01 1Alembic Pharmaceuticals Limited
01 1TELMISARTAN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-21
DMF Number : 20285
Submission : 2007-02-07
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 TELMISARTAN USP, with a corresponding US DMF Number 20285.
Remarkably, this DMF maintains an Active status since its submission on February 07, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2013, and payment made on December 21, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
