01 1Amoli Organics
01 1SERTRALINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-20
Pay. Date : 2022-05-06
DMF Number : 36258
Submission : 2021-10-15
Status : Active
Type : II
20
Amoli Organics 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 SERTRALINE HYDROCHLORIDE USP, with a corresponding US DMF Number 36258.
Remarkably, this DMF maintains an Active status since its submission on October 15, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 20, 2022, and payment made on May 06, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
