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盐酸米诺环素原料药
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海正药业(600267.SH)子公司通过药品GMP符合性检查
智通财经网· 2025-12-03 09:44
Core Viewpoint - Haizheng Pharmaceutical (600267.SH) announced that its wholly-owned subsidiary, Haizheng Nantong Company, received a notice from the Jiangsu Provincial Drug Administration regarding the compliance inspection of drug GMP [1] Group 1: GMP Compliance Inspection - The GMP compliance inspection pertains to the active pharmaceutical ingredient Minocycline Hydrochloride, marking the first GMP compliance check prior to its market launch [1] - This inspection is the first for the newly established production line, which has now successfully passed the GMP compliance check [1] Group 2: Financial Investment - The total fixed asset investment in the relevant workshop has reached approximately 99.16 million yuan, with about 86.30 million yuan already completed (unaudited) [1]
海正药业: 浙江海正药业股份有限公司关于全资子公司盐酸米诺环素原料药获得《化学原料药上市申请批准通知书》的公告
Zheng Quan Zhi Xing· 2025-08-25 17:05
Core Viewpoint - Zhejiang Hai Zheng Pharmaceutical Co., Ltd. has received approval for the production of Minocycline Hydrochloride API, which is expected to enhance the company's product line and market competitiveness [1][3]. Group 1: Drug Approval Details - The Minocycline Hydrochloride API has been granted a registration number Y20240000032 and a notification number 2025YS00742 by the National Medical Products Administration [1]. - The product is packaged in 5kg bags and is approved for domestic production [1]. Group 2: Indications and Market Data - Minocycline Hydrochloride is indicated for various infections caused by sensitive pathogens, including but not limited to urinary tract infections, superficial pyogenic infections, and bacterial pneumonia [2][3]. - Global sales of Minocycline Hydrochloride API are projected to be approximately 35,648.65 kg in 2024, with domestic sales around 7,914.50 kg [3]. Group 3: Company Investment and Development - The company has invested approximately 19.21 million RMB in the research and development of this drug [3]. - The approval signifies that the product meets national technical standards for drug approval, allowing for production and sales [3].
海正药业:全资子公司盐酸米诺环素原料药获批准通知书
Xin Lang Cai Jing· 2025-08-25 11:33
Core Viewpoint - Haizheng Pharmaceutical's subsidiary has received approval for the marketing of Minocycline Hydrochloride raw material from the National Medical Products Administration, indicating a significant advancement in the company's product portfolio and potential revenue growth [1] Group 1: Regulatory Approval - Haizheng Pharmaceutical's wholly-owned subsidiary, Haizheng Pharmaceutical Nantong Co., Ltd., has been granted the marketing approval for Minocycline Hydrochloride raw material by the National Medical Products Administration [1] Group 2: Sales Projections - The global sales volume for Minocycline Hydrochloride is projected to be approximately 35,648.65 kilograms in 2024, with domestic sales expected to reach around 7,914.5 kilograms [1] - For the first quarter of 2025, the global sales volume is estimated at about 8,572.46 kilograms, while domestic sales are anticipated to be approximately 2,092.66 kilograms [1] Group 3: Investment in Development - The company has invested approximately 19.21 million RMB in the development project for this pharmaceutical product [1]