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    Home > Medical News > Latest Medical News > Conformity evaluation of amoxicillin capsule of Lukang medicine through generic drugs

    Conformity evaluation of amoxicillin capsule of Lukang medicine through generic drugs

    • Last Update: 2019-11-08
    • Source: Internet
    • Author: User
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    On November 7, Lu Kang medicine announced that the company had recently received the approval document for supplementary application of amoxicillin capsule (hereinafter referred to as "the drug") issued by the State Drug Administration (approval No.: 2019b04059, 2019b04060), which passed the consistency evaluation of quality and efficacy of generic drugs Amoxicillin is a broad-spectrum β - lactam antibiotic of penicillin It has strong antibacterial and bactericidal effects on most of the pathogenic Gram-positive and Gram-negative bacteria It is widely used in the treatment of upper respiratory tract infection, urogenital tract infection, skin and soft tissue infection, lower respiratory tract infection caused by sensitive bacteria and in combination with other drugs to eradicate Helicobacter pylori, and it is light and medium There is no need to adjust the dosage in patients with DN It is widely recommended by authoritative guidelines and consensus such as diagnosis and treatment of adult community acquired pneumonia in China (2016 Edition) and guidelines for clinical application of antibiotics (2015 Edition) Amoxicillin capsule has entered the category a medical insurance and national basic drug catalog in 2018 In 2018, the domestic sales volume of amoxicillin capsule is about 2.4 billion yuan, and the sales revenue of Lukang medicine is 146 million yuan At present, there are 239 approval documents for amoxicillin capsule production in China As of the date of this announcement, 5 manufacturers (Zhongshan branch of Zhuhai federal Pharmaceutical Co., Ltd (0.25g), Zhejiang Jinhua Kangenbei Biological Pharmaceutical Co., Ltd (0.25g), Sinopharm (Shijiazhuang) Co., Ltd (0.25g, 0.5g), Hunan Kelun Pharmaceutical Co., Ltd (0.25g), Shandong Lukang Pharmaceutical Co., Ltd (0.125g, 0.25g)) have passed through China Consistency evaluation and approval of national drug administration Since the consistency evaluation of the drug was carried out, the cumulative R & D investment of Lukang medicine is about 8 million yuan (Unaudited) Penicillin is the reprinted content of yaozhi.com, and the copyright belongs to the original author The purpose of reprinting is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.
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