润都股份（002923）公告，公司于2025年3月17日至2025年3月21日接受了巴西国家卫生监督局的现场 GMP认证，认证范围为化学原料药：坎地沙坦酯、沙库巴曲缬沙坦钠、替米沙坦、缬沙坦。近日，公 司收到巴西ANVISA签发的两张GMP认证证书，认证有效期至2027年5月26日和2027年6月9日。巴西 ANVISA现场检查结论为合格，即公司上述四个原料药产品均通过了巴西ANVISA现场GMP认证。 ...

Core Viewpoint - The company successfully passed the FDA's cGMP inspection, which is a significant achievement that enhances its competitiveness and supports its expansion into the U.S. raw material drug market [1][2]. Group 1: FDA Inspection Details - The company underwent an FDA cGMP inspection from February 12 to February 17, 2025, focusing on the production of nine active pharmaceutical ingredients [1]. - The inspection covered various systems including quality, production, equipment, laboratory control, and material management [1]. - The company received the Establishment Inspection Report (EIR) confirming the successful completion of the inspection [1]. Group 2: Implications for the Company - Passing the FDA inspection establishes a solid foundation for the company's further expansion into the U.S. raw material drug market [2]. - This achievement is expected to inject momentum into the company's ongoing international market expansion efforts [2]. - The successful inspection is anticipated to enhance the company's overall competitiveness and promote future development [2].

2 / 3 | | 未来几年收入增速会加快吗？ | | --- | --- | | | 答：预计 2025 年销售收入增长 10%左右，由于新产能投放， | | | 预计 2026-2027 年销售收入增速会加快。 | | | 10、问：与印度公司的竞争情况? | | | 答：大多数品种都有来自印度的竞争。成本控制上双方各 | | | 有优势，有些品种成本印度低，有些品种同和更低；公司 | | | 在合成工艺成熟度、研发速度、原料成本方面强于印度公 | | | 司，但国内安全环保要求高，安全、环保费及设备折旧费 | | | 用高于印度公司。总体来看净利率相差不大。 | | | 11、问：预计今后销售量级较大的新品种有哪些？ | | | 答：利伐沙班、阿派沙班、恩格列净、卡格列净、维格列 | | | 汀、非布司他、阿齐沙坦这几个品种未来都会有不错的销 | | | 售表现。 | | 附件清单（如有） | 无 | 3 / 3 江西同和药业股份有限公司投资者关系活动记录表 | 证券简称:同和药业 | 证券代码:300636 编号:2025004 | | --- | --- | | 投资者关系活动类型 | 特定对象调 ...