Core Viewpoint - The article highlights the cancellation of the procurement qualification of Ningbo Dayang Pharmaceutical Co., Ltd. for its fluorouracil injection due to violations of quality standards, emphasizing the increasing scrutiny on drug quality in the national centralized procurement process [2][4]. Group 1: Company Overview - Ningbo Dayang 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 [3]. - Fluorouracil is a widely used first-generation antimetabolite chemotherapy drug, applicable in treating various cancers, including gastrointestinal, gynecological, head and neck, lung, liver, and bladder cancers [3]. Group 2: Procurement and Regulatory Actions - The National Organization for Drug Procurement Office announced the cancellation of Dayang Pharmaceutical's qualification for fluorouracil injection, which was part of the tenth batch of national centralized procurement, due to the production of substandard drugs [2][4]. - Dayang Pharmaceutical's bid price for fluorouracil injection was 2.97 yuan per 10ml (0.25g), which was relatively high compared to other bidders, as there were seven companies that won the bid [3]. - Since the implementation of the tenth batch of national drug procurement, there has been a trend of increased regulatory scrutiny on the production quality of selected drugs, with four companies, including Dayang Pharmaceutical, being disqualified due to quality issues [4][5]. Group 3: Industry Implications - The article indicates that three out of the four disqualified companies are classified as pure B-license enterprises, which lack production capabilities and rely on contract manufacturing [5]. - The regulatory challenges posed by the increasing participation of pure B-license enterprises in the bidding process highlight the need for stricter quality oversight in the pharmaceutical industry [5].
因生产劣药,这家药企被踢出集采
Di Yi Cai Jing·2025-10-15 09:02