01 1Aurore Life Sciences
01 1VERAPAMIL HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-22
Pay. Date : 2023-05-30
DMF Number : 34043
Submission : 2019-07-31
Status : Active
Type : II
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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 VERAPAMIL HYDROCHLORIDE USP, with a corresponding US DMF Number 34043.
Remarkably, this DMF maintains an Active status since its submission on July 31, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 22, 2023, and payment made on May 30, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
