01 1Hetero Drugs
01 1DABIGATRAN ETEXILATE MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-13
Pay. Date : 2014-08-25
DMF Number : 28177
Submission : 2014-08-05
Status : Active
Type : II
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Hetero Drugs 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 28177.
Remarkably, this DMF maintains an Active status since its submission on August 05, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 13, 2014, and payment made on August 25, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
