01 1Alembic Pharmaceuticals Limited
01 1SOLIFENACIN SUCCINATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-03-15
DMF Number : 25887
Submission : 2012-04-02
Status : Active
Type : II
20
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 SOLIFENACIN SUCCINATE, with a corresponding US DMF Number 25887.
Remarkably, this DMF maintains an Active status since its submission on April 02, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 04, 2013, and payment made on March 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
