Core Viewpoint - The company has successfully obtained GMP certification from Brazil's National Health Surveillance Agency (ANVISA) for four chemical raw materials, indicating compliance with international quality standards [1] Group 1: Certification Details - The GMP certification was conducted from March 17 to March 21, 2025, covering the following products: Candesartan Cilexetil, Sacubitril/Valsartan, Telmisartan, and Valsartan [1] - The certification is valid until May 26, 2027, and June 9, 2027, respectively, for the two certificates issued by ANVISA [1] - The on-site inspection by ANVISA concluded that the company’s facilities met the required standards, resulting in a qualified status for the four raw material products [1]

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].