Newest! Suspension of export of Huahai 2 sartan APIs to Europe
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Last Update: 2019-01-16
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Source: Internet
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Author: User
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New progress has been made in the detection of NDEA impurities in irbesartan and losartan potassium APIs of Huahai pharmaceutical On January 15, Huahai Pharmaceutical Co., Ltd announced that due to the influence of several batches of irbesartan API products detected that the NDEA exceeded the standard, as well as the risk assessment of the products of sarbesartan API, the European Pharmacopoeia Committee decided to suspend the European Pharmacopoeia adaptability Certificate (CEP) of irbesartan API and losartan potassium API Other CEP certificates of sartan API products of the company are still valid after evaluation by the European Pharmacopoeia Committee The full text of the announcement is as follows:
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