转自：福建省药品监督管理局网站 2026年2月14日 福建省药品监督管理局GMP符合性检查结果公告（2026年第6号） 根据《药品管理法》、《药品生产监督管理办法》有关规定，经现场检查并综合评定，现将厦门伯马药业有限公司《药品生产质量管理规范》 符合性检查结果公告。 | 企业名称 | 检查地址 | 检查范围 | 检查时间 | 检 类 查 | | --- | --- | --- | --- | --- | | | | | | 型 结 | | | | | | 果 | | | 1. 持有人检查地址：厦门市 | 1.检查范围：盐酸莫西沙星氯化钠注射液（250ml：盐酸莫 | 1.持有人检查时 | 符 | | | 海沧区海沧大道567号厦门中 | 西沙星（按C21H24FN3O4计）0.4g与氯化钠2.0g，批准文 | 间：2025年12月25 | | | 厦门伯马药业有限公司 | 心E座913单元 | 号：国药准字H20243011） | 日-12月26日 | 依 | | （受托方：广东大翔制 | | | | 申 | | 药有限公司） | 2.延伸检查地址：广州市增 | 2.生产类型：委托生产 | 2.延伸检查时间： ...

Core Points - The Heilongjiang Provincial Drug Administration announced that 14 companies, including Heilongjiang Fuhua Pharmaceutical Group Co., Ltd., passed the GMP compliance inspection as per the requirements of the Drug Administration Law and the revised Drug Production Supervision and Administration Measures [2][3] Group 1: Compliance Inspection Results - Heilongjiang Fuhua Pharmaceutical Group Co., Ltd. was inspected on February 17, 2025, for its small-volume injection production line [2] - Heilongjiang Ruige Pharmaceutical Co., Ltd. was inspected on February 7, 2025, for its solid dosage form production line [2] - Harbin Tiandi Pharmaceutical Co., Ltd. was inspected on January 8, 2025, for its solid dosage and traditional Chinese medicine extraction production lines [2] - Lantai Pharmaceutical Co., Ltd. was inspected from January 17 to 22, 2025, for its solid dosage production area [2] - Heilongjiang Hasan Pharmaceutical Co., Ltd. was inspected on February 17, 2025, for its raw material drug production line [2] Group 2: Additional Inspections - Heilongjiang Yuheng Pharmaceutical Co., Ltd. was inspected from March 4 to 6, 2025, for its oral dosage and capsule production lines [2] - Heilongjiang Bujia Tang Pharmaceutical Co., Ltd. was inspected from February 6 to 9, 2025, for its solid dosage production line [2] - Heilongjiang Songhua River Pharmaceutical Technology Co., Ltd. was inspected from February 13 to 16, 2025, for its freeze-dried powder injection and extraction production lines [3] - Heilongjiang Tianlong Pharmaceutical Co., Ltd. was inspected from September 26 to 29, 2024, for its eye drop production line [3] - Heilongjiang Jinjiao Pharmaceutical Co., Ltd. was inspected on February 13, 2025, for its small-volume injection production line [3]

Core Viewpoint - The company reported a decline in revenue and profit for the fiscal year ending December 31, 2024, with a focus on improving market accessibility and product approvals despite challenging market conditions [1][2]. Group 1: Financial Performance - The company's revenue for the year was HKD 57.73 billion, a decrease of 10.67% year-on-year [1]. - Shareholders' profit was HKD 10.61 billion, down 19.53% compared to the previous year [1]. - Basic earnings per share were HKD 0.3582, with a proposed final dividend of HKD 0.095 per share [1]. Group 2: Product Approvals and Market Access - The company successfully completed the market access for 44 generic names and 56 specifications, with significant approvals in various provinces [2]. - The company participated in over a thousand bidding activities, achieving notable success in national and regional procurement initiatives [2]. - The company has 162 products listed in the national medical insurance directory, with new products successfully entering the 2024 updated directory [2]. Group 3: Business Segments Performance - The infusion and ampoule water products maintained stable performance, with total sales volume reaching 2.036 billion bottles (bags), a year-on-year increase of 6.7% [3]. - Sales revenue for infusion products was HKD 37.35 billion, a decrease of 7.6% due to market demand and pricing pressures [3]. - The oral formulation segment saw significant growth, with sales revenue reaching approximately HKD 5.02 billion, up about 4.9% year-on-year [4]. Group 4: Raw Material Drug Segment - The raw material drug segment experienced a sales revenue decline of 11.7%, totaling approximately HKD 7.85 billion [4]. - Caffeine sales volume increased by about 44% to 5,478 tons, while sales of metronidazole decreased by 43% [4]. - The company anticipates a stabilization and recovery in the raw material drug business in the coming year [4].