01 1Quimica Sintetica
01 1APREMILAST
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-02
Pay. Date : 2017-11-06
DMF Number : 32119
Submission : 2017-10-10
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 APREMILAST, with a corresponding US DMF Number 32119.
Remarkably, this DMF maintains an Active status since its submission on October 10, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 02, 2018, and payment made on November 06, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
