01 1Quimica Sintetica
01 1OMEPRAZOLE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-18
Pay. Date : 2014-04-15
DMF Number : 12605
Submission : 1997-07-23
Status : Active
Type : II
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Quimica Sintetica Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is OMEPRAZOLE, with a corresponding US DMF Number 12605.
Remarkably, this DMF maintains an Active status since its submission on July 23, 1997, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 18, 2014, and payment made on April 15, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
