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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 FLUCYTOSINE, USP, with a corresponding US DMF Number 28247.
Remarkably, this DMF maintains an Active status since its submission on June 16, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 28, 2014, and payment made on June 15, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II