01 1Lupin Ltd
01 1BREXPIPRAZOLE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-02
Pay. Date : 2019-02-07
DMF Number : 33421
Submission : 2019-02-07
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 BREXPIPRAZOLE, with a corresponding US DMF Number 33421.
Remarkably, this DMF maintains an Active status since its submission on February 07, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 02, 2019, and payment made on February 07, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
