01 1Aurobindo Pharma Limited
01 1ESLICARBAZEPINE ACETATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-22
Pay. Date : 2020-08-13
DMF Number : 35094
Submission : 2020-08-14
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 ESLICARBAZEPINE ACETATE, with a corresponding US DMF Number 35094.
Remarkably, this DMF maintains an Active status since its submission on August 14, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 22, 2020, and payment made on August 13, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
