01 1UQUIFA
01 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-24
Pay. Date : 2017-07-31
DMF Number : 30036
Submission : 2016-04-15
Status : Active
Type : II
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Union Quimico Farmaceutica Sa (uquifa Sa), based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ESOMEPRAZOLE MAGNESIUM DIHYDRATE, with a corresponding US DMF Number 30036.
Remarkably, this DMF maintains an Active status since its submission on April 15, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 24, 2018, and payment made on July 31, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
