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    Home > Medical News > Latest Medical News > In July, 136 product regulations passed the consistency evaluation of generic drugs

    In July, 136 product regulations passed the consistency evaluation of generic drugs

    • Last Update: 2021-09-04
    • Source: Internet
    • Author: User
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    According to data from the National Medical Products Administration on August 25th, in July this year, the Center for Drug Evaluation (CDE) of the National Medical Products Administration undertook 80 applications for the consistency evaluation of generic drugs (calculated by the acceptance number), and 54 varieties were accepted.
    A total of 54 companies are involved
    .
    Compared with June, the number of acceptance, the number of varieties and the number of enterprises involved have all increased
    .
     
    Judging from the treatment fields involved in the consistency evaluation of generic drugs accepted in July, the system uses the most anti-infective drugs, followed by the blood and hematopoietic system drugs, which is similar to the situation in June
    .
    In terms of the dosage forms of various varieties, injections accounted for over 70% of the total number of declarations; followed by tablets, accounting for 20%; and capsules and granules ranked third
    .
     
    Among the 80 applications for consistency evaluation of generic drugs newly undertaken by CDE in July, ambroxol hydrochloride injection received the largest number of accepted numbers, reaching 6, involving two companies, Shanxi Guorun Pharmaceutical and Shandong Qidu Pharmaceutical; octreotide acetate injection Liquid, piperacillin sodium and tazobactam sodium for injection followed closely behind
    .
     
    In July, there were 136 product regulations that passed the generic drug consistency evaluation (including deemed approval), including 90 varieties, involving 94 companies
    .
    From the perspective of dosage form classification, tablets are the most (passed 28 product regulations, deemed to have passed 42 product regulations), accounting for over 50%; injections ranked second in the number of reviews (passed 32 product regulations, deemed to have passed 15 product regulations) Product regulations), accounting for 35%; the third is capsules, accounting for close to 10%
    .
    From the perspective of the treatment field, the over-rated varieties are mainly concentrated in the field of systemic anti-infective drugs, neurological drugs and cardiovascular system drugs
    .
    Among them, systemic anti-infective drugs accounted for over 20%
    .
    Among the reviewed varieties, the number of metoprolol succinate sustained-release tablets passed the most, reaching six, all of which were deemed approved, involving two companies
    .
    In terms of the number of manufacturers, there are 19 varieties that have passed the number of manufacturers 10 or more, among which 36 manufacturers are involved in the hypoglycemic drug metformin hydrochloride tablets; there are 29 varieties that have passed 4-9 manufacturers; the number of passed manufacturers There are 13 varieties for 3 companies
    .
     
      Among the 136 drug product regulations reviewed in July, 16 were the first to be reviewed
    .
    Among them, Haisco Pharmaceuticals and Chia Tai Tianqing Pharmaceuticals each won two first products, and companies such as Simcere Pharmaceuticals, Renfu Pharmaceuticals and Chengdu Better Pharmaceuticals have included one of the first approved products
    .
     
      In July, the company with the largest number of approved drugs was Yangzijiang Pharmaceutical, with 5 approved drugs
    .
    So far, the total number of reviewed products under Yangtze River Pharmaceutical Group has reached 76
    .
    In second place is Chia Tai Tianqing Pharmaceutical, which passed 4 varieties; Chengdu Better Pharmaceutical and Guangzhou Pharmaceutical Group followed closely behind
    .
    (Contributed by Yaorong Circle)
      According to data from the National Medical Products Administration on August 25th, in July this year, the Center for Drug Evaluation (CDE) of the National Medical Products Administration undertook 80 applications for the consistency evaluation of generic drugs (calculated by the acceptance number), and 54 varieties were accepted.
    A total of 54 companies are involved
    .
    Compared with June, the number of acceptance, the number of varieties and the number of enterprises involved have all increased
    .
     
      Judging from the treatment fields involved in the consistency evaluation of generic drugs accepted in July, the system uses the most anti-infective drugs, followed by the blood and hematopoietic system drugs, which is similar to the situation in June
    .
    In terms of the dosage forms of various varieties, injections accounted for over 70% of the total number of declarations; followed by tablets, accounting for 20%; and capsules and granules ranked third
    .
     
      Among the 80 applications for consistency evaluation of generic drugs newly undertaken by CDE in July, ambroxol hydrochloride injection received the largest number of accepted numbers, reaching 6, involving two companies, Shanxi Guorun Pharmaceutical and Shandong Qidu Pharmaceutical; octreotide acetate injection Liquid, piperacillin sodium and tazobactam sodium for injection followed closely behind
    .
     
