01 1Alembic Pharmaceuticals Limited
01 1FENOFIBRIC ACID CHOLINE SALT USP (CHOLINE FENOFIBRATE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2014-03-24
DMF Number : 23047
Submission : 2009-08-10
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 FENOFIBRIC ACID CHOLINE SALT USP (CHOLINE FENOFIBRATE), with a corresponding US DMF Number 23047.
Remarkably, this DMF maintains an Active status since its submission on August 10, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2014, and payment made on March 24, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
