Core Viewpoint - The cancellation of Dahuoying Pharmaceutical's qualification for the procurement of fluorouracil injection highlights the strict enforcement of quality standards in China's centralized drug procurement system, with increasing scrutiny on the production quality of selected enterprises [1][3]. Group 1: Company Overview - Dahuoying Pharmaceutical, founded in 1956, is a comprehensive pharmaceutical company involved in manufacturing, research, and sales, and is currently controlled by Haier Shijie Biomedical Co., Ltd. since 2013 [2]. - The fluorouracil injection, produced by Dahuoying Pharmaceutical, is a widely used first-generation antimetabolite chemotherapy drug, applicable in treating various cancers including gastrointestinal, gynecological, and lung cancers [2]. Group 2: Procurement and Regulatory Actions - Dahuoying Pharmaceutical was not the lowest bidder in the tenth batch of national drug procurement, with a bid price of 2.97 yuan per 10ml (0.25g) injection, indicating a relatively high price among the seven selected enterprises [2]. - Since the implementation of the tenth batch of national drug procurement, there has been a trend of increased quality supervision on selected products by the National Drug Procurement Office [3]. - As of now, four companies have been removed from the tenth batch of drug procurement due to production quality issues, with Dahuoying Pharmaceutical being the latest addition [4]. Group 3: Industry Challenges - Among the four companies removed from the procurement list, three are classified as pure B-license enterprises, which lack production capabilities and rely on contract manufacturing [5]. - The increasing participation of pure B-license enterprises in bidding raises concerns about the need for stricter quality control measures from regulatory authorities [5].
因生产劣药,这家药企被踢出集采,第十批集采被取消的企业已达4家
Di Yi Cai Jing·2025-10-15 07:56