01 1Intas Pharmaceuticals
01 1BENDAMUSTINE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-05
Pay. Date : 2023-08-11
DMF Number : 38685
Submission : 2023-08-31
Status : Active
Type : II
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Intas 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 BENDAMUSTINE HYDROCHLORIDE, with a corresponding US DMF Number 38685.
Remarkably, this DMF maintains an Active status since its submission on August 31, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 05, 2023, and payment made on August 11, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
