Changshan pharmaceutical heavy weight chemical "daparin sodium injection" review process returned to normal

According to the website of the State Food and Drug Administration (CFDA) on March 31, the review status of the blockbuster drug "heparin sodium" bulk drug and injection in Changshan pharmaceutical industry, which had experienced a backward review, has now changed to "under approval" and disappeared from the publicity of CFDA's supplementary information Changshan pharmaceutical industry confirmed that the product review process has returned to normal According to the new drug review process, there are only regular signing processes such as certificate preparation and approval documents in the follow-up The product is expected to be approved in the second quarter, achieving the first domestic imitation On January 21 this year, the heparin sodium product declared by Changshan pharmaceutical industry passed the on-site inspection and was about to be approved Due to some reasons, the review process regressed from "in review" to "in review" 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 At present, there is no domestic enterprise producing heparin sodium injection 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 Zhang Wei, Secretary of the board of directors of the company, once said that daparin sodium injection is the first imitation of the company With the help of the hospital departments that have been opened up at present, daparin sodium injection is expected to be accepted by the market in advance after being listed.