01 1Alembic Pharmaceuticals Limited
01 1VALSARTAN USP (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-19
Pay. Date : 2014-12-16
DMF Number : 23584
Submission : 2010-02-24
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 VALSARTAN USP (PROCESS II), with a corresponding US DMF Number 23584.
Remarkably, this DMF maintains an Active status since its submission on February 24, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 19, 2014, and payment made on December 16, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
