01 1Alembic Pharmaceuticals Limited
01 1FESOTERODINE FUMARATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-06
Pay. Date : 2012-11-02
DMF Number : 26241
Submission : 2012-09-04
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 FESOTERODINE FUMARATE, with a corresponding US DMF Number 26241.
Remarkably, this DMF maintains an Active status since its submission on September 04, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 06, 2013, and payment made on November 02, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
