Announcement of (second batch) (2018 No. 20)
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Announcement of the General Administration on the conformity evaluation of the quality and efficacy of generic drugs of 5 varieties including rosuvastatin calcium tablets (second batch) (2018 No. 20)
After review, five varieties of rosuvastatin calcium tablets (see annex for catalog) meet the requirements for the consistency evaluation of the quality and efficacy of generic drugs, and are now released. The information of the above-mentioned varieties' specifications, enterprise research reports and bioequivalence test data can be found on the website of the State Food and Drug Administration's Drug Evaluation Center (www.cde.org.cn).
Special announcement.
Annex: Catalogue of varieties approved for the consistency and evaluation of quality and efficacy of generic drugs in February 2018 (second batch)
Food and Drug Administration
February 13, 2018