title 21 of the United States Federal Regulations), the FDA confirmed that the inspection has ended, and Baike Pharmaceutical passed this on-site inspection.