01 1Lupin Ltd
01 1NORGESTREL USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-04
Pay. Date : 2024-10-30
DMF Number : 23612
Submission : 2011-03-30
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 NORGESTREL USP, with a corresponding US DMF Number 23612.
Remarkably, this DMF maintains an Active status since its submission on March 30, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 04, 2024, and payment made on October 30, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
