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    Home > Active Ingredient News > Drugs Articles > Huabei pharmaceutical subsidiary obtained GMP certificate, and both production lines met the requirements

    Huabei pharmaceutical subsidiary obtained GMP certificate, and both production lines met the requirements

    • Last Update: 2020-02-12
    • Source: Internet
    • Author: User
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    [industry trends of pharmaceutical network] on February 11, Huabei pharmaceutical announced that its subsidiary, Xiantai company, had recently received the GMP certificate issued by Hebei drug administration The scope of this certification is API (ampicillin) and sterile API (benzathine penicillin), mainly involving two production lines of workshop 801 and 808 Among them, 801 workshop chemical method production line is the re certification after the certificate expires, while 808 workshop production line is the first certification after the workshop transformation The two production lines invested a total of 29.52 million yuan, mainly for the transformation, maintenance and repair of the plant and main equipment and facilities Data show that ampicillin is a β - lactam, broad-spectrum semi synthetic antibiotic, belonging to aminopenicillin, which can be used to treat a variety of bacterial infections and urinary tract infections Indications include respiratory tract infection, urinary tract infection, meningitis, Salmonella infection, and endocarditis According to 2015-2017 statistics of China Association of chemical and pharmaceutical industries, the annual output of ampicillin in China is about 3600 tons / year In addition to Xiantai company, the main manufacturers include Zhuhai federal and Petrochemicals Group In 2017, Xiantai's market share of ampicillin was about 22% In 2018, the sales revenue of this product of Xiantai company is about 132 million yuan Benzathine penicillin is a long-acting penicillin antibiotic, which is used to treat penicillin sensitive pathogens Because of its slow absorption and low blood concentration, it is suitable for patients who need long-term penicillin prevention, such as patients with chronic rheumatic heart disease According to 2015-2018 statistics of China Chemical Pharmaceutical Industry Association, the annual output of benzathine penicillin in China is 200-400 tons / year In addition to Xiantai company, the main production enterprises include Jiangxi Dongfeng, Sinopharm, etc It is understood that benzathine penicillin of Xiantai company is mainly used for export, and its share in the domestic market is relatively small In 2018, the sales volume of this product of Xiantai company accounted for nearly half of the total export volume of this product in China In 2018, sales revenue of this product of Xiantai company totaled RMB 27.51 million Huabei pharmaceutical said that Xiantai company obtained the GMP certificate issued by Hebei drug administration, indicating that all aspects of the relevant production lines of Xiantai company meet the requirements of the new GMP, which is conducive to the improvement of production capacity and market demand while ensuring product quality It is pointed out in the industry that GMP certification system plays an important role in improving the quality of drugs in China, ensuring the safety and effectiveness of drug use by the masses of the people, and pharmaceutical enterprises obtaining GMP certificates play a positive role in improving their production capacity and opening up the market According to the data, Xiantai company is committed to the R & D, production and business activities of semi synthetic penicillin APIs as the leading products, and is an important production base of semi synthetic penicillin APIs in China At present, it is in a special period, and many pharmaceutical manufacturers are also fighting against the epidemic through active production It is understood that various API enterprises under North China Pharmaceutical are also taking action The main production lines of Xiantai company are continuously produced during the festival without any reduction in batch or production suspension Among them, amoxicillin, ampicillin sodium and other raw drug products related to anti epidemic drugs have achieved full load production  
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