01 1Quimica Sintetica
01 1APREMILAST (PROCESS II)
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-04
Pay. Date : 2020-07-14
DMF Number : 34915
Submission : 2020-06-17
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 (PROCESS II), with a corresponding US DMF Number 34915.
Remarkably, this DMF maintains an Active status since its submission on June 17, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2020, and payment made on July 14, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
