01 1Lek Pharmaceuticals
01 1ROSUVASTATIN CALCIUM (PROCESS C)
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-06
Pay. Date : 2016-11-25
DMF Number : 30932
Submission : 2016-12-01
Status : Active
Type : II
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Lek Pharmaceuticals Dd, based in Slovenia, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ROSUVASTATIN CALCIUM (PROCESS C), with a corresponding US DMF Number 30932.
Remarkably, this DMF maintains an Active status since its submission on December 01, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 06, 2017, and payment made on November 25, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
