01 1Lupin Ltd
01 1DULOXETINE HYDROCHLORIDE USP (PROCESS B)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-10-09
DMF Number : 28961
Submission : 2015-03-27
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 DULOXETINE HYDROCHLORIDE USP (PROCESS B), with a corresponding US DMF Number 28961.
Remarkably, this DMF maintains an Active status since its submission on March 27, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2015, and payment made on October 09, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
