01 1F.I.S. Fabbrica Italiana Sintetici
01 1NIFEDIPINE USP
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-15
Pay. Date : 2013-02-27
DMF Number : 6339
Submission : 1986-03-14
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 NIFEDIPINE USP, with a corresponding US DMF Number 6339.
Remarkably, this DMF maintains an Active status since its submission on March 14, 1986, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 15, 2013, and payment made on February 27, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
