Clinical approval for ceftetan disodium injection and API
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Last Update: 2020-04-03
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Source: Internet
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Author: User
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Lizhu Pharmaceutical (01513 HK) announced that its wholly-owned subsidiary, Lizhu pharmaceutical, has independently developed a new chemical medicine category 3.1, cefotetan disodium injection and API, which have been approved and issued by the State Food and Drug Administration (CFDA) and the notice of approval opinions It is suitable for infection of abdominal, skin and soft tissue, urinary tract, lower respiratory tract, gynecology and obstetrics caused by susceptible bacteria Up to now, the company has invested about 2.9 million yuan in R & D of cefotetan disodium for injection and raw materials (the same below) Related products of cefotetan disodium did not enter the domestic market After obtaining the official clinical approval documents of cefotetan disodium for injection and raw materials, the company needs to carry out clinical research It is preliminarily estimated that it will take 2 to 3 years to complete the clinical research After that, the company must submit the application for production After being approved, it can be listed only after passing the GMP verification of raw materials.
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