Changshan pharmaceutical is expected to obtain the production approval this month

According to the website of the State Food and Drug Administration (CFDA) on May 6, the declaration and production status of the first heavy generic drug of Changshan Pharmaceutical Co., Ltd for heparin sodium API and injection has been changed to "approved - to be prepared certificate" If there is no accident, the company is expected to obtain the product production approval document this month, ending the eight-year review run Changshan Pharmaceutical Co., Ltd is mainly engaged in heparin series products There are only two kinds of heparin preparations: low molecular weight heparin calcium injection and heparin sodium injection When the heparin sodium injection is listed on the market, it will reduce the risk of the company's excessive dependence on the two products Relevant persons of the company have said that daparin sodium injection is the first imitated product of the company With the help of the hospital departments that have been opened up at present, the product is expected to be accepted by the market in advance after being launched It is estimated that the production approval document will be obtained in the second quarter and the profit will be contributed in the fourth quarter Daparin sodium injection is mainly used for the treatment of acute deep vein thrombosis, unstable coronary heart disease, etc the original research drug is faming of Pfizer, which was listed in China in 2012 According to Pfizer's annual report, the sales of faming from 2008 to 2010 were 316 million, 359 million and 341 million US dollars respectively.