Securities code: 600227 securities abbreviation: shengjitang No.: 2022-005 Guizhou Salvage Pharmaceutical Co.Ltd(600227)
About the wholly-owned subsidiary Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical product glimepiride tablets
Supplementary announcement on suspension of production and sales
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
The company was posted on the website of Shanghai Stock Exchange (www.sse. Com. CN.) on January 29, 2022 Disclosed the announcement of Guizhou Salvage Pharmaceutical Co.Ltd(600227) on the suspension of production and sales of glimepiride tablets, a pharmaceutical product of Guizhou Salvage Pharmaceutical Co.Ltd(600227) wholly owned subsidiary (Announcement No.: 2022-004). On January 29, 2022, the company learned from the public information of the notice on the results of drug production supervision and inspection in 2021 by Guizhou Provincial Drug Administration and the announcement on canceling the qualification of glimepiride tablets of Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd. and listing the enterprise in the list of violations. The relevant information is hereby supplemented and disclosed as follows:
1、 Report on the results of drug production supervision and inspection of Guizhou Provincial Drug Administration in 2021
Enterprise name: Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd
Inspection time: December 23 - December 25, 2021
Inspection results and measures: the enterprise has serious defects in plant maintenance, equipment cleaning and stability inspection. Through comprehensive research and judgment, it is determined that the enterprise does not meet the drug production quality management norms. The production and sales of glimepiride tablets of the enterprise shall be suspended according to law, and further investigation and handling shall be carried out. Inspection type: flight inspection (the inspection object is glimepiride tablets)
Remarks: 1 The State Food and Drug Administration and Guizhou food and Drug Administration jointly organized the inspection.
2. No unqualified products were found during the sampling inspection at the enterprise site and circulation links.
3. After the rectification of the enterprise is completed, the risk control measures can be removed only after the comprehensive GMP compliance inspection of Guizhou food and Drug Administration meets the regulations.
2、 Announcement on canceling the qualification of glimepiride tablets of Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd. and listing the enterprise in the list of violations
The member office of the State Council issued the opinions on promoting the normalization of drug procurement on February 29, 2021 (the office of the State Council organized the review of the drug procurement system, and carried out the work in accordance with the opinions on promoting the normalization of drug procurement issued by the office of the State Council on February 29, 2021), In violation of the relevant provisions of the national centralized drug procurement document (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", Suspend 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.
3、 Impact on the company and risk tips
(I) impact on the production and operation of listed companies
1. The company's glimepiride tablets are the second batch of selected drugs for centralized drug procurement organized by the state. The supply period is from April 2020 to April 2023. The winning regions are seven provinces (cities) of Shanxi, Shanghai, Jiangsu, Fujian, Guangdong, Guangxi and Hainan. After being disqualified, they cannot continue to supply to the above regions.
2. At present, the company's drugs that have passed the consistency evaluation are glimepiride tablets. There are three drugs that are undergoing the consistency evaluation, and one drug that is deemed to have passed the consistency evaluation. The company is listed in the "list of violations". After suspending the application qualification for participating in the centralized drug procurement activities organized by the state from January 29, 2022 to July 28, 2023, It will have an impact on the company's participation in national centralized procurement of drugs that pass the consistency evaluation and are deemed to pass the consistency evaluation.
(II) impact on the performance of listed companies
In 2021, the operating revenue of Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical glimepiride tablets was RMB 2006.3 million (Unaudited), accounting for 16.43% of the company's pharmaceutical business revenue and 0.93% of the company's total operating revenue. The total operating amount of the company's drug purchase was RMB 16.4781 million, accounting for 2.981% of the total operating revenue of the company in 2027. The total operating revenue of the three drugs for which the company is conducting consistency evaluation in 2021 is 8.2433 million yuan (Unaudited), accounting for 6.75% of the operating revenue of the company's pharmaceutical business and 0.38% of the company's total operating revenue. A drug deemed to have passed the consistency evaluation has obtained the drug registration approval on December 23, 2021, and no operating revenue has been generated in 2021.
The company's production and sales of glimepiride tablets were suspended and included in the "list of violations", and the state organized drug joint procurement office suspended the company's qualification to participate in the centralized drug procurement activities organized by the state from January 29, 2022 to July 28, 2023, which will have a certain impact on the company's business performance from 2022 to 2023.
(III) other risk tips
The company will attach great importance to and pay close attention to the progress of this rectification event, and the company will perform the obligation of information disclosure in time. The information disclosure media designated by the company are China Securities News, Shanghai Securities News, securities times and the website of Shanghai Stock Exchange (www.sse. Com. CN), The relevant information of the company shall be subject to the information disclosed by the company in the above designated media. Please pay attention to investment risks.
It is hereby announced
Guizhou Salvage Pharmaceutical Co.Ltd(600227) board of directors February 7, 2002
