01 1Srini Pharmaceuticals
01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-27
Pay. Date : 2021-06-16
DMF Number : 32909
Submission : 2018-06-30
Status : Active
Type : II
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Srini Pharmaceuticals Private 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 USP, with a corresponding US DMF Number 32909.
Remarkably, this DMF maintains an Active status since its submission on June 30, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 27, 2021, and payment made on June 16, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
