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Alkem Laboratories 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 ESOMEPRAZOLE MAGNESIUM DIHYDRATE, with a corresponding US DMF Number 28581.
Remarkably, this DMF maintains an Active status since its submission on October 01, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 26, 2014, and payment made on October 14, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II