01 1Lek Pharmaceuticals
01 1SUGAMMADEX SODIUM
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-15
Pay. Date : 2019-05-22
DMF Number : 33817
Submission : 2019-06-05
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 SUGAMMADEX SODIUM, with a corresponding US DMF Number 33817.
Remarkably, this DMF maintains an Active status since its submission on June 05, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 15, 2019, and payment made on May 22, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
