The spokesperson of the National Medical Products Administration introduces the relevant situation of valsartan raw materials of Huahai Pharmaceutical
Published Time:
2018-07-29
On July 29, the spokesperson of the National Medical Products Administration (NMPA) introduced the situation concerning the detection of trace amounts of N-nitrosodimethylamine (NDMA) impurities in valsartan raw materials produced by Zhejiang Huahai Pharmaceutical Co., Ltd. (hereinafter referred to as Huahai Pharmaceutical).
On July 6, Huahai Pharmaceutical reported to the NMPA the detection of trace amounts of N-nitrosodimethylamine (NDMA) impurities in valsartan raw materials used for export. In accordance with relevant regulations and requirements, it proactively disclosed relevant information to the public. After detecting the impurity, Huahai Pharmaceutical immediately suspended the release and shipment of all valsartan raw materials to both domestic and international markets and initiated a proactive recall. The company's current raw material production processes were approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in 2012 and 2013, respectively. As of July 23, Huahai Pharmaceutical has completed the recall of all domestic raw materials.
Since July 6, the NMPA has maintained close communication and contact with the European EMA and the U.S. FDA, closely monitoring risk assessment announcements and developments released by international regulatory agencies, and organizing experts to conduct risk assessments. After assessment, based on toxicological data, the maximum daily intake limit of NDMA is estimated to be 0.1 μg, equivalent to the EMA's provisional reference limit of 0.3 ppm (calculated based on a daily intake of 320 mg of valsartan). Based on this limit, a risk assessment was conducted on all seven valsartan raw material manufacturers (including Huahai Pharmaceutical) currently in production in China. Except for Huahai Pharmaceutical's valsartan raw materials, where NDMA impurities exceeded the limit, the NDMA impurity levels detected in other domestic valsartan raw material manufacturers were below the limit or not detected.
In China, a total of six pharmaceutical manufacturers use valsartan raw materials from Huahai Pharmaceutical. Valsartan capsules (National Drug Approval Number H20103521) produced by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd. have not yet been shipped. The NDMA levels in the listed products of the other five manufacturers exceeded the limit. These are valsartan/hydrochlorothiazide capsules (National Drug Approval Number H20080097) produced by Chongqing Conquer Pharmaceutical Co., Ltd.; valsartan dispersible tablets (National Drug Approval Number H20050508) produced by Hainan Huanglong Pharmaceutical Co., Ltd.; valsartan dispersible tablets (National Drug Approval Number H20061058) produced by Harbin Sanlian Pharmaceutical Co., Ltd.; valsartan/hydrochlorothiazide dispersible tablets (National Drug Approval Number H20090262) produced by Jiangsu Wangao Pharmaceutical Co., Ltd.; and valsartan dispersible tablets (National Drug Approval Number H20090319) produced by Shandong Yijian Pharmaceutical Co., Ltd. The above five pharmaceutical manufacturers have stopped using valsartan raw materials from Huahai Pharmaceutical and have recalled the relevant drugs as required.
The NMPA has instructed provincial food and drug administration departments to urge relevant pharmaceutical manufacturers to take recall measures and to publicly disclose relevant recall information, including the contact telephone number of the company responsible for the recall, on the websites of the five manufacturers. To facilitate the public's timely understanding of whether the valsartan drugs they are currently using are subject to the recall, the five manufacturers have cooperated with information technology companies to launch a QR code scanning query function at 10 PM on July 26, 2018. This allows for real-time queries via mobile phone APP scanning of product traceability codes. Specific details can be found by checking the company's website.
|
Company Name |
Website |
|
Chongqing Conquer Pharmaceutical Co., Ltd. |
|
|
Hainan Huanglong Pharmaceutical Co., Ltd. |
|
|
Harbin Sanlian Pharmaceutical Co., Ltd. |
|
|
Jiangsu Wangao Pharmaceutical Co., Ltd. |
|
|
Shandong Yijian Pharmaceutical Co., Ltd. |
The NMPA spokesperson emphasized that, apart from the above five pharmaceutical manufacturers, other valsartan products are not subject to the recall.
Currently, drug regulatory agencies in the EU and many other countries consider NDMA to be a Group 2A carcinogen (i.e., sufficient evidence in animal experiments, possible carcinogenicity in humans but limited evidence). This substance is commonly encountered in daily life (e.g., pickled foods). Analysis indicates that the drugs involved in this incident will not pose a serious health risk to patients, but for safety reasons, risk control measures such as discontinuation of sales and recall should be taken. On July 27, the U.S. FDA issued an announcement stating that patients taking the recalled valsartan should continue taking their current medication until their doctor or pharmacist provides an alternative medication or a different treatment plan.
The NMPA spokesperson reminds patients currently taking valsartan that they should not stop taking the medication without consulting a doctor. Stopping the medication abruptly poses a more direct and serious risk to patients with hypertension. Whether to stop or change medication must be done under the guidance of a doctor. Patients can contact their doctor to switch to other valsartan-containing drugs not involved in the recall or choose alternative drug therapies.
The NMPA requires relevant provincial food and drug administration departments to continue to supervise companies in effectively carrying out product recalls in accordance with the relevant provisions of the "Drug Recall Management Measures" to protect the safety of the public's medication.
Tips:
1. Valsartan is mainly used to treat hypertension.
2. According to the list of carcinogens published by the International Agency for Research on Cancer (IARC) of the World Health Organization on October 27, 2017, and compiled by the Safety Evaluation Institute of the China National Institute for Food and Drug Control, there are 116 substances listed as Group 1 carcinogens, including aflatoxins, tobacco, and alcoholic beverages; 380 substances listed as Group 2 carcinogens, including fried foods, glycidol, and red meat (intake); 502 substances listed as Group 3 carcinogens, including caffeine, coffee, and saccharin and its salts; and 1 substance listed as Group 4 carcinogen, caprolactam. Detailed information can be found on the website of the former State Food and Drug Administration.
[Related Links]
International Agency for Research on Cancer (IARC) List of Carcinogens
Original link: http://cnda.cfda.gov.cn/WS04/CL2056/329744.html
Previous Page
Previous Page:
Recommended News
Email: marcos.yuan@wangao.com.cn
Address: No. 688, Dinghai Road, Haimen City, Jiangsu Province
Mobile Version QR Code
Whatsapp Account
Copyright © 2025 Jiangsu Wangao Pharmaceutical Co., Ltd.