01 1Lupin Ltd
01 1SIMVASTATIN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2017-02-28
DMF Number : 17934
Submission : 2004-12-27
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 SIMVASTATIN USP, with a corresponding US DMF Number 17934.
Remarkably, this DMF maintains an Active status since its submission on December 27, 2004, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2017, and payment made on February 28, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
