01 1Hetero Drugs
01 1AMLODIPINE BESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-12-17
DMF Number : 18787
Submission : 2005-09-19
Status : Active
Type : II
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Hetero Drugs 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, with a corresponding US DMF Number 18787.
Remarkably, this DMF maintains an Active status since its submission on September 19, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 27, 2012, and payment made on December 17, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
