Huahai Pharmaceuticals Issues Clarification Announcement on the Shansatan Incident

recently, the detection of "toxic" impurities in the raw materials of the shatan, has become the focus of public opinion. Yesterday (July 24), in response to the "Shatan incident", Huahai Pharmaceuticals issued a clarification announcement. The announcement said that when the company found nitro-metformin (NDMA) impurities, national regulators had not established an acceptable control limit severance standard for the impurity, and the company was in compliance with regulatory standards In a responsible attitude towards public health, the company actively recalls related products. the timeline of the "Shatan Incident" began to ferment on July 5th, and so far, Huahai Pharmaceuticals has issued seven announcements on the event. On July 5, the European Medicines Agency (EMA) issued a recall notice saying it was reviewing drugs containing the active substance of parate. The review was prompted by the accidental discovery of the impurity nitromedimetiamine (NDMA) in some of the raw materials of the paracetaman preparations available to the European market. THE EMA SAID IT WOULD INVESTIGATE THE LEVEL OF NDMA IN THESE STATIN DRUGS, THEIR POSSIBLE IMPACT ON THE PATIENTS WHO TOOK THEM, AND WHAT CAN BE DONE TO REDUCE OR ELIMINATE IMPURITIES IN FUTURE BATCHES PRODUCED BY THE COMPANY In addition, Germany, Italy, Finland, Austria, Japan have also issued a recall notice, the recall of pharmaceutical products provided by Huahai Pharmaceuticals. 2, July 7, Huahai Pharmaceuticals issued "on the unknown impurities of the raw materials of the zisatan found very trace trace of genotoxic impurities." The announcement said that after the discovery of the situation, the company immediately stopped the commercial production of existing pasatan api, and actively with the United States Food and Drug Administration (FDA) and other national regulatory agencies to actively communicate, hoping to be able to work out as soon as possible the RAW materials on the NDMA impurities acceptable control limits of the industry standards. The company has evaluated other satan products, due to different production processes, confirmed that other satan products do not exist in the NDMA impurities At present, the company's shattan preparations in the domestic has not been listed for sale. 3, July 9, Huahai Pharmaceuticals issued "on the unknown impurities of the raw materials of the zisatan found very trace trace of genotoxic impurities notice." The announcement describes the issue of recall notices by the European Medicines Agency (EMA), Germany, Italy, Finland, Austria, Japan and other countries. The ema will investigate the ndA in the statin preparation and the potential impact on the patients who take the drug, as well as methods and measures to reduce or eliminate the impurity in the future company's supply of prosatin raw materials, the statement said In addition, as a precautionary measure, the review will also investigate whether other statins may also be affected. 4, July 10, Huahai Pharmaceuticals issued "on the investor briefing will be held in the announcement." "At present, the company has taken the initiative to suspend the market supply, pending the official results of the investigation," the company said on the investor interactive platform This incident is likely to involve claims of compensation, depending on the negotiation of supply agreements, quality agreements and other relevant transaction documents with the customer ""Due to different process conditions, the company's other products, except shattan, do not detect the genetic toxic impurities On July 13th, Huahai Pharmaceuticals issued the Progress Announcement on the Discovery of Extreme Trace Genotoxic Impurities in Unknown Impurities of Shatan Raw Materials. The announcement said that from the perspective of risk prevention, the company decided to take the initiative to recall the domestic and foreign listed psatan raw materials The company has not yet been listed in the domestic, the company and the relevant domestic customers jointly decided to take the initiative to recall the use of Huahai pharmaceutical industry shattan raw materials produced in the domestic market of the shatan preparation products. 6, July 16, Huahai Pharmaceuticals issued "on the unknown impurities of the raw materials of the zisatan found very trace trace genotoxic impurities of the progress of the announcement." The announcement said that in view of the company's statin api in the unknown impurities found in the very trace trace of genotoxic impurities, from the perspective of risk prevention, the company decided to the United States listed the use of Huahai shattan api preparation products from the pharmacy level to carry out an active recall Losses due to active recalls are not yet accurately estimated, depending on the pharmacy stock data. At the same time, the company voluntarily suspended the supply of the U.S market, may face compensation losses due to the suspension of supply. 7, July 20, Huahai Pharmaceuticals issued "on the unknown impurities of the raw materials of the zisatan found very trace trace genotoxic impurities of the progress of the announcement." The announcement said that at present, Shouke Health USA, a subsidiary of the company, is notifying its distributors and customers by letter and e-mail, actively arranging consumer returns, and the company will actively assist Shouke Health in implementing the relevant recall work, and in accordance with the relevant agreement documents signed with customers, actively negotiate solutions with customers to minimize losses. 8, July 24, Huahai Pharmaceuticals issued a clarification announcement. "Shatan" cancer? Recently, according to CNN, the dexcel standonats made by Dexcel Pharma Ltd and Accord Healthcare were recalled in 22 countries for cancer risk, involving 2,300 batches of the drug. After the incident broke out, many patients worried that we take the satanan, should not also lie down the gun? In fact, the main reason for the recall was that these batches of the active pharmaceutical ingredients (APIs) of the satane were found during testing "raw materials from external suppliers containing impurities" The supplier of this API is Huahai Pharmaceuticals from China. The whole incident, the specific explanation is very simple, just as we combed above And what is the end of this "toxic" impurity that can cause cancer detected by the satan? According to the EMA bulletin, the drug is used to treat patients with high blood pressure to reduce complications such as heart attacks and strokes, and it is also used in patients with heart failure or recent heart attacks Based on laboratory tests, the found impurity N-nitrometamide (NDMA) is classified as a possible human carcinogen. The list of carcinogens listed by the International Agency for Research on Cancer (IAM) on 27 October 2017 is a category 2A carcinogen. Huahai Pharmaceuticals said in the clarification announcement, according to the relevant literature, the World Health Organization 's body IARC (International Agency for Research on Cancer) classified NDMA as a class 2A carcinogen, class 2A refers to animal experiments have the corresponding data to support, but limited evidence of carcinogenicity in humans The carcinogenicity of these impurities in rodents is affected by the dual factors of time and dose, and the effect on human body is not yet clear. Does have an impact on domestic products? With the continuous fermentation of the "Shatan incident", the domestic production enterprises of the preparation of the shatan, has also issued relevant statements It is understood that the current domestic products affected not much. Data show that in 2017, Huahai Pharmaceutical Shatan raw materials sales amounted to about 328 million yuan During the year, sales of its satan preparations were $20.43 million The production of the tablets was about 406 million tablets and the sales volume was about 340 million pieces, while the production of the pyridine tablets was about 85.25 million tablets, with sales of about 93.4 million tablets. According to Huahai Pharmaceutical Seion's announcement, the company's Lushatan preparations have not been listed for sale in China. In addition, Novartis, Lunanbet and other pharmaceutical companies, have also issued a statement that its production of the preparation of the shattan is not affected. Among them, it is worth noting that Harbin Sanlian Pharmaceutical sanlian pharmaceutical company issued a notice, announced the recall of the use of Huahai Pharmaceutical's raw materials produced by the paratetan dispersion tablets. In addition to Ha Sanlian, the Chinese market is there any use of Huahai Pharmaceutical's lushatan raw materials enterprises have not been recalled? In response to the issue, Huahai Pharmaceuticals said there was no way to disclose information about other companies because of confidentiality agreements with all its co-customers, the Beijing News reported Huahai has officially informed these enterprises, they will be announced later. What will happen next in response to the "Shatan" incident? Let's pay close attention.