01 1Quimica Sintetica
01 1RIVAROXABAN
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-12
Pay. Date : 2024-02-07
DMF Number : 39227
Submission : 2024-01-29
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 RIVAROXABAN, with a corresponding US DMF Number 39227.
Remarkably, this DMF maintains an Active status since its submission on January 29, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 12, 2024, and payment made on February 07, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
