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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 DOFETILIDE USP, POLYMORPH P162B, with a corresponding US DMF Number 29722.
Remarkably, this DMF maintains an Active status since its submission on October 07, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 23, 2015, and payment made on September 18, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II