Zhongxin Jingwei, January 29 (Xinhua) on the 29th, the state organized joint drug procurement office announced on Shanghai Sunshine pharmaceutical procurement network that Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd. was disqualified from the selection of glimepiride tablets and included the enterprise in the list of violations.
According to the announcement, the results of the second batch of national drug centralized procurement have been launched and implemented in all regions in April 2020. Recently, during the flight inspection, the drug regulatory department found that the glimepiride tablets produced by Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd., the second batch of products centrally purchased by the state, did not meet the drug production quality management specifications. On January 28, 2022, Guizhou Provincial Drug Administration released public information, suspended the production and sales of glimepiride tablets according to law, and further investigated and handled them.
In accordance with the spirit of the opinions of the general office of the State Council on promoting the normalization and institutionalization of centralized drug procurement (GBF [2021] No. 2), after the collective deliberation of relevant members of the state organized joint drug procurement office, the enterprise violated the commitments made in the application materials and the relevant provisions of the national document on centralized drug procurement (gy-yd2019-2), The joint procurement office decided to cancel the qualification of glimepiride tablets of Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd., and included Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd. in the "list of violations", and suspended the application qualification of the enterprise to participate in the centralized drug procurement activities organized by the state from January 29, 2022 to July 28, 2023.
The joint procurement office will start the replacement procedure of glimepiride tablets according to the relevant provisions of the national centralized drug procurement document (gy-yd2019-2), and other qualified winning enterprises will supply the original supply provinces of Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd. to ensure the drug supply in relevant regions. The specific results will be announced separately.
Public information shows that Glimepiride Tablets is suitable for controlling diet, exercise therapy and reducing weight loss of type 2 diabetes.
Guizhou Salvage Pharmaceutical Co.Ltd(600227) official website shows that Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd. is China's well-known diabetes medicine professional production enterprise, now has more than ten GMP production lines, a number of national two categories of new drugs and national invention patents.
Zhongxin Jingwei noted that on the 28th of Guizhou Salvage Pharmaceutical Co.Ltd(600227) , it was announced that Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd. (hereinafter referred to as Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical), a wholly-owned subsidiary of the company, received the notice of suspension of production and sales (hereinafter referred to as the notice) from Guizhou Provincial Drug Administration on the 27th. The inspection center of the State Food and drug administration was conducting a flight inspection on Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical from December 23 to 25, 2021, It was found that there were 2 serious defects, 2 major defects and 8 general defects. The production quality management of Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical glimepiride tablets did not meet the requirements of the code for quality management of drug production. According to Article 59 of the measures for the supervision and administration of drug production and Article 62 of the measures for the administration of drug inspection (for Trial Implementation), notify Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical to suspend the production and sales of glimex} tablets immediately after receiving the notice.
According to the announcement, Guizhou provincial drug administration requires Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical to seriously rectify the existing problems, carry out risk assessment and judgment, and submit the rectification report and risk assessment report to the drug and cosmetics production supervision department of Guizhou Provincial Bureau before February 20, 2022.
After receiving the notice, Guizhou Salvage Pharmaceutical Co.Ltd(600227) immediately suspended the production and sales of glimepiride tablets as required, established a special working group to take charge of the rectification work, comprehensively reviewed the Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical quality management system according to the drug production quality management specification, took measures, formulated a practical rectification plan, and immediately started the rectification work of relevant production lines, Strive to resume normal production and sales as soon as possible.
Guizhou Salvage Pharmaceutical Co.Ltd(600227) said that through this rectification, Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical will fully learn lessons, carefully analyze relevant problems and deficiencies, further improve the product quality management system, ensure product quality and strictly prevent the recurrence of such events.
Guizhou Salvage Pharmaceutical Co.Ltd(600227) the annual performance forecast for 2021 shows that the net profit attributable to the shareholders of the listed company in 2021 is expected to be a loss compared with the same period of the previous year. The net profit loss attributable to the shareholders of the listed company is 45 million yuan to 65 million yuan, and the net profit loss attributable to the shareholders of the listed company after deducting non recurring profits and losses is 50 million yuan to 70 million yuan.
