01 1Unichem Laboratories Limited
01 1AMLODIPINE BESYLATE (ADP PROCESS) USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-23
Pay. Date : 2024-10-15
DMF Number : 40438
Submission : 2024-08-29
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 BESYLATE (ADP PROCESS) USP, with a corresponding US DMF Number 40438.
Remarkably, this DMF maintains an Active status since its submission on August 29, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 23, 2024, and payment made on October 15, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
