01 1Apicore
01 1BELZUTIFAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-01
Pay. Date : 2025-05-27
DMF Number : 41515
Submission : 2025-05-06
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 BELZUTIFAN, with a corresponding US DMF Number 41515.
Remarkably, this DMF maintains an Active status since its submission on May 06, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 01, 2025, and payment made on May 27, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
