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Mylan Laboratories Ltd, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS I), with a corresponding US DMF Number 27954.
Remarkably, this DMF maintains an Active status since its submission on March 13, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 01, 2014, and payment made on February 12, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II