01 1Lupin Ltd
01 1BICTEGRAVIR SODIUM (MICRONIZED)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-26
Pay. Date : 2021-04-28
DMF Number : 35795
Submission : 2021-04-09
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 BICTEGRAVIR SODIUM (MICRONIZED), with a corresponding US DMF Number 35795.
Remarkably, this DMF maintains an Active status since its submission on April 09, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 26, 2021, and payment made on April 28, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
