01 1Lupin Ltd
01 1ESTRADIOL HEMIHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-05
Pay. Date : 2013-02-26
DMF Number : 25816
Submission : 2012-04-02
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 ESTRADIOL HEMIHYDRATE USP, with a corresponding US DMF Number 25816.
Remarkably, this DMF maintains an Active status since its submission on April 02, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 05, 2014, and payment made on February 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
