01 1Lek Pharmaceuticals
01 1TICAGRELOR
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-05
Pay. Date : 2015-01-21
DMF Number : 28915
Submission : 2015-02-06
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 TICAGRELOR, with a corresponding US DMF Number 28915.
Remarkably, this DMF maintains an Active status since its submission on February 06, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 05, 2015, and payment made on January 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
