01 1Aurore Life Sciences
01 1AMLODIPINE BESYLATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-22
Pay. Date : 2020-08-25
DMF Number : 34318
Submission : 2019-11-22
Status : Active
Type : II
20
Aurore Life Sciences Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for An integrated company with complete control of key starting materials, advanced intermediates & high-quality APIs.
One of their notable products is AMLODIPINE BESYLATE USP, with a corresponding US DMF Number 34318.
Remarkably, this DMF maintains an Active status since its submission on November 22, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 22, 2020, and payment made on August 25, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
