01 1Arene Lifesciences
01 1AMLODIPINE BESYLATE USP (PROCESS-I)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-18
Pay. Date : 2021-10-29
DMF Number : 35997
Submission : 2021-06-24
Status : Active
Type : II
20
Arene Life Sciences Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is AMLODIPINE BESYLATE USP (PROCESS-I), with a corresponding US DMF Number 35997.
Remarkably, this DMF maintains an Active status since its submission on June 24, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2022, and payment made on October 29, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
