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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 BENDAMUSTINE HYDROCHLORIDE USP, with a corresponding US DMF Number 25807.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 19, 2013, and payment made on September 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II