echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > [good medicine record] weekly trend of consistency evaluation: 2 species over evaluation; 64 enterprises 88 injection accepted, Qilu won the title, Renfu, Zhengda Tianqing, Kelun

    [good medicine record] weekly trend of consistency evaluation: 2 species over evaluation; 64 enterprises 88 injection accepted, Qilu won the title, Renfu, Zhengda Tianqing, Kelun

    • Last Update: 2019-04-19
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    As of April 18, the acceptance number of CDE acceptance consistency evaluation reached 1054 (322 varieties of 340 enterprises, calculated according to supplementary application, the same below), among which 184 acceptance numbers (87 varieties) have passed; this week, another 2 varieties have been evaluated, 2 varieties are about to be evaluated, and 10 varieties have been undertaken Details of over evaluation 2 kinds of over evaluation, 1 the first 13 full members and 2 varieties passed the evaluation of consistency tablets this week, the third one of Yuanda pharmaceutical's Sodium Bicarbonate Tablets passed the evaluation, and the first one of Chengdu Beite pharmaceutical's cefixime capsule passed the evaluation This week, we focused on cefixime capsule of Beite medicine Cefixime is the third generation of cephalosporin broad-spectrum antibiotics, and belongs to class B of national medical insurance It is suitable for the treatment of respiratory, urinary and biliary tract infections caused by sensitive bacteria According to the monitoring data of Zhongkang CMH, in 2016, cefixime accounted for more than 12% of the market of systemic anti infective chemicals, with a large market volume It is reported that in 2018, the market capacity of cefixime oral products has exceeded 4 billion According to the pharmaceutical intelligence data, the cefixime dosage forms listed in China include capsules, suspensions, tablets, etc., among which there are 38 approvals for the domestic market of capsules, involving 24 manufacturing enterprises, and 14 enterprises have filed the consistency evaluation reference book Three enterprises of Chengdu Beite, Qilu, and Ouyi of petrochemicals have been accepted Chengdu Beite pharmaceutical industry is the first one to pass the evaluation and win the policy red Profit will expand market share It is worth mentioning that cefixime capsule is the fourth drug in Chengdu Beite pharmaceutical industry to pass the consistency evaluation At present, there are 13 acceptance numbers and 8 varieties of drugs for conformity assessment applied by Beite pharmaceutical industry, most of which are cephalosporins In addition to cefixime capsule, fluconazole capsule is also the first evaluated variety of Beite pharmaceutical industry In addition, according to the progress database of drug intelligence consistency evaluation, the be test of finasteride tablets and cefixime dispersible tablets has been completed among the varieties that have applied for consistency evaluation, and the date of evaluation is coming New trend of review and approval of drug consistency evaluation details of Beite pharmaceutical industry: the sixth evaluated enterprise of rosuvastatin calcium tablet will be born this week, with another 2 varieties approved It is indapamide tablet of Tianjin Pacific pharmaceutical and rosuvastatin calcium tablet of Shanghai Novartis This week's details of the completion of the consistency rating approval according to the pharmaceutical intelligence data, at present, two indapamide tablets have passed the consistency evaluation, and they are Guangdong Anor Pharmaceutical Co., Ltd and Chongqing Yaoyou If Tianjin Pacific Pharmaceutical Co., Ltd has passed the evaluation successfully, it will form a three pronged trend At present, there are five enterprises that have reviewed rosuvastatin calcium tablets, and whether Shanghai Novartis Pharmaceutical Co., Ltd can become the sixth one remains to be seen! Details of consistency evaluation of indapamide tablets This week, the acceptance of application for conformity assessment was steadily moving forward, with 14 new acceptance numbers (10 varieties) added to CDE, of which 3 varieties were the first ones, namely biapenem for injection of Zhengda Tianqing, ammonitiol tablets of Shandong new era ketochromate, nedaplatin for injection of Jiangsu aosaikang Pharmaceutical Co., Ltd.; in addition, cephalosporin of Yangzijiang Pharmaceutical Co., Ltd and Nanjing Yihua Pharmaceutical Co., Ltd The first application of the accepted varieties was made weekly Note: the red part is for the first time to declare the acceptance details of the conformity assessment It is noteworthy that more than half of the 10 conformity assessment varieties declared this week are injections According to the statistics of drug registration and acceptance database, there are 251 acceptance numbers of injection consistency evaluation, involving 88 varieties of 64 enterprises However, according to the supplementary application, only one variety of azithromycin for injection of Hainan Puli pharmaceutical has been evaluated From the perspective of application enterprises, Qilu Pharmaceutical Co., Ltd has 23 acceptance numbers for injection consistency evaluation and 13 varieties, ranking first among injection application enterprises In addition, Qilu (Hainan) and qilutian and Huishi pharmaceutical have 13 acceptance No 8 varieties and 3 acceptance No 1 varieties, respectively As a result, Qilu pharmaceutical has 24 injection applications accepted and is in the front end of injection consistency evaluation Secondly, Yichang humanwell Pharmaceutical Co., Ltd and Zhengda Tianqing Pharmaceutical Co., Ltd have 16 acceptance numbers and 15 acceptance numbers respectively In addition, Kelun Pharmaceutical Co., Ltd., including Sichuan Kelun, Hunan Kelun and Hubei Kelun, has 17 injection applications accepted Top 10 enterprises applying for injection consistency evaluation note: No enterprise ownership in the above statistics In addition, from the perspective of the declared varieties, gemcitabine hydrochloride for injection and parecoxib sodium for injection have become the hot varieties declared by enterprises, with 11 acceptance numbers and 5 enterprises applying for them, followed by ropivacaine hydrochloride injection, ceftriaxone sodium for injection and ropivacaine hydrochloride injection with 10 acceptance numbers and 3 enterprises applying for them In addition, it is worth noting that among the top 10 injections, dextromethoridine hydrochloride injection, docetaxel injection and pemetrexed disodium for injection have entered the catalogue of Chinese listed drugs by overtaking, which are deemed to have passed the consistency evaluation, namely, Yangzi pharmaceutical and Sichuan Huiyu pharmaceutical Top 10 information sources of application consistency evaluation injection varieties: enterprise announcement, yaozhi.com and online public information data sources: Yaozhi data [good medicine record] column tracks the latest trend of consistency evaluation in a week for you! Please pay attention to the online (yaozhu service (1569612300)), query the consistency evaluation progress, click "read the original" to enter the consistency evaluation progress database.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.