01 1Alembic Pharmaceuticals Limited
01 1FELODIPINE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-03
Pay. Date : 2013-09-27
DMF Number : 25373
Submission : 2011-10-11
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 FELODIPINE USP, with a corresponding US DMF Number 25373.
Remarkably, this DMF maintains an Active status since its submission on October 11, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 03, 2014, and payment made on September 27, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
