China Fund News reporter Lu Ling
Last year, Shanghai Pharmaceutical, which was investigated by many executives, had another accident.
According to the recent disclosure of Zhejiang Provincial Food and Drug Administration and Shanghai Municipal Food and Drug Administration, Xinyi Jinzhu, a wholly-owned subsidiary of Shanghai Pharmaceutical The ribavirin injection produced with the batch number of 2110704 was found to have visible foreign matter items that did not comply with the provisions of the Chinese Pharmacopoeia, Part II, 2020 Edition.
Because of the above production of substandard drugs, Xinyi Jinzhu was fined 1.4 million yuan by Shanghai Food and Drug Administration 。
On May 21, Xinyi Jinzhu actively recalled 20 batches of ribavirin injection nationwide.
On the morning of May 24, Shanghai Pharmaceutical closed at 18.28 yuan, up 2.01%, with a market value of 67.7 billion yuan.
The production of substandard drugs was found by the regulatory authorities
On May 22, Zhejiang Drug Administration issued the Notice on Drug Quality Spot Check and Inspection in Zhejiang Province (the first issue in 2024), which showed that Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd The ribavirin injection with the batch number of 2110704 was found in the supervision sampling inspection of Lishui Institute of Quality Inspection and Testing in Zhejiang Province that the visible foreign matter item did not comply with the provisions of the Chinese Pharmacopoeia, Volume II, Version 2020.
Before that, according to the disclosure of the Shanghai Municipal Drug Administration, due to the production of inferior drugs, according to the relevant provisions of the Drug Administration Law, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. was fined 1.4 million yuan and confiscated 3209.19 yuan of illegal income on May 11 。 The main illegal facts are consistent with the above release of Zhejiang Drug Administration, that is, the foreign matter item visible under the inspection [inspection] of ribavirin injection (batch number: 2110704) produced by the party concerned does not comply with the provisions of the Chinese Pharmacopoeia, Volume II, Version 2020.
On May 21, Shanghai Xinyi Jinzhu According to the official WeChat, the company carried out product quality assessment and analysis on ribavirin injection products (specification: 1ml: 100mg, approval number: GYZZ H19999488), and found that there was a risk that visible foreign matters could not meet the requirements in individual batches during the storage period.
In order to control the risk, 20 batches of ribavirin injection are recalled actively. The recall level is Level III and the recall scope is nationwide. All dealers are requested to recall the sold related batches of ribavirin injection drugs from the date of announcement, stop selling the unsold products of this batch immediately, and cooperate with the recall.
In April 2023, the State Food and Drug Administration added a black box warning to several ribavirin dosage forms, including ribavirin injection, in the Announcement on Revising the Instructions of Ribavirin Preparations for Systemic Use. The black box warns that ribavirin may cause birth defects, miscarriage or stillbirth. All animal species exposed to ribavirin showed severe teratogenic and/or fetal lethal effects, and there were reports of testicular sperm morphological changes.
Investigated by Anhui Food and Drug Administration
Also on May 11, Shanghai Xinyi Tianyi Pharmaceutical Co., Ltd. was confiscated by Shanghai Food and Drug Administration of 588.76 yuan for selling inferior drugs 。 The main illegal fact is that on September 11, 2023, Shanghai Institute for Drug Control sampled the honeycombs (batch number: 20230607) marked as produced by Shanghai Qingpu Herbal Medicine Co., Ltd. According to the inspection and re inspection conducted by Shanghai Institute for Drug Control in accordance with the first and fourth parts of the Chinese Pharmacopoeia (2020), the aflatoxin item under the [inspection] item of the honeycombs of this batch of Chinese herbal pieces does not meet the requirements.
In addition, the Drug Quality Announcement (2024, Issue 2) issued by Anhui Food and Drug Administration on March 1 shows that the batch of azathioprine tablets marked as produced by Shanghai Shangyao Xinyi Pharmaceutical Factory Co., Ltd. does not meet the requirements after inspection by Chuzhou Food and Drug Inspection Center, and the item that does not meet the requirements is [inspection] dissolution.
In this regard, the relevant drug regulatory departments of Anhui Province have required relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc., investigate the causes of non conformance and make practical rectification. At the same time, the Anhui Provincial Food and Drug Administration has requested the relevant drug regulatory departments under their jurisdiction to file and investigate the violations of laws and regulations of relevant enterprises and units in accordance with the Drug Administration Law and other laws and regulations, and publicize the investigation results as required.
"Xinyi Department" has repeatedly had criminal record
Enterprise inspection shows that, Shanghai Xinyi Tianyi Pharmaceutical Co., Ltd. and Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd Both are wholly-owned subsidiaries of Shanghai Pharmaceutical Xinyi Pharmaceutical Co., Ltd., and Shanghai Pharmaceutical Xinyi is wholly-owned by Shanghai Pharmaceutical.
According to the official website of Sinopharm Xinyi, the Xinyi brand, founded in 1916, is the largest industrial manufacturing enterprise of Sinopharm Group. At present, Xinyi has become one of the industrial entities with the most complete product varieties and dosage forms in China. It has 11 industrial enterprises, 2 commercial companies and 1 procurement center.
Prior to this, "Xinyi" related companies were also fined for other matters.
In April 2021, the Ministry of Finance issued the Announcement on the Quality Inspection of Accounting Information (No. 40), imposing administrative penalties on 19 pharmaceutical enterprises inspected by the relevant regulatory bureau of the Ministry of Finance.
Among them, Xinyi Pharmaceutical Business Department affiliated to Shanghai Xinyi United Medical Materials Co., Ltd. falsely increased travel expenses by 200.336 million yuan in 2018. The attached information of the research and consulting fees disbursed by the affiliated Xinyi United Business Unit in 2018 in the business promotion fees is untrue, involving an amount of 6.3162 million yuan.
Shanghai Xinyi Tianyi Pharmaceutical Co., Ltd. was punished due to some false information attached to the academic activity fees disbursed in 2018, involving 5.6572 million yuan.
Shandong Xinyi Pharmaceutical Co., Ltd. disbursed part-time salesperson fees and office rental fees in 2018. The vouchers are attached with refueling invoices and transportation invoices, involving an amount of 11.373 million yuan.
At that time, the Ministry of Finance imposed an administrative penalty of 50000 yuan on each of the three "Xinyi" companies according to law.
In January 2017, the relevant notice issued by the State Food and Drug Administration showed that the bifidobacteria triple viable capsules with the batch number of 04720150830 produced by Shanghai Xinyi Pharmaceutical Co., Ltd. were unqualified after inspection by six drug inspection institutions including Henan Food and Drug Inspection Institute.
Editor: Xiao Mo
Reviewed by: Xu Wen
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