Zhi Tong Cai Jing·2025-10-14 10:59Core Viewpoint - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for Doxycycline Capsules, marking a significant milestone for the company in the U.S. market [1] Group 1: Company Announcement - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has been notified by the U.S. FDA regarding the approval of its ANDA for Doxycycline Capsules [1] - The Doxycycline Capsules (40mg) contain two types of micro-pellets: 30mg immediate-release and 10mg delayed-release, primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The original drug was developed by Galderma Laboratories LP and was launched in the U.S. in 2006 [1] Group 2: Financial Investment - As of the date of the announcement, the company has invested approximately RMB 10.83 million in the research and development of this drug [1] - The ANDA application for the drug was submitted to the U.S. FDA in September 2024 and has recently been approved for marketing [1]