Nanjing jianyouda heparin sodium injection and low molecular weight heparin calcium injection were inspected on site this month

According to the website of the State Food and Drug Administration (CFDA) on June 17, the daparin sodium injection and low molecular weight heparin calcium injection declared by Nanjing Jianyou for production were inspected on site this month and are expected to obtain the product production approval document this year With the related products of many domestic enterprises approved in this year, the competition in the field of low molecular weight heparin preparation will be increasingly fierce Low molecular weight heparin is mainly used to prevent postoperative thromboembolism, pulmonary embolism, anticoagulation during cardiopulmonary bypass during hemodialysis, etc common low molecular weight heparin includes: heparin sodium, enoxaparin sodium, natroxobin calcium (low molecular weight heparin calcium), etc After sorting out, there will be a number of products in the field of low molecular weight heparin concentrated and approved for production this year At present, there are three domestic enterprises producing enoxaparin sodium preparations This year, enoxaparin sodium injection of Qianhong pharmaceutical, enoxaparin sodium injection of Chengdu Baiyu, enoxaparin sodium for injection and enoxaparin sodium for injection of Suzhou Erye are expected to join this camp Among them, Qianhong pharmaceutical and Chengdu Baiyu's related varieties have been notified to wait for on-site inspection at the end of March and last year respectively, and are now waiting for on-site inspection; Suzhou Erye's products have finished on-site inspection and entered the three in one review this month At present, there are five domestic enterprises producing low molecular weight heparin calcium preparations, and this year, Nanjing Jianyou and Dongcheng Pharmaceutical (002675 SZ) are expected to be added Among them, Nanjing Jianyou's low molecular weight heparin calcium injection has been inspected on the production site this month; Dongcheng pharmaceutical's low molecular weight heparin calcium for injection has not made clear progress at present, but the company's management has repeatedly said that it is expected to obtain production approval in the second half of the year In contrast, there are few domestic enterprises producing heparin sodium preparation, only Changshan Pharmaceutical Co., Ltd obtained the first imitation production approval of heparin sodium injection in the middle of last month, and the product is expected to go on the market in the fourth quarter However, Changshan pharmaceutical's monopoly of the product market may be broken soon This month, Nanjing Jianyou's daparin sodium injection was inspected on the production site and is expected to be approved for production within this year As the price of heparin sodium API remains low and the gross profit of LMWH preparation is relatively high, Qianhong pharmaceutical, Nanjing Jianyou and other industry companies are extending to LMWH preparation with higher added value in succession, so as to reduce the impact of price fluctuation of API on the company's performance.