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Dipharma Francis Srl, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ISOSORBIDE-5-MONONITRATE (5-ISMN), with a corresponding US DMF Number 6778.
Remarkably, this DMF maintains an Active status since its submission on January 09, 1987, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 15, 2013, and payment made on December 24, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II