01 1Apicore
01 1MTB008
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-04
Pay. Date : 2021-09-27
DMF Number : 36079
Submission : 2021-07-31
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 MTB008, with a corresponding US DMF Number 36079.
Remarkably, this DMF maintains an Active status since its submission on July 31, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 04, 2021, and payment made on September 27, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
