01 1Lek Pharmaceuticals
01 1TACROLIMUS (PROCESS II)
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-24
Pay. Date : 2020-12-03
DMF Number : 34063
Submission : 2020-08-06
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 TACROLIMUS (PROCESS II), with a corresponding US DMF Number 34063.
Remarkably, this DMF maintains an Active status since its submission on August 06, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 24, 2021, and payment made on December 03, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
