01 1Ajanta Pharma Limited
01 1DULOXETINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-18
Pay. Date : 2022-09-29
DMF Number : 37458
Submission : 2022-09-30
Status : Active
Type : II
20
Ajanta Pharma 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 DULOXETINE HYDROCHLORIDE USP, with a corresponding US DMF Number 37458.
Remarkably, this DMF maintains an Active status since its submission on September 30, 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 29, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
