01 1KOLON Life Science, Inc
01 1ROSUVASTATIN CALCIUM
01 1South Korea
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-27
Pay. Date : 2016-12-15
DMF Number : 30556
Submission : 2016-12-06
Status : Active
Type : II
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Kolon Life Science Inc, based in South Korea, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is ROSUVASTATIN CALCIUM, with a corresponding US DMF Number 30556.
Remarkably, this DMF maintains an Active status since its submission on December 06, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 27, 2017, and payment made on December 15, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
