01 1Fresenius Kabi AB Brunna
01 1OCTREOTIDE ACETATE
01 1Sweden
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-26
Pay. Date : 2020-11-24
DMF Number : 34118
Submission : 2020-12-21
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 OCTREOTIDE ACETATE, with a corresponding US DMF Number 34118.
Remarkably, this DMF maintains an Active status since its submission on December 21, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 26, 2021, and payment made on November 24, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
