01 1Biocon
01 1DABIGATRAN ETEXILATE MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-19
Pay. Date : 2018-09-19
DMF Number : 33112
Submission : 2018-09-28
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 DABIGATRAN ETEXILATE MESYLATE, with a corresponding US DMF Number 33112.
Remarkably, this DMF maintains an Active status since its submission on September 28, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 19, 2018, and payment made on September 19, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
