01 1Fresenius Kabi AB Brunna
01 1AZTREONAM NON STERILE ALPHA
01 1Sweden
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-05-23
Pay. Date : 2025-04-18
DMF Number : 40841
Submission : 2025-04-24
Status : Active
Type : II
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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 AZTREONAM NON STERILE ALPHA, with a corresponding US DMF Number 40841.
Remarkably, this DMF maintains an Active status since its submission on April 24, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 23, 2025, and payment made on April 18, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
