01 1Jubilant Generics
01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-01
Pay. Date : 2016-06-16
DMF Number : 28053
Submission : 2014-03-29
Status : Active
Type : II
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Jubilant Biosys 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 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP, with a corresponding US DMF Number 28053.
Remarkably, this DMF maintains an Active status since its submission on March 29, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 01, 2016, and payment made on June 16, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