      In July, there were 136 product regulations that passed the generic drug consistency evaluation (including deemed approval), including 90 varieties, involving 94 companies
    .
    From the perspective of dosage form classification, tablets are the most (passed 28 product regulations, deemed to have passed 42 product regulations), accounting for over 50%; injections ranked second in the number of reviews (passed 32 product regulations, deemed to have passed 15 product regulations) Product regulations), accounting for 35%; the third is capsules, accounting for close to 10%
    .
    From the perspective of the treatment field, the over-rated varieties are mainly concentrated in the field of systemic anti-infective drugs, neurological drugs and cardiovascular system drugs
    .
    Among them, systemic anti-infective drugs accounted for over 20%
    .
    Among the reviewed varieties, the number of metoprolol succinate sustained-release tablets passed the most, reaching six, all of which were deemed approved, involving two companies
    .
    In terms of the number of manufacturers, there are 19 varieties that have passed the number of manufacturers 10 or more, among which 36 manufacturers are involved in the hypoglycemic drug metformin hydrochloride tablets; there are 29 varieties that have passed 4-9 manufacturers; the number of passed manufacturers There are 13 varieties for 3 companies
    .
     
      Among the 136 drug product regulations reviewed in July, 16 were the first to be reviewed
    .
    Among them, Haisco Pharmaceuticals and Chia Tai Tianqing Pharmaceuticals each won two first products, and companies such as Simcere Pharmaceuticals, Renfu Pharmaceuticals and Chengdu Better Pharmaceuticals have included one of the first approved products
    .
     
      In July, the company with the largest number of approved drugs was Yangzijiang Pharmaceutical, with 5 approved drugs
    .
    So far, the total number of reviewed products under Yangtze River Pharmaceutical Group has reached 76
    .
    In second place is Chia Tai Tianqing Pharmaceutical, which passed 4 varieties; Chengdu Better Pharmaceutical and Guangzhou Pharmaceutical Group followed closely behind
    .
    (Contributed by Yaorong Circle)
      According to data from the National Medical Products Administration on August 25th, in July this year, the Center for Drug Evaluation (CDE) of the National Medical Products Administration undertook 80 applications for the consistency evaluation of generic drugs (calculated by the acceptance number), and 54 varieties were accepted.
    A total of 54 companies are involved
    .
    Compared with June, the number of acceptance, the number of varieties and the number of enterprises involved have all increased
    .
     
      Judging from the treatment fields involved in the consistency evaluation of generic drugs accepted in July, the system uses the most anti-infective drugs, followed by the blood and hematopoietic system drugs, which is similar to the situation in June
    .
    In terms of the dosage forms of various varieties, injections accounted for over 70% of the total number of declarations; followed by tablets, accounting for 20%; and capsules and granules ranked third
    .
     
      Among the 80 applications for consistency evaluation of generic drugs newly undertaken by CDE in July, ambroxol hydrochloride injection received the largest number of accepted numbers, reaching 6, involving two companies, Shanxi Guorun Pharmaceutical and Shandong Qidu Pharmaceutical; octreotide acetate injection Liquid, piperacillin sodium and tazobactam sodium for injection followed closely behind
    .
     
      In July, there were 136 product regulations that passed the generic drug consistency evaluation (including deemed approval), including 90 varieties, involving 94 companies
    .
    From the perspective of dosage form classification, tablets are the most (passed 28 product regulations, deemed to have passed 42 product regulations), accounting for over 50%; injections ranked second in the number of reviews (passed 32 product regulations, deemed to have passed 15 product regulations) Product regulations), accounting for 35%; the third is capsules, accounting for close to 10%
    .
    From the perspective of the treatment field, the over-rated varieties are mainly concentrated in the field of systemic anti-infective drugs, neurological drugs and cardiovascular system drugs
    .
    Among them, systemic anti-infective drugs accounted for over 20%
    .
    Among the reviewed varieties, the number of metoprolol succinate sustained-release tablets passed the most, reaching six, all of which were deemed approved, involving two companies
    .
    In terms of the number of manufacturers, there are 19 varieties that have passed the number of manufacturers 10 or more, among which 36 manufacturers are involved in the hypoglycemic drug metformin hydrochloride tablets; there are 29 varieties that have passed 4-9 manufacturers; the number of passed manufacturers There are 13 varieties for 3 companies
    .
     
      Among the 136 drug product regulations reviewed in July, 16 were the first to be reviewed
    .
    Among them, Haisco Pharmaceuticals and Chia Tai Tianqing Pharmaceuticals each won two first products, and companies such as Simcere Pharmaceuticals, Renfu Pharmaceuticals and Chengdu Better Pharmaceuticals have included one of the first approved products
    .
    Drugs Drugs Drugs pharmaceutical medicine pharmaceutical companies business enterprises
     
      In July, the company with the largest number of approved drugs was Yangzijiang Pharmaceutical, with 5 approved drugs
    .
    So far, the total number of reviewed products under Yangtze River Pharmaceutical Group has reached 76
    .
    In second place is Chia Tai Tianqing Pharmaceutical, which passed 4 varieties; Chengdu Better Pharmaceutical and Guangzhou Pharmaceutical Group followed closely behind
    .
    (Contributed by Yaorong Circle)
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