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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 DOCETAXEL TRIHYDRATE USP (PROCESS II), with a corresponding US DMF Number 27771.
Remarkably, this DMF maintains an Active status since its submission on January 10, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 05, 2014, and payment made on December 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II