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Emcure Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is FLECAINIDE ACETATE USP, with a corresponding US DMF Number 27859.
Remarkably, this DMF maintains an Active status since its submission on January 28, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 04, 2014, and payment made on February 05, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II