01 1Lupin Ltd
01 1AMLODIPINE BESILATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-27
Pay. Date : 2014-01-21
DMF Number : 18839
Submission : 2005-10-05
Status : Active
Type : II
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Lupin 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 BESILATE USP, with a corresponding US DMF Number 18839.
Remarkably, this DMF maintains an Active status since its submission on October 05, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 27, 2014, and payment made on January 21, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
