Core Viewpoint - Xuantai Pharmaceutical's wholly-owned subsidiary, Jiangsu Xuantai Pharmaceutical Co., Ltd., has received the EU GMP certification, enhancing its international quality standards and market competitiveness [1] Group 1: Certification Achievements - The company has obtained the GMP certificate from the Hungarian National Public Health and Pharmacy Center for its solid tablet production line [1] - This certification follows previous GMP certifications from NMPA, FDA, PMDA, and SFDA, indicating a consistent alignment with international standards [1] Group 2: Market Implications - The EU GMP certification is expected to facilitate the company's expansion into overseas markets and improve its market competitiveness [1] - However, the production and sales of pharmaceuticals may be influenced by various factors such as market environment and channel expansion, leading to uncertainties in short-term operational performance [1]

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 - Tianyu Co., Ltd. has received the European Pharmacopoeia Certificate of Suitability (CEP) for its raw material drug Eprosartan, which is used for treating primary hypertension and diabetic nephropathy associated with hypertension [1] Group 1 - The company submitted its drug registration application in December 2024 and obtained the CEP certificate, numbered CEP2025-025-Rev00, which is valid for five years starting from May 15, 2025 [1] - Eprosartan is classified as an antihypertensive medication, indicating its significance in the treatment of high blood pressure [1] - The company now holds two CEP certificates for Eprosartan raw materials, which is expected to positively impact its efforts to expand into international markets [1]