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天坛生物:云南项目已完成主要品种的注册现场核查和GMP符合性现场检查,现正在进行检查缺陷整改
Mei Ri Jing Ji Xin Wen· 2025-08-15 11:44
Core Viewpoint - The approval process for seven products from Kunming Blood Products has progressed to the comprehensive review and final approval stage, raising questions about the timeline for production post-approval [1] Group 1: Company Updates - Tian Tan Bio (600161.SH) confirmed that the Yunnan project has completed the on-site verification of major product registrations and GMP compliance inspections [1] - The company is currently addressing inspection deficiencies and is proceeding with the review of the registered products according to the registration progress [1] - Tian Tan Bio plans to actively communicate with government departments to expedite the transfer of production sites for major products related to the Shanghai Yunnan project [1]
仙琚制药:噻托溴铵吸入喷雾剂药品注册申请获得受理
news flash· 2025-07-11 07:47
Group 1 - The company, Xianju Pharmaceutical (002332.SZ), has received a drug registration acceptance notice from the National Medical Products Administration for the production of Tiotropium Bromide Inhalation Spray [1] - The specifications of the Tiotropium Bromide Inhalation Spray include a delivery dose of 2.5μg per spray and a liquid concentration of 0.2262mg/ml [1] - The drug registration process has entered the review stage, and successful approval will enhance the company's product line and market competitiveness [1] Group 2 - The drug registration approval process has an uncertain timeline, which may affect investment decisions [1]