01 1Zydus Lifesciences
01 1AMLODIPINE BESYLATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-18
Pay. Date : 2014-04-04
DMF Number : 22930
Submission : 2009-07-08
Status : Active
Type : II
20
Zydus Lifesciences 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 AMLODIPINE BESYLATE USP, with a corresponding US DMF Number 22930.
Remarkably, this DMF maintains an Active status since its submission on July 08, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 18, 2014, and payment made on April 04, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
