01 1Apicore
01 1TRABECTEDIN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-13
Pay. Date : 2021-06-07
DMF Number : 35828
Submission : 2021-04-19
Status : Active
Type : II
20
Apicore Llc, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is TRABECTEDIN, with a corresponding US DMF Number 35828.
Remarkably, this DMF maintains an Active status since its submission on April 19, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 13, 2021, and payment made on June 07, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
