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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 DILTIAZEM HYDROCHLORIDE, with a corresponding US DMF Number 7600.
Remarkably, this DMF maintains an Active status since its submission on July 18, 1988, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2013, and payment made on December 12, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II