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四川双马:关于控股子公司湖北健翔获得俄罗斯GMP证书的公告
Zheng Quan Ri Bao· 2025-09-22 14:04
证券日报网讯 9月22日晚间,四川双马发布公告称,公司控股子公司湖北健翔生物制药有限公司(简 称"湖北健翔")于2025年7月30日至2025年8月1日接受了俄罗斯联邦工业和贸易部下属国家药品检查机 构的现场检查。近日,公司收到俄罗斯联邦工业和贸易部签发的《欧亚经济联盟药品良好生产规范符合 性证书》(简称"GMP证书"),确认湖北健翔顺利通过该次检查。 (文章来源:证券日报) ...
海正药业:替加环素原料药获CEP证书
Xin Lang Cai Jing· 2025-09-12 09:09
Core Viewpoint - The company has received the CEP certificate for tigecycline active pharmaceutical ingredient from the European Directorate for the Quality of Medicines and HealthCare (EDQM), marking a significant achievement as the first domestic enterprise to obtain this certification [1] Group 1 - The global sales volume of tigecycline active pharmaceutical ingredient is approximately 290.22 kilograms for the period from January to June 2025 [1]
中国医药:子公司原料药获得CEP证书
Group 1 - The core point of the article is that China Medical announced the approval of a CEP certificate for Clindamycin Phosphate by its subsidiary Tianfang Pharmaceutical from the European Directorate for the Quality of Medicines (EDQM) [1] Group 2 - The approval of the CEP certificate indicates that the product meets the European Pharmacopoeia standards, which may enhance the company's marketability in Europe [1] - This development could potentially open new avenues for revenue growth for the company in the European pharmaceutical market [1] - The issuance of the CEP certificate reflects the company's commitment to quality and compliance with international standards [1]
宣泰医药:全资子公司江苏宣泰药业有限公司通过欧盟GMP认证
news flash· 2025-07-17 07:34
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]
润都股份:通过巴西国家卫生监督局GMP认证
news flash· 2025-06-27 10:54
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]
天宇股份:原料药厄贝沙坦获CEP证书
news flash· 2025-06-13 11:36
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]