Ino heparin sodium injections and injections with Parexib sodium were reviewed on a supplementary basis

On October 22, 2020, the data monitored the consistency evaluation of 11 varieties, including inoheparin sodium injection and injection of Parexib sodium two injections, respectively, from Tiando Pharmaceuticals and Qilu Pharmaceuticals in Shenzhen.
, in addition to the injection of azithromycin in Hainan Puli, for the first time to supplement the application for a consistent evaluation of the injection varieties.
Ino heparin sodium injection Shenzhen Tiando Medicine's innoparin sodium injection is the first imitation product in China, this time through the consistent evaluation, and became the first domestic evaluation.
Sanofi, the original manufacturer of serotonin sodium injections, can be used to prevent venous thromboembolism disease (prevention of intravenous thrombosis).
Ino heparin sodium injection belongs to the low molecular heparin, the current domestic market market sales of low molecular heparin including low molecular weight heparin calcium injection, inoparin sodium injection, heparin calcium injection, heparin sodium injection and so on.
According to statistics, a total of 9 domestic enterprises produce and sell Ino heparin injections, including: Sanofi (original research manufacturers), Shenzhen Tiando Pharmaceuticals, Chengdu Baiyu Pharmaceuticals, Hebei Changshan Biopharmaceuticals, Nanjing Jianyou Biopharmaceuticals, Dongying Tiandong Pharmaceuticals, Beijing Shuangyu Pharmaceuticals, Hangzhou Jiuyuan Gene, Changzhou Chihong Bio-Chemical.
,2019, Nanjing Jianyou Bio-Biogenic Ino Heparin Sodium Injection was approved by the FDA on November 29, 2019, with a total of 7 specifications.
sodium ininoparin injection from Tiando Pharmaceuticals in Shenzhen, China, was approved for sale by the European Union as early as September 15, 2016.
Figure 1: Tiando Pharmaceuticals approved by the EMA for the approval of the Ino Heparin Sodium Injection Xenophon Drug Registry Time Axis shows that Tiando Pharmaceuticals submitted a supplementary application on May 4, 2018, the application specifications include 0.2ml:20 mg, 0.4ml: 40mg, 0.6ml: 60mg, 0.8ml: 80mg, 1ml: 100mg a total of 5 specifications, all 5 specifications were approved.
figure 2: Tiando Pharmaceutical Ino heparin sodium injection consistent evaluation time axis in addition, in addition to Shenzhen Tiando Medicine, Nanjing Jianyou Biobics, Changzhou Chihong Biobics and Beijing Shuangyi Pharmaceuticals Ino heparin sodium injection consistency evaluation supplementary application is being reviewed and approved, and have received CDE supplement notice.
the declaration of generic drugs, Tianjin Red Day Pharmaceuticals and Shandong New Era in accordance with the four types of drugs declared production, is also in the stage of supplementation.
Injection with Parexib sodium injection With Parexib sodium introposis for short-term treatment of post-surgery pain, is the first selectable COX-2 inhibitor developed by the American company Famascia, by specific inhibition of COX-2 blocking peanut tetraoleic acid synthetic prostatin anti-inflammatory analgesic effect, and can reduce the amount of anesthetic analgesics.
listed in Europe in 2002 under the name Dynastat.
2008 by the State Drug Administration approved imports, commodity name: Special.
Injection with Parexib sodium has good analgesic effect, rapid effect, long-lasting effect, can effectively suppress pain hypersensitiveness, high gastrointestinal safety, does not affect plate plate plate function, does not increase cardiovascular risk and so on; There is no interaction between propofol, heparin, suffentanil, etc., both intravenously and intramuscular injection, which can effectively meet the clinical needs of postoperative analgesic needs and patients can not eat, and since its listing, it has been widely recommended by authoritative guidelines at home and abroad for the treatment of postoperative pain in various departments such as general surgery, gynecology, orthopaedics, orthopaedics, etc.
