01 1Everest Organics
01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-04
Pay. Date : 2021-05-21
DMF Number : 33443
Submission : 2018-12-20
Status : Active
Type : II
20
Everest Organics Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, with a corresponding US DMF Number 33443.
Remarkably, this DMF maintains an Active status since its submission on December 20, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 04, 2021, and payment made on May 21, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
