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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 RABEPRAZOLE SODIUM USP, with a corresponding US DMF Number 27403.
Remarkably, this DMF maintains an Active status since its submission on September 01, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 24, 2015, and payment made on March 20, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II