01 1Alembic Pharmaceuticals Limited
01 1DABIGATRAN ETEXILATE MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-28
Pay. Date : 2014-03-18
DMF Number : 27781
Submission : 2013-12-31
Status : Active
Type : II
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Alembic Pharmaceuticals 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 DABIGATRAN ETEXILATE MESYLATE, with a corresponding US DMF Number 27781.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 28, 2014, and payment made on March 18, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
