依维莫司原料药
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海正药业:子公司依维莫司原料药获欧洲药典适用性认证证书
Zheng Quan Shi Bao Wang· 2025-12-12 09:17
Core Viewpoint - Haizheng Pharmaceutical (600267) announced that its wholly-owned subsidiary, Haizheng Hangzhou, received the Certificate of Suitability (CEP) for the active pharmaceutical ingredient Everolimus from the European Directorate for the Quality of Medicines (EDQM) [1] Group 1 - The receipt of the CEP certificate indicates that the Everolimus active pharmaceutical ingredient meets the quality standards set by the European regulatory authority [1] - This certification may enhance the company's marketability and competitiveness in the European pharmaceutical market [1] - The approval is expected to facilitate the company's expansion and strengthen its position in the global pharmaceutical industry [1]
海正药业(600267.SH):子公司依维莫司原料药获得CEP证书
Ge Long Hui A P P· 2025-12-12 09:02
Core Viewpoint - Haizheng Pharmaceutical (600267.SH) has received the Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for the active pharmaceutical ingredient Everolimus, indicating compliance with European Pharmacopoeia standards [1]. Group 1 - Haizheng Pharmaceutical's subsidiary, Haizheng Pharmaceutical Hangzhou Co., Ltd., is the entity that received the CEP certificate [1]. - The CEP certification is crucial for the marketing and distribution of Everolimus in Europe, enhancing the company's competitive position in the pharmaceutical market [1]. Group 2 - Everolimus is primarily indicated for adult patients with advanced renal cell carcinoma who have failed prior treatment with Sunitinib or Sorafenib [2]. - The drug is also applicable for adults with unresectable, locally advanced, or metastatic well-differentiated neuroendocrine tumors of the pancreas, gastrointestinal tract, or lung [2]. - Additionally, Everolimus is used in the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) in both adults and children, as well as for the prevention of organ transplant rejection [2].
海正药业子公司依维莫司原料药获得CEP证书
Zhi Tong Cai Jing· 2025-12-12 08:56
Core Viewpoint - Haizheng Pharmaceutical's subsidiary, Haizheng Hangzhou Company, has received the Certificate of Suitability to Monograph of European Pharmacopoeia (CEP) for its active pharmaceutical ingredient, Everolimus, indicating recognition of its quality in the European market and enhancing its qualifications for international market expansion [1] Group 1 - Haizheng Hangzhou Company has been awarded the CEP certificate by the European Directorate for the Quality of Medicines & HealthCare (EDQM) [1] - The CEP certification signifies that the quality of Everolimus meets European standards, allowing the product to enter the EU and other markets that recognize the CEP certificate [1] - This certification is expected to have a positive impact on the company's efforts to expand its international market presence [1]