智通财经网·2025-10-14 10:56Core Viewpoint - Shanghai Pharmaceuticals has received approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Doxycycline Capsules, indicating a significant milestone for the company in the U.S. market [1] Group 1: Company Announcement - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has successfully obtained FDA approval for Doxycycline Capsules [1] - The drug is 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 - The company has invested approximately RMB 10.83 million in research and development for this drug as of the announcement date [1] - The Doxycycline Capsules consist of two types of microcapsules: 30mg immediate-release and 10mg delayed-release [1] Group 3: Regulatory Milestone - The ANDA application for Doxycycline was submitted to the FDA in September 2024 and has now been approved [1]