01 1Fresenius SE & Co. KGaA
01 1LIRAGLUTIDE
01 1Germany
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-17
Pay. Date : 2022-04-08
DMF Number : 35242
Submission : 2022-01-31
Status : Active
Type : II
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Fresenius Kabi Ipsum Srl, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is LIRAGLUTIDE, with a corresponding US DMF Number 35242.
Remarkably, this DMF maintains an Active status since its submission on January 31, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 17, 2022, and payment made on April 08, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
