01 1Biocon
01 1EMPAGLIFLOZIN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-10
Pay. Date : 2021-11-26
DMF Number : 36477
Submission : 2021-11-30
Status : Active
Type : II
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Biocon Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is EMPAGLIFLOZIN, with a corresponding US DMF Number 36477.
Remarkably, this DMF maintains an Active status since its submission on November 30, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 10, 2022, and payment made on November 26, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
