01 1KOLON Life Science, Inc
01 1PITAVASTATIN CALCIUM
01 1South Korea
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-16
Pay. Date : 2018-01-25
DMF Number : 32169
Submission : 2018-01-17
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 PITAVASTATIN CALCIUM, with a corresponding US DMF Number 32169.
Remarkably, this DMF maintains an Active status since its submission on January 17, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 16, 2018, and payment made on January 25, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
