01 1Macleods Pharmaceuticals Limited
01 1EZETIMIBE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-31
Pay. Date : 2016-12-27
DMF Number : 30981
Submission : 2016-11-22
Status : Active
Type : II
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Macleods Pharmaceuticals 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 EZETIMIBE, with a corresponding US DMF Number 30981.
Remarkably, this DMF maintains an Active status since its submission on November 22, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 31, 2017, and payment made on December 27, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
