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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 BUSULFAN USP, with a corresponding US DMF Number 25433.
Remarkably, this DMF maintains an Active status since its submission on December 29, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 29, 2014, and payment made on January 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II