01 1Fresenius Kabi AB Brunna
01 1CALCITONIN SALMON
01 1Sweden
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-08
Pay. Date : 2023-11-07
DMF Number : 37738
Submission : 2023-12-20
Status : Active
Type : II
20
Fresenius Kabi Ipsum Srl, based in Sweden, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is CALCITONIN SALMON, with a corresponding US DMF Number 37738.
Remarkably, this DMF maintains an Active status since its submission on December 20, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 08, 2024, and payment made on November 07, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
