01 1F.I.S. Fabbrica Italiana Sintetici
01 1INDOMETHACIN SODIUM
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-31
Pay. Date : 2015-09-30
DMF Number : 29441
Submission : 2015-09-30
Status : Active
Type : II
20
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 INDOMETHACIN SODIUM, with a corresponding US DMF Number 29441.
Remarkably, this DMF maintains an Active status since its submission on September 30, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 31, 2016, and payment made on September 30, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
