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: 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