01 1Quimica Sintetica
01 1CAPTOPRIL
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-01
Pay. Date : 2017-11-06
DMF Number : 8460
Submission : 1990-03-05
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 CAPTOPRIL, with a corresponding US DMF Number 8460.
Remarkably, this DMF maintains an Active status since its submission on March 05, 1990, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 01, 2017, and payment made on November 06, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
