01 1Lupin Ltd
01 1FENOFIBRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2016-11-14
DMF Number : 21551
Submission : 2008-04-18
Status : Active
Type : II
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Lupin 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 FENOFIBRATE USP, with a corresponding US DMF Number 21551.
Remarkably, this DMF maintains an Active status since its submission on April 18, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 01, 2017, and payment made on November 14, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
