Progress analysis of consistency evaluation of metformin hydrochloride tablets

On January 15, 2020, North China Pharmaceutical Co., Ltd issued a notice that metformin hydrochloride tablets (0.5g) of the company passed the consistency evaluation At present, there are eight metformin hydrochloride tablets (0.5g) in China, and the company is the second enterprise that has passed the consistency evaluation of the product (0.5g) At present, the drug audit center of the State Administration of drug supervision has accepted 38 applications for consistency evaluation of metformin hydrochloride tablets, and has approved 15 application numbers, including 14 metformin hydrochloride tablets (0.25g) and 1 metformin hydrochloride tablet (0.5g) In addition, Ouyi's metformin hydrochloride tablet was successfully reported in China as anda in the United States, and was included in the catalogue of Chinese drugs on the market It was deemed to have passed the consistency evaluation, with specifications of 0.5g and 0.85g Table 1: pass the consistency evaluation of metformin hydrochloride tablets 1 Brief introduction metformin hydrochloride tablets are oral hypoglycemic drugs of biguanide type, which are widely used in the population, and belong to category A of national medical insurance catalogue (2019 version) and category of essential drugs catalogue (2018 version) Metformin hydrochloride tablets were developed and launched by Merck Sante SA (now part of Merck KGaA) and Bristol Myers Squibb (BMS) In 1959, metformin hydrochloride tablets were marketed in France and the United Kingdom under the trade name of Glucophage On March 3, 1995, it was approved by FDA to be marketed in the United States There are 122 approval numbers of metformin hydrochloride tablets in China, including 112 of 0.25g, 8 of 0.5g and 2 of 0.85g Fig 1 Document No and specification of metformin hydrochloride tablets on the market in China 2 First, see the reference preparations published by nmpa Metformin hydrochloride tablets have no original imported products in China Nmpa selected nipponshinyaku Co., Ltd.'s glycoran as the reference preparation with the specification of 0.25g, and Merck Sant é S.A.S.'s Glucophage as the reference preparation with the specification of 0.5g and 0.85g, which were listed in France Table 2 The reference preparations of metformin hydrochloride tablets can be seen again At present, there are 84 reference preparations filing information from 53 Enterprises that can be queried The number of reference preparations of each specification is: 70 0.25g, 10 0.5g, 4 0.85g In addition to Nippon and Merck Sant é published by CFDA, Bristol Myers Squibb, Japan new drug Co., Ltd and Shanghai Shiguibao of China and the United States were also selected 3 There are 48 bioequivalence tests of metformin hydrochloride tablets currently registered on the national drug clinical trial registration and information publicity platform, including 46 be tests for conformity assessment of generic drugs and 2 be tests newly registered (Guangdong Saikang Pharmaceutical Factory Co., Ltd.) Of the 46 generic drug conformity evaluation be tests registered, 36 have been completed, accounting for 78% In addition, nine be tests are in progress, including five that have not yet been recruited, and one of the three that have been recruited has been completed; one be test is suspended actively due to changes in the test plan Fig 2 test status of be test of conformity evaluation 4 Up to now, except 15 acceptance numbers that have passed the conformity evaluation of generic drugs, 23 acceptance numbers are still in the review, with no conclusion at present, among which 4 acceptance numbers are shown as issued Table 3 data sources of acceptance of consistency evaluation of metformin hydrochloride tablets: drug intelligence data, announcement of listed enterprises, list of drugs on the market in China Listen to the white statement: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.