01 1API Pharma
01 1LEVOCARNITINE USP
01 1Croatia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-03
Pay. Date : 2023-02-20
DMF Number : 37166
Submission : 2022-10-20
Status : Active
Type : II
20
Api Pharma Tech Llc, based in Croatia, is a pharmaceutical company.
One of their notable products is LEVOCARNITINE USP, with a corresponding US DMF Number 37166.
Remarkably, this DMF maintains an Active status since its submission on October 20, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 03, 2023, and payment made on February 20, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
