01 1Lupin Ltd
01 1EZETIMIBE USP (PROCESS-B)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2014-04-23
DMF Number : 28173
Submission : 2014-04-14
Status : Active
Type : II
20
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 EZETIMIBE USP (PROCESS-B), with a corresponding US DMF Number 28173.
Remarkably, this DMF maintains an Active status since its submission on April 14, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 20, 2014, and payment made on April 23, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
