01 1Apicore
01 1SAFINAMIDE MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-05
Pay. Date : 2020-09-26
DMF Number : 34399
Submission : 2020-02-13
Status : Active
Type : II
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Apicore Pharmaceuticals Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is SAFINAMIDE MESYLATE, with a corresponding US DMF Number 34399.
Remarkably, this DMF maintains an Active status since its submission on February 13, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 05, 2020, and payment made on September 26, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
