Another enterprise metformin hydrochloride tablets have been evaluated; 12 product specifications 3 sets!

On February 19, Boya biology issued an enterprise announcement that its holding subsidiary Guizhou Tian'an Pharmaceutical Co., Ltd received the approval document for supplementary application of metformin hydrochloride tablets approved and issued by the State Drug Administration The quality and efficacy of the drug were evaluated Photo source: the enterprise announced that metformin hydrochloride tablet is the basic drug for the treatment of diabetes, and it is the first choice for type 2 diabetes which is ineffective in simple diet control and physical exercise control of blood sugar For adults, this product can be used for single drug treatment, or combined with sulfonylurea or insulin treatment For children and adolescents aged 10 and over, this product can be used for single drug treatment or combined treatment with insulin According to the public information on the Internet, no other capsules, enteric solution or sustained-release dosage forms are considered at present Only in terms of the market pattern of metformin hydrochloride tablets, the market value of 0.25g in 2017 was about 100 million yuan According to the statistics of domestic database of pharmaceutical intelligence, there are 122 domestic market approvals for metformin hydrochloride tablets in China, involving 113 manufacturers, 22 of which have applied for the consistency evaluation, and the products of Beijing Sihuan pharmaceutical, Ouyi, Guangdong South China Pharmaceutical and Guizhou Tian'an pharmaceutical have been evaluated successively Table 1 details of consistency evaluation of metformin hydrochloride tablets It is worth noting that the specifications of Ouyi tablets are 0.5g and 0.85g through the consistency evaluation, and they are deemed to have been evaluated through entering the catalogue of Chinese listed drugs At present, only one enterprise of Ouyi has ever evaluated these two specifications; the specifications of metformin tablets evaluated by Beijing Sihuan Pharmaceutical Co., Ltd., Guangdong South China Pharmaceutical Co., Ltd and Guizhou Tianan Pharmaceutical Co., Ltd are all 0.25g, so far There are also three conformity evaluation sets of product specifications According to the statistics of pharmaceutical intelligence data, up to now, there are totally 12 product specifications, among which there are 6 enterprises that have reviewed amlodipine besylate tablets, 4 enterprises that have reviewed 7 varieties of rosuvastatin calcium tablets, tenofovir dipivoxil fumarate tablets, entecavir dispersible tablets, entecavir capsules, montmorillonite powder, cefuroxime dipivoxil tablets and Amoxicillin Capsules See the following table for more details: Table 2: the number of enterprises that have passed the conformity evaluation of drug product regulations is up to 3 detailed sources: enterprise announcement, data source of drug intelligence network: drug intelligence database statement: this opinion only represents the author, not the position of drug intelligence network, 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.