Ge Long Hui·2025-10-14 10:54Core Viewpoint - Shanghai Pharmaceuticals has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, which is significant for expanding its overseas market presence and gaining valuable experience [1] Group 1: Product Information - Doxycycline Capsules (40mg) contain two types of microcapsules: 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 and was launched in the U.S. in 2006 [1] Group 2: Regulatory Approval - The ANDA application for Doxycycline was submitted to the U.S. FDA in September 2024 and has recently been approved for market entry [1] - The company has invested approximately RMB 10.83 million in research and development for this drug as of the announcement date [1] Group 3: Strategic Implications - The approval of Doxycycline Capsules is expected to positively impact the company's efforts to expand into international markets [1] - This achievement is seen as a way to accumulate valuable experience for future endeavors in the pharmaceutical industry [1]