01 1F.I.S. Fabbrica Italiana Sintetici
01 1IMATINIB MESYLATE (ALPHA FORM)
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-24
Pay. Date : 2015-12-21
DMF Number : 25206
Submission : 2011-07-27
Status : Active
Type : II
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Fis Fabbrica Italiana Sintetici Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is IMATINIB MESYLATE (ALPHA FORM), with a corresponding US DMF Number 25206.
Remarkably, this DMF maintains an Active status since its submission on July 27, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 24, 2017, and payment made on December 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
