01 1Raks Pharma
01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (ROUTE CODE - "ES")
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-09
Pay. Date : 2015-06-17
DMF Number : 29403
Submission : 2015-07-17
Status : Active
Type : II
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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 (ROUTE CODE - "ES"), with a corresponding US DMF Number 29403.
Remarkably, this DMF maintains an Active status since its submission on July 17, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 09, 2015, and payment made on June 17, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
