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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 CLOTRIMAZOLE, with a corresponding US DMF Number 7548.
Remarkably, this DMF maintains an Active status since its submission on June 21, 1988, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 07, 2015, and payment made on December 18, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II