01 1Quimica Sintetica
01 1ITRACONAZOLE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-31
Pay. Date : 2013-10-07
DMF Number : 13012
Submission : 1998-05-28
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 ITRACONAZOLE, with a corresponding US DMF Number 13012.
Remarkably, this DMF maintains an Active status since its submission on May 28, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 31, 2013, and payment made on October 07, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
