01 1Apicore
01 1FERUMOXYTOL
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-12-23
Pay. Date : 2025-11-21
DMF Number : 39032
Submission : 2023-10-24
Status : Active
Type : II
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Apicore Llc, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is FERUMOXYTOL, with a corresponding US DMF Number 39032.
Remarkably, this DMF maintains an Active status since its submission on October 24, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 23, 2025, and payment made on November 21, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
