01 1Alembic Pharmaceuticals Limited
01 1O-DESMETHYL VENLAFAXINE SUCCINATE MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-29
Pay. Date : 2015-07-22
DMF Number : 22691
Submission : 2009-03-27
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 O-DESMETHYL VENLAFAXINE SUCCINATE MONOHYDRATE USP, with a corresponding US DMF Number 22691.
Remarkably, this DMF maintains an Active status since its submission on March 27, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 29, 2015, and payment made on July 22, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
