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健康元(600380.SH):下属子公司获得PIC/S GMP认证
Ge Long Hui A P P· 2025-12-30 12:29
Core Viewpoint - Health元's subsidiary, Health元海滨药业有限公司, has successfully passed the PIC/S GMP compliance inspection by the Malaysian National Pharmaceutical Regulatory Agency (NPRA) and received the GMP certificate, which will facilitate the registration and market entry of its inhalation products in Malaysia and other PIC/S member countries [1] Group 1 - Health元海滨's inhalation suspension (hormone) and inhalation solution production lines have been certified by NPRA, indicating compliance with international GMP standards [1] - The PIC/S GMP certification is essential for drug registration and market entry, as it signifies that the production and quality management systems meet the required standards [1] - The PIC/S (Pharmaceutical Inspection Co-operation Scheme) is an authoritative body for drug inspection and certification, consisting of regulatory agencies from multiple countries [1]
健康元:下属子公司获得PIC/S GMP认证
Ge Long Hui· 2025-12-30 12:12
Core Viewpoint - Health元's subsidiary, Health元海滨, has successfully passed the PIC/S GMP compliance inspection by the Malaysian National Pharmaceutical Regulatory Agency (NPRA) and received the GMP certificate, which will facilitate the registration and market entry of its inhalation products in Malaysia and other PIC/S member countries [1] Group 1 - Health元海滨's inhalation suspension (hormone) and inhalation solution production lines have been certified by NPRA, indicating compliance with international GMP standards [1] - The PIC/S GMP certification is essential for drug registration and market entry, as it signifies that the production and quality management systems meet the required standards [1] - The PIC/S (Pharmaceutical Inspection Co-operation Scheme) is an authoritative body for drug inspection and certification, consisting of regulatory agencies from multiple countries [1]
健康元:子公司通过马来西亚药监局GMP认证
Core Viewpoint - Health元's subsidiary, Health元 Haibin Pharmaceutical Co., Ltd., has successfully passed the compliance inspection by the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for its inhalation suspension (hormone) and inhalation solution production line, receiving the GMP certificate on November 20, 2025 [1] Group 1 - The certification indicates that Health元 Haibin's production and quality management systems meet the PIC/SGMP standards [1] - This achievement will facilitate the registration and market launch of the company's inhalation formulation products in Malaysia and other PIC/S member countries [1] - The certification is expected to have a positive impact on the overseas market expansion of the subsidiary's related products [1]