01 1Lek Pharmaceuticals
01 1FERRIC CARBOXYMALTOSE
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-06-19
Pay. Date : 2018-05-02
DMF Number : 32437
Submission : 2018-03-29
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 FERRIC CARBOXYMALTOSE, with a corresponding US DMF Number 32437.
Remarkably, this DMF maintains an Active status since its submission on March 29, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 19, 2018, and payment made on May 02, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
