智通财经网·2025-09-15 11:36Core Viewpoint - 康龙化成's subsidiary, 康龙化成(绍兴)药业有限公司, successfully passed the FDA's pre-approval inspection, confirming its compliance with cGMP standards, which enhances its capability to supply commercialized innovative drug APIs globally [1][2]. Group 1 - 康龙化成(绍兴) underwent an FDA cGMP pre-approval inspection from May 29 to June 4, 2025, covering various quality and production systems [1]. - The establishment inspection report confirmed that 康龙化成(绍兴) met the cGMP quality standards set by the FDA, marking the first successful pre-approval inspection for its API production base [2]. - This achievement indicates that 康龙化成's quality systems are aligned with international standards, enabling it to supply commercialized innovative drug APIs to the US and global markets [2]. Group 2 - 康龙化成 aims to be a trusted and responsible high-quality partner in the global pharmaceutical market, contributing meaningfully to clients' success [3]. - The successful FDA inspection reflects the company's commitment to adhering to the highest international quality standards and validates the effective operation of its quality management system [3]. - This milestone is expected to have a positive and far-reaching impact on 康龙化成's continued expansion in the global innovative drug CDMO sector [3].