01 1Aurobindo Pharma Limited
01 1AMLODIPINE BESYLATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-17
DMF Number : 18965
Submission : 2005-11-09
Status : Active
Type : II
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Apitoria Pharma Private 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 18965.
Remarkably, this DMF maintains an Active status since its submission on November 09, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2013, and payment made on December 17, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
