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On February 25, Chengdu Yuandong Biotech announced that the company's supplementary application for consistency evaluation of caffeine citrate injection was approved by the State Food and Drug Administration, passed the consistency evaluation, and agreed to change the prescription and production process.
Caffeine citrate injection was approved for marketing in France in December 1997, and was approved as an orphan drug in the United States in September 1998, and was approved by the FDA for marketing in September 1999.
In addition to the original research manufacturers, there are currently 4 generic drug companies in China that have production approvals for caffeine citrate injections.
Application status of consistency evaluation of caffeine citrate injection
Source: Mi Nei Net Consistency Evaluation Database
According to data from Minai.
From 2021 to the present, Chengdu Yuandong Biological Over-rated Varieties
Source: Meinenet MED2.
Since 2021, Chengdu Yuandong Biology has passed the consistency evaluation of 3 varieties, all of which are injections, and all have been evaluated in the form of supplementary applications.
Source: Mi Nei.
Note: The statistics are as of February 25.
