01 1Aurobindo Pharma Limited
01 1TRAMETINIB ACETIC ACID
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-18
Pay. Date : 2022-09-12
DMF Number : 37504
Submission : 2022-09-13
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 TRAMETINIB ACETIC ACID, with a corresponding US DMF Number 37504.
Remarkably, this DMF maintains an Active status since its submission on September 13, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 18, 2022, and payment made on September 12, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
