01 1Unichem Laboratories Limited
01 1AMLODIPINE BESILATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-14
Pay. Date : 2013-09-06
DMF Number : 16509
Submission : 2003-04-01
Status : Active
Type : II
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Unichem Laboratories 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 16509.
Remarkably, this DMF maintains an Active status since its submission on April 01, 2003, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2013, and payment made on September 06, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
