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].