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    Home > Active Ingredient News > Drugs Articles > In December, 5 pharmaceutical enterprises got GMP certificate for catching the "last bus"

    In December, 5 pharmaceutical enterprises got GMP certificate for catching the "last bus"

    • Last Update: 2019-12-10
    • Source: Internet
    • Author: User
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    [industry trends of pharmaceutical network] pharmaceutical enterprises obtain GMP certificate, which means that the production line meets GMP requirements, helps to improve industry influence and competitiveness, and enables enterprises to continue to maintain stable product quality, improve production capacity, meet market demand, etc However, according to the new drug administration law, from December 1, 2019, GMP and GSP certification will be cancelled, GMP and GSP certification applications will no longer be accepted, and GMP and GSP certificates will no longer be issued Does the cancellation of GMP certification mean that the pharmaceutical industry will become more and more difficult? Industry insiders pointed out that although the GMP sports certification is cancelled, the drug supervision will be turned into daily supervision, which is actually good for enterprises that attach importance to quality management In addition, the new version of the drug administration law also points out that before December 1, 2019, the accepted certification applications shall be handled in accordance with the relevant provisions of the original GMP and GSP certification, and the GMP and GSP certificates shall be issued if the on-site inspection is completed and the requirements are met That's why, since December, there have been news that pharmaceutical companies have obtained GMP certificates Aoxiang pharmaceutical announced in the evening of December 4 that the company recently received the GMP certificate issued by Zhejiang drug administration According to the announcement, the production workshop certified by the company is a workshop, and the design capacity of the production line involved is: entecavir 200kg / year, bicyclol 6t / year The data showed that entecavir was mainly used to treat chronic hepatitis B infection with active virus replication and continuous increase of serum transaminase, while dicyclohol was used to produce bacenol generic drug, mainly used to treat the increase of transaminase caused by chronic hepatitis Aoxiang pharmaceutical said that the GMP certificate obtained this time means that the relevant production lines of the company meet the GMP requirements, which is conducive to improving the industry's influence and competitiveness, and has positive significance for maintaining stable product quality, improving production capacity, meeting market demand and stable development in the future Jingfeng Pharmaceutical Co., Ltd., a subsidiary of Jingfeng pharmaceutical, announced in the evening of December 4 that Dalian Jinggang, a subsidiary of the company, recently received the GMP certificate issued by Liaoning drug administration, which covers the scope of GMP certification for mixture and extraction of traditional Chinese medicine It is reported that Dalian Jingang oral liquid production line (including extraction) has basically completed the hardware technical transformation and started the verification work After GMP certification, it is expected that the production line will be put into production in the first half of next year Jingfeng pharmaceutical said that obtaining GMP certificate is conducive to improving the company's industry influence and competitiveness, and has positive significance for maintaining stable product quality, improving production capacity, meeting market demand and the company's stable development in the future Saps, a wholly-owned subsidiary of saps, announced on the evening of December 2 that recently, the company's wholly-owned subsidiary, Jianshen pharmaceutical industry, received the GMP certificate issued by Jilin drug administration According to the announcement, the certification workshop is the second production line (including pre-treatment and extraction of traditional Chinese Medicine) of the liquor workshop of Qiangshen Pharmaceutical Co., Ltd.; by the end of September 2019, the accumulative investment of the above production line is about 97.4157 million yuan Yongtai technology, a subsidiary of Yongtai technology, announced in the evening of December 2 that Foshan handxin, a subsidiary of the company, recently received the GMP certificate issued by Guangdong Drug Administration According to the announcement, the scope of GMP certificate certification of the above drugs includes koufo solution, liniment, soft capsule, traditional Chinese medicine pretreatment and extraction workshop (oral preparation), tablet (including hormone), hard capsule (including penicillin and cephalosporin), dry suspension (penicillin), and the validity period is until November 28, 2024 According to Yongtai science and technology, the GMP certificate is obtained again after the expiry of the original GMP certificate of Foshan handxin The acquisition of this GMP certificate shows that the above production line of Foshan handxin meets the requirements of the GMP, ensures the continuous and stable production capacity of Foshan handxin, and has a positive impact on the future business performance of the company Bohui innovation, a subsidiary of Bohui innovation, announced that Guangdong Weilun, the holding subsidiary of the company, recently received the GMP certificate issued by Guangdong Drug Administration, which is valid until November 25, 2024 The company said that the GMP certificate was obtained in accordance with the provisions of the drug management law, and was recertified after the expiration of the Guangdong weilunyuan GMP certificate The certification passed, which proved that the production and product quality of Guangdong Weilun products are stable and meet the needs of customers.
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