01 1Aurobindo Pharma Limited
01 1CENOBAMATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-09-15
DMF Number : 38814
Submission : 2023-09-26
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 CENOBAMATE, with a corresponding US DMF Number 38814.
Remarkably, this DMF maintains an Active status since its submission on September 26, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 13, 2023, and payment made on September 15, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
