01 1Aurobindo Pharma Limited
01 1SAFINAMIDE MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-14
Pay. Date : 2020-09-09
DMF Number : 35179
Submission : 2020-09-10
Status : Active
Type : II
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Apitoria Pharma Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is SAFINAMIDE MESYLATE, with a corresponding US DMF Number 35179.
Remarkably, this DMF maintains an Active status since its submission on September 10, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 14, 2020, and payment made on September 09, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