According to the data, in addition to Qilu Pharmaceutical Co. , Ltd. injection of Parehieb sodium through the consistent evaluation, Chengdu Baiyu Pharmaceuticals, Zhejiang Hangkang Pharmaceuticals and Hongguan Biopharmaceuticals 3 enterprises according to the 4 categories of declared applications for the listing of injection Parehieb sodium has been approved, and as if through the consistent evaluation. in terms of
consistency evaluation, 10 enterprises, such as Hunan Colum, Zhengda Tianqing Pharmaceuticals, Nanjing Zhengtianqing, Shanghai Hengrui, Jiangsu Osaikang, Yuandong Bio, Yangzijiang Pharmaceuticals, Haizheng Pharmaceuticals, Sanhe Pharmaceuticals, Luoxin Pharmaceuticals, have submitted supplementary applications for consistent evaluation, which are currently under review and approval;
Pharmaceutical Co., Ltd.'s injection of Parexib sodium was commissioned by the Drug Review Center on August 14, 2018 and entered the supplementary information task (first round) on July 28, 2018, which took a total of 798 days to pass the consistency evaluation.
Figure 3: The review time axis for the evaluation of sodium peroxide consistency in Qilu pharmaceutical injections, according to data, as of October 22, 45 injection varieties had passed/assimised through consistency evaluation.
Table 1 adopts/treats the number of enterprises receiving the name of the injectable drug through consistent evaluation through the enterprise number ibuprofen injection 84 Yuandong Bio, Jilin Four Drugs, Minsheng Pharmaceutical Industry, Yuandong Bioinstation with Parexib sodium 54 Chengdu Baiyu, Zhejiang Hangkang, Hongguan Bio, Qilu Pharmaceutical Inoheparin sodium injection 51 days of medicine left ethyl lahitan injection with a thick solution 44 Kikawa Pharmaceuticals, Renhe Yikang, San Huayi, Hainan Puli injection with yew alcohol (albumin binding type) 44 stone drug Ohi, Hengrui Pharmaceuticals, Qilu Pharmaceuticals, Hunan Colum hydrochloric acid right metomide injection 32 Yangzijiang Pharmaceuticals, National Pharmaceutical Group Oshali platinum injection 31 Qilu Hainan hydrochlorite injection 31 Yichang people Fuzo oxyfluorosa star sodium chloride injection 32 Hengdo Pharmaceuticals, Qidu Pharmaceutical Salt Ammonia bromoso injection 22 U.S. Dakang Huakang, Chinese medicine iodized par alcohol injection 22 Shanghai Steyri, Zhengda Tianqing dosso tea alkali injection 22 Shijiazhuang four drugs, Yangzijiang Pharmaceuticals hydrochloric acid Moxisha star sodium chloride injection 22 Hainan Aike, Tianjin Red Day injection with Biva Luding 22 Qilu Pharmaceuticals, Hainan Puli injections with Aza cytosine 22 Huiyu Pharmaceuticals, Zhengda Tianqing amino acids (16)/glucose (48%) electrolyte injections 21 Colum Pharmaceuticals injections with methyl sulfonate mosta 21 Dury Pharmaceutical injections with hydrochloric acid Idabi Star 2 1 Zhengda Tianqing iodized sea alcohol injection 21 Shanghai Stalytone glycine triamol injection 21 times special pharmaceutical injection with Peme qusser 21 Huiyu pharmaceutical injection with hydrochloric acid cephalosporine/ sodium chloride injection 21 Suzhou Otsidossi injection 21 Huiyu pharmaceutical propofol / Long-chain fat emulsion 11 PCCW bio-estiracetam injection 110,000 high pharmaceutical injection with Fusapitan double glutamate 11 Haussen pharmaceutical door dongaline birdine injection 11 stone drug Silver Lake injection with hydrochloric acid benzoestin 11 Zhengtian QingIdalafeng Sodium chloride injection 11 Zhengda Fenghai acid caffeine injection 11 double helimin to pyridolic acid injection 11 Koren Pharmaceuticals fluorobilofenster injection 11 Wuhan Da'an Quprofen Neil injection 11 M. Pharmaceutical injection cephalosporine sodium / chlorination Sodium injection 11Otsuka injection with sylveth sodium 11 Shanghai Huilun Jiangsu hydrochloric acid rodekain sodium chloride injection 11 Huaxin pharmaceutical injection with tymoamine 11 Hengrui pharmaceutical hydrochloric acid lorikain injection 11 Shijiazhuang tetrapharline ketamine injection 11 Hengrui Pharmaceutical injection with boron zomi 11 stone drug Oyeflueth group injection 11 Zhengtian Qing sulfonic acid injection 11 sub-bao pharmaceutical iodized kesha alcohol injection 11 Shanghai Stailigron ammonium bromide injection 11 Hengrui medicine injection with Achimycin 11 Hainan Puli