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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 CHLORDIAZEPOXIDE HCL, with a corresponding US DMF Number 467.
Remarkably, this DMF maintains an Active status since its submission on February 15, 1962, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 16, 2017, and payment made on October 26, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II