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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 ELUXADOLINE, with a corresponding US DMF Number 33372.
Remarkably, this DMF maintains an Active status since its submission on January 02, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 01, 2019, and payment made on December 21, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II