01 1Hetero Drugs
01 1BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-31
Pay. Date : 2013-01-04
DMF Number : 25800
Submission : 2012-02-21
Status : Active
Type : II
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Hetero Labs 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 BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE USP, with a corresponding US DMF Number 25800.
Remarkably, this DMF maintains an Active status since its submission on February 21, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2013, and payment made on January 04, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
