One imported drug - vitamin C injection, withdraw from China
Medical Network May 11th The State Food and Drug Administration issued an announcement that an importer of an auxiliary drug should apply to cancel the drug approval.
Yesterday, the State Food and Drug Administration issued the "National drug Supervision Authority on cancellation of vitamin C injection and other 3 Drug Registration Announcement of approval of the document (No. 17 of 2018).
The largest infusion drug company in Fujian Province gave up vitamin C injection
According to the announcement, according to Jilin Cornell Pharmaceutical Co., Ltd., Italy Laboratorio Farmaceutico C.T.S.R.L. enterprise For the application, the State Drug Administration decided to write off the registration approval documents for three drugs, including vitamin C injection and reduced glutathione sodium for injection.
According to inquiries, there are altogether 655 domestic pharmaceutical approvals for vitamin C injection. There are numerous manufacturers, including Baiyun Mountain, Shiyao, Sunflower Pharmaceutical, Lingwei, Shenwei and other famous pharmaceutical companies.
And Jilin Cornell Pharmaceuticals holds 136 production approval number products, covering large volume injections, small volume injections, tablets, capsules, oral liquids, etc.
According to its official website, it has an annual output of 250 million bottles/bags for large volume injections. It is the largest infusion production and sales enterprise in Jilin Province.
Analysis of the industry, this time to give up the intense market competition for small volume injection of vitamin C injection should belong to the normal market adjustment.
▍Auxiliary drugs were used to write off approvals, leaving only one pharmaceutical company in China
According to Cybra Blue's inquiry, the use of reduced glutathione sodium for injections for approval was previously punished by the State Food and Drug Administration.
On August 30, 2016, the State Food and Drug Administration issued an announcement.
Bulletin revealed that the injectable reduced glutathione sodium (trade name: Guladine, import drug registration number: H20130775, H20130776, packaging approval number: Guo Yaozhun character J20140016) of Italy Laboratorio Farmaceutico CTSRL Company was not suspected Approved to change the actual production plant outside the country from Pharminvest SPA to Laboratorio Italiano Biochimico Farmaceutico Lisapharm SPA.
The State Food and Drug Administration decided to suspend the import and sales of reduced glutathione sodium for injection by Laboratorio Farmaceutico C.T.S.R.L., Italy, and suspended the review and approval of applications for registration of imported varieties.
And demanded that Yunnan Province Food and Drug Administration promptly urge the Kunming JiDa Pharmaceutical Co., Ltd., a sub-package manufacturer of reduced glutathione sodium, to suspend imports, sub-package, sell the above-mentioned drugs, and investigate the import and sub-package production of the drug. , And supervise the enterprises to do a good job of recalling sales of products already sold.
According to the inquiry, the reduced glutathione sodium for injection belongs to Cancer Assisted medication, also used in part hospital Focus on monitoring drug catalog.
There were 7 approvals for the reduction of glutathione sodium for injection, 3 imports, and 4 domestic production. The approval for the import of pharmaceuticals was cancelled at the same time. The four domestic approvals belonged to Kunming Jida Pharmaceutical Co., Ltd.
According to industry sources, the cancellation of import approvals may have a positive impact on Kunming Jida Pharmaceutical.
