01 1Raks Pharma
01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-17
Pay. Date : 2013-09-11
DMF Number : 27472
Submission : 2013-09-17
Status : Active
Type : II
20
Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP, with a corresponding US DMF Number 27472.
Remarkably, this DMF maintains an Active status since its submission on September 17, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 17, 2013, and payment made on September 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
