01 1Vasudha Pharma Chem
01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-04
Pay. Date : 2019-01-28
DMF Number : 31975
Submission : 2017-09-08
Status : Active
Type : II
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Vasudha Pharma Chem Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP, with a corresponding US DMF Number 31975.
Remarkably, this DMF maintains an Active status since its submission on September 08, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 04, 2019, and payment made on January 28, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
